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Phase III Trial of Ipilimumab Combined With Paclitaxel and Carboplatin in Advanced Squamous Non-Small-Cell Lung Cancer.

Identifieur interne : 000615 ( Main/Exploration ); précédent : 000614; suivant : 000616

Phase III Trial of Ipilimumab Combined With Paclitaxel and Carboplatin in Advanced Squamous Non-Small-Cell Lung Cancer.

Auteurs : Ramaswamy Govindan [États-Unis] ; Aleksandra Szczesna [États-Unis] ; Myung-Ju Ahn [États-Unis] ; Claus-Peter Schneider [États-Unis] ; Pablo Fernando Gonzalez Mella [États-Unis] ; Fabrice Barlesi [États-Unis] ; Baohui Han [États-Unis] ; Doina Elena Ganea [États-Unis] ; Joachim Von Pawel [États-Unis] ; Vladimir Vladimirov [États-Unis] ; Natalia Fadeeva [États-Unis] ; Ki Hyeong Lee [États-Unis] ; Takayasu Kurata [États-Unis] ; Li Zhang [États-Unis] ; Tomohide Tamura [États-Unis] ; Pieter E. Postmus [États-Unis] ; Jacek Jassem [États-Unis] ; Kenneth O'Byrne [États-Unis] ; Justin Kopit [États-Unis] ; Mingshun Li [États-Unis] ; Marina Tschaika [États-Unis] ; Martin Reck [États-Unis]

Source :

RBID : pubmed:28854067

Descripteurs français

English descriptors

Abstract

Purpose Patients with squamous non-small-cell lung cancer (NSCLC) have poor prognosis and limited treatment options. This randomized, double-blind, phase III study investigated the efficacy and safety of first-line ipilimumab or placebo plus paclitaxel and carboplatin in advanced squamous NSCLC. Patients and Methods Patients with stage IV or recurrent chemotherapy-naïve squamous NSCLC were randomly assigned (1:1) to receive paclitaxel and carboplatin plus blinded ipilimumab 10 mg/kg or placebo every 3 weeks on a phased induction schedule comprising six chemotherapy cycles, with ipilimumab or placebo from cycles 3 to 6 and then, after induction treatment, ipilimumab or placebo maintenance every 12 weeks for patients with stable disease or better. The primary end point was overall survival (OS) in patients receiving at least one dose of blinded study therapy. Results Of 956 randomly assigned patients, 749 received at least one dose of blinded study therapy (chemotherapy plus ipilimumab, n = 388; chemotherapy plus placebo, n = 361). Median OS was 13.4 months for chemotherapy plus ipilimumab and 12.4 months for chemotherapy plus placebo (hazard ratio, 0.91; 95% CI, 0.77 to 1.07; P = .25). Median progression-free survival was 5.6 months for both groups (hazard ratio, 0.87; 95% CI, 0.75 to 1.01). Rates of grade 3 or 4 treatment-related adverse events (TRAEs), any-grade serious TRAEs, and TRAEs leading to discontinuation were numerically higher with chemotherapy plus ipilimumab (51%, 33%, and 28%, respectively) than with chemotherapy plus placebo (35%, 10%, and 7%, respectively). Seven treatment-related deaths occurred with chemotherapy plus ipilimumab, and one occurred with chemotherapy plus placebo. Conclusion The addition of ipilimumab to first-line chemotherapy did not prolong OS compared with chemotherapy alone in patients with advanced squamous NSCLC. The safety profile of chemotherapy plus ipilimumab was consistent with that observed in previous lung and melanoma studies. Ongoing studies are evaluating ipilimumab in combination with nivolumab in this population.

