S-1 as adjuvant chemotherapy for stage III colon cancer: A randomized phase III study (ACTS-CC trial)

Annals of Oncology

Volumn 25, Issue 9, 2014, Pages 1743-1749

  Yoshida, M ^a   Ishiguro, M ^b   Ikejiri, K ^c   Mochizuki, I ^d   Nakamoto, Y ^e   Kinugasa, Y ^f   Takagane, A ^g   Endo, T ^h   Shinozaki, H ⁱ   Takii, Y ^j   Mochizuki, H ^k   Kotake, K ^l   Kameoka, S ^m   Takahashi, K ⁿ   Watanabe, T ^o   Watanabe, M ^p   Boku, N ^q   Tomita, N ^r   Nakatani, E ^s   Sugihara, K ^b   Kusunoki, Yasuyo ^t   Kinoshita, Fumie ^t   Kono, Hideki ^t   Kashiwagi, Naoko ^t   Ogasawara, Akinori ^t   Ueda, Yuri ^t   Uetake, Hiroyuki ^t   Ishikawa, Toshiaki ^t   Takagi, Yoko ^t   Saito, Aiko ^t   Kishiro, Sachiko ^t   Okamoto, Yasuyo ^t   Fukushima, Masanori ^t   Takiuchi, Hiroya ^t   more..

^a OSAKA MEDICAL COLLEGE HOSPITAL   (Japan)

^b TOKYO MEDICAL AND DENTAL UNIVERSITY   (Japan)

^c NATIONAL HOSPITAL ORGANIZATION KYUSHU MEDICAL CENTER   (Japan)

^d Iwate Prefectural Central Hospital   (Japan)

^e KOBE CITY MEDICAL CENTER WEST HOSPITAL   (Japan)

^f SHIZUOKA CANCER CENTER   (Japan)

^g Hakodate Goryoukaku Hospital   (Japan)

^h JAPANESE RED CROSS MEDICAL CENTER   (Japan)

ⁱ Imperial Foundation Saiseikai Utsunomiya Hospital   (Japan)

^j NIIGATA CANCER CENTER HOSPITAL   (Japan)

^k NATIONAL DEFENSE MEDICAL COLLEGE   (Japan)

^l TOCHIGI CANCER CENTER   (Japan)

^m TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

ⁿ TOKYO METROPOLITAN KOMAGOME HOSPITAL   (Japan)

^o UNIVERSITY OF TOKYO   (Japan)

^p KITASATO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^q ST MARIANNA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^r HYOGO COLLEGE OF MEDICINE   (Japan)

^s Translational Research Informatics Center   (Japan)

^t NONE

more..

Author keywords

Adjuvant chemotherapy; Colon cancer; S 1; UFT LV

Indexed keywords

CARCINOEMBRYONIC ANTIGEN; FOLINIC ACID; GIMERACIL PLUS OTERACIL POTASSIUM PLUS TEGAFUR; UFT; ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; ANTINEOPLASTIC AGENT; DRUG COMBINATION; OTERACIL; S 1 (COMBINATION); TEGAFUR; URACIL;

ADJUVANT THERAPY; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CANCER ADJUVANT THERAPY; CANCER STAGING; CANCER SURVIVAL; COLON CANCER; CONTROLLED STUDY; DISEASE FREE SURVIVAL; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HAZARD RATIO; HEMATOLOGIC DISEASE; HISTOPATHOLOGY; HUMAN; HYPERPIGMENTATION; JAPAN; LYMPH NODE METASTASIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; PHASE 3 CLINICAL TRIAL; POSTOPERATIVE CARE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STOMATITIS; SURVIVAL TIME; TUMOR INVASION; TUMOR LOCALIZATION; VERY ELDERLY; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER SURGERY; COLON ADENOCARCINOMA; COLON RESECTION; DRUG SCREENING; HUMAN TISSUE; LIVER TOXICITY; OVERALL SURVIVAL; SURVIVAL RATE; TREATMENT DURATION; ADJUVANT CHEMOTHERAPY; CLINICAL TRIAL; COLONIC NEOPLASMS; DRUG COMBINATION; MIDDLE AGED; MORTALITY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHEMOTHERAPY, ADJUVANT; COLONIC NEOPLASMS; DISEASE-FREE SURVIVAL; DRUG COMBINATIONS; FEMALE; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; NEOPLASM STAGING; OXONIC ACID; TEGAFUR; URACIL; YOUNG ADULT;

EID: 84906851329     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdu232     Document Type: Article

