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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Evaluation of Immune-Related Response Criteria and RECIST v1.1 in Patients With Advanced Melanoma Treated With Pembrolizumab</title><author><name sortKey="Hodi, F Stephen" sort="Hodi, F Stephen" uniqKey="Hodi F" first="F. Stephen" last="Hodi">F. Stephen Hodi</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Hwu, Wen Jen" sort="Hwu, Wen Jen" uniqKey="Hwu W" first="Wen-Jen" last="Hwu">Wen-Jen Hwu</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Kefford, Richard" sort="Kefford, Richard" uniqKey="Kefford R" first="Richard" last="Kefford">Richard Kefford</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Weber, Jeffrey S" sort="Weber, Jeffrey S" uniqKey="Weber J" first="Jeffrey S." last="Weber">Jeffrey S. Weber</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Daud, Adil" sort="Daud, Adil" uniqKey="Daud A" first="Adil" last="Daud">Adil Daud</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Patnaik, Amita" sort="Patnaik, Amita" uniqKey="Patnaik A" first="Amita" last="Patnaik">Amita Patnaik</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Gangadhar, Tara C" sort="Gangadhar, Tara C" uniqKey="Gangadhar T" first="Tara C." last="Gangadhar">Tara C. Gangadhar</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Joshua, Anthony M" sort="Joshua, Anthony M" uniqKey="Joshua A" first="Anthony M." last="Joshua">Anthony M. Joshua</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Hersey, Peter" sort="Hersey, Peter" uniqKey="Hersey P" first="Peter" last="Hersey">Peter Hersey</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Dronca, Roxana" sort="Dronca, Roxana" uniqKey="Dronca R" first="Roxana" last="Dronca">Roxana Dronca</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Joseph, Richard" sort="Joseph, Richard" uniqKey="Joseph R" first="Richard" last="Joseph">Richard Joseph</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Hille, Darcy" sort="Hille, Darcy" uniqKey="Hille D" first="Darcy" last="Hille">Darcy Hille</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Xue, Dahai" sort="Xue, Dahai" uniqKey="Xue D" first="Dahai" last="Xue">Dahai Xue</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Li, Xiaoyun Nicole" sort="Li, Xiaoyun Nicole" uniqKey="Li X" first="Xiaoyun Nicole" last="Li">Xiaoyun Nicole Li</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Kang, S Peter" sort="Kang, S Peter" uniqKey="Kang S" first="S. Peter" last="Kang">S. Peter Kang</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Ebbinghaus, Scot" sort="Ebbinghaus, Scot" uniqKey="Ebbinghaus S" first="Scot" last="Ebbinghaus">Scot Ebbinghaus</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Perrone, Andrea" sort="Perrone, Andrea" uniqKey="Perrone A" first="Andrea" last="Perrone">Andrea Perrone</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Wolchok, Jedd D" sort="Wolchok, Jedd D" uniqKey="Wolchok J" first="Jedd D." last="Wolchok">Jedd D. Wolchok</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26951310</idno><idno type="pmc">5070547</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070547</idno><idno type="RBID">PMC:5070547</idno><idno type="doi">10.1200/JCO.2015.64.0391</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">001963</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001963</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Evaluation of Immune-Related Response Criteria and RECIST v1.1 in Patients With Advanced Melanoma Treated With Pembrolizumab</title><author><name sortKey="Hodi, F Stephen" sort="Hodi, F Stephen" uniqKey="Hodi F" first="F. Stephen" last="Hodi">F. Stephen Hodi</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Hwu, Wen Jen" sort="Hwu, Wen Jen" uniqKey="Hwu W" first="Wen-Jen" last="Hwu">Wen-Jen Hwu</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Kefford, Richard" sort="Kefford, Richard" uniqKey="Kefford R" first="Richard" last="Kefford">Richard Kefford</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Weber, Jeffrey S" sort="Weber, Jeffrey S" uniqKey="Weber J" first="Jeffrey S." last="Weber">Jeffrey S. Weber</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Daud, Adil" sort="Daud, Adil" uniqKey="Daud A" first="Adil" last="Daud">Adil Daud</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Patnaik, Amita" sort="Patnaik, Amita" uniqKey="Patnaik A" first="Amita" last="Patnaik">Amita Patnaik</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Gangadhar, Tara C" sort="Gangadhar, Tara C" uniqKey="Gangadhar T" first="Tara C." last="Gangadhar">Tara C. Gangadhar</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Joshua, Anthony M" sort="Joshua, Anthony M" uniqKey="Joshua A" first="Anthony M." last="Joshua">Anthony M. Joshua</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Hersey, Peter" sort="Hersey, Peter" uniqKey="Hersey P" first="Peter" last="Hersey">Peter Hersey</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Dronca, Roxana" sort="Dronca, Roxana" uniqKey="Dronca R" first="Roxana" last="Dronca">Roxana Dronca</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Joseph, Richard" sort="Joseph, Richard" uniqKey="Joseph R" first="Richard" last="Joseph">Richard