Efficacy and safety of nivolumab in Japanese patients with previously untreated advanced melanoma: A phase II study

Cancer Science

Volumn 108, Issue 6, 2017, Pages 1223-1230

  Yamazaki, Naoya ^a   Kiyohara, Yoshio ^b   Uhara, Hisashi ^c   Uehara, Jiro ^d   Fujimoto, Manabu ^e   Takenouchi, Tatsuya ^f   Otsuka, Masaki ^g   Uchi, Hiroshi ^h   Ihn, Hironobu ⁱ   Minami, Hironobu ^j  

^a NATIONAL CANCER CENTER HOSPITAL   (Japan)

^b SHIZUOKA CANCER CENTER   (Japan)

^c SHINSHU UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^d ASAHIKAWA MEDICAL COLLEGE   (Japan)

^e UNIVERSITY OF TSUKUBA HOSPITAL   (Japan)

^f NIIGATA CANCER CENTER HOSPITAL   (Japan)

^g OKAYAMA UNIVERSITY   (Japan)

^h KYUSHU UNIVERSITY   (Japan)

ⁱ KUMAMOTO UNIVERSITY   (Japan)

^j KOBE UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

more..

Author keywords

Immune checkpoint inhibitor; Japanese patients; melanoma; nivolumab; programmed death 1 (PD 1) inhibitor

Indexed keywords

B RAF KINASE; CORTICOSTEROID; DACARBAZINE; LACTATE DEHYDROGENASE; NIVOLUMAB; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ADULT; ADVANCED CANCER; ADVERSE OUTCOME; AGED; ANTINEOPLASTIC ACTIVITY; APPETITE DISORDER; ARTHRALGIA; ARTICLE; CANCER RECURRENCE; CANCER STAGING; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL EVALUATION; COLITIS; CONTROLLED STUDY; DISEASE COURSE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EARLY DIAGNOSIS; ENDOCRINE DISEASE; FEMALE; GASTROINTESTINAL TOXICITY; GENOTYPE; HUMAN; HYPOTHYROIDISM; JAPANESE (PEOPLE); KIDNEY DYSFUNCTION; LIVER DYSFUNCTION; LIVER TOXICITY; LUNG TOXICITY; MACULOPAPULAR RASH; MALAISE; MALE; MANAGED CARE; MELANOMA; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEPHROTOXICITY; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; PRIORITY JOURNAL; PRURITUS; SIDE EFFECT; SKIN TOXICITY; TREATMENT DURATION; TREATMENT RESPONSE; VITILIGO; WEIGHT REDUCTION; ASIAN CONTINENTAL ANCESTRY GROUP; CLINICAL TRIAL; DISEASE FREE SURVIVAL; METABOLISM; SURVIVAL RATE; TUMOR RECURRENCE;

AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; ASIAN CONTINENTAL ANCESTRY GROUP; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; MALE; MELANOMA; NEOPLASM RECURRENCE, LOCAL; PROTO-ONCOGENE PROTEINS B-RAF; SURVIVAL RATE;

EID: 85021175906     PISSN: 13479032     EISSN: 13497006     Source Type: Journal    
DOI: 10.1111/cas.13241     Document Type: Article

References (35)

