96P - Comparing the outcome of doublet therapy (gemcitabine and cisplatin) with triplet therapy (gemcitabine and cisplatin, nab paclitaxel) in locally advanced or metastatic gall bladder cancer patients an open label randomised control trial

Background

To compare the doublet gemcitabine and cisplatin which is a standard of care in locally advanced or metastatic gall bladder cancer to a triplet gemcitabine, cisplatin and nab paclitaxel regime which has shown promising results in a single arm phase II study.

Methods

A total of 60 patients with locally advanced or metastatic gall bladder cancer were randomized 30 in each arm after imaging [contrast enhanced CT scan of chest, abdomen, and pelvis / MRI abdomen and pelvis with CECT chest /whole-body PET CT scan] and biopsy. Arm A received two drugs gemcitabine 1000mg/m2 i.v and cisplatin 25mg/m2 i.v on Day1 and Day8 of 21-day cycle and arm B received three drugs gemcitabine, 1000 mg/m2 , cisplatin, 25 mg/m2 , and nab-paclitaxel, 125 mg/m2 , on days 1 and 8 of 21-day cycle. Evaluation was done post 3 and 6 cycles of chemotherapy. Then patients were followed up every 6 months for 2 years period for assessment of primary and secondary endpoints of the study.

Results

The combination of gemcitabine and cisplatin (arm A) showed an overall radiological response rate (complete response and partial response) of 13.3% while it was 61.9 % in patients who received gemcitabine, cisplatin, and nab-paclitaxel. This difference was statistically significant with a p-value of 0.004. The median progression-free survival for the patients who received gemcitabine and cisplatin was 4.5 months (95% CI, 4.0-4.9) vs 7.6 months (95% CI, 3.9-11.2) for the patients who were treated with gemcitabine, cisplatin, and nab-paclitaxel. This difference was statistically significant with a p-value of ≤ 0.05. The median overall survival for the doublet was 9.2 months (95% CI 2.6-15.7) vs not reached for the patients who were treated with gemcitabine, cisplatin, and nab-paclitaxel. There was no increase in grade 3 adverse events with the addition of nab-paclitaxel.

Conclusions

To conclude, our study showed that the triplet chemotherapy with gemcitabine and cisplatin and nab-paclitaxel was significantly better in terms of overall response rate, and median progression-free survival with a longer follow up needed to comment on median overall survival.

Clinical trial identification

CTRI/2021/09/036362.

Editorial acknowledgement

Legal entity responsible for the study

C. Khatri.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.