DOI: 10.1200/JCO.2016.71.7629
PubMed: 28854067


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<name sortKey="Gonzalez Mella, Pablo Fernando" sort="Gonzalez Mella, Pablo Fernando" uniqKey="Gonzalez Mella P" first="Pablo Fernando" last="Gonzalez Mella">Pablo Fernando Gonzalez Mella</name>
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<name sortKey="Han, Baohui" sort="Han, Baohui" uniqKey="Han B" first="Baohui" last="Han">Baohui Han</name>
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<nlm:affiliation>Ramaswamy Govindan, Washington University School of Medicine, St Louis, MO; Aleksandra Szczesna, Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy, Otwock; Jacek Jassem, Medical University of Gdansk, Gdansk, Poland; Myung-Ju Ahn, Samsung Medical Center, Sungkyunkwan University, Seoul; Ki Hyeong Lee, Chungbuk National University Hospital, Cheongju-si, Republic of Korea; Claus-Peter Schneider, Zentralklinik Bad Berka, Bad Berka; Joachim Von Pawel, Asklepius Fachkliniken, Gauting; Martin Reck, LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany; Pablo Fernando Gonzalez Mella, Centro de Investigaciones Clinicas, Universidad de Valparaíso and Fundación Arturo López Pérez, Santiago, Chile; Fabrice Barlesi, Aix Marseille University, Assistance Publique-Hôpitaux de Marseille, Marseille, France; Baohui Han, Shanghai Chest Hospital Affiliated to Shanghai JiaoTong University, Shanghai; Li Zhang, Sun Yat-Sen University Cancer Center, Guangzhou, People's Republic of China; Doina Elena Ganea, Spitalul Judetean De Urgenta Suceava, Sfântul loan cel Nou, Suceava, Romania; Vladimir Vladimirov, State Healthcare Institute, Pyatigorsk Oncology Dispensary, Pyatigorsk; Natalia Fadeeva, Chelyabinsk Regional Oncology Dispensary, Chelyabinsk, Russian Federation; Takayasu Kurata, Kansai Medical University Hirakata Hospital, Osaka; Tomohide Tamura, St Luke's International Hospital, Tokyo, Japan; Pieter E. Postmus, University of Liverpool, Liverpool, United Kingdom; Kenneth O'Byrne, Princess Alexandra Hospital and Queensland University of Technology, Brisbane, Queensland, Australia; and Justin Kopit, Mingshun Li, and Marina Tschaika, Bristol-Myers Squibb, Princeton, NJ.</nlm:affiliation>
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<name sortKey="Ganea, Doina Elena" sort="Ganea, Doina Elena" uniqKey="Ganea D" first="Doina Elena" last="Ganea">Doina Elena Ganea</name>
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<name sortKey="Von Pawel, Joachim" sort="Von Pawel, Joachim" uniqKey="Von Pawel J" first="Joachim" last="Von Pawel">Joachim Von Pawel</name>
<affiliation wicri:level="2">
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<country xml:lang="fr">États-Unis</country>
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<name sortKey="Vladimirov, Vladimir" sort="Vladimirov, Vladimir" uniqKey="Vladimirov V" first="Vladimir" last="Vladimirov">Vladimir Vladimirov</name>
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<name sortKey="Fadeeva, Natalia" sort="Fadeeva, Natalia" uniqKey="Fadeeva N" first="Natalia" last="Fadeeva">Natalia Fadeeva</name>
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<name sortKey="Lee, Ki Hyeong" sort="Lee, Ki Hyeong" uniqKey="Lee K" first="Ki Hyeong" last="Lee">Ki Hyeong Lee</name>
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<nlm:affiliation>Ramaswamy Govindan, Washington University School of Medicine, St Louis, MO; Aleksandra Szczesna, Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy, Otwock; Jacek Jassem, Medical University of Gdansk, Gdansk, Poland; Myung-Ju Ahn, Samsung Medical Center, Sungkyunkwan University, Seoul; Ki Hyeong Lee, Chungbuk National University Hospital, Cheongju-si, Republic of Korea; Claus-Peter Schneider, Zentralklinik Bad Berka, Bad Berka; Joachim Von Pawel, Asklepius Fachkliniken, Gauting; Martin Reck, LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany; Pablo Fernando Gonzalez Mella, Centro de Investigaciones Clinicas, Universidad de Valparaíso and Fundación Arturo López Pérez, Santiago, Chile; Fabrice Barlesi, Aix Marseille University, Assistance Publique-Hôpitaux de Marseille, Marseille, France; Baohui Han, Shanghai Chest Hospital Affiliated to Shanghai JiaoTong University, Shanghai; Li Zhang, Sun Yat-Sen University Cancer Center, Guangzhou, People's Republic of China; Doina Elena Ganea, Spitalul Judetean De Urgenta Suceava, Sfântul loan cel Nou, Suceava, Romania; Vladimir Vladimirov, State Healthcare Institute, Pyatigorsk Oncology Dispensary, Pyatigorsk; Natalia Fadeeva, Chelyabinsk Regional Oncology Dispensary, Chelyabinsk, Russian Federation; Takayasu Kurata, Kansai Medical University Hirakata Hospital, Osaka; Tomohide Tamura, St Luke's International Hospital, Tokyo, Japan; Pieter E. Postmus, University of Liverpool, Liverpool, United Kingdom; Kenneth O'Byrne, Princess Alexandra Hospital and Queensland University of Technology, Brisbane, Queensland, Australia; and Justin Kopit, Mingshun Li, and Marina Tschaika, Bristol-Myers Squibb, Princeton, NJ.</nlm:affiliation>
