100P - A prospective single arm study evaluating the outcome of neoadjuvant chemotherapy in locally advanced/border line resectable gall bladder cancer

Background

Since most of the Gallbladder carcinoma(GBC) patients present at advanced stage, curative surgery is not feasible and they have high recurrence rate. As surgical resection is curative for GBC, downstaging by neoadjuvant chemotherapy (NACT) like Gemcitabine and Cisplatin may increase the chances of complete resection with no microscopic residual (R0 resection) and thereby improving survival. The present prospective study is being undertaken to assess the response of NACT in locally advanced Gall Bladder cancer(LAGBC) patients and further asses them for surgical resection.

Methods

This phase II,prospective, single Arm Study was conducted from 1^st January 2020 to April 2021 and followed for 6 months. A total of 30 histopathologically verified patients of LAGBC patients (T3 ,T4 OR N1 OR vascular T4 with P.S 0-2) were included in the study. All these patients received NACT- gemcitabine1(000 mg/ m² IV and cisplatin 25 mg/m2 on day 1 and 8, followed by 2 weeks rest), (3 weekly cycle). Response evaluation was done radiologically after 3 cycles of NACT and was further evaluated for eligibility for resection. And was followed for 6 months thereafter for survival analysis.

Results

In response to NACT (RECIST criteria)- 1 patient had complete response, 6 patients had partial response, 12 patients had stable disease and 11 patients had progressive disease. Post NACT resection status - 23 patients were unresectable and 7 patient were resected. All 7 patients who underwent surgery were alive. And median overall survival and event free survival for was 7 months and 6 months respectively. On univariate analysis of survival – Patients with higher T stage, higher N stage, raised CA 19-9 level and ECOG PS had lesser survival. But only association with ECOG PS was statistically significant. (p value<0.001). On multivariate analysis - only ECOG PS was statistically significantly associated with survival with P value of 0.009.

Conclusions

This study concluded that by having favourable response to NACT, LAGBC patients can be offered curative treatment in the form of surgery. NACT helps in downsizing the tumour thereby making the patient eligible to underwent surgery eventually leading to improve survival in resected patients.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.