Randomized phase II study of gemcitabine plus S-1 versus S-1 in advanced biliary tract cancer: A Japan Clinical Oncology Group trial (JCOG 0805)

Cancer Science

Volumn 104, Issue 9, 2013, Pages 1211-1216

  Morizane, Chigusa ^a   Okusaka, Takuji ^a   Mizusawa, Junki ^b   Takashima, Atsuo ^b   Ueno, Makoto ^c   Ikeda, Masafumi ^d   Hamamoto, Yasuo ^e   Ishii, Hiroshi ^f   Boku, Narikazu ^g   Furuse, Junji ^h  

^a NATIONAL CANCER CENTER HOSPITAL   (Japan)

^b NATIONAL CANCER CENTER   (Japan)

^c KANAGAWA CANCER CENTER   (Japan)

^d NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^e TOCHIGI CANCER CENTER   (Japan)

^f CANCER INSTITUTE HOSPITAL   (Japan)

^g ST MARIANNA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^h KYORIN UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CREATININE; GEMCITABINE; GIMERACIL PLUS OTERACIL POTASSIUM PLUS TEGAFUR;

ACUTE HEART INFARCTION; ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ALOPECIA; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIARY TRACT CANCER; BILIRUBIN BLOOD LEVEL; CANCER COMBINATION CHEMOTHERAPY; CHEILITIS; CONSTIPATION; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG FATALITY; DRUG SAFETY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERPIGMENTATION; HYPONATREMIA; INFECTION; LEUKOCYTE COUNT; LEUKOPENIA; LIVER DYSFUNCTION; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MUCOSA INFLAMMATION; NAUSEA; NEUTROPENIA; NEUTROPHIL COUNT; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; REPEATED DRUG DOSE; SIDE EFFECT; SURVIVAL RATE; SURVIVAL TIME; TASTE DISORDER; THROMBOCYTE COUNT; THROMBOCYTOPENIA; TREATMENT DURATION; VOMITING;

ADULT; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BILIARY TRACT NEOPLASMS; DEOXYCYTIDINE; DRUG COMBINATIONS; FEMALE; HUMANS; JAPAN; MALE; MIDDLE AGED; OXONIC ACID; TEGAFUR;

EID: 84883463984     PISSN: 13479032     EISSN: 13497006     Source Type: Journal    
DOI: 10.1111/cas.12218     Document Type: Article

References (19)

1. McGlynn KA, Tarone RE, El-Serag HB. A comparison of trends in the incidence of hepatocellular carcinoma and intrahepatic cholangiocarcinoma in the United States. Cancer Epidemiol Biomarkers Prev 2006; 15: 1198-203.
2. Patel T. Increasing incidence and mortality of primary intrahepatic cholangiocarcinoma in the United States. Hepatology 2001; 33: 1353-7.
3. Shaib Y, El-Serag HB. The epidemiology of cholangiocarcinoma. Semin Liver Dis 2004; 24: 115-25.
4. West J, Wood H, Logan RF, Quinn M, Aithal GP. Trends in the incidence of primary liver and biliary tract cancers in England and Wales 1971-2001. Br J Cancer 2006; 94: 1751-8.
5. Furuse J, Takada T, Miyazaki M et al. Guidelines for chemotherapy of biliary tract and ampullary carcinomas. J Hepatobiliary Pancreat Surg 2008; 15: 55-62.
6. Hezel AF, Zhu AX. Systemic therapy for biliary tract cancers. Oncologist 2008; 13: 415-23.
7. Valle J, Wasan H, Palmer DH et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med 2010; 362: 1273-81.
8. Okusaka T, Nakachi K, Fukutomi A et al. Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan. Br J Cancer 2010; 103: 469-74.
9. Furuse J, Okusaka T, Boku N et al. S-1 monotherapy as first-line treatment in patients with advanced biliary tract cancer: a multicenter phase II study. Cancer Chemother Pharmacol 2008; 62: 849-55.
10. Kanai M, Yoshimura K, Tsumura T et al. A multi-institution phase II study of gemcitabine/S-1 combination chemotherapy for patients with advanced biliary tract cancer. Cancer Chemother Pharmacol 2011; 67: 1429-34.
11. Sasaki T, Isayama H, Nakai Y et al. Multicenter, phase II study of gemcitabine and S-1 combination chemotherapy in patients with advanced biliary tract cancer. Cancer Chemother Pharmacol 2010; 65: 1101-7.
12. Ioka T, Ikeda M, Ohkawa S et al. Randomized phase III study of gemcitabine plus S-1 (GS) versus S-1 versus gemcitabine (GEM) in unresectable advanced pancreatic cancer (PC) in Japan and Taiwan: GEST study. J Clin Oncol 2011; 29(Suppl.): abstr 4007.
13. Simon R, Wittes RE, Ellenberg SS. Randomized phase II clinical trials. Cancer Treat Rep 1985; 69: 1375-81.
14. Doval DC, Sekhon JS, Gupta SK et al. A phase II study of gemcitabine and cisplatin in chemotherapy-naive, unresectable gall bladder cancer. Br J Cancer 2004; 90: 1516-20.
15. Eckel F, Schmid RM. Chemotherapy in advanced biliary tract carcinoma: a pooled analysis of clinical trials. Br J Cancer 2007; 96: 896-902.
16. Kim ST, Park JO, Lee J et al. A Phase II study of gemcitabine and cisplatin in advanced biliary tract cancer. Cancer 2006; 106: 1339-46.
17. Wagner AD, Buechner-Steudel P, Moehler M et al. Gemcitabine, oxaliplatin and 5-FU in advanced bile duct and gallbladder carcinoma: two parallel, multicentre phase-II trials. Br J Cancer 2009; 101: 1846-52.
18. Valle JW, Wasan H, Johnson P et al. Gemcitabine alone or in combination with cisplatin in patients with advanced or metastatic cholangiocarcinomas or other biliary tract tumours: a multicentre randomised phase II study - The UK ABC-01 Study. Br J Cancer 2009; 101: 621-7.
19. Park I, Lee JL, Ryu MH et al. Prognostic factors and predictive model in patients with advanced biliary tract adenocarcinoma receiving first-line palliative chemotherapy. Cancer 2009; 115: 4148-55.