Gemcitabine(G) plus cisplatin (C) in advanced carcinoma gallbladder - A large single center experience

Abstract

4136 Background: Carcinoma gallbladder (CaGb) is one of the commonest cancers in North India. Patients usually present with locally advanced or metastatic disease where curative surgical resection is not possible. The role of chemotherapy in this situation has not been defined. There exists a need for new effective chemotherapeutic regimens. G has shown some promise in patients with CaGb. We therefore conducted a phase II single institution study of G and C in advanced CaGb patients. Primary end point was response rate (RR) and secondary end points were time to progression (TTP), overall survival and treatment toxicity. Methods: Patients with unresectable or metastatic, cytologically or histologically proven CaGb with ECOG PS ≤ 2, no other malignancy, age ≤ 75 years and serum bilirubin ≤ 2.0 mg/dl received G 1000 mg/m2 on d 1, 8, 15 and C 80 mg/m2 on d 16,17 in divided dose, every 28 days, for a total of 6 courses. Treatment was discontinued for unacceptable toxicity or disease progression. RR was evaluated by abdominal CT scan. Results: From Nov. 1999 to Dec. 2003, 40 patients were included in the study. Patient characteristics: M/F 11/29, median age 55.5 years (range-29–74) median number of cycles 3.5 (range 1- 6). 38 patients were evaluable for response. There were 2 CR and 19 PR, for an objective RR of 55.3% (95% CI, 38.3%–71.4%). 7 patients had SD and 10 were NR. All 40 patients were evaluable for toxicity. Main grade 3/4 toxicities included anemia (22.5%), neutropenia (5%), thrombocytopenia (7.5%) and nausea/vomiting (20%). Median TTP for all patients was 24 weeks (95%CI, 20–32 weeks). Median survival time was 32 weeks (95% CI, 18–36 weeks) for the entire population, 44 weeks (95% CI, 32–56) for responders, 32 weeks (95% CI, 20–32) for SD and 12 weeks (95% CI, 4–16) for NR. Patients presenting with jaundice whose jaundice was relieved by biliary stenting had response and survival similar to non-jaundiced patients. Conclusions: G plus C is an effective combination for patients with unresectable or metastatic CaGb and is associated with favorable toxicity profile. This regimen should be evaluated in a phase III trial. No significant financial relationships to disclose.