Randomized phase II trial of first-line treatment with tailored irinotecan and S-1 therapy versus S-1 monotherapy for advanced or recurrent gastric carcinoma (JFMC31-0301)

Anti-Cancer Drugs

Volumn 22, Issue 6, 2011, Pages 576-583

  Komatsu, Yoshito ^a   Takahashi, Yutaka ^b   Kimura, Yutaka ^c   Oda, Hisashi ^d   Tajima, Yusuke ^e   Tamura, Shigeyuki ^f   Sakurai, Jo ^g   Wakasugi, Takehiro ^h   Tatebe, Shigeru ⁱ   Takahashi, Masahiro ^j   Sakata, Yuh ^k   Kitajima, Masaki ^l   Sakamoto, Junichi ^m   Saji, Shigetoyo ^m  

^a HOKKAIDO UNIVERSITY HOSPITAL   (Japan)

^b International University of Health and Welfare Ichikawa Hospital   (Japan)

^c OSAKA POLICE HOSPITAL   (Japan)

^d KUSHIRO ROSAI HOSPITAL   (Japan)

^e SHOWA UNIVERSITY   (Japan)

^f INTERNATIONAL UNIVERSITY OF HEALTH AND WELFARE   (Japan)

^g Japanese Foundation for Multidisciplinary Treatment of Cancer   (Japan)

^h KANSAI ROSAI HOSPITAL   (Japan)

ⁱ ST MARIANNA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^j NAGOYA CITY UNIVERSITY GRADUATE SCHOOL OF MEDICAL SCIENCES   (Japan)

^k TOTTORI UNIVERSITY   (Japan)

^l Asahikawa Kosei Hospital   (Japan)

^m Misawa Municipal Hospital   (Japan)

more..

Author keywords

gastric cancer; irinotecan; S 1; tailored chemotherapy

Indexed keywords

GIMERACIL PLUS OTERACIL POTASSIUM PLUS TEGAFUR; IRINOTECAN;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; BLOOD TOXICITY; CANCER RECURRENCE; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; COMBINATION CHEMOTHERAPY; DIARRHEA; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HUMAN; HUMAN TISSUE; LEUKOCYTE COUNT; LEUKOPENIA; MAJOR CLINICAL STUDY; MALAISE; MALE; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; NEUTROPHIL COUNT; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STOMACH CARCINOMA; STOMATITIS; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT REFUSAL; TREATMENT RESPONSE;

ADULT; AGED; AMBULATORY CARE; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS, PHYTOGENIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BLOOD CELL COUNT; CAMPTOTHECIN; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG COMBINATIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; OXONIC ACID; STOMACH NEOPLASMS; TEGAFUR; TREATMENT OUTCOME; YOUNG ADULT;

EID: 79958270201     PISSN: 09594973     EISSN: 14735741     Source Type: Journal    
DOI: 10.1097/CAD.0b013e328345b509     Document Type: Article

References (17)

1. Aiba K, Funakoshi S, Mizunuma N, Dobashi N, Hirano A, Sano M, et al. Antitumor effect of SN-38, active form of CPT-11, on human colorectal cancer cell line. Gan To Kagaku Ryoho 1994; 21:1601-1606. (Pubitemid 24278396)
2. Fukushima M, Fujioka A, Uchida J, Nakagawa F, Takechi T. Thymidylate synthase (TS) and ribonucleotide reductase (RNR) may be involved in acquired resistance to 5-fluorouracil (5-FU) in human cancer xenografts in vivo. Eur J Cancer 2001; 37:1681-1687. (Pubitemid 32778616)
3. Narahara H, Takiuchi H, Tsujinaka T, Furukawa H, Tsukuma H, Taguchi H. Phase I study of CPT-11 plus S-1 in patients with metastatic gastric cancer. Proc Am Soc Clin Oncol 2002; 21:170. abstr 677.
4. Komatsu y, Takeda H, Takei M, Kato T, Tateyama M, Miyagishima T. Phase I and PK study of S-1 and irinotecan (CPT-11) in patients with advanced gastric cancer (AGC). Proc Am Soc Clin Oncol 2002; 21:171. abstr 683.
5. Inokuchi M, Yamashita T, Yamada H, Kojima K, Ichikawa W, Nihei Z, et al. Phase I/II study of S-1 combined with irinotecan for metastatic advanced gastric cancer. Br J Cancer 2006; 94:1130-1135.
6. Koizumi W, Kurihara M, Nakano S, Hasegawa K. Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. For the S-1 Cooperative Gastric Cancer Study Group. Oncology 2000; 58:191-197. (Pubitemid 30189900)
7. Sakata Y, Ohtsu A, Horikoshi N, Sugimachi K, Mitachi Y, Taguchi T. Late phase II study of novel oral fluoropyrimidine anticancer drug S-1 (1 mol/l tegafur-0.4 mol/l gimestat-1 mol/l otastat potassium) in advanced gastric cancer patients. Eur J Cancer 1998; 34:1715-1720. (Pubitemid 28474225)
8. Bergh J, Wiklund T, Erikstein B, Lidbrink E, Lindman H, Malmstrom P, et al. Tailored fluorouracil, epirubicin, and cyclophosphamide compared with marrow-supported high-dose chemotherapy as adjuvant treatment for highrisk breast cancer: a randomised trial. Scandinavian Breast Group 9401 study. Lancet 2000; 356:1384-1391.
9. Takahashi Y, Mai M, Sawabu N, Nishioka K. A pilot study of individualized maximum repeatable dose (iMRD), a new dose finding system, of weekly gemcitabine for patients with metastatic pancreas cancer. Pancreas 2005; 30:206-210. (Pubitemid 40397369)
10. Simon R, Wittes RE, Ellenberg SS. Randomized phase II clinical trials. Cancer Treat Rep 1985; 69:1375-1381. (Pubitemid 16163075)
11. Takahashi Y, Sakamoto J, Takeuchi T, Mai M, Kubota T, Kitajima M, et al. A randomized phase II clinical trial of tailored CPT-11 + S-1 versus S-1 in patients with advanced or recurrent gastric carcinoma as the first line chemotherapy. Jpn J Clin Oncol 2004; 34:342-345. (Pubitemid 43115316)
12. Japanese Gastric Cancer Association. Japanese classification of gastric carcinoma-2nd English edition. Gastric Cancer 1998; 1:10-24.
13. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000; 92:205-216.
14. Trotti A, Byhardt R, Stetz J, Gwede C, Corn B, Fu K, et al. Common toxicity criteria: version 2.0. An improved reference for grading the acute effects of cancer treatment: impact on radiotherapy. Int J Radiat Oncol Biol Phys 2000; 47:13-47. (Pubitemid 30179675)
15. Takahashi Y, Yamashita K, Kitakata H, Mai M. A new dose finding system in chemotherapy for solid tumors-individualized maximum repeatable dose (iMRD) of weekly gemcitabine for metastatic pancreas cancer. Proc Am Soc Clin Oncol 2003; 22:303. abstr 1217.
16. Imamura H, IIishi H, Tsuburaya A, Hatake K, Imamoto H, Esaki T, et al. Randomized phase III study of irinotecan plus S-1 (IRIS) versus S-1 alone as first-line treatment for advanced gastric cancer (GC0301/TOP-002). Presented at the 2008 Gastrointestinal Cancers Symposium, Orlando, FL, January 15-17, 2008; 2008. p. abstr 5.
17. Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, 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 2008; 9:215-221.