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<name sortKey="Kurata, Takayasu" sort="Kurata, Takayasu" uniqKey="Kurata T" first="Takayasu" last="Kurata">Takayasu Kurata</name>
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<name sortKey="Zhang, Li" sort="Zhang, Li" uniqKey="Zhang L" first="Li" last="Zhang">Li Zhang</name>
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<name sortKey="Tamura, Tomohide" sort="Tamura, Tomohide" uniqKey="Tamura T" first="Tomohide" last="Tamura">Tomohide Tamura</name>
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<name sortKey="Postmus, Pieter E" sort="Postmus, Pieter E" uniqKey="Postmus P" first="Pieter E" last="Postmus">Pieter E. Postmus</name>
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<name sortKey="Jassem, Jacek" sort="Jassem, Jacek" uniqKey="Jassem J" first="Jacek" last="Jassem">Jacek Jassem</name>
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<name sortKey="O Byrne, Kenneth" sort="O Byrne, Kenneth" uniqKey="O Byrne K" first="Kenneth" last="O'Byrne">Kenneth O'Byrne</name>
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<name sortKey="Kopit, Justin" sort="Kopit, Justin" uniqKey="Kopit J" first="Justin" last="Kopit">Justin Kopit</name>
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<name sortKey="Li, Mingshun" sort="Li, Mingshun" uniqKey="Li M" first="Mingshun" last="Li">Mingshun Li</name>
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<name sortKey="Tschaika, Marina" sort="Tschaika, Marina" uniqKey="Tschaika M" first="Marina" last="Tschaika">Marina Tschaika</name>
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<title xml:lang="en">Phase III Trial of Ipilimumab Combined With Paclitaxel and Carboplatin in Advanced Squamous Non-Small-Cell Lung Cancer.</title>
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<name sortKey="Govindan, Ramaswamy" sort="Govindan, Ramaswamy" uniqKey="Govindan R" first="Ramaswamy" last="Govindan">Ramaswamy Govindan</name>
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<name sortKey="Ahn, Myung Ju" sort="Ahn, Myung Ju" uniqKey="Ahn M" first="Myung-Ju" last="Ahn">Myung-Ju Ahn</name>
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<name sortKey="Schneider, Claus Peter" sort="Schneider, Claus Peter" uniqKey="Schneider C" first="Claus-Peter" last="Schneider">Claus-Peter Schneider</name>
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<name sortKey="Gonzalez Mella, Pablo Fernando" sort="Gonzalez Mella, Pablo Fernando" uniqKey="Gonzalez Mella P" first="Pablo Fernando" last="Gonzalez Mella">Pablo Fernando Gonzalez Mella</name>
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<name sortKey="Barlesi, Fabrice" sort="Barlesi, Fabrice" uniqKey="Barlesi F" first="Fabrice" last="Barlesi">Fabrice Barlesi</name>
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<name sortKey="Han, Baohui" sort="Han, Baohui" uniqKey="Han B" first="Baohui" last="Han">Baohui Han</name>
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<name sortKey="Ganea, Doina Elena" sort="Ganea, Doina Elena" uniqKey="Ganea D" first="Doina Elena" last="Ganea">Doina Elena Ganea</name>
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<country xml:lang="fr">États-Unis</country>
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<name sortKey="Von Pawel, Joachim" sort="Von Pawel, Joachim" uniqKey="Von Pawel J" first="Joachim" last="Von Pawel">Joachim Von Pawel</name>
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<name sortKey="Vladimirov, Vladimir" sort="Vladimirov, Vladimir" uniqKey="Vladimirov V" first="Vladimir" last="Vladimirov">Vladimir Vladimirov</name>
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<name sortKey="Fadeeva, Natalia" sort="Fadeeva, Natalia" uniqKey="Fadeeva N" first="Natalia" last="Fadeeva">Natalia Fadeeva</name>
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<nlm:affiliation>Ramaswamy Govindan, Washington University School of Medicine, St Louis, MO; Aleksandra Szczesna, Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy, Otwock; Jacek Jassem, Medical University of Gdansk, Gdansk, Poland; Myung-Ju Ahn, Samsung Medical Center, Sungkyunkwan University, Seoul; Ki Hyeong Lee, Chungbuk National University Hospital, Cheongju-si, Republic of Korea; Claus-Peter Schneider, Zentralklinik Bad Berka, Bad Berka; Joachim Von Pawel, Asklepius Fachkliniken, Gauting; Martin Reck, LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany; Pablo Fernando Gonzalez Mella, Centro de Investigaciones Clinicas, Universidad de Valparaíso and Fundación Arturo López Pérez, Santiago, Chile; Fabrice Barlesi, Aix Marseille University, Assistance Publique-Hôpitaux de Marseille, Marseille, France; Baohui