A Multicenter Phase II Trial of Gemcitabine Plus Oxaliplatin in Unresectable Gallbladder Cancer
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Background/Aims: No standard chemotherapy has been established for advanced gallbladder cancer. The authors studied the activity and tolerability of a gemcitabine and oxaliplatin (GEMOX) combination in unresectable gallbladder cancer (GBC). Methods: Adult patients with pathologically confirmed unresectable GBC were prospectively recruited at three centers. No patient had received prior chemotherapy or radiotherapy. Patients received cycles of gemcitabine at 1,000 mg/m2 on day 1, followed by oxaliplatin at 100 mg/m2 on day 2, every 2 weeks. The primary study endpoint was time to progression. Results: Forty patients with unresectable GBC were enrolled. The median age was 60 years (range,38 to 79 years). All patients showed good performance status. Of the 33 analyzable patients, 12 achieved partial response (36%), 17 stable disease (52%), and four progressive disease (12%). No patient achieved a complete response. The tumor control rate was 88%. At a median follow-up of 6.8 months, the median time to progression was 5.3 months (95% confidence interval [CI], 3.7 to 6.9), and median overall survival was 6.8 months (95% CI, 6.1 to 7.5). Nine of the 40patients (23%) experienced at least a grade-3 adverse event,but no patient experienced a grade-4 adverse event. Conclusions:GEMOX combination therapy is a feasible option and is well tolerated in unresectable GBC.
Abstract
Background/Aims: No standard chemotherapy has been established for advanced gallbladder cancer. The authors studied the activity and tolerability of a gemcitabine and oxaliplatin (GEMOX) combination in unresectable gallbladder cancer (GBC). Methods: Adult patients with pathologically confirmed unresectable GBC were prospectively recruited at three centers. No patient had received prior chemotherapy or radiotherapy. Patients received cycles of gemcitabine at 1,000 mg/m2 on day 1, followed by oxaliplatin at 100 mg/m2 on day 2, every 2 weeks. The primary study endpoint was time to progression. Results: Forty patients with unresectable GBC were enrolled. The median age was 60 years (range,38 to 79 years). All patients showed good performance status. Of the 33 analyzable patients, 12 achieved partial response (36%), 17 stable disease (52%), and four progressive disease (12%). No patient achieved a complete response. The tumor control rate was 88%. At a median follow-up of 6.8 months, the median time to progression was 5.3 months (95% confidence interval [CI], 3.7 to 6.9), and median overall survival was 6.8 months (95% CI, 6.1 to 7.5). Nine of the 40patients (23%) experienced at least a grade-3 adverse event,but no patient experienced a grade-4 adverse event. Conclusions:GEMOX combination therapy is a feasible option and is well tolerated in unresectable GBC.
참고문헌 (24)
- Misra S, "Carcinoma of the gallbladder", Lancet Oncol, 4, pp.167~176 (2003)
- Lazcano-Ponce EC, "Epidemiology and molecular pathology of gallbladder cancer", CA Cancer J Clin, 51, pp.349~364 (2001)
- Hai-Rim Shin, "2002 Annual Report of the Korea Central Cancer Registry: Based on Registered Data from 139 Hospitals", Cancer Research and Treatment, 36(2), pp.103~114 (2004), 대한암학회
- Randi G, "Gallbladder cancer worldwide: geographical distribution and risk factors", Int J Cancer, 118, pp.1591~1602 (2006)
- de Groen PC, "Biliary tract cancers", N Engl J Med, 341, pp.1368~1378 (1999)
- Glimelius B, "Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer", Ann Oncol, 7, pp.593~600 (1996)
- Valle J, "Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer", N Engl J Med, 362, pp.1273~1281 (2010)
- Jarnagin WR, "Differential cell cycle-regulatory protein expression in biliary tract adenocarcinoma: correlation with anatomic site, pathologic variables, and clinical outcome", J Clin Oncol, 24, pp.1152~1160 (2006)
- Yonemoto N, "A multi-center retrospective analysis of survival benefits of chemotherapy for unresectable biliary tract cancer", Jpn J Clin Oncol, 37, pp.843~851 (2007)
- Eckel F, "Chemotherapy in advanced biliary tract carcinoma: a pooled analysis of clinical trials", Br J Cancer, 96, pp.896~902 (2007)
- Kimura K, "Association of gallbladder carcinoma and anomalous pancreaticobiliary ductal union", Gastroenterology, 89, pp.1258~1265 (1985)
- Park YK, "A clinical study of gallbladder carcinoma", Korean J Gastroenterol, 21, pp.113~122 (1989)
- Hanada K, "K-ras and p53 mutations in stage I gallbladder carcinoma with an anomalous junction of the pancreaticobiliary duct", Cancer, 77, pp.452~458 (1996)
- Andre T, "Gemcitabine combined with oxaliplatin (GEMOX) in advanced biliary tract adenocarcinoma: a GERCOR study", Ann Oncol, 15, pp.1339~1343 (2004)
- Andre T, "Gemcitabine and oxaliplatin in advanced biliary tract carcinoma: a phase II study", Br J Cancer, 99, pp.862~867 (2008)
- "A phase II study of gemcitabine in combination with oxaliplatin as first-line chemotherapy in patients with inoperable biliary tract cancer", CANCER CHEMOTHERAPY AND PHARMACOLOGY, 64, pp.371~377 (2009), Springer Verlag
- Sharma A, "A phase II study of gemcitabine and oxaliplatin (Oxigem) in unresectable gall bladder cancer", Cancer Chemother Pharmacol, 65, pp.497~502 (2010)
- Harder J, "Outpatient chemotherapy with gemcitabine and oxaliplatin in patients with biliary tract cancer", Br J Cancer, 95, pp.848~852 (2006)
- "Gemcitabine and oxaliplatin with or without erlotinib in advanced biliary-tract cancer: a multicentre, open-label, randomised, phase 3 study", LANCET ONCOLOGY, 13(2), pp.181~188 (2012), ELSEVIER SCIENCE INC
- Therasse P, "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, 92, pp.205~216 (2000)
- Gallardo JO, "A phase II study of gemcitabine in gallbladder carcinoma", Ann Oncol, 12, pp.1403~1406 (2001)
- Malik IA, "Gemcitabine and Cisplatin is a highly effective combination chemotherapy in patients with advanced cancer of the gallbladder", Am J Clin Oncol, 26, pp.174~177 (2003)
- Doval DC, "A phase II study of gemcitabine and cisplatin in chemotherapy-naive, unresectable gall bladder cancer", Br J Cancer, 90, pp.1516~1520 (2004)
- Chatni SS, "Infusion chemotherapy with cisplatinum and fluorouracil in the treatment of locally-advanced and metastatic gallbladder cancer", J Cancer Res Ther, 4, pp.151~155 (2008)