A phase II study of gemcitabine and oxaliplatin (Oxigem) in unresectable gall bladder cancer.

Abstract:

PURPOSE:There is a need for effective chemotherapy protocols for gall bladder cancer (GBC). Gemcitabine has antitumor activity in pancreatic cancer. Oxaliplatin is effective in GI cancers. Based on evidence of synergy between these two, we designed this study to evaluate efficacy of this combination in unresectable GBC. DESIGN:Unresectable GBC was enrolled for single center phase II study. Drugs gemcitabine 900 mg/m2 and oxaliplatin 80 mg/m2 IV infusion (Oxigem) on days 1 and 8 every 3 weeks for a maximum of six cycles or unacceptable toxicity which ever was earlier. MATERIALS AND METHODS:Fifty patients were enrolled and analysis was restricted to 48 who were treated. Median age was 50 years and 31 patients were females. RESULTS:CR 3 (6.2%), PR 7 (15%), SD 17 (35.4%), and PD 18. One had complete pathological response. Median OS and PFS were 7.5 and 3 months, respectively. OS in responders was 10.5 versus 4 months in non-responders (p<0.0000). Eleven patients (23%) survived for a year or more. There was no toxic death and grade III/IV toxicity seen in 10 (22%) patients: diarrhea 3, vomiting 2, neutropenia and thrombocytopenia 5 patients. CONCLUSION:This combination of Oxigem effective in unresectable GBC. It may even induce complete pathological response. One-year survival was 20%. There is a need for controlled trial to assess efficacy of this combination.

authors

Sharma A,Mohanti B,Raina V,Shukla N,Pal S,Dwary A,Deo S,Sahni P,Garg P,Thulkar S,DattaGupta S,Rath G

doi

10.1007/s00280-009-1055-0

subject

Has Abstract

pub_date

2010-02-01 00:00:00

pages

497-502

issue

3

eissn

0344-5704

issn

1432-0843

journal_volume

65

pub_type

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