Han, Shanghai Chest Hospital Affiliated to Shanghai JiaoTong University, Shanghai; Li Zhang, Sun Yat-Sen University Cancer Center, Guangzhou, People's Republic of China; Doina Elena Ganea, Spitalul Judetean De Urgenta Suceava, Sfântul loan cel Nou, Suceava, Romania; Vladimir Vladimirov, State Healthcare Institute, Pyatigorsk Oncology Dispensary, Pyatigorsk; Natalia Fadeeva, Chelyabinsk Regional Oncology Dispensary, Chelyabinsk, Russian Federation; Takayasu Kurata, Kansai Medical University Hirakata Hospital, Osaka; Tomohide Tamura, St Luke's International Hospital, Tokyo, Japan; Pieter E. Postmus, University of Liverpool, Liverpool, United Kingdom; Kenneth O'Byrne, Princess Alexandra Hospital and Queensland University of Technology, Brisbane, Queensland, Australia; and Justin Kopit, Mingshun Li, and Marina Tschaika, Bristol-Myers Squibb, Princeton, NJ.</nlm:affiliation>
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<name sortKey="Lee, Ki Hyeong" sort="Lee, Ki Hyeong" uniqKey="Lee K" first="Ki Hyeong" last="Lee">Ki Hyeong Lee</name>
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<nlm:affiliation>Ramaswamy Govindan, Washington University School of Medicine, St Louis, MO; Aleksandra Szczesna, Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy, Otwock; Jacek Jassem, Medical University of Gdansk, Gdansk, Poland; Myung-Ju Ahn, Samsung Medical Center, Sungkyunkwan University, Seoul; Ki Hyeong Lee, Chungbuk National University Hospital, Cheongju-si, Republic of Korea; Claus-Peter Schneider, Zentralklinik Bad Berka, Bad Berka; Joachim Von Pawel, Asklepius Fachkliniken, Gauting; Martin Reck, LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany; Pablo Fernando Gonzalez Mella, Centro de Investigaciones Clinicas, Universidad de Valparaíso and Fundación Arturo López Pérez, Santiago, Chile; Fabrice Barlesi, Aix Marseille University, Assistance Publique-Hôpitaux de Marseille, Marseille, France; Baohui Han, Shanghai Chest Hospital Affiliated to Shanghai JiaoTong University, Shanghai; Li Zhang, Sun Yat-Sen University Cancer Center, Guangzhou, People's Republic of China; Doina Elena Ganea, Spitalul Judetean De Urgenta Suceava, Sfântul loan cel Nou, Suceava, Romania; Vladimir Vladimirov, State Healthcare Institute, Pyatigorsk Oncology Dispensary, Pyatigorsk; Natalia Fadeeva, Chelyabinsk Regional Oncology Dispensary, Chelyabinsk, Russian Federation; Takayasu Kurata, Kansai Medical University Hirakata Hospital, Osaka; Tomohide Tamura, St Luke's International Hospital, Tokyo, Japan; Pieter E. Postmus, University of Liverpool, Liverpool, United Kingdom; Kenneth O'Byrne, Princess Alexandra Hospital and Queensland University of Technology, Brisbane, Queensland, Australia; and Justin Kopit, Mingshun Li, and Marina Tschaika, Bristol-Myers Squibb, Princeton, NJ.</nlm:affiliation>
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<name sortKey="Kurata, Takayasu" sort="Kurata, Takayasu" uniqKey="Kurata T" first="Takayasu" last="Kurata">Takayasu Kurata</name>
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<name sortKey="Zhang, Li" sort="Zhang, Li" uniqKey="Zhang L" first="Li" last="Zhang">Li Zhang</name>
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<name sortKey="Tamura, Tomohide" sort="Tamura, Tomohide" uniqKey="Tamura T" first="Tomohide" last="Tamura">Tomohide Tamura</name>
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<name sortKey="Postmus, Pieter E" sort="Postmus, Pieter E" uniqKey="Postmus P" first="Pieter E" last="Postmus">Pieter E. Postmus</name>
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<name sortKey="Jassem, Jacek" sort="Jassem, Jacek" uniqKey="Jassem J" first="Jacek" last="Jassem">Jacek Jassem</name>
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<name sortKey="O Byrne, Kenneth" sort="O Byrne, Kenneth" uniqKey="O Byrne K" first="Kenneth" last="O'Byrne">Kenneth O'Byrne</name>
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<name sortKey="Kopit, Justin" sort="Kopit, Justin" uniqKey="Kopit J" first="Justin" last="Kopit">Justin Kopit</name>
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<name sortKey="Li, Mingshun" sort="Li, Mingshun" uniqKey="Li M" first="Mingshun" last="Li">Mingshun Li</name>
<affiliation wicri:level="2">
