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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Patient Reported Outcomes in a Practice Changing Randomized Trial of Bevacizumab in the Treatment of Advanced Cervical Cancer: An NRG Oncology/Gynecologic Oncology Group Study</title><author><name sortKey="Penson, Richard T" sort="Penson, Richard T" uniqKey="Penson R" first="Richard T." last="Penson">Richard T. Penson</name><affiliation><nlm:aff id="A1">Massachusetts General Hospital, Boston MA</nlm:aff></affiliation></author><author><name sortKey="Huang, Helen Q" sort="Huang, Helen Q" uniqKey="Huang H" first="Helen Q." last="Huang">Helen Q. Huang</name><affiliation><nlm:aff id="A2">NRG Oncology/Gynecologic Oncology Group; Roswell Park Cancer Institute, Buffalo, Buffalo, NY</nlm:aff></affiliation></author><author><name sortKey="Wenzel, Lari B" sort="Wenzel, Lari B" uniqKey="Wenzel L" first="Lari B." last="Wenzel">Lari B. Wenzel</name><affiliation><nlm:aff id="A3">University of California, Irvine Medical Center, Orange, CA</nlm:aff></affiliation></author><author><name sortKey="Monk, Bradley J" sort="Monk, Bradley J" uniqKey="Monk B" first="Bradley J." last="Monk">Bradley J. Monk</name><affiliation><nlm:aff id="A4">University of Arizona Cancer Center and Creighton University at St. Joseph's Hospital and Medical Center, Phoenix, AZ</nlm:aff></affiliation></author><author><name sortKey="Stockman, Sharon" sort="Stockman, Sharon" uniqKey="Stockman S" first="Sharon" last="Stockman">Sharon Stockman</name><affiliation><nlm:aff id="A5">University of Iowa Hospitals, Iowa City, IA</nlm:aff></affiliation></author><author><name sortKey="Long, Harry J" sort="Long, Harry J" uniqKey="Long H" first="Harry J." last="Long">Harry J. Long</name><affiliation><nlm:aff id="A6">Mayo Clinic, Rochester, MN</nlm:aff></affiliation></author><author><name sortKey="Ramondetta, Lois M" sort="Ramondetta, Lois M" uniqKey="Ramondetta L" first="Lois M." last="Ramondetta">Lois M. Ramondetta</name><affiliation><nlm:aff id="A7">MD Anderson Cancer Center, Houston, TX</nlm:aff></affiliation></author><author><name sortKey="Landrum, Lisa M" sort="Landrum, Lisa M" uniqKey="Landrum L" first="Lisa M." last="Landrum">Lisa M. Landrum</name><affiliation><nlm:aff id="A8">Oklahoma University Health Science Center, Oklahoma, OK</nlm:aff></affiliation></author><author><name sortKey="Oaknin, Ana" sort="Oaknin, Ana" uniqKey="Oaknin A" first="Ana" last="Oaknin">Ana Oaknin</name><affiliation><nlm:aff id="A9">Vall d´Hebron University Hospital, Vall d´Hebron Institute of Oncology, Barcelona, Spain</nlm:aff></affiliation></author><author><name sortKey="Reid, Thomas J A" sort="Reid, Thomas J A" uniqKey="Reid T" first="Thomas J. A." last="Reid">Thomas J. A. Reid</name><affiliation><nlm:aff id="A10">University of Cincinnati College of Medicine/Women’s Cancer Center at Kettering, Kettering, OH</nlm:aff></affiliation></author><author><name sortKey="Leitao, Mario M" sort="Leitao, Mario M" uniqKey="Leitao M" first="Mario M." last="Leitao">Mario M. Leitao</name><affiliation><nlm:aff id="A11">Memorial Sloan-Kettering Cancer Center, New York, NY</nlm:aff></affiliation></author><author><name sortKey="Method, Michael" sort="Method, Michael" uniqKey="Method M" first="Michael" last="Method">Michael Method</name><affiliation><nlm:aff id="A12">Michiana Hematology Oncology PC-Mishawaka; Mishawaka, IN</nlm:aff></affiliation></author><author><name sortKey="Michael, Helen" sort="Michael, Helen" uniqKey="Michael H" first="Helen" last="Michael">Helen Michael</name><affiliation><nlm:aff id="A13">Indiana University School of Medicine, Indianapolis, IN</nlm:aff></affiliation></author><author><name sortKey="Tewari, Krishnansu S" sort="Tewari, Krishnansu S" uniqKey="Tewari K" first="Krishnansu S." last="Tewari">Krishnansu S. Tewari</name><affiliation><nlm:aff