Phase III study comparing oxaliplatin plus S-1 with cisplatin plus S-1 in chemotherapy-naïve patients with advanced gastric cancer

Annals of Oncology

Volumn 26, Issue 1, 2015, Pages 141-148

  Yamada, Y ^a   Higuchi, K ^b   Nishikawa, K ^c   Gotoh, M ^d   Fuse, N ^e   Sugimoto, N ^f   Nishina, T ^g   Amagai, K ^h   Chin, K ⁱ   Niwa, Y ^j   Tsuji, A ^k   Imamura, H ^l   Tsuda, M ^m   Yasui, H ^n,q   Fujii, H ^o   Yamaguchi, K ^p   Hironaka, S ^r   Shimada, K ^s   Miwa, H ^t   Hamada, C ^u   Hyodo, I ^v   more..

^a NATIONAL CANCER CENTER HOSPITAL   (Japan)

^b KITASATO UNIVERSITY HOSPITAL   (Japan)

^c OSAKA GENERAL MEDICAL CENTER   (Japan)

^d OSAKA MEDICAL COLLEGE HOSPITAL   (Japan)

^e NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^f OSAKA MEDICAL CENTER FOR CANCER AND CARDIOVASCULAR DISEASES   (Japan)

^g NATIONAL HOSPITAL ORGANIZATION SHIKOKU CANCER CENTER   (Japan)

^h IBARAKI PREFECTURAL CENTRAL HOSPITAL   (Japan)

ⁱ CANCER INSTITUTE HOSPITAL   (Japan)

^j AICHI CANCER CENTER HOSPITAL   (Japan)

^k Kochi Health Sciences Center   (India)

^l Sakai City Medical Center   (Japan)

^m HYOGO CANCER CENTER   (Japan)

ⁿ SHIZUOKA CANCER CENTER   (Japan)

^o JICHI MEDICAL UNIVERSITY   (Japan)

^p SAITAMA CANCER CENTER   (Japan)

^q NATIONAL HOSPITAL ORGANIZATION KYOTO MEDICAL CENTER   (Japan)

^r CHIBA CANCER CENTER   (Japan)

^s SHOWA UNIVERSITY NORTHERN YOKOHAMA HOSPITAL   (Japan)

^t HYOGO COLLEGE OF MEDICINE   (Japan)

^u TOKYO UNIVERSITY OF SCIENCE   (Japan)

^v UNIVERSITY OF TSUKUBA   (Japan)

more..

Author keywords

Advanced gastric cancer; Cisplatin; Oxaliplatin; Phase III study; S 1

Indexed keywords

CISPLATIN; CREATINE; GIMERACIL PLUS OTERACIL POTASSIUM PLUS TEGAFUR; IRINOTECAN; OXALIPLATIN; ANTINEOPLASTIC AGENT; DRUG COMBINATION; OTERACIL; PLATINUM COMPLEX; S 1 (COMBINATION); TEGAFUR;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ARTICLE; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER RECURRENCE; CONTROLLED STUDY; CREATININE CLEARANCE; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPONATREMIA; INTENTION TO TREAT ANALYSIS; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUTROPENIA; OPEN STUDY; OVERALL SURVIVAL; PARALLEL DESIGN; PHASE 3 CLINICAL TRIAL; POPULATION RESEARCH; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SENSORY NEUROPATHY; SIDE EFFECT; STOMACH CANCER; THROMBOCYTOPENIA; TREATMENT RESPONSE; VERY ELDERLY; CLINICAL TRIAL; COMPARATIVE STUDY; DISEASE FREE SURVIVAL; DRUG ADMINISTRATION; DRUG COMBINATION; MIDDLE AGED; MORTALITY; STOMACH NEOPLASMS; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CISPLATIN; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; ORGANOPLATINUM COMPOUNDS; OXONIC ACID; STOMACH NEOPLASMS; TEGAFUR; YOUNG ADULT;

EID: 84924176167     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/ANNONC/MDU472     Document Type: Article

References (16)

1. Waters JS, Norman A, Cunningham D et al. Long-term survival after epirubicin, cisplatin and fluorouracil for gastric cancer: results of a randomized trial. Br J Cancer 1999; 80: 269-272
2. Vanhoefer U, Rougier P, Wilke H et al. Final results of a randomized phase III trial of sequential high-dose methotrexate, fluorouracil, and doxorubicin versus etoposide, leucovorin, and fluorouracil versus infusional fluorouracil and cisplatin in advanced gastric cancer: a trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group. J Clin Oncol 2000; 18: 2648-2657
3. 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 2006; 24: 4991-4997
4. Kang YK, Kang WK, Shin DB et al. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol 2009; 20: 666-673
5. Al-Batran SE, Hartmann JT, Probst S et al. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol 2008; 26: 1435-1442
6. Cunningham D, Starling N, Rao S et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med 2008; 358: 36-46
7. Shirasaka T. Development history and concept of an oral anticancer agent S-1 (TS-1): its clinical usefulness and future vistas. Jpn J Clin Oncol 2009; 39: 2-15
8. Boku N, Yamamoto S, Fukuda H et al. Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomised phase 3 study. Lancet Oncol 2009; 10: 1063-1069
9. Koizumi W, Narahara H, Hara T et al. S-1 plus cisplatin versus S-1 alone for firstline treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol 2008; 9: 215-221
10. Ajani JA, Rodriguez W, Bodoky G et al. Multicenter phase III comparison of cisplatin/S-1 with cisplatin/infusional fluorouracil in advanced gastric or gastroesophageal adenocarcinoma study: the FLAGS trial. J Clin Oncol 2010; 28: 1547-1553
11. Ajani JA, Buyse M, Lichinitser M et al. Combination of cisplatin/S-1 in the treatment of patients with advanced gastric or gastroesophageal adenocarcinoma: results of noninferiority and safety analyses compared with cisplatin/5-fluorouracil in the First-Line Advanced Gastric Cancer Study. Eur J Cancer 2013; 49: 3616-3624
12. Koizumi W, Takiuchi H, Yamada Y et al. Phase II study of oxaliplatin plus S-1 as first-line treatment for advanced gastric cancer (G-SOX study). Ann Oncol 2010; 21: 1001-1005
13. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975; 31: 103-115
14. Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000; 92: 205-216
15. Comets E, Ikeda K, HoffP et al. Comparison of the pharmacokinetics of S-1, an oral anticancer agent, in Western and Japanese patients. J Pharmacokinet Pharmacodyn 2003; 30: 257-283
16. Chuah B, Goh BC, Lee SC et al. Comparison of the pharmacokinetics and pharmacodynamics of S-1 between Caucasian and East Asian patients. Cancer Sci 2011; 102: 478-483