<nlm:affiliation>Ramaswamy Govindan, Washington University School of Medicine, St Louis, MO; Aleksandra Szczesna, Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy, Otwock; Jacek Jassem, Medical University of Gdansk, Gdansk, Poland; Myung-Ju Ahn, Samsung Medical Center, Sungkyunkwan University, Seoul; Ki Hyeong Lee, Chungbuk National University Hospital, Cheongju-si, Republic of Korea; Claus-Peter Schneider, Zentralklinik Bad Berka, Bad Berka; Joachim Von Pawel, Asklepius Fachkliniken, Gauting; Martin Reck, LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany; Pablo Fernando Gonzalez Mella, Centro de Investigaciones Clinicas, Universidad de Valparaíso and Fundación Arturo López Pérez, Santiago, Chile; Fabrice Barlesi, Aix Marseille University, Assistance Publique-Hôpitaux de Marseille, Marseille, France; Baohui Han, Shanghai Chest Hospital Affiliated to Shanghai JiaoTong University, Shanghai; Li Zhang, Sun Yat-Sen University Cancer Center, Guangzhou, People's Republic of China; Doina Elena Ganea, Spitalul Judetean De Urgenta Suceava, Sfântul loan cel Nou, Suceava, Romania; Vladimir Vladimirov, State Healthcare Institute, Pyatigorsk Oncology Dispensary, Pyatigorsk; Natalia Fadeeva, Chelyabinsk Regional Oncology Dispensary, Chelyabinsk, Russian Federation; Takayasu Kurata, Kansai Medical University Hirakata Hospital, Osaka; Tomohide Tamura, St Luke's International Hospital, Tokyo, Japan; Pieter E. Postmus, University of Liverpool, Liverpool, United Kingdom; Kenneth O'Byrne, Princess Alexandra Hospital and Queensland University of Technology, Brisbane, Queensland, Australia; and Justin Kopit, Mingshun Li, and Marina Tschaika, Bristol-Myers Squibb, Princeton, NJ.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
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<region type="state">New Jersey</region>
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<author>
<name sortKey="Tschaika, Marina" sort="Tschaika, Marina" uniqKey="Tschaika M" first="Marina" last="Tschaika">Marina Tschaika</name>
<affiliation wicri:level="2">
<nlm:affiliation>Ramaswamy Govindan, Washington University School of Medicine, St Louis, MO; Aleksandra Szczesna, Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy, Otwock; Jacek Jassem, Medical University of Gdansk, Gdansk, Poland; Myung-Ju Ahn, Samsung Medical Center, Sungkyunkwan University, Seoul; Ki Hyeong Lee, Chungbuk National University Hospital, Cheongju-si, Republic of Korea; Claus-Peter Schneider, Zentralklinik Bad Berka, Bad Berka; Joachim Von Pawel, Asklepius Fachkliniken, Gauting; Martin Reck, LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany; Pablo Fernando Gonzalez Mella, Centro de Investigaciones Clinicas, Universidad de Valparaíso and Fundación Arturo López Pérez, Santiago, Chile; Fabrice Barlesi, Aix Marseille University, Assistance Publique-Hôpitaux de Marseille, Marseille, France; Baohui Han, Shanghai Chest Hospital Affiliated to Shanghai JiaoTong University, Shanghai; Li Zhang, Sun Yat-Sen University Cancer Center, Guangzhou, People's Republic of China; Doina Elena Ganea, Spitalul Judetean De Urgenta Suceava, Sfântul loan cel Nou, Suceava, Romania; Vladimir Vladimirov, State Healthcare Institute, Pyatigorsk Oncology Dispensary, Pyatigorsk; Natalia Fadeeva, Chelyabinsk Regional Oncology Dispensary, Chelyabinsk, Russian Federation; Takayasu Kurata, Kansai Medical University Hirakata Hospital, Osaka; Tomohide Tamura, St Luke's International Hospital, Tokyo, Japan; Pieter E. Postmus, University of Liverpool, Liverpool, United Kingdom; Kenneth O'Byrne, Princess Alexandra Hospital and Queensland University of Technology, Brisbane, Queensland, Australia; and Justin Kopit, Mingshun Li, and Marina Tschaika, Bristol-Myers Squibb, Princeton, NJ.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Ramaswamy Govindan, Washington University School of Medicine, St Louis, MO; Aleksandra Szczesna, Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy, Otwock; Jacek Jassem, Medical University of Gdansk, Gdansk, Poland; Myung-Ju Ahn, Samsung Medical Center, Sungkyunkwan University, Seoul; Ki Hyeong Lee, Chungbuk National University Hospital, Cheongju-si, Republic of Korea; Claus-Peter Schneider, Zentralklinik Bad Berka, Bad Berka; Joachim Von Pawel, Asklepius Fachkliniken, Gauting; Martin Reck, LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany; Pablo Fernando Gonzalez Mella, Centro de Investigaciones Clinicas, Universidad de Valparaíso and Fundación Arturo López Pérez, Santiago, Chile; Fabrice Barlesi, Aix Marseille University, Assistance Publique-Hôpitaux de Marseille, Marseille, France; Baohui Han, Shanghai Chest Hospital Affiliated to Shanghai JiaoTong University, Shanghai; Li Zhang, Sun Yat-Sen University Cancer Center, Guangzhou, People's Republic of China; Doina Elena Ganea, Spitalul Judetean De Urgenta Suceava, Sfântul loan cel Nou, Suceava, Romania; Vladimir Vladimirov, State Healthcare Institute, Pyatigorsk Oncology Dispensary, Pyatigorsk; Natalia Fadeeva, Chelyabinsk Regional Oncology Dispensary, Chelyabinsk, Russian Federation; Takayasu Kurata, Kansai Medical University Hirakata Hospital, Osaka; Tomohide Tamura, St Luke's International Hospital, Tokyo, Japan; Pieter E. Postmus, University of Liverpool, Liverpool, United Kingdom; Kenneth O'Byrne, Princess Alexandra Hospital and Queensland University of Technology, Brisbane, Queensland, Australia; and Justin Kopit, Mingshun Li, and Marina Tschaika, Bristol-Myers Squibb, Princeton</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Reck, Martin" sort="Reck, Martin" uniqKey="Reck M" first="Martin" last="Reck">Martin Reck</name>
