Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial

The Lancet

Volumn 390, Issue 10111, 2017, Pages 2461-2471

  Kang, Yoon Koo ^a   Boku, Narikazu ^b   Satoh, Taroh ^c   Ryu, Min Hee ^a   Chao, Yee ^d   Kato, Ken ^b   Chung, Hyun Cheol ^e   Chen, Jen Shi ^f   Muro, Kei ^g   Kang, Won Ki ^h   Yeh, Kun Huei ⁱ   Yoshikawa, Takaki ^j   Oh, Sang Cheul ^k   Bai, Li Yuan ^l   Tamura, Takao ^m   Lee, Keun Wook ⁿ   Hamamoto, Yasuo ^o   Kim, Jong Gwang ^p   Chin, Keisho ^q   Oh, Do Youn ^r   Minashi, Keiko ^s   Cho, Jae Yong ^t   Tsuda, Masahiro ^u   Chen, Li Tzong ^v,w   more..

^a University of Ulsan College of Medicine   (South Korea)

^b NATIONAL CANCER CENTER HOSPITAL   (Japan)

^c OSAKA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^d TAIPEI VETERANS GENERAL HOSPITAL   (Taiwan)

^e Yonsei University College of Medicine   (South Korea)

^f CHANG GUNG UNIVERSITY   (Taiwan)

^g AICHI CANCER CENTER HOSPITAL   (Japan)

^h Sungkyunkwan University School of Medicine   (South Korea)

ⁱ NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^j KANAGAWA CANCER CENTER   (Japan)

^k Korea University College of Medicine   (South Korea)

^l CHINA MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

^m KINKI UNIVERSITY   (Japan)

ⁿ Seoul National University Bundang Hospital   (South Korea)

^o KEIO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^p Kyungpook National University School of Medicine   (South Korea)

^q CANCER INSTITUTE HOSPITAL   (Japan)

^r Seoul National University Hospital   (South Korea)

^s CHIBA CANCER CENTER   (Japan)

^t Yonsei University College of Medicine   (South Korea)

^u HYOGO CANCER CENTER   (Japan)

^v NATIONAL HEALTH RESEARCH INSTITUTES   (Taiwan)

^w NATIONAL CHENG KUNG UNIVERSITY HOSPITAL   (Taiwan)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; IMMUNOGLOBULIN G4; IRINOTECAN; NIVOLUMAB; PLACEBO; PROGRAMMED DEATH 1 LIGAND 1; PYRIMIDINE; RAMUCIRUMAB; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ACUTE HEPATITIS; ADULT; ADVANCED CANCER; AGED; ARTICLE; AUTOIMMUNE THYROIDITIS; CANCER CHEMOTHERAPY; CANCER FATIGUE; CANCER GRADING; CANCER SURGERY; CANCER SURVIVAL; COLITIS; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DIGESTIVE SYSTEM PERFORATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; ELECTROCORTICOGRAPHY; FEMALE; FEVER; GASTRECTOMY; GASTROESOPHAGEAL JUNCTION; GASTROESOPHAGEAL JUNCTION CANCER; HEART ARREST; HUMAN; HYPERTHYROIDISM; HYPOPITUITARISM; INTENTION TO TREAT ANALYSIS; INTERSTITIAL LUNG DISEASE; MACULOPAPULAR RASH; MAJOR CLINICAL STUDY; MALE; MUSCLE WEAKNESS; NAUSEA; OVERALL SURVIVAL; PATIENT HISTORY OF CHEMOTHERAPY; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SOUTH KOREA; STOMACH CANCER; TAIWAN; URINARY TRACT INFECTION; ADENOCARCINOMA; CLINICAL TRIAL; MIDDLE AGED; MORTALITY; STOMACH TUMOR; TREATMENT FAILURE;

ADENOCARCINOMA; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; DOUBLE-BLIND METHOD; ESOPHAGOGASTRIC JUNCTION; FEMALE; HUMANS; MALE; MIDDLE AGED; STOMACH NEOPLASMS; TREATMENT FAILURE;

EID: 85030626436     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(17)31827-5     Document Type: Article

References (34)

