A multicenter, open-label, randomized phase II study evaluating adjuvant gemcitabine plus cisplatin (GC) and capecitabine with concurrent capecitabine radiotherapy (CAPE-RT) in patients with operated gallbladder adenocarcinoma (GBC): The GECCOR-GB trial.

Authors

null

Anant Ramaswamy

Tata Memorial Hospital (HBNI), Mumbai, India

Anant Ramaswamy , Vikas S. Ostwal , Reena Engineer , Manali Parulekar , Sarika Mandavkar , Nanda Aier , Prabhat Ghanshyam Bhargava , Sujay Srinivas , Shraddha Patkar , RAHUL KRISHNATRY , Shivakumar Gudi , Akhil Kapoor , Durgatosh Pandey , Swapnil Patel , Abhishek Shinghal , Alok Goel , Tapas Kumar Dora , Debashish Chaudhary , Suman Kumar Ankathi , Mahesh Goel

Organizations

Tata Memorial Hospital (HBNI), Mumbai, India, HBNI University, Mumbai, India, Homi Bhabha Cancer Hospital, Varanasi, Varanasi, India, Homi Bhabha Cancer Hospital, Sangrur, Sangrur, India, Homi Bhabha Cancer Hospital &Research Centre, Sangrur, India, Homi Bhabha Cancer Hospital, Sangrur, India, Tata Memorial Center (HBNI), Mumbai, India

Research Funding

Other
Educational grants to the istitute from reddy's lab pvt for this study

Background: Adjuvant gemcitabine plus cisplatin (GC) and concurrent chemo-radiotherapy are commonly used treatment options for resected GBC. Methods: GB-GECCOR is a multicentre, open-label randomized non-comparative phase II study in patients of Gallbladder cancer (GBC), with R0 or R1 resection within 3 months of randomization. Patients were randomized 1:1 to GC arm (Gem 1000 mg/m2 and Cisplatin 25mg/m2 on day 1 and 8, q 3 weeks) for 6 cycles or CAPE-RT arm {Capecitabine 1000mg/m2 BD on days 1-14, q 3 weeks for 2-4 cycles followed by chemoradiation (RT: 45 Gy over 25 fractions concurrent with capecitabine: 825mg/m2 twice) followed by 2-4 cycles of capecitabine for a total of 6 cycles}. The primary end point was 1-year disease-free survival (DFS). With 80% power to detect the difference between a 59% (minimum sufficient activity of the regimen) and a 77% (sufficient activity for future larger studies with the regimen) 1-year DFS rate assuming an attrition of 10%, a total of 90 patients were required for the study. Results: Between May 2019 and February 2022, 90 patients (45 in each arm), were included. Stage II and stage III GBC were seen in 50 (56%) and 40 patients (44%) respectively, with R0 resection observed in 86 patients (96%). Patient characteristics were well balanced between the 2 arms except for R1 resections which were greater in the CAPE-RT arm (p=0.041). With a median follow-up duration of 23 months, the 1-year DFS rate was 88.9% (95% CI: 79.5-98.3) in the GC group and 77.8% (95% CI: 65.4 – 90.2) in the CAPE-RT group, respectively. The most common AEs were grade 3/4 neutropenia in 6 patients (13.3%) in the GC group and grade 2/3 HFS in 14 patients (31.1.%) in the CAPE-RT group. The distant metastases were seen in 12 patients (26.6 %) in each arm and loco-regional metastases in 3 patients (6.6 %) in the GC arm. Conclusions: In this study of operated GBC, GC and CAPE-RT successfully achieved the minimum pre-specified DFS rates. Within the confines of a non-comparative randomised study, GC had narrowed the gap in survivals of stage III vs. stage II GBCs, which was not noted in the CAPE-RT arm. This study results give credence to the use of both regimens as reasonable standards of care till evaluation in larger phase 3 studies. Clinical trial information: CTRI/2019/05/019323.

CharacteristicsGC arm (%) (n=45)CAPE-RT arm (%) (n=45)p-value
Stage
II
III

23
22

27
18

0.396
Treatment completion rates84.473.3
1 - year DFS
Stage II
Stage III
88.9 (95% CI: 79.5-98.3)
95.7
81.8
77.8% (95% CI: 65.4 – 90.2)
96.3
50
2-year DFS
Stage II
Stage III
74.8% (95% CI: 60.4-89.2)
76.8
72.2
73.1% (59.9-86.3)
92.3
44.4
1 - year OS95.6% (95% CI: 89.4 – 98.7)88.9 (95% CI: 79.5-98.3)

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Hepatobiliary Cancer - Local-Regional Disease

Clinical Trial Registration Number

CTRI/2019/05/019323

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr 4017)

DOI

10.1200/JCO.2023.41.16_suppl.4017

Abstract #

4017

Poster Bd #

338

Abstract Disclosures