References (20)

1. Labianca R, Nordlinger B, Beretta GD et al. Early colon cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2013; 24 (suppl 6): vi64-vi72.
2. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology; Colon cancer version 3. 2014; http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf (9 June 2014, date last accessed).
3. André T, Boni C, Navarro M et al. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol 2009; 27: 3109-3116.
4. Haller DG, Tabernero J, Maroun J et al. Capecitabine plus oxaliplatin compared with fluorouracil and folnic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol 2011; 29: 1465-1471.
5. Lembersky BC, Wieand HS, Petrelli NJ et al. Oral uracil and tegafur plus leucovorin compared with intravenous fluorouracil and leucovorin in stage II and III carcinoma of the colon: results from National Surgical Adjuvant Breast and Bowel Project Protocol C-06. J Clin Oncol 2006; 24: 2059-2064.
6. Shimada Y, Hamaguchi T, Mizusawa J et al. Randomised phase III trial of adjuvant chemotherapy with oral uracil and tegafur plus leucovorin versus intravenous fluorouracil and levofolinate in patients with stage III colorectal cancer who have undergone Japanese D2/D3 lymph node dissection: final results of JCOG0205. Eur J Cancer 2014 June 20 [epub ahead of print], doi: 10.1016/j. ejca.2014.05.025.
7. Satoh T, Sakata Y. S-1 for the treatment of gastrointestinal cancer. Expert Opin Pharmacother 2012; 13: 1943-1959.
8. Yamada Y, Takahari D, Matsumoto H et al. Leucovorin, fluorouracil, and oxaliplatin plus bevacizumab versus S-1 and oxaliplatin plus bevacizmab in patients with metastatic colorectal cancer (SOFT): an open-label, non-inferiority, randomized phase 3 trial. Lancet Oncol 2013; 14: 1278-1286.
9. Uesaka K, Fukutomi A, Boku N et al. Randomized phase III trial of adjuvant chemotherapy with gemcitabine versus S-1 for patients with resected pancreatic cancer (JASPAC-01 study). J Clin Oncol 2013; 31: 4s (abstr 145).
10. Mochizuki I, Takiuchi H, Ikejiri K et al. Safety of UFT/LV and S-1 as adjuvant therapy for stage III colon cancer in phase III trial: ACTS-CC trial. Br J Cancer 2012; 106: 1268-1273.
11. Hamaguchi T, Shirao K, Moriya Y et al. Final results of randomized trials by the National Surgical Adjuvant Study of Colorectal Cancer (NSAS-CC). Cancer Chemother Pharmacol 2011; 67: 587-596.
12. Watanabe T, Itabashi M, Shimada Y et al. Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2010 for the treatment of colorectal cancer. Int J Clin Oncol 2012; 17: 1-29.
13. Schoenfeld DA, Richter JR. Nomograms for calculating the number of patients needed for a clinical trial with survival as an endpoint. Biometrics 1982; 38: 163-170.
14. Kalbfleisch JD, Prentice RL. The Statistical Analysis of Failure Time Data. New York: John Wiley & Sons, 1980.
15. Japanese Society for Cancer of the Colon and Rectum. Japanese Classification of Colorectal Carcinoma-Second English Edition. Tokyo: Kanehara & Co., Ltd., 2009.
16. Twelves C, Wong A, Nowacki MP et al. Capecitabine as adjuvant treatment for stage III colon cancer. N Eng J Med 2005; 352: 2696-2704.
17. de Gramont A, Chibaudel B, Bachet JB et al. From chemotherapy to targeted therapy in adjuvant treatment for stage III colon cancer. Semin Oncol 2011; 38: 521-532.
18. Tournigand C, André T, Bonnetain F et al. Adjuvant therapy with fluorouracil and oxaliplatin in stage II and elderly patients (between ages 70 and 75 years) with colon cancer: subgroup analyses of the Multicenter International Study of Oxaliplatin, Fluorouracil, and Leucovorin in the Adjuvant Treatment of Colon Cancer Trial. J Clin Oncol 2012; 30: 3353-3360.
19. Foundation for Promotion of Cancer Research. Cancer statistics in Japan 2013; http://ganjoho.jp/pro/statistics/en/backnumber/2013_en.html (9 June 2014, date last accessed).
20. McCleary NJ, Meyerhardt JA, Green E et al. Impact of age on the efficacy of newer adjuvant therapies in patients with stage II/III colon cancer: findings from the ACCENT database. J Clin Oncol 2013; 31: 2600-2606.