Doublet versus triplet therapy in Indian patients with locally advanced & metastatic gall bladder cancer: a randomised trial.

To evaluate the efficacy of triplet chemotherapy (gemcitabine, cisplatin, and nab-paclitaxel) to the standard of care in locally advanced or metastatic gall bladder cancer. A total of 60 patients with locally advanced (unresectable) and metastatic gall bladder cancer were randomized to either of the 2 arms. Arm A received two drugs gemcitabine and cisplatin and arm B received three drugs gemcitabine, cisplatin and nab-paclitaxel. The evaluation was done post 3 and 6 cycles of chemotherapy. Patients were then followed up every 6 months for 2 years to assess response rates (RR), progression-free survival (PFS), and overall survival (OS). The combination of gemcitabine and cisplatin (arm A) had an overall response rate of 13.3% whereas it was 61.9% in patients who received gemcitabine, cisplatin, and nab-paclitaxel (0.004). The median progression-free survival for patients who received gemcitabine and cisplatin was 4.5 months (95% CI, 4.0-4.9) compared to 7.6 months (95% CI, 3.9-11.2) for patients treated with gemcitabine, cisplatin, and nab-paclitaxel (p ≤ 0.05). There was no increase in grade 3 adverse events with the addition of nab-paclitaxel. This study showed promising results, with triplet chemotherapy having a significantly better overall response rate and median progression-free survival.