Abstract 163P
Background
Gall Bladder Cancers(GBC) comprise a feared entity among all oncologists. Advanced stage of disease at presentation and grave prognosis despite use of all the armamentarium has led to GBC patients faring worse than other sites of malignancy.The goal of this study is to evaluate the efficacy and safety of chemotherapy alone versus radiotherapy alone in patients with locally advanced unresectable gallbladder carcinoma.
Methods
This was a randomized control study done in Regional Institute of Medical Sciences, Imphal, Manipur from 1st August 2017 to 31st July 2019. All histopathologically confirmed locally advanced unresectable carcinoma gall bladder patients were enrolled in this study. Patients who refused to give consent, metastatic disease and Child Pugh Score C were excluded. Patients who received any treatment for obstructiion was also excluded from the study. All patients were randomized into two arms. In Arm A, patients were treated with palliative chemotherapy and in Arm B patients received external beam radiotherapy. Treatment response of both radiotherapy and chemotherapy were assessed using RECIST Criteria Version1.1. Early radiation toxicity was assessed during treatment using RTOG grading. Chemotherapy toxicity was assessed using NCI-CTCAE Criteria (version 4.03). The study was carried out after obtaining approval from the Research Ethics Board. Written informed consent was taken from all the patients before enrolment of the study.
Results
Baseline characteristics of patients are listed in the table. Symptomatic response after one month of treatment in chemotherapy and radiotherapy arm were 80.7% and 61.4%. Overall response rate in chemotherapy arm was 38.4% in chemotherapy arm while 26.8% in radiotherapy arm. Median progression free survival in chemotherapy and radiotherapy arm were 7.24 vs 6.11 months (p= 0.034) respectively. Table: 163P
| Chemotherapy arm (n=30) | Radiotherapy arm (n=30) | |
| Median age | 61 years | 61 years |
| Gender | ||
| Male | 6 (20%) | 4 (13.3%) |
| Female | 24 (80%) | 26 (86.7%) |
| KPS | ||
| >80% | 13 (43.3%) | 13 (43.3%) |
| <60% | 17 (56.66%) | 17 (56.66%) |
| History of cholelithiasis | 19 (63.3%) | 20 (66.7%) |
| Clinical presentation | ||
| Jaundice | 7 (23%) | 10 (33%) |
| Abdominal pain | 6 (20%) | 7 (23%) |
| Abdominal mass | 2 (7%) | 9 (30%) |
| Ascites | 10 (33%) | 0 |
| Nausea/vomit | 5 (17%) | 4 (13%) |
| Stage | ||
| IIIA | 7 (11.7%) | 5 (8.7%) |
| IIIB | 13 (21.7%) | 12 (20%) |
| IV | 10 (16.7%) | 13 (21.7%) |
| Response | ||
| Complete response | 1 (3.8%) | 1 (3.8%) |
| Partial response | 9 (34.6%) | 6 (23%) |
| Stable disease | 11 (42.3%) | 9 (34.6%) |
| Progressive disease | 5 (19.2%) | 10 (38.4%) |
Conclusions
In advanced inoperable gallbladder cancer chemotherapy has better response rates and survival outcomes compared to radiotherapy.
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.
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