id="A3">University of California, Irvine Medical Center, Orange, CA</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25638326</idno><idno type="pmc">4479218</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4479218</idno><idno type="RBID">PMC:4479218</idno><idno type="doi">10.1016/S1470-2045(15)70004-5</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">003447</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">003447</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Patient Reported Outcomes in a Practice Changing Randomized Trial of Bevacizumab in the Treatment of Advanced Cervical Cancer: An NRG Oncology/Gynecologic Oncology Group Study</title><author><name sortKey="Penson, Richard T" sort="Penson, Richard T" uniqKey="Penson R" first="Richard T." last="Penson">Richard T. Penson</name><affiliation><nlm:aff id="A1">Massachusetts General Hospital, Boston MA</nlm:aff></affiliation></author><author><name sortKey="Huang, Helen Q" sort="Huang, Helen Q" uniqKey="Huang H" first="Helen Q." last="Huang">Helen Q. Huang</name><affiliation><nlm:aff id="A2">NRG Oncology/Gynecologic Oncology Group; Roswell Park Cancer Institute, Buffalo, Buffalo, NY</nlm:aff></affiliation></author><author><name sortKey="Wenzel, Lari B" sort="Wenzel, Lari B" uniqKey="Wenzel L" first="Lari B." last="Wenzel">Lari B. Wenzel</name><affiliation><nlm:aff id="A3">University of California, Irvine Medical Center, Orange, CA</nlm:aff></affiliation></author><author><name sortKey="Monk, Bradley J" sort="Monk, Bradley J" uniqKey="Monk B" first="Bradley J." last="Monk">Bradley J. Monk</name><affiliation><nlm:aff id="A4">University of Arizona Cancer Center and Creighton University at St. Joseph's Hospital and Medical Center, Phoenix, AZ</nlm:aff></affiliation></author><author><name sortKey="Stockman, Sharon" sort="Stockman, Sharon" uniqKey="Stockman S" first="Sharon" last="Stockman">Sharon Stockman</name><affiliation><nlm:aff id="A5">University of Iowa Hospitals, Iowa City, IA</nlm:aff></affiliation></author><author><name sortKey="Long, Harry J" sort="Long, Harry J" uniqKey="Long H" first="Harry J." last="Long">Harry J. Long</name><affiliation><nlm:aff id="A6">Mayo Clinic, Rochester, MN</nlm:aff></affiliation></author><author><name sortKey="Ramondetta, Lois M" sort="Ramondetta, Lois M" uniqKey="Ramondetta L" first="Lois M." last="Ramondetta">Lois M. Ramondetta</name><affiliation><nlm:aff id="A7">MD Anderson Cancer Center, Houston, TX</nlm:aff></affiliation></author><author><name sortKey="Landrum, Lisa M" sort="Landrum, Lisa M" uniqKey="Landrum L" first="Lisa M." last="Landrum">Lisa M. Landrum</name><affiliation><nlm:aff id="A8">Oklahoma University Health Science Center, Oklahoma, OK</nlm:aff></affiliation></author><author><name sortKey="Oaknin, Ana" sort="Oaknin, Ana" uniqKey="Oaknin A" first="Ana" last="Oaknin">Ana Oaknin</name><affiliation><nlm:aff id="A9">Vall d´Hebron University Hospital, Vall d´Hebron Institute of Oncology, Barcelona, Spain</nlm:aff></affiliation></author><author><name sortKey="Reid, Thomas J A" sort="Reid, Thomas J A" uniqKey="Reid T" first="Thomas J. A." last="Reid">Thomas J. A. Reid</name><affiliation><nlm:aff id="A10">University of Cincinnati College of Medicine/Women’s Cancer Center at Kettering, Kettering, OH</nlm:aff></affiliation></author><author><name sortKey="Leitao, Mario M" sort="Leitao, Mario M" uniqKey="Leitao M" first="Mario M." last="Leitao">Mario M. Leitao</name><affiliation><nlm:aff id="A11">Memorial Sloan-Kettering Cancer Center, New York, NY</nlm:aff></affiliation></author><author><name sortKey="Method, Michael" sort="Method, Michael" uniqKey="Method M" first="Michael" last="Method">Michael Method</name><affiliation><nlm:aff id="A12">Michiana Hematology Oncology PC-Mishawaka; Mishawaka, IN</nlm:aff></affiliation></author><author><name