Joseph</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Hille, Darcy" sort="Hille, Darcy" uniqKey="Hille D" first="Darcy" last="Hille">Darcy Hille</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Xue, Dahai" sort="Xue, Dahai" uniqKey="Xue D" first="Dahai" last="Xue">Dahai Xue</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Li, Xiaoyun Nicole" sort="Li, Xiaoyun Nicole" uniqKey="Li X" first="Xiaoyun Nicole" last="Li">Xiaoyun Nicole Li</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Kang, S Peter" sort="Kang, S Peter" uniqKey="Kang S" first="S. Peter" last="Kang">S. Peter Kang</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Ebbinghaus, Scot" sort="Ebbinghaus, Scot" uniqKey="Ebbinghaus S" first="Scot" last="Ebbinghaus">Scot Ebbinghaus</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Perrone, Andrea" sort="Perrone, Andrea" uniqKey="Perrone A" first="Andrea" last="Perrone">Andrea Perrone</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author><author><name sortKey="Wolchok, Jedd D" sort="Wolchok, Jedd D" uniqKey="Wolchok J" first="Jedd D." last="Wolchok">Jedd D. Wolchok</name><affiliation><nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff></affiliation></author></analytic><series><title level="j">Journal of Clinical Oncology</title><idno type="ISSN">0732-183X</idno><idno type="eISSN">1527-7755</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Purpose</title><p>We evaluated atypical response patterns and the relationship between overall survival and best overall response measured per immune-related response criteria (irRC) and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) in patients with advanced melanoma treated with pembrolizumab in the phase Ib KEYNOTE-001 study (clinical trial information: NCT01295827).</p></sec><sec><title>Patients and Methods</title><p>Patients received pembrolizumab 2 or 10 mg/kg every 2 weeks or every 3 weeks. Atypical responses were identified by using centrally assessed irRC data in patients with ≥ 28 weeks of imaging. Pseudoprogression was defined as ≥ 25% increase in tumor burden at week 12 (early) or any assessment after week 12 (delayed) that was not confirmed as progressive disease at next assessment. Response was assessed centrally per irRC and RECIST v1.1.</p></sec><sec><title>Results</title><p>Of the 655 patients with melanoma enrolled, 327 had ≥ 28 weeks of imaging follow-up. Twenty-four (7%) of these 327 patients had atypical responses (15 [5%] with early pseudoprogression and nine [3%] with delayed pseudoprogression). Of the 592 patients who survived ≥ 12 weeks, 84 (14%) experienced progressive disease per RECIST v1.1 but nonprogressive disease per irRC. Two-year overall survival rates were 77.6% in patients with nonprogressive disease per both criteria (n = 331), 37.5% in patients with progressive disease per RECIST v1.1 but nonprogressive disease per irRC (n = 84), and 17.3% in patients with progressive disease per both criteria (n = 177).</p></sec><sec><title>Conclusion</title><p>Atypical responses were observed in patients with melanoma treated with pembrolizumab. Based on survival analysis, conventional RECIST might underestimate the benefit of pembrolizumab in approximately 15% of patients; modified criteria that permit treatment beyond initial progression per RECIST v1.1 might prevent premature cessation of treatment.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">J Clin Oncol</journal-id><journal-id journal-id-type="iso-abbrev">J. Clin. Oncol</journal-id><journal-id journal-id-type="hwp">jco</journal-id><journal-id journal-id-type="pmc">jco</journal-id><journal-id journal-id-type="publisher-id">JCO</journal-id><journal-title-group><journal-title>Journal of Clinical Oncology</journal-title></journal-title-group><issn pub-type="ppub">0732-183X</issn><issn pub-type="epub">1527-7755</issn><publisher><publisher-name>American Society of Clinical Oncology</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26951310</article-id><article-id pub-id-type="pmc">5070547</article-id><article-id pub-id-type="publisher-id">640391</article-id><article-id pub-id-type="doi">10.1200/JCO.2015.64.0391</article-id><article-categories><subj-group subj-group-type="hwp-journal-coll"><subject>Mela5</subject><subject>Timg3</subject></subj-group><subj-group subj-group-type="heading"><subject>Original Reports</subject><subj-group><subject>Immunotherapy</subject></subj-group></subj-group></article-categories><title-group><article-title>Evaluation of Immune-Related Response Criteria and RECIST v1.1 in Patients With Advanced Melanoma Treated With Pembrolizumab</article-title><alt-title alt-title-type="short">Patterns of Response With Pembrolizumab in Advanced Melanoma</alt-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Hodi</surname><given-names>F. Stephen</given-names></name><xref ref-type="aff" rid="aff1"></xref><xref ref-type="corresp" rid="cor1"></xref></contrib><contrib contrib-type="author"><name><surname>Hwu</surname><given-names>Wen-Jen</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Kefford</surname><given-names>Richard</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Weber</surname><given-names>Jeffrey S.