Nivolumab in combination with platinum-based doublet chemotherapy for first-line treatment of advanced non-small-cell lung cancer

Journal of Clinical Oncology

Volumn 34, Issue 25, 2016, Pages 2969-2979

  Rizvi, Naiyer A ^a,l,m   Hellmann, Matthew D ^a   Brahmer, Julie R ^b   Juergens, Rosalyn A ^c   Borghaei, Hossein ^f   Gettinger, Scott ^g   Chow, Laura Q ^h   Gerber, David E ⁱ   Laurie, Scott A ^d   Goldman, Jonathan W ^j   Shepherd, Frances A ^e   Chen, Allen C ^k   Shen, Yun ^k   Nathan, Faith E ^k   Harbison, Christopher T ^k   Antonia, Scott ^k  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b JOHNS HOPKINS UNIVERSITY   (United States)

^c Juravinski Cancer Centre   (United States)

^d MCMASTER UNIVERSITY   (Canada)

^e OTTAWA REGIONAL CANCER CENTRE   (Canada)

^f PRINCESS MARGARET HOSPITAL   (Canada)

^g FOX CHASE CANCER CENTER   (United States)

^h YALE CANCER CENTER   (United States)

ⁱ UNIVERSITY OF WASHINGTON   (United States)

^j UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^k UNIVERSITY OF CALIFORNIA   (United States)

^l H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^m NewYork Presbyterian Hospital   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CARBOPLATIN; CISPLATIN; GEMCITABINE; NIVOLUMAB; PACLITAXEL; PEMETREXED; PROGRAMMED DEATH 1 LIGAND 1; ANTINEOPLASTIC AGENT; CD274 PROTEIN, HUMAN; DEOXYCYTIDINE; EGFR PROTEIN, HUMAN; EPIDERMAL GROWTH FACTOR RECEPTOR; KRAS PROTEIN, HUMAN; MONOCLONAL ANTIBODY; PROTEIN P21;

ACUTE KIDNEY FAILURE; ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTHRALGIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER CYTODIAGNOSIS; CANCER FATIGUE; CANCER GRADING; CANCER GROWTH; CANCER PAIN; CANCER STAGING; CANCER SURVIVAL; CONSTIPATION; COUGHING; DECREASED APPETITE; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY SKIN; DYSGEUSIA; EPISTAXIS; FEMALE; FEVER; FLU LIKE SYNDROME; HEADACHE; HUMAN; HYPERSENSITIVITY; HYPERTHYROIDISM; HYPESTHESIA; HYPOMAGNESEMIA; HYPOTHYROIDISM; IMMUNE COMPLEX NEPHRITIS; INFUSION RELATED REACTION; INTERSTITIAL NEPHRITIS; LEUKOPENIA; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL DISEASE; MUSCULOSKELETAL PAIN; MYALGIA; NAUSEA; NEUROPATHY; NEUTROPENIA; NON SMALL CELL LUNG CANCER; OVERALL SURVIVAL; PERIPHERAL NEUROPATHY; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; PRURITUS; RASH; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; SIDE EFFECT; THROMBOCYTOPENIA; TINNITUS; TREATMENT RESPONSE; TUMOR VOLUME; VOMITING; ANALOGS AND DERIVATIVES; BIOSYNTHESIS; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; COHORT ANALYSIS; DISEASE FREE SURVIVAL; DOSE RESPONSE; GENETICS; LUNG NEOPLASMS; METABOLISM; MIDDLE AGED; PHASE 1 CLINICAL TRIAL; SURVIVAL RATE;

AGED; ANTIBODIES, MONOCLONAL; ANTIGENS, CD274; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; CARCINOMA, NON-SMALL-CELL LUNG; CISPLATIN; COHORT STUDIES; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; PEMETREXED; PROTO-ONCOGENE PROTEINS P21(RAS); RECEPTOR, EPIDERMAL GROWTH FACTOR; SURVIVAL RATE;

