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Clinical Trial
. 2024 Aug 1;10(8):1116-1120.
doi: 10.1001/jamaoncol.2024.1944.

Adjuvant Gemcitabine Plus Cisplatin and Chemoradiation in Patients With Gallbladder Cancer: A Randomized Clinical Trial

Vikas Ostwal  1 , Shraddha Patkar  2 , Reena Engineer  3 , Manali Parulekar  1 , Sarika Mandavkar  1 , Prabhat Bhargava  1 , Sujay Srinivas  1 , Rahul Krishnatry  3 , Shivakumar Gudi  3 , Akhil Kapoor  4 , Durgatosh Pandey  5 , Swapnil Patel  5 , Abhishek Singhal  6 , Alok Goel  7 , Tapas Kumar Dora  7 , Debashish Chaudhary  8 , Deepali Chaugule  9 , Deepali Naughane  9 , Anuprita Daddi  10 , Rajshree Patil  9 , Suman Kumar Ankathi  11 , Anant Ramaswamy  9 , Mahesh Goel  12
Affiliations
Clinical Trial

Adjuvant Gemcitabine Plus Cisplatin and Chemoradiation in Patients With Gallbladder Cancer: A Randomized Clinical Trial

Vikas Ostwal et al. JAMA Oncol. .

Abstract

Importance: There is limited evidence with regard to the benefit of adjuvant chemotherapy chemoradiotherapy in resected gallbladder cancers (GBCs).

Objective: To establish a baseline survival rate for operated GBCs in patients receiving either gemcitabine plus cisplatin (GC) or capecitabine and capecitabine concurrent with chemoradiation (CCRT).

Design, setting, and participants: The GECCOR-GB study was a multicenter, open-label, randomized phase 2 noncomparator "pick the winner" design trial of adjuvant GC and CCRT in patients with resected histologically confirmed adenocarcinoma or adenosquamous carcinoma of the gallbladder, (stage II/III) with no local residual tumor (R0) or microscopic residual tumor (R1). The study was carried out in 3 tertiary cancer institutions in India. Patients 18 years or older with adequate end-organ functions, and Eastern Cooperative Oncology Group Performance Status of 1 or lower between May 2019 and February 2022 were enrolled. The cutoff date for data analysis was February 28, 2023.

Interventions: Patients were randomized 1:1 to receive either GC every 3 weeks (maximum of 6 cycles) or CCRT comprising capecitabine with concurrent chemoradiation (capecitabine concurrent with radiotherapy) sandwiched between capecitabine chemotherapy.

Main outcomes and measures: The primary outcome was disease-free survival (DFS) at 1 year in randomized patients. This study was conducted as 2 parallel, single-stage phase 2 clinical trials. Within each treatment arm, a 1-year DFS rate of less than 59% was considered as insufficient activity, whereas a 1-year DFS rate of 77% or higher would be considered as sufficient activity.

Results: With a median follow-up of 23 months, 90 patients were randomized, 45 in each arm. Overall, there were 31 women (69%) and 14 men (31%) in the GC arm with a mean (range) age of 56 (33-72) years and 34 women (76%) and 11 men (24%) in the CCRT group with a mean (range) age of 55 (26-69) years. In the GC and CCRT arms, 1-year DFS and estimated 2-year DFS was 88.9% (95% CI, 79.5-98.3) and 74.8% (95% CI, 60.4-89.2), and 77.8% (95% CI, 65.4-90.2) and 74.8% (95% CI, 59.9-86.3), respectively. Completion rates for planned treatment was 82% in the GC arm and 62% in the CCRT arm.

Conclusions and relevance: In this randomized clinical trial, GC and CCRT crossed the prespecified trial end points of 1-year DFS in patients with resected stage II/III GBCs. The results set a baseline for a larger phase 3 trial evaluating both regimens in operated GBCs.

Trial registration: ClinicalTrials.gov Identifier: CTRI/2019/05/019323I.

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Conflict of interest statement

Conflict of Interest Disclosures: Drs Ostwal, Parulekar, and Mandavkar reported grants from Dr Reddy’s Lab Pvt Ltd to the institution to support the study during the conduct of the study. In addition, Dr Parulekar reported grants from Zydus Pharma to the institution during the conduct of the study and Dr Mandavkar reported grants from Zydus Lifesciences to the institution during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram
Figure 2.
Figure 2.. Disease-Free Survival Probability by Intervention
See this image and copyright information in PMC

References

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