sortKey="Michael, Helen" sort="Michael, Helen" uniqKey="Michael H" first="Helen" last="Michael">Helen Michael</name><affiliation><nlm:aff id="A13">Indiana University School of Medicine, Indianapolis, IN</nlm:aff></affiliation></author><author><name sortKey="Tewari, Krishnansu S" sort="Tewari, Krishnansu S" uniqKey="Tewari K" first="Krishnansu S." last="Tewari">Krishnansu S. Tewari</name><affiliation><nlm:aff id="A3">University of California, Irvine Medical Center, Orange, CA</nlm:aff></affiliation></author></analytic><series><title level="j">The Lancet. Oncology</title><idno type="ISSN">1470-2045</idno><idno type="eISSN">1474-5488</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title><p id="P2">To analyze patient reported outcomes (PROs) in GOG 240, the practice-changing, randomized phase 3 trial that concluded that chemotherapy (cisplatin-paclitaxel or topotecan-paclitaxel) plus bevacizumab significantly improves overall survival (OS), progression-free survival (PFS), and response rates compared to chemotherapy alone in advanced cervical cancer. Trial registration number: NCT00803062.</p></sec><sec id="S2"><title>Methods</title><p id="P3">Patients were assessed pre-cycle 1, 2, and 5 and at 6 and 9 months post-cycle 1 with the Functional Assessment of Cancer Therapy-Cervix Trial Outcome Index (FACT-Cx TOI), and items from the FACT/GOG-Neurotoxicity (Ntx) subscale, and a worst pain item from the Brief Pain Inventory (BPI). Differences in FACT-Cx TOI scores were assessed using a linear mixed model adjusting for baseline score and age. A mixed effects mixed distributions model was fitted to evaluate treatment differences of likelihood to report neurotoxicity and pain, and severity of these symptoms, once reported. The association between baseline health-related quality of life and survival was analyzed using Cox proportional hazards models.</p></sec><sec id="S3"><title>Findings</title><p id="P4">Among 390 evaluable patients, PRO completion rates declined from 96% (baseline) to 63% (9 months post-cycle 1). Completion rates were not statistically different among treatment regimens (p=0.67). Patients receiving chemotherapy plus bevacizumab reported 1.2 points lower on average (98.75% CI: −4.1, 1.7; p=0.30) in the FACT-Cx TOI scores than those with chemotherapy alone. Patients treated with chemotherapy plus bevacizumab were less likely to report neurotoxicty (overall odds ratio: 0.58; 98.75% CI: 0.17, 0.98; p=0.01). Severity of neurotoxic symptoms did not differ between the two groups (p=0.69). Both groups had similar odds of complaining of pain (odds ratio=0.96; 95% CI: 0.39, 1.52; p=0.78) and reported similar severity of pain (p=0.1). For the entire population, the baseline FACT-Cx TOI score was significantly associated with OS (HR 0.80; 95% CI 0.74, 0.87; p<0.001) and PFS (0.88; 95% CI: 0.83, 0.95; p<0.001).</p></sec><sec id="S4"><title>Interpretation</title><p id="P5">Improvements in OS and PFS attributed to the incorporation of bevacizumab in the treatment of advanced cervical cancer were not accompanied by any significant deterioration in health-related quality of life. Study supported by NIH funding.</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>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">100957246</journal-id><journal-id journal-id-type="pubmed-jr-id">27004</journal-id><journal-id journal-id-type="nlm-ta">Lancet Oncol</journal-id><journal-id journal-id-type="iso-abbrev">Lancet Oncol.</journal-id><journal-title-group><journal-title>The Lancet. Oncology</journal-title></journal-title-group><issn pub-type="ppub">1470-2045</issn><issn pub-type="epub">1474-5488</issn></journal-meta><article-meta><article-id pub-id-type="pmid">25638326</article-id><article-id pub-id-type="pmc">4479218</article-id><article-id pub-id-type="doi">10.1016/S1470-2045(15)70004-5</article-id><article-id pub-id-type="manuscript">NIHMS669479</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Patient Reported Outcomes in a Practice Changing Randomized Trial of Bevacizumab in the Treatment of Advanced Cervical Cancer: An NRG Oncology/Gynecologic Oncology Group Study</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Penson</surname><given-names>Richard T.