mGEMOX FOR GALLBLADDER CANCER

NEW YORK (Reuters Health) Oct 08 - Chemotherapy with gemcitabine and oxaliplatin improved overall and progression-free survival in patients with unresectable gallbladder cancer in a study in India.

"Currently, there is no standard chemotherapy for gallbladder cancer, and the majority of studies have included patients from all subsites of biliary tract cancers," researchers write in a September 20th online paper in the Journal of Clinical Oncology.

Dr. Atul Sharma, the lead study author from the All India Institute of Medical Sciences in New Delhi, told Reuters Health in an e-mail that in previous work, both gemcitabine and oxaliplatin administered alone have shown activity in pancreatic and some gastrointestinal cancers.

In this study, Dr. Sharma and colleagues randomized 82 patients to three study arms: 27 patients received best supportive care (blood transfusion, analgesics and other symptomatic treatment); 28 patients received a weekly bolus of fluorouracil and folinic acid (FUFA) for 30 weeks; and 26 patients received the modified GEMOX regimen, consisting of gemcitabine 900 mg/m2 and oxaliplatin 80 mg/m2 IV on days one and eight every three weeks for a maximum of six cycles.

Eight patients in the mGEMOX arm (30.7%) had a complete or partial response, compared with four in the FUFA group (14.3%). The median overall duration of survival for the mGEMOX, FUFA and supportive care groups was 9.5, 4.6 and 4.5 months, respectively (p = 0.039). Median progression-free survival also improved with mGEMOX, at 8.5 months compared to 3.5 and 2.8 months, respectively (p < 0.001).

Rates of grade 3 and 4 toxicities were similar in the two chemotherapy arms, although there were four patients with grade 3 transaminitis in the mGEMOX group and none in the FUFA group (p = 0.04). Other toxicities included vomiting, myelosuppression and neurotoxicity.

"I am more or less convinced that this combination should be tried by more and more physicians," Dr. Sharma told Reuters Health. He noted that a 2010 paper in the New England Journal of Medicine by Valle et al reported on the use of gemcitabine and cisplatin in patients with locally advanced or metastatic biliary tract cancers (rather than only gallbladder cancer). That study too found significant improvements in both overall and progression-free survival with treatment, he said.

"We are starting a study that will directly compare the combination used by us with a gemcitabine and cisplatin combination," Dr. Sharma added.