<affiliation wicri:level="2">
<nlm:affiliation>Ramaswamy Govindan, Washington University School of Medicine, St Louis, MO; Aleksandra Szczesna, Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy, Otwock; Jacek Jassem, Medical University of Gdansk, Gdansk, Poland; Myung-Ju Ahn, Samsung Medical Center, Sungkyunkwan University, Seoul; Ki Hyeong Lee, Chungbuk National University Hospital, Cheongju-si, Republic of Korea; Claus-Peter Schneider, Zentralklinik Bad Berka, Bad Berka; Joachim Von Pawel, Asklepius Fachkliniken, Gauting; Martin Reck, LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany; Pablo Fernando Gonzalez Mella, Centro de Investigaciones Clinicas, Universidad de Valparaíso and Fundación Arturo López Pérez, Santiago, Chile; Fabrice Barlesi, Aix Marseille University, Assistance Publique-Hôpitaux de Marseille, Marseille, France; Baohui Han, Shanghai Chest Hospital Affiliated to Shanghai JiaoTong University, Shanghai; Li Zhang, Sun Yat-Sen University Cancer Center, Guangzhou, People's Republic of China; Doina Elena Ganea, Spitalul Judetean De Urgenta Suceava, Sfântul loan cel Nou, Suceava, Romania; Vladimir Vladimirov, State Healthcare Institute, Pyatigorsk Oncology Dispensary, Pyatigorsk; Natalia Fadeeva, Chelyabinsk Regional Oncology Dispensary, Chelyabinsk, Russian Federation; Takayasu Kurata, Kansai Medical University Hirakata Hospital, Osaka; Tomohide Tamura, St Luke's International Hospital, Tokyo, Japan; Pieter E. Postmus, University of Liverpool, Liverpool, United Kingdom; Kenneth O'Byrne, Princess Alexandra Hospital and Queensland University of Technology, Brisbane, Queensland, Australia; and Justin Kopit, Mingshun Li, and Marina Tschaika, Bristol-Myers Squibb, Princeton, NJ.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Ramaswamy Govindan, Washington University School of Medicine, St Louis, MO; Aleksandra Szczesna, Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy, Otwock; Jacek Jassem, Medical University of Gdansk, Gdansk, Poland; Myung-Ju Ahn, Samsung Medical Center, Sungkyunkwan University, Seoul; Ki Hyeong Lee, Chungbuk National University Hospital, Cheongju-si, Republic of Korea; Claus-Peter Schneider, Zentralklinik Bad Berka, Bad Berka; Joachim Von Pawel, Asklepius Fachkliniken, Gauting; Martin Reck, LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany; Pablo Fernando Gonzalez Mella, Centro de Investigaciones Clinicas, Universidad de Valparaíso and Fundación Arturo López Pérez, Santiago, Chile; Fabrice Barlesi, Aix Marseille University, Assistance Publique-Hôpitaux de Marseille, Marseille, France; Baohui Han, Shanghai Chest Hospital Affiliated to Shanghai JiaoTong University, Shanghai; Li Zhang, Sun Yat-Sen University Cancer Center, Guangzhou, People's Republic of China; Doina Elena Ganea, Spitalul Judetean De Urgenta Suceava, Sfântul loan cel Nou, Suceava, Romania; Vladimir Vladimirov, State Healthcare Institute, Pyatigorsk Oncology Dispensary, Pyatigorsk; Natalia Fadeeva, Chelyabinsk Regional Oncology Dispensary, Chelyabinsk, Russian Federation; Takayasu Kurata, Kansai Medical University Hirakata Hospital, Osaka; Tomohide Tamura, St Luke's International Hospital, Tokyo, Japan; Pieter E. Postmus, University of Liverpool, Liverpool, United Kingdom; Kenneth O'Byrne, Princess Alexandra Hospital and Queensland University of Technology, Brisbane, Queensland, Australia; and Justin Kopit, Mingshun Li, and Marina Tschaika, Bristol-Myers Squibb, Princeton</wicri:cityArea>
</affiliation>
</author>
</analytic>
<series>
<title level="j">Journal of clinical oncology : official journal of the American Society of Clinical Oncology</title>
<idno type="eISSN">1527-7755</idno>
<imprint>
<date when="2017" type="published">2017</date>
</imprint>
</series>
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<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Anemia (chemically induced)</term>
<term>Antibodies, Monoclonal (administration & dosage)</term>
<term>Antibodies, Monoclonal (adverse effects)</term>
<term>Antineoplastic Combined Chemotherapy Protocols (adverse effects)</term>
<term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term>
<term>Carboplatin (administration & dosage)</term>
<term>Carboplatin (adverse effects)</term>
<term>Carcinoma, Non-Small-Cell Lung (drug therapy)</term>
<term>Carcinoma, Non-Small-Cell Lung (pathology)</term>
<term>Diarrhea (chemically induced)</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
<term>Kaplan-Meier Estimate</term>
<term>Lung Neoplasms (drug therapy)</term>
<term>Lung Neoplasms (pathology)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neutropenia (chemically induced)</term>
<term>Outcome Assessment (Health Care) (methods)</term>