1. Avril MF, Aamdal S, Grob JJ et al. Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: a phase III study. J Clin Oncol 2004; 22: 1118–25.
2. Middleton MR, Grob JJ, Aaronson N et al. Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol 2000; 18: 158–66.
3. Balch CM, Buzaid AC, Soong SJ et al. Final version of the American Joint Committee on Cancer staging system for cutaneous melanoma. J Clin Oncol 2001; 19: 3635–48.
4. Balch CM, Gershenwald JE, Soong SJ et al. Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol 2009; 27: 6199–206.
5. Freeman GJ, Long AJ, Iwai Y et al. Engagement of the PD-1 immunoinhibitory receptor by a novel B7 family member leads to negative regulation of lymphocyte activation. J Exp Med 2000; 192: 1027–34.
6. Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer 2012; 12: 252–64.
7. Ishida Y, Agata Y, Shibahara K, Honjo T. Induced expression of PD-1, a novel member of the immunoglobulin gene superfamily, upon programmed cell death. EMBO J 1992; 11: 3887–95.
8. Dong H, Strome SE, Salomao DR et al. Tumor-associated B7-H1 promotes T-cell apoptosis: a potential mechanism of immune evasion. Nat Med 2002; 8: 793–800.
9. Latchman Y, Wood CR, Chernova T et al. PD-L2 is a second ligand for PD-1 and inhibits T cell activation. Nat Immunol 2001; 2: 261–8.
10. Hino R, Kabashima K, Kato Y et al. Tumor cell expression of programmed cell death-1 ligand 1 is a prognostic factor for malignant melanoma. Cancer 2010; 116: 1757–66.
11. Weber JS, D'Angelo SP, Minor D et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol 2015; 16: 375–84.
12. Robert C, Long GV, Brady B et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med 2015; 372: 320–30.
13. Larkin J, Chiarion-Sileni V, Gonzalez R et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med 2015; 373: 23–34.
14. Oken MM, Creech RH, Tormey DC et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982; 5: 649–55.
15. Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45: 228–47.
16. Yamazaki N, Tahara H, Uhara H, Moroi Y, Kiyohara Y. Phase 2 study of nivolumab (Anti-PD-1; ONO-4538/BMS-936558) in patients with advanced melanoma [abstract no. 3738]. Eur J Cancer. 2013; 49 (Suppl 2): S868.
17. McDermott DF, Drake CG, Sznol M et al. Survival, durable response, and long-term safety in patients with previously treated advanced renal cell carcinoma receiving Nivolumab. J Clin Oncol 2015; 33: 2013–20.
18. Motzer RJ, Escudier B, McDermott DF et al. Nivolumab versus everolimus in advanced renal-cell carcinoma. N Engl J Med 2015; 373: 1803–13.
19. Brahmer J, Reckamp KL, Baas P et al. Nivolumab versus Docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med 2015; 373: 123–35.
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 2015; 373: 1627–39.
21. Gettinger SN, Horn L, Gandhi L et al. Overall survival and long-term safety of nivolumab (anti-programmed death 1 antibody, BMS-936558, ONO-4538) in patients with previously treated advanced non-small-cell lung cancer. J Clin Oncol 2015; 33: 2004–12.
22. Ansell SM, Lesokhin AM, Borrello I et al. PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma. N Engl J Med 2015; 372: 311–9.
23. Lesokhin AM, Ansell SM, Armand P et al. Nivolumab in patients with relapsed or refractory hematologic malignancy: preliminary results of a phase Ib study. J Clin Oncol 2016; 34: 2698–704.
24. Hamanishi J, Mandai M, Ikeda T et al. Safety and antitumor activity of anti-PD-1 antibody, nivolumab, in patients with platinum-resistant ovarian cancer. J Clin Oncol 2015; 33: 4015–22.
25. Weber JS, Kudchadkar RR, Yu B et al. Safety, efficacy, and biomarkers of nivolumab with vaccine in ipilimumab-refractory or -naive melanoma. J Clin Oncol 2013; 31: 4311–8.
26. Larkin J, Lao CD, Urba WJ et al. Efficacy and safety of nivolumab in patients with BRAF V600 mutant and BRAF wild-type advanced melanoma: a pooled analysis of 4 clinical trials. JAMA Oncol 2015; 1: 433–40.
27. Long GV, Menzies AM, Nagrial AM et al. Prognostic and clinicopathologic associations of oncogenic BRAF in metastatic melanoma. J Clin Oncol 2011; 29: 1239–46.
28. Flaherty KT, Puzanov I, Kim KB et al. Inhibition of mutated, activated BRAF in metastatic melanoma. N Engl J Med 2010; 363: 809–19.
29. Arozarena I, Sanchez-Laorden B, Packer L et al. Oncogenic BRAF induces melanoma cell invasion by downregulating the cGMP-specific phosphodiesterase PDE5A. Cancer Cell 2011; 19: 45–57.
30. Gogas H, Eggermont AM, Hauschild A et al. Biomarkers in melanoma. Ann Oncol 2009; 20 Suppl 6: vi8–13.
31. Nakamura Y, Kitano S, Takahashi A et al. Nivolumab for advanced melanoma: pretreatment prognostic factors and early outcome markers during therapy. Oncotarget 2016; 7: 77404–15.
32. Freeman-Keller M, Kim Y, Cronin H, Richards A, Gibney G, Weber JS. Nivolumab in resected and unresectable metastatic melanoma: characteristics of immune-related adverse events and association with outcomes. Clin Cancer Res 2016; 22: 886–94.
33. Belum VR, Benhuri B, Postow MA et al. Characterisation and management of dermatologic adverse events to agents targeting the PD-1 receptor. Eur J Cancer 2016; 60: 12–25.
34. Weber JS, Hodi FS, Wolchok JD et al. Safety profile of nivolumab monotherapy: a pooled analysis of patients with advanced melanoma. J Clin Oncol 2016; 35: 785–92.
35. Bowyer S, Prithviraj P, Lorigan P et al. Efficacy and toxicity of treatment with the anti-CTLA-4 antibody ipilimumab in patients with metastatic melanoma after prior anti-PD-1 therapy. Br J Cancer 2016; 114: 1084–9.