</given-names></name><degrees>MD MRCP</degrees><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Huang</surname><given-names>Helen Q.</given-names></name><degrees>MS</degrees><xref ref-type="aff" rid="A2">2</xref></contrib><contrib contrib-type="author"><name><surname>Wenzel</surname><given-names>Lari B.</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Monk</surname><given-names>Bradley J.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A4">4</xref></contrib><contrib contrib-type="author"><name><surname>Stockman</surname><given-names>Sharon</given-names></name><degrees>BA</degrees><xref ref-type="aff" rid="A5">5</xref></contrib><contrib contrib-type="author"><name><surname>Long</surname><given-names>Harry J.</given-names><suffix>III</suffix></name><degrees>MD</degrees><xref ref-type="aff" rid="A6">6</xref><xref ref-type="author-notes" rid="FN1">*</xref></contrib><contrib contrib-type="author"><name><surname>Ramondetta</surname><given-names>Lois M.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A7">7</xref></contrib><contrib contrib-type="author"><name><surname>Landrum</surname><given-names>Lisa M.</given-names></name><degrees>MD PhD</degrees><xref ref-type="aff" rid="A8">8</xref></contrib><contrib contrib-type="author"><name><surname>Oaknin</surname><given-names>Ana</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A9">9</xref></contrib><contrib contrib-type="author"><name><surname>Reid</surname><given-names>Thomas J.A.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A10">10</xref></contrib><contrib contrib-type="author"><name><surname>Leitao</surname><given-names>Mario M.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A11">11</xref></contrib><contrib contrib-type="author"><name><surname>Method</surname><given-names>Michael</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A12">12</xref></contrib><contrib contrib-type="author"><name><surname>Michael</surname><given-names>Helen</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A13">13</xref></contrib><contrib contrib-type="author"><name><surname>Tewari</surname><given-names>Krishnansu S.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A3">3</xref></contrib></contrib-group><aff id="A1"><label>1</label>Massachusetts General Hospital, Boston MA</aff><aff id="A2"><label>2</label>NRG Oncology/Gynecologic Oncology Group; Roswell Park Cancer Institute, Buffalo, Buffalo, NY</aff><aff id="A3"><label>3</label>University of California, Irvine Medical Center, Orange, CA</aff><aff id="A4"><label>4</label>University of Arizona Cancer Center and Creighton University at St. Joseph's Hospital and Medical Center, Phoenix, AZ</aff><aff id="A5"><label>5</label>University of Iowa Hospitals, Iowa City, IA</aff><aff id="A6"><label>6</label>Mayo Clinic, Rochester, MN</aff><aff id="A7"><label>7</label>MD Anderson Cancer Center, Houston, TX</aff><aff id="A8"><label>8</label>Oklahoma University Health Science Center, Oklahoma, OK</aff><aff id="A9"><label>9</label>Vall d´Hebron University Hospital, Vall d´Hebron Institute of Oncology, Barcelona, Spain</aff><aff id="A10"><label>10</label>University of Cincinnati College of Medicine/Women’s Cancer Center at Kettering, Kettering, OH</aff><aff id="A11"><label>11</label>Memorial Sloan-Kettering Cancer Center, New York, NY</aff><aff id="A12"><label>12</label>Michiana Hematology Oncology PC-Mishawaka; Mishawaka, IN</aff><aff id="A13"><label>13</label>Indiana University School of