<term>Outcome Assessment (Health Care) (statistics & numerical data)</term>
<term>Paclitaxel (administration & dosage)</term>
<term>Paclitaxel (adverse effects)</term>
<term>Proportional Hazards Models</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Anticorps monoclonaux (administration et posologie)</term>
<term>Anticorps monoclonaux (effets indésirables)</term>
<term>Anémie ()</term>
<term>Carboplatine (administration et posologie)</term>
<term>Carboplatine (effets indésirables)</term>
<term>Carcinome pulmonaire non à petites cellules (anatomopathologie)</term>
<term>Carcinome pulmonaire non à petites cellules (traitement médicamenteux)</term>
<term>Diarrhée ()</term>
<term>Estimation de Kaplan-Meier</term>
<term>Femelle</term>
<term>Humains</term>
<term>Modèles de hasards proportionnels</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Neutropénie ()</term>
<term>Paclitaxel (administration et posologie)</term>
<term>Paclitaxel (effets indésirables)</term>
<term>Protocoles de polychimiothérapie antinéoplasique (effets indésirables)</term>
<term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Tumeurs du poumon (anatomopathologie)</term>
<term>Tumeurs du poumon (traitement médicamenteux)</term>
<term>Évaluation de résultat (soins) ()</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en">
<term>Antibodies, Monoclonal</term>
<term>Carboplatin</term>
<term>Paclitaxel</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en">
<term>Antibodies, Monoclonal</term>
<term>Carboplatin</term>
<term>Paclitaxel</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr">
<term>Anticorps monoclonaux</term>
<term>Carboplatine</term>
<term>Paclitaxel</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en">
<term>Antineoplastic Combined Chemotherapy Protocols</term>
</keywords>
<keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr">
<term>Carcinome pulmonaire non à petites cellules</term>
<term>Tumeurs du poumon</term>
</keywords>
<keywords scheme="MESH" qualifier="chemically induced" xml:lang="en">
<term>Anemia</term>
<term>Diarrhea</term>
<term>Neutropenia</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en">
<term>Carcinoma, Non-Small-Cell Lung</term>
<term>Lung Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr">
<term>Anticorps monoclonaux</term>
<term>Carboplatine</term>
<term>Paclitaxel</term>
<term>Protocoles de polychimiothérapie antinéoplasique</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en">
<term>Outcome Assessment (Health Care)</term>
</keywords>
<keywords scheme="MESH" qualifier="pathology" xml:lang="en">
<term>Carcinoma, Non-Small-Cell Lung</term>
<term>Lung Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="statistics & numerical data" xml:lang="en">
<term>Outcome Assessment (Health Care)</term>
</keywords>
<keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en">
<term>Antineoplastic Combined Chemotherapy Protocols</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr">
<term>Carcinome pulmonaire non à petites cellules</term>
<term>Tumeurs du poumon</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr">
<term>Protocoles de polychimiothérapie antinéoplasique</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
<term>Kaplan-Meier Estimate</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Proportional Hazards Models</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Anémie</term>
<term>Diarrhée</term>
<term>Estimation de Kaplan-Meier</term>
<term>Femelle</term>
<term>Humains</term>
<term>Modèles de hasards proportionnels</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Neutropénie</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Évaluation de résultat (soins)</term>
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<front>
<div type="abstract" xml:lang="en">Purpose Patients with squamous non-small-cell lung cancer (NSCLC) have poor prognosis and limited treatment options. This randomized, double-blind, phase III study investigated the efficacy and safety of first-line ipilimumab or placebo plus paclitaxel and carboplatin in advanced squamous NSCLC. Patients and Methods Patients with stage IV or recurrent chemotherapy-naïve squamous NSCLC were randomly assigned (1:1) to receive paclitaxel and carboplatin plus blinded ipilimumab 10 mg/kg or placebo every 3 weeks on a phased induction schedule comprising six chemotherapy cycles, with ipilimumab or placebo from cycles 3 to 6 and then, after induction treatment, ipilimumab or placebo maintenance every 12 weeks for patients with stable disease or better. The primary end point was overall survival (OS) in patients receiving at least one dose of blinded study therapy. Results Of 956 randomly assigned patients, 749 received at least one dose of blinded study therapy (chemotherapy plus ipilimumab, n = 388; chemotherapy plus placebo, n = 361). Median OS was 13.4 months for