CC BY-NC-ND 4.0 · South Asian J Cancer 2020; 09(04): 204-208
DOI: 10.1055/s-0040-1721216
Original Article: Hepatobiliary Cancer

Role of Maintenance Gemcitabine in Advanced Carcinoma Gallbladder

Manish Sharma
1  Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India
,
Vineet Talwar
1  Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India
,
Udip Maheshwari
1  Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India
,
Venkata Pradeep Babu Koyyala
1  Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India
,
Varun Goel
1  Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India
,
Sumit Goyal
1  Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India
,
Prasanta Kumar Dash
1  Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India
,
Ullas Batra
1  Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India
,
Rajat Bajaj
2  Department of Medical Oncology, Fortis Escorts Hospital, Faridabad, Haryana, India
,
Abhishek Yadav
3  Department of Medical Oncology, Fortis Escorts Hospitals, Delhi, India
,
Pankaj Goyal
1  Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India
,
Dinesh Chandra Doval
1  Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India
› Author Affiliations
FundingNil.

Abstract

Objective The aim of this study is to investigate the effects of gemcitabine maintenance on progression-free survival (PFS) in patients with metastatic gallbladder cancer (GBC).

Materials and Methods Sixty patients with unresectable or metastatic GBC having ongoing response to treatment with initial six cycles of gemcitabine and a platinum-based doublet chemotherapy were prospectively randomized on day 21 of the 6th cycle in 1:1 fashion to receive either maintenance gemcitabine 1 g/m2 intravenously on day 1 and day 8 of three weekly cycle or observation. Survival analysis was performed using the Kaplan–Meier method and comparisons by the log-rank test. A p-value < 0.05 was considered as statistically significant.

Results Of 60 patients, a total of 56 were available for final analysis. The median PFS was 4.7 months (3.1–6.3) in gemcitabine arm and 2.6 months (2.4–2.8) in observation arm, hazard ratio (HR) 0.196 (95% confidence interval [CI]: 0.1–0.39), p < 0.001. Median overall survival in gemcitabine arm was 12.4 months (9.15–15.6) as opposed to 9.9 months (8.29–11.5) in observation arm, HR 0.76 (95% CI: 0.43–1.35), p = 0.354. The grade 3 or 4 side effects in maintenance arm were transaminitis (17.9%), thrombocytopenia (17.8%), neutropenia (14.2%), and febrile neutropenia (7.1%).

Conclusions Maintenance gemcitabine therapy in unresectable/metastatic GBC patients responding to first-line gemcitabine and platinum treatment contributes to increase PFS with minimal and manageable side effects.



Publication History

Publication Date:
12 June 2021 (online)

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