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Daud</surname><given-names>Adil</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Hamid</surname><given-names>Omid</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Patnaik</surname><given-names>Amita</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Ribas</surname><given-names>Antoni</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Robert</surname><given-names>Caroline</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Gangadhar</surname><given-names>Tara C.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Joshua</surname><given-names>Anthony M.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Hersey</surname><given-names>Peter</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Dronca</surname><given-names>Roxana</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Joseph</surname><given-names>Richard</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Hille</surname><given-names>Darcy</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Xue</surname><given-names>Dahai</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Li</surname><given-names>Xiaoyun Nicole</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Kang</surname><given-names>S. Peter</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Ebbinghaus</surname><given-names>Scot</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Perrone</surname><given-names>Andrea</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Wolchok</surname><given-names>Jedd D.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</aff></contrib-group><author-notes><corresp id="cor1">Corresponding author: F. Stephen Hodi, MD, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02215; e-mail: <email>stephen_hodi@dfci.harvard.edu</email>.</corresp><fn id="fn2" fn-type="presented-at"><p>Presented at the 50th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 30-June 3, 2014; Society for Immunotherapy of Cancer 2014 Annual Meeting & Associated Programs, National Harbor, MD, November 6-9, 2014; and 51st Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 29-June 2, 2015.</p></fn></author-notes><pub-date pub-type="ppub"><day>1</day><month>5</month><year>2016</year></pub-date><pub-date pub-type="epub"><day>7</day><month>3</month><year>2016</year></pub-date><pub-date pub-type="pmc-release"><day>1</day><month>12</month><year>2016</year></pub-date><pmc-comment> PMC Release delay is 7 months and
0 days and was based on the
<volume>34</volume><issue>13</issue><fpage>1510</fpage><lpage>1517</lpage><permissions><copyright-statement>© 2016 by American Society of Clinical Oncology</copyright-statement><copyright-year>2016</copyright-year><copyright-holder>American Society of Clinical Oncology</copyright-holder></permissions><self-uri xlink:title="pdf" xlink:type="simple" xlink:href="JCO640391.pdf"></self-uri><abstract><sec><title>Purpose</title><p>We evaluated atypical response patterns and the relationship between overall survival and best overall response measured per immune-related response criteria (irRC) and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) in patients with advanced melanoma treated with pembrolizumab in the phase Ib KEYNOTE-001 study (clinical trial information: NCT01295827).</p></sec><sec><title>Patients and Methods</title><p>Patients received pembrolizumab 2 or 10 mg/kg every 2 weeks or every 3 weeks. Atypical responses were identified by using centrally assessed irRC data in patients with ≥ 28 weeks of imaging. Pseudoprogression was defined as ≥ 25% increase in tumor burden at week 12 (early) or any assessment after week 12 (delayed) that was not confirmed as progressive disease at next assessment. Response was assessed centrally per irRC and RECIST v1.1.</p></sec><sec><title>Results</title><p>Of the 655 patients with melanoma enrolled, 327 had ≥ 28 weeks of imaging follow-up. Twenty-four (7%) of these 327 patients had atypical responses (15 [5%] with early pseudoprogression and nine [3%] with delayed pseudoprogression). Of the 592 patients who survived ≥ 12 weeks, 84 (14%) experienced progressive disease per RECIST v1.1 but nonprogressive disease per irRC. Two-year overall survival rates were 77.6% in patients with nonprogressive disease per both criteria (n = 331), 37.5% in patients with progressive disease per RECIST v1.1 but nonprogressive disease per irRC (n = 84), and 17.3% in patients with progressive disease per both criteria (n = 177).</p></sec><sec><title>Conclusion</title><p>Atypical responses were observed in patients with melanoma treated with pembrolizumab. Based on survival analysis, conventional RECIST might underestimate the benefit of pembrolizumab in approximately 15% of patients; modified criteria that permit treatment beyond initial progression per RECIST v1.1 might prevent premature cessation of treatment.</p></sec></abstract><counts><fig-count count="5"></fig-count><table-count count="4"></table-count><equation-count count="0"></equation-count><ref-count count="22"></ref-count><page-count count="8"></page-count></counts><custom-meta-group><custom-meta><meta-name> DJS Export </meta-name><meta-value>v1</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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