Medicine, Indianapolis, IN</aff><author-notes><corresp id="cor1">Corresponding Author: Richard T. Penson, MD, MRCP, Associate Professor, Division of Hematology & Oncology, Department of Medicine, Massachusetts General Hospital, 55 Fruit Street, Yawkey 9-064 9E, Boston, MA 02114-2617, Telephone: 617-726-5867, Fax: 617-724-6898, <email>rpenson@partners.org</email></corresp><fn id="FN1"><label>*</label><p id="P1">Dr. Harry Long III passed away in January 2013</p></fn></author-notes><pub-date pub-type="nihms-submitted"><day>11</day><month>3</month><year>2015</year></pub-date><pub-date pub-type="epub"><day>29</day><month>1</month><year>2015</year></pub-date><pub-date pub-type="ppub"><month>3</month><year>2015</year></pub-date><pub-date pub-type="pmc-release"><day>01</day><month>3</month><year>2016</year></pub-date><volume>16</volume><issue>3</issue><fpage>301</fpage><lpage>311</lpage><pmc-comment>elocation-id from pubmed: 10.1016/S1470-2045(15)70004-5</pmc-comment>
<permissions><copyright-statement>© 2015 Elsevier Ltd. All rights reserved.</copyright-statement><copyright-year>2015</copyright-year></permissions><abstract><sec id="S1"><title>Background</title><p id="P2">To analyze patient reported outcomes (PROs) in GOG 240, the practice-changing, randomized phase 3 trial that concluded that chemotherapy (cisplatin-paclitaxel or topotecan-paclitaxel) plus bevacizumab significantly improves overall survival (OS), progression-free survival (PFS), and response rates compared to chemotherapy alone in advanced cervical cancer. Trial registration number: NCT00803062.</p></sec><sec id="S2"><title>Methods</title><p id="P3">Patients were assessed pre-cycle 1, 2, and 5 and at 6 and 9 months post-cycle 1 with the Functional Assessment of Cancer Therapy-Cervix Trial Outcome Index (FACT-Cx TOI), and items from the FACT/GOG-Neurotoxicity (Ntx) subscale, and a worst pain item from the Brief Pain Inventory (BPI). Differences in FACT-Cx TOI scores were assessed using a linear mixed model adjusting for baseline score and age. A mixed effects mixed distributions model was fitted to evaluate treatment differences of likelihood to report neurotoxicity and pain, and severity of these symptoms, once reported. The association between baseline health-related quality of life and survival was analyzed using Cox proportional hazards models.</p></sec><sec id="S3"><title>Findings</title><p id="P4">Among 390 evaluable patients, PRO completion rates declined from 96% (baseline) to 63% (9 months post-cycle 1). Completion rates were not statistically different among treatment regimens (p=0.67). Patients receiving chemotherapy plus bevacizumab reported 1.2 points lower on average (98.75% CI: −4.1, 1.7; p=0.30) in the FACT-Cx TOI scores than those with chemotherapy alone. Patients treated with chemotherapy plus bevacizumab were less likely to report neurotoxicty (overall odds ratio: 0.58; 98.75% CI: 0.17, 0.98; p=0.01). Severity of neurotoxic symptoms did not differ between the two groups (p=0.69). Both groups had similar odds of complaining of pain (odds ratio=0.96; 95% CI: 0.39, 1.52; p=0.78) and reported similar severity of pain (p=0.1). For the entire population, the baseline FACT-Cx TOI score was significantly associated with OS (HR 0.80; 95% CI 0.74, 0.87; p<0.001) and PFS (0.88; 95% CI: 0.83, 0.95; p<0.001).</p></sec><sec id="S4"><title>Interpretation</title><p id="P5">Improvements in OS and PFS attributed to the incorporation of bevacizumab in the treatment of advanced cervical cancer were not accompanied by any significant deterioration in health-related quality of life. Study supported by NIH funding.</p></sec></abstract><kwd-group><kwd>Cervical cancer</kwd><kwd>quality of life</kwd><kwd>bevacizumab</kwd></kwd-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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