Gemcitabine and Carboplatin in Inoperable, Loco-Regionally Advanced and Metastatic Gallbladder Cancer- A Study from Northern Indian Cancer Institute

Aims: The primary objective of this study was to determine the response rates of the gemcitabine and carboplatin combination chemotherapy in treatment naïve patients with inoperable gall bladder cancer. The secondary objectives were to evaluate the toxicity, progression free survival (PFS), and overall survival (OS).

Methodology: Treatment naïve patients with histologically proven inoperable gall bladder cancer treated with gemcitabine and carboplatin chemotherapy between February 2011 and December 2014 were included in this study. The dose of gemcitabine was 1 gm/m2 on day 1 and 8, and carboplatin [target AUC (area under the concentration versus time curve in mg/ml) of 5] on day 1, in a 21 day cycle. CT scan was used for response assessment.

Results: There were 32 men and 92 women with a median age of 59 years (range 26-75 years). Of the 124 patients, 9 (7.3%) patients achieved a complete response and 54 (43.5%) patients achieved a partial response for an overall response rate of 50.8%. The median PFS was 4.6 months [95% confidence interval (CI) 4–5.5 months], with 1-year survival rate of 20.2%. Common toxicity criteria (CTC) grade 3 anaemia was seen in 6 (4.8%) patients. Grade 3 and 4 neutropenia was observed in 11 (8.9%) and 4 (3.2%) patients respectively, whereas 9 (7.3%) patients experienced Grade 3 thrombocytopenia.

Conclusion: The combination of gemcitabine and carboplatin is active in advanced gall bladder carcinoma with mild toxicity.