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.
Resources from the same session
397P - Comparison between Y-site co-infusion versus standard dexamethasone for preventing hypersensitivity reactions from oxaliplatin administration: A randomized controlled trial
Presenter: jarearnjit Phavirunsiri
Session: Poster Display
Resources:
Abstract
398P - Evaluation of the effectiveness of denosumab therapy giant cell tumor of the pelvis
Presenter: Abbos Nurjabov
Session: Poster Display
Resources:
Abstract
399P - Long-term outcomes of patients with gastric cancer who received the best supportive care without any anticancer treatment
Presenter: Yohei Arihara
Session: Poster Display
Resources:
Abstract
401TiP - Oral opioid vs intravenous patient-controlled analgesia (PCA) with hydromorphone bolus-only or continuous infusion to maintain analgesia for severe cancer pain: A randomized phase III trial
Presenter: Cheng Huang
Session: Poster Display
Resources:
Abstract
407P - K-TrackTM: A streamlined personalized assay to detect molecular residual disease in solid tumors
Presenter: Nam Vo
Session: Poster Display
Resources:
Abstract
408P - Increased EGFR and MET expression and corresponding tumor microenvironment (TME) change in hepatocellular carcinoma (HCC) tissues after sorafenib (Sora) treatment
Presenter: Chia Jui Yen
Session: Poster Display
Resources:
Abstract
410P - Systematic evaluation of cell-free DNA fragmentation patterns for cancer diagnosis and enhanced cancer detection through integration of multiple fragmentations
Presenter: Xiangy-Yu Meng
Session: Poster Display
Resources:
Abstract
412P - Multiplex digital spatial profiling (DSP) of protein reveals distinct immune and molecular phenotypes in hepatocellular carcinoma
Presenter: Chia Jui Yen
Session: Poster Display
Resources:
Abstract
413P - Clinical utility of advanced features provided by circulating tumor DNA-based comprehensive genomic profiling
Presenter: Young-gon Kim
Session: Poster Display
Resources:
Abstract
414P - Landscape of ERBB2 mutations in advanced cancers (AC) using circulating tumor DNA (ctDNA) next-generation sequencing (NGS) in Asia and Middle East (AME)
Presenter: Byoung Chul Cho
Session: Poster Display
Resources:
Abstract