A Multicenter Phase II Trial of Gemcitabine Plus Oxaliplatin in Unresectable Gallbladder Cancer.
OBJECTIVE
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/m(2) on day 1, followed by oxaliplatin at 100 mg/m(2) 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 40 patients (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.
Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea. ; Center for Liver Cancer, National Cancer Center, Goyang, Korea.
Sang Myung
SM
Woo
Sang Hyub
SH
Lee
Ji Won
JW
Yoo
Ki Young
KY
Yang
Jung Gyun
JG
Seo
Joo Kyung
JK
Park
Jin-Hyeok
JH
Hwang
Woo Jin
WJ
Lee
Ji Kon
JK
Ryu
Yong-Tae
YT
Kim
Yong Bum
YB
Yoon
Gallbladder neoplasms; Gemcitabine; Oxaliplatin