chemotherapy plus ipilimumab and 12.4 months for chemotherapy plus placebo (hazard ratio, 0.91; 95% CI, 0.77 to 1.07; P = .25). Median progression-free survival was 5.6 months for both groups (hazard ratio, 0.87; 95% CI, 0.75 to 1.01). Rates of grade 3 or 4 treatment-related adverse events (TRAEs), any-grade serious TRAEs, and TRAEs leading to discontinuation were numerically higher with chemotherapy plus ipilimumab (51%, 33%, and 28%, respectively) than with chemotherapy plus placebo (35%, 10%, and 7%, respectively). Seven treatment-related deaths occurred with chemotherapy plus ipilimumab, and one occurred with chemotherapy plus placebo. Conclusion The addition of ipilimumab to first-line chemotherapy did not prolong OS compared with chemotherapy alone in patients with advanced squamous NSCLC. The safety profile of chemotherapy plus ipilimumab was consistent with that observed in previous lung and melanoma studies. Ongoing studies are evaluating ipilimumab in combination with nivolumab in this population.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>États-Unis</li>
</country>
<region>
<li>New Jersey</li>
</region>
</list>
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<country name="États-Unis">
<region name="New Jersey">
<name sortKey="Govindan, Ramaswamy" sort="Govindan, Ramaswamy" uniqKey="Govindan R" first="Ramaswamy" last="Govindan">Ramaswamy Govindan</name>
</region>
<name sortKey="Ahn, Myung Ju" sort="Ahn, Myung Ju" uniqKey="Ahn M" first="Myung-Ju" last="Ahn">Myung-Ju Ahn</name>
<name sortKey="Barlesi, Fabrice" sort="Barlesi, Fabrice" uniqKey="Barlesi F" first="Fabrice" last="Barlesi">Fabrice Barlesi</name>
<name sortKey="Fadeeva, Natalia" sort="Fadeeva, Natalia" uniqKey="Fadeeva N" first="Natalia" last="Fadeeva">Natalia Fadeeva</name>
<name sortKey="Ganea, Doina Elena" sort="Ganea, Doina Elena" uniqKey="Ganea D" first="Doina Elena" last="Ganea">Doina Elena Ganea</name>
<name sortKey="Gonzalez Mella, Pablo Fernando" sort="Gonzalez Mella, Pablo Fernando" uniqKey="Gonzalez Mella P" first="Pablo Fernando" last="Gonzalez Mella">Pablo Fernando Gonzalez Mella</name>
<name sortKey="Han, Baohui" sort="Han, Baohui" uniqKey="Han B" first="Baohui" last="Han">Baohui Han</name>
<name sortKey="Jassem, Jacek" sort="Jassem, Jacek" uniqKey="Jassem J" first="Jacek" last="Jassem">Jacek Jassem</name>
<name sortKey="Kopit, Justin" sort="Kopit, Justin" uniqKey="Kopit J" first="Justin" last="Kopit">Justin Kopit</name>
<name sortKey="Kurata, Takayasu" sort="Kurata, Takayasu" uniqKey="Kurata T" first="Takayasu" last="Kurata">Takayasu Kurata</name>
<name sortKey="Lee, Ki Hyeong" sort="Lee, Ki Hyeong" uniqKey="Lee K" first="Ki Hyeong" last="Lee">Ki Hyeong Lee</name>
<name sortKey="Li, Mingshun" sort="Li, Mingshun" uniqKey="Li M" first="Mingshun" last="Li">Mingshun Li</name>
<name sortKey="O Byrne, Kenneth" sort="O Byrne, Kenneth" uniqKey="O Byrne K" first="Kenneth" last="O'Byrne">Kenneth O'Byrne</name>
<name sortKey="Postmus, Pieter E" sort="Postmus, Pieter E" uniqKey="Postmus P" first="Pieter E" last="Postmus">Pieter E. Postmus</name>
<name sortKey="Reck, Martin" sort="Reck, Martin" uniqKey="Reck M" first="Martin" last="Reck">Martin Reck</name>
<name sortKey="Schneider, Claus Peter" sort="Schneider, Claus Peter" uniqKey="Schneider C" first="Claus-Peter" last="Schneider">Claus-Peter Schneider</name>
<name sortKey="Szczesna, Aleksandra" sort="Szczesna, Aleksandra" uniqKey="Szczesna A" first="Aleksandra" last="Szczesna">Aleksandra Szczesna</name>
<name sortKey="Tamura, Tomohide" sort="Tamura, Tomohide" uniqKey="Tamura T" first="Tomohide" last="Tamura">Tomohide Tamura</name>
<name sortKey="Tschaika, Marina" sort="Tschaika, Marina" uniqKey="Tschaika M" first="Marina" last="Tschaika">Marina Tschaika</name>
<name sortKey="Vladimirov, Vladimir" sort="Vladimirov, Vladimir" uniqKey="Vladimirov V" first="Vladimir" last="Vladimirov">Vladimir Vladimirov</name>
<name sortKey="Von Pawel, Joachim" sort="Von Pawel, Joachim" uniqKey="Von Pawel J" first="Joachim" last="Von Pawel">Joachim Von Pawel</name>
<name sortKey="Zhang, Li" sort="Zhang, Li" uniqKey="Zhang L" first="Li" last="Zhang">Li Zhang</name>
</country>
</tree>
</affiliations>
</record>

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   |area=    AustralieFrV1
   |flux=    Main
   |étape=   Exploration
   |type=    RBID
   |clé=     pubmed:28854067
   |texte=   Phase III Trial of Ipilimumab Combined With Paclitaxel and Carboplatin in Advanced Squamous Non-Small-Cell Lung Cancer.
}}

Pour générer des pages wiki

HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i   -Sk "pubmed:28854067" \
       | HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd   \
       | NlmPubMed2Wicri -a AustralieFrV1 

Wicri

This area was generated with Dilib version V0.6.33.
Data generation: Tue Dec 5 10:43:12 2017. Site generation: Tue Mar 5 14:07:20 2024