PMID- 28841387 OWN - NLM STAT- MEDLINE DCOM- 20171211 LR - 20240210 IS - 1527-7755 (Electronic) IS - 0732-183X (Print) IS - 0732-183X (Linking) VI - 35 IP - 34 DP - 2017 Dec 1 TI - Efficacy and Safety Outcomes in Patients With Advanced Melanoma Who Discontinued Treatment With Nivolumab and Ipilimumab Because of Adverse Events: A Pooled Analysis of Randomized Phase II and III Trials. PG - 3807-3814 LID - 10.1200/JCO.2017.73.2289 [doi] AB - Purpose Approximately 40% of patients with advanced melanoma who received nivolumab combined with ipilimumab in clinical trials discontinued treatment because of adverse events (AEs). We conducted a retrospective analysis to assess the efficacy and safety of nivolumab plus ipilimumab in patients who discontinued treatment because of AEs. Methods Data were pooled from phase II and III trials of patients who received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, every 3 weeks for four doses, followed by nivolumab monotherapy 3 mg/kg every 2 weeks (N = 409). Efficacy was assessed in all randomly assigned patients who discontinued because of AEs during the induction phase (n = 96) and in those who did not discontinue because of AEs (n = 233). Safety was assessed in treated patients who discontinued because of AEs (n = 176) at any time and in those who did not discontinue because of AEs (n = 231). Results At a minimum follow-up of 18 months, median progression-free survival was 8.4 months for patients who discontinued treatment because of AEs during the induction phase and 10.8 months for patients who did not discontinue because of AEs ( P = .97). Median overall survival had not been reached in either group ( P = .23). The objective response rate was 58.3% for patients who discontinued because of AEs during the induction phase and 50.2% for patients who did not discontinue. The vast majority of grade 3 or 4 AEs occurred during the induction phase, with most resolving after appropriate management. Conclusion Efficacy outcomes seemed similar between patients who discontinued nivolumab plus ipilimumab treatment because of AEs during the induction phase and those who did not discontinue because of AEs. Therefore, even after discontinuation, many patients may continue to derive benefit from combination therapy. FAU - Schadendorf, Dirk AU - Schadendorf D AD - Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Universite, Assistance Publique Hopitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Universite Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom. FAU - Wolchok, Jedd D AU - Wolchok JD AD - Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Universite, Assistance Publique Hopitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Universite Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom. FAU - Hodi, F Stephen AU - Hodi FS AD - Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Universite, Assistance Publique Hopitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Universite Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom. FAU - Chiarion-Sileni, Vanna AU - Chiarion-Sileni V AD - Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Universite, Assistance Publique Hopitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Universite Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom. FAU - Gonzalez, Rene AU - Gonzalez R AD - Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Universite, Assistance Publique Hopitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Universite Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom. FAU - Rutkowski, Piotr AU - Rutkowski P AD - Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Universite, Assistance Publique Hopitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Universite Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom. FAU - Grob, Jean-Jacques AU - Grob JJ AD - Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Universite, Assistance Publique Hopitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Universite Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom. FAU - Cowey, C Lance AU - Cowey CL AD - Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Universite, Assistance Publique Hopitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Universite Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom. FAU - Lao, Christopher D AU - Lao CD AD - Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Universite, Assistance Publique Hopitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Universite Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom. FAU - Chesney, Jason AU - Chesney J AD - Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Universite, Assistance Publique Hopitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Universite Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom. FAU - Robert, Caroline AU - Robert C AD - Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Universite, Assistance Publique Hopitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Universite Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom. FAU - Grossmann, Kenneth AU - Grossmann K AD - Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Universite, Assistance Publique Hopitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Universite Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom. FAU - McDermott, David AU - McDermott D AD - Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Universite, Assistance Publique Hopitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Universite Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom. FAU - Walker, Dana AU - Walker D AD - Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Universite, Assistance Publique Hopitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Universite Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom. FAU - Bhore, Rafia AU - Bhore R AD - Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Universite, Assistance Publique Hopitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Universite Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom. FAU - Larkin, James AU - Larkin J AD - Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Universite, Assistance Publique Hopitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Universite Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom. FAU - Postow, Michael A AU - Postow MA AD - Dirk Schadendorf, University Hospital Essen and the German Cancer Consortium, Essen, Germany; Jedd D. Wolchok and Michael A. Postow, Memorial Sloan Kettering Cancer Center; Michael A. Postow, Weill Cornell Medical College, New York, NY; F. Stephen Hodi, Dana-Farber Cancer Institute; David McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Vanna Chiarion-Sileni, Istituto Oncologico Veneto, Veneto, Italy; Rene Gonzalez, University of Colorado Denver, Aurora, CO; Piotr Rutkowski, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; Jean-Jacques Grob, Aix-Marseille Universite, Assistance Publique Hopitaux de Marseille Timone, Marseille; Caroline Robert, Gustave Roussy and Universite Paris-Sud, Paris, France; C. Lance Cowey, Texas Oncology-Baylor Cancer Center, Dallas, TX; Christopher D. Lao, University of Michigan, Ann Arbor, MI; Jason Chesney, University of Louisville, Louisville, KY; Kenneth Grossmann, Huntsman Cancer Institute, Salt Lake City, UT; Dana Walker and Rafia Bhore, Bristol-Myers Squibb, Princeton, NJ; and James Larkin, Royal Marsden Hospital, London, United Kingdom. LA - eng GR - 20265/CRUK_/Cancer Research UK/United Kingdom GR - P30 CA008748/CA/NCI NIH HHS/United States PT - Evaluation Study PT - Journal Article DEP - 20170825 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Antibodies, Monoclonal) RN - 0 (Ipilimumab) RN - 31YO63LBSN (Nivolumab) SB - IM CIN - J Clin Oncol. 2017 Dec 1;35(34):3792-3793. PMID: 29048973 CIN - J Clin Oncol. 2018 Mar 1;36(7):722-723. PMID: 29337635 CIN - J Clin Oncol. 2018 Mar 1;36(7):720-721. PMID: 29337638 CIN - J Clin Oncol. 2018 Mar 1;36(7):721. PMID: 29337639 MH - Antibodies, Monoclonal/administration & dosage/*adverse effects MH - Clinical Trials, Phase II as Topic MH - Clinical Trials, Phase III as Topic MH - Databases, Factual MH - Disease-Free Survival MH - Dose-Response Relationship, Drug MH - Drug Administration Schedule MH - Drug Therapy, Combination MH - Female MH - Humans MH - Ipilimumab/administration & dosage/*adverse effects MH - Kaplan-Meier Estimate MH - Male MH - Melanoma/*drug therapy/*mortality/pathology MH - Neoplasm Invasiveness/pathology MH - Neoplasm Staging MH - Nivolumab MH - Patient Safety/statistics & numerical data MH - Prognosis MH - Proportional Hazards Models MH - Randomized Controlled Trials as Topic MH - Retrospective Studies MH - Skin Neoplasms/*drug therapy/*mortality/pathology MH - Statistics, Nonparametric MH - Survival Analysis MH - Treatment Outcome MH - Withholding Treatment PMC - PMC5791828 EDAT- 2017/08/26 06:00 MHDA- 2017/12/12 06:00 PMCR- 2018/01/01 CRDT- 2017/08/26 06:00 PHST- 2017/08/26 06:00 [pubmed] PHST- 2017/12/12 06:00 [medline] PHST- 2017/08/26 06:00 [entrez] PHST- 2018/01/01 00:00 [pmc-release] AID - 732289 [pii] AID - 10.1200/JCO.2017.73.2289 [doi] PST - ppublish SO - J Clin Oncol. 2017 Dec 1;35(34):3807-3814. doi: 10.1200/JCO.2017.73.2289. Epub 2017 Aug 25.