EID: 84983598249     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2016.66.9861     Document Type: Article

References (39)

1. National Comprehensive Cancer Network: National Comprehensive Cancer Network Guidelines in Oncology. Non-Small Cell Lung Cancer Version 7.2015. www.nccn.org/professionals/physician-gls/ f-guidelines.asp
2. Kelly K, Crowley J, Bunn PA Jr, et al: Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advancednon-small-cell lung cancer: A Southwest Oncology Group trial. J Clin Oncol 19: 3210-3218, 2001
3. Sandler A, Gray R, Perry MC, et al: Paclitaxelcarboplatin alone or with bevacizumab for nonsmall-cell lung cancer. N Engl J Med 355:2542-2550, 2006
4. Scagliotti GV, De Marinis F, Rinaldi M, et al: Phase III randomized trial comparing three platinumbased doublets in advanced non-small-cell lung cancer. J Clin Oncol 20:4285-4291, 2002
5. Scagliotti GV, Parikh P, von Pawel J, et al: Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapynaive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 26:3543-3551, 2008
6. Schiller JH, Harrington D, Belani CP, et al: Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346: 92-98, 2002
7. Barlesi F, Scherpereel A, Gorbunova V, et al: Maintenance bevacizumab-pemetrexed after first-line cisplatin-pemetrexed-bevacizumab for advanced nonsquamous nonsmall-cell lung cancer: Updated survival analysis of the AVAPERL (MO22089) randomized phase III trial. Ann Oncol 25:1044-1052, 2014
8. Scagliotti GV, Gridelli C, de Marinis F, et al: Efficacy and safety of maintenance pemetrexed in patients with advanced nonsquamous non-small cell lung cancer following pemetrexed plus cisplatin induction treatment: A cross-trial comparison of two phase III trials. Lung Cancer 85:408-414, 2014
9. Patel JD, Socinski MA, Garon EB, et al: PointBreak: A randomized phase III study of pemetrexed plus carboplatin and bevacizumab followed by maintenance pemetrexed and bevacizumab versus paclitaxel plus carboplatin and bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. J Clin Oncol 31:4349-4357, 2013
10. Chang A: Chemotherapy, chemoresistance and the changing treatment landscape for NSCLC. Lung Cancer 71:3-10, 2011
11. Chang CL, Hsu YT, Wu CC, et al: Dose-dense chemotherapy improves mechanisms of antitumor immune response. Cancer Res 73:119-127, 2013
12. Apetoh L, Ghiringhelli F, Tesniere A, et al: Tolllike receptor 4-dependent contribution of the immune system to anticancer chemotherapy and radiotherapy. Nat Med 13:1050-1059, 2007
13. Zitvogel L, Apetoh L, Ghiringhelli F, et al: Immunological aspects of cancer chemotherapy. Nat Rev Immunol 8:59-73, 2008
14. Hato SV, Khong A, de Vries IJ, et al: Molecular pathways: The immunogenic effects of platinumbased chemotherapeutics. Clin Cancer Res 20: 2831-2837, 2014
15. Nowak AK, Robinson BWS, Lake RA: Gemcitabine exerts a selective effect on the humoral immune response: Implications for combination chemo-immunotherapy. Cancer Res 62:2353-2358, 2002
16. Suzuki E, Kapoor V, Jassar AS, et al: Gemcitabine selectively eliminates splenic Gr-1+/CD11b+ myeloid suppressor cells in tumor-bearing animals and enhances antitumor immune activity. Clin Cancer Res 11:6713-6721, 2005
17. Brahmer JR, Drake CG, Wollner I, et al: Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: Safety, clinical activity, pharmacodynamics, and immunologic correlates. J Clin Oncol 28:3167-3175, 2010
18. Wang C, Thudium KB, Han M, et al: In vitro characterization of the anti-PD-1 antibody nivolumab, BMS-936558, and in vivo toxicology in nonhuman primates. Cancer Immunol Res 2:846-856, 2014