1. Ferlay, J, Soerjomataram, I, Dikshit, R, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer 136 (2015), E359–E386.
2. International Agency for Research on Cancer. GLOBOCAN 2012: Estimated cancer incidence, mortality and prevalence worldwide in. http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx, 2012 (accessed July 14, 2016).
3. Ohtsu, A, Yoshida, S, Saijo, N, Disparities in gastric cancer chemotherapy between the East and West. J Clin Oncol 24 (2006), 2188–2196.
4. Sugano, S, Screening of gastric cancer in Asia. Best Pract Res Clin Gastroenterol 29 (2015), 895–905.
5. Ajani, JA, D'Amico, TA, Almhanna, K, et al. Gastric cancer, version 3. 2016, NCCN Clinical Pratice Guidelines in Oncology. J Natl Compr Canc Netw 14 (2016), 1286–1312.
6. Smyth, EC, Verheij, M, Allum, W, et al. Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment, and follow-up. Ann Oncol 27:suppl 5 (2016), v38–v49.
7. Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer 20 (2017), 1–9.
8. Shen, L, Shan, YS, Hu, HM, et al. Management of gastric cancer in Asia: resource-stratified guidelines. Lancet Oncol 14 (2013), e535–e547.
9. Ford, HE, Marshall, A, Bridgewater, JA, et al. Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial. Lancet Oncol 15 (2014), 78–86.
10. Thuss-Patience, PC, Kretzschmar, A, Bichev, D, et al. Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer—a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer 47 (2011), 2306–2314.
11. Kang, JH, Lee, SI, Lim do, H, et al. Salvage chemotherapy for pretreated gastric cancer: a randomized phase III trial comparing chemotherapy plus best supportive care with best supportive care alone. J Clin Oncol 30 (2012), 1513–1518.
12. Hironaka, S, Ueda, S, Yasui, H, et al. Randomized, open-label, phase III study comparing irinotecan with paclitaxel in patients with advanced gastric cancer without severe peritoneal metastasis after failure of prior combination chemotherapy using fluoropyrimidine plus platinum: WJOG 4007 trial. J Clin Oncol 31 (2013), 4438–4444.
13. Fuchs, CS, Tomasek, J, Yong, CJ, et al. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet 383 (2014), 31–39.
14. Wilke, H, Muro, K, Van Cutsem, E, et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol 15 (2014), 1224–1235.
15. Sharma, P, Allison, JP, Immune checkpoint targeting in cancer therapy: toward combination strategies with curative potential. Cell 161 (2015), 205–214.
16. Ferris, RL, Blumenschein, G Jr, Fayette, J, et al. Nivolumab for recurrent squamous-cell carcinoma of the head and neck. N Engl J Med 375 (2016), 1856–1867.
17. 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 (2015), 1627–1639.
18. Motzer, RJ, Escudier, B, McDermott, DF, et al. Nivolumab versus everolimus in advanced Renal-cell carcinoma. N Engl J Med 373 (2015), 1803–1813.
19. Larkin, J, Chiarion-Sileni, V, Gonzalez, R, et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med 373 (2015), 23–34.
20. Yuan, J, Zhang, J, Zhu, Y, et al. Programmed death-ligand-1 expression in advanced gastric cancer detected with RNA in situ hybridization and its clinical significance. Oncotarget 7 (2016), 39671–39679.
21. Kawazoe, A, Kuwata, T, Kuboiki, Y, et al. Clinicopathological features of programed death ligand 1 expression with tumor-infiltrating lymphocyte, mismatch repair, and Epstein-Barr virus status in a large cohort of gastric cancer patients. Gastric Cancer 20 (2017), 407–415.
22. Zhang, M, Dong, Y, Liu, H, et al. The clinicopathological and prognostic significance of PD-L1 expression in gastric cancer: a meta-analysis of 10 studies with 1,901 patients. Sci Rep 6 (2016), 1–9.
23. Janjigian YY, Ott PA, Calvo E, et al. Nivolumab ± ipilimumab in pts with advanced (adv)/metastatic chemotherapy-refractory (CTx-R) gastric (G), esophageal (E), or gastroesophageal junction (GEJ) cancer: CheckMate 032 study. ASCO General Meeting; Chicago, IL; June 2–4, 2017. 4014.
24. Muro, K, Chung, HC, Shankaran, V, et al. Pembrolizumab for patients with PD-L1-positive advanced gastric cancer (KEYNOTE-012): a multicentre, open-label, phase 1b trial. Lancet Oncol 17 (2016), 717–726.
25. 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 (2009), 228–247.
26. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf, 2010 (accessed April 13, 2017).
27. Li, J, Qin, S, Xu, J, et al. Randomized, double-blind, placebo-controlled phase III trial of apatinib in patients with chemotherapy-refractory advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction. J Clin Oncol 34 (2016), 1448–1454.
28. Cancer Genome Atlas Research Network. Comprehensive molecular characterization of gastric adenocarcinoma. Nature 513 (2014), 202–209.
29. Le, DT, Uram, JN, Wang, H, et al. PD-1 Blockade in tumors with mismatch-repair deficiency. N Engl J Med 372 (2015), 2509–2520.
30. Johnson, DB, Frampton, GM, Rioth, MJ, et al. Targeted next generation sequencing identifies markers of response to PD-1 blockade. Cancer Immunol Res 4 (2016), 959–967.
31. Van Cutsem, E, Moiseyenko, VM, Tjulandin, S, et al. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol 24 (2006), 4991–4997.
32. Koizumi, W, Narahara, H, Hara, T, et al. S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol 9 (2008), 215–221.
33. Ohtsu, A, Shah, MA, Van Cutsem, E, et al. Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol 29 (2011), 3968–3976.
34. Lin, SJ, Gagnon-Bartsch, JA, Tan, IB, et al. Signatures of tumour immunity distinguish Asian and non-Asian gastric carcinomas. Gut 64 (2015), 1721–1731.