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A randomized controlled trial (RCT) comparing best supportive care (BSC), 5-FU plus folinic acid (FUFA) and, gemcitabine plus oxaliplatin (Gem-Ox) in management of unresectable gallbladder cancer (GBC)
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2009
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Surgical OncologyCancer EpidemiologyHealth SciencesGastrointestinal OncologyMedicineCancer ManagementBiliary CancerFolinic AcidClinical TrialsSurgeryMedian OsCancer TreatmentChemotherapy ArmsOncologyRadiation OncologyUnresectable Gallbladder CancerCancer ResearchBone Marrow Reserve
4521 Background: GBC is common in females residing in the northern part of India. Surgery is the only curative treatment. Unfortunately most patients present in advance and unresectable stage (median survival 3–4 months). Chemotherapy regimens for GBC are not yet standardized. Studies are few and mostly retrospective with small sample size and usually combine heterogeneous malignancies. Adequately powered RCT are not available. This was rationale to undertake study. Methods: It was single center, open label, three armed RCT. Ethical clearance was taken. Planned sample size was 81 to have type I & type II error probabilities of 0.05 & 0.2 respectively. Primary end point was to compare OS in unresectable GBC between BSC vs. FUFA vs. Gem-Ox arms. Secondary end points were to compare PFS in three arms and toxicity analysis of chemotherapy arms. Inclusion criteria were: proven unresectable GBC, performance state ≤2, adequate bone marrow reserve and normal biochemical profile (bilirubin≤3 mg % & liver enzymes within 5 times of upper limit). Patients in BSC group received symptomatic treatment without anticancer therapy. In FUFA group, weekly bolus doses of 5-FU (425mg/m2) plus Folinic acid (20 mg/m2) were given for a maximum of 30 weeks. In Gem-Ox group patients received gemcitabine (900 mg/m2) plus oxaliplatin (80 mg/m2) days 1 and 8 q3 weekly till maximum of 6 cycles. Results: Eighty one patients were randomized (BSC=27, FUFA=28, Gem-Ox=26). Median OS in BSC, FUFA and gem- Ox arms was 4.5 (CI 0.2–8.8), 5.3 (CI 3–6.2) and 9.3 (CI 5–14) months respectively (p= 0.039)). Median PFS was 2.8 (CI 1.8–3.8), 3.5 (CI 3.2–3.8) and 8.5 (CI 5.7–11.3) months in BSC, FUFA and Gem-Ox arm respectively (p= 0.0001). Chemotherapy arms were generally well tolerated. There was no difference in grade 3/4 toxicities in FUFA and Gem-Ox arm except for deranged liver function test, which was more in Gem-Ox arm (p=0.04). There was no toxic death. Conclusions: Probably this is the first RCT confirming efficacy of chemotherapy (Gem-Ox) compared to BSC in improving OS and PFS in unresectable GBC. Both chemotherapy arms were well tolerated. No significant financial relationships to disclose.