19. Brahmer JR, Reckamp K, Baas P, et al: Nivolumab versus docetaxel in advanced squamous nonsmall cell lung cancer. N Engl J Med 373:123-135, 2015
20. Borghaei H, Paz-Ares L, Horn L, et al: Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med 373: 1627-1639, 2015
21. Bristol-Myers Squibb: OPDIVO (nivolumab) [package insert]. Princeton, NJ, Bristol-Myers Squibb, 2015
22. European Medicines Agency: European public assessment report (EPAR) for nivolumab BMS product information: Summary of product characteristics. http://www.ema.europa.eu/docs/en-GB/ document-library/EPAR-Product-Information/human/ 003985/WC500189765.pdf
23. Gettinger SN, Hellmann MD, Shepherd FA, et al: First-line monotherapy with nivolumab (NIVO) in advanced non-small cell lung cancer (NSCLC): Safety, efficacy, and biomarker analyses. European Cancer Conference 2015, Vienna, Austria, January 25-29, 2015 (abstr P348)
24. Eisenhauer EA, Therasse P, Bogaerts J, et al: New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 45:228-247, 2009
25. Ji Y, Liu P, Li Y, et al: A modified toxicity probability interval method for dose-finding trials. Clin Trials 7:653-663, 2010
26. Topalian SL, Hodi FS, Brahmer JR, et al: Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 366:2443-2454, 2012
27. Goldstraw P: International Association for the Study of Lung Cancer: Staging Manual in Thoracic Oncology. Orange Park, FL, Editorial Rx Press, 2009
28. National Cancer Institute: Common Terminology Criteria for Adverse Events v4.0 NCI, NIH, DHHS. May 29, 2009 (v4.03: June 14, 2010) NIH publication # 09-7473. http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE- 4.03-2010-06-14-QuickReference-8.5x11.pdf
29. Clopper CJ, Pearson ES: The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 26:404-413, 1934
30. Greenwood M: The Natural Duration of Cancer. Reports on Public Health and Medical Subjects 33: 1-26. London, United Kingdom, HM Stationery Office, 1926
31. Syrigos KN, Vansteenkiste J, Parikh P, et al: Prognostic and predictive factors in a randomized phase III trial comparing cisplatin-pemetrexed versus cisplatin-gemcitabine in advanced non-smallcell lung cancer. Ann Oncol 21:556-561, 2010
32. Gettinger S, Rizvi NA, Chow LQ, et al: Nivolumab monotherapy for first-line treatment of advanced non-small-cell lung cancer. J Clin Oncol 34: 2980-2987, 2016
33. Garon EB, Gandhi L, Rizvi N, et al: Antitumor activity of pembrolizumab (Pembro; MK-3475) and correlation with programmed death ligand 1 (PD-L1) expression in a pooled analysis of patients (pts) with advanced non-small cell lung cancer (NSCLC). Ann Oncol 25:1-41, 2014
34. Garon EB, Rizvi NA, Hui R, et al: Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med 372:2018-2028, 2015
35. Soria JC, Cruz C, Bahleda R, et al: Clinical activity, safety and biomarkers of PD-L1 blockade in non-small cell lung cancer (NSCLC): Additional analyses from a clinical study of the engineered antibody MPDL3280A (anti-PDL1). Eur J Cancer 49, 2013 (suppl 2, abstr 3408)
36. Rizvi NA, Mazières J, Planchard D, et al: Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (Check-Mate 063): A phase 2, single-arm trial. Lancet Oncol 16: 257-265, 2015
37. Herbst RS, Soria JC, Kowanetz M, et al: Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature 515: 563-567, 2014
38. Rizvi NA, Hellmann MD, Snyder A, et al: Cancer immunology: Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science 348:124-128, 2015
39. Champiat S, Ferté C, Lebel-Binay S, et al: Exomics and immunogenics: Bridging mutational load and immune checkpoints efficacy. Oncoimmunology 3:e27817, 2014