In an Indian phase II trial (GECCOR-GB) reported in JAMA Oncology, Ostwal et al found that both adjuvant gemcitabine/cisplatin (GC) and capecitabine and capecitabine given concurrently with chemoradiation therapy (CCRT) showed activity in patients with resected gallbladder cancer.
Study Details
In the open-label study, 90 patients enrolled at three centers between May 2019 and February 2022 were randomly assigned to receive either:
- GC (n = 45) given as gemcitabine at 1,000 mg/m2 and cisplatin at 25 mg/m2 on days 1 and 8 every 3 weeks for up to six cycles
- CCRT (n = 45) given as capecitabine at 2,000 mg/m2 in two divided doses for 14 days on/1 week off for two to four cycles, followed by concurrent chemoradiation with capecitabine at 1,650 mg/m2 in two divided doses concurrent with radiotherapy at 45 Gy in 25 fractions over 5 weeks, followed by two to four cycles of capecitabine to complete a total of six cycles before and after concurrent chemoradiation therapy.
Patients had to have stage II/III adenocarcinoma or adenosquamous carcinoma of the gallbladder with no local residual tumor or microscopic residual tumor after resection.
The primary outcome measure was disease-free survival at 1 year. For each treatment group, a 1-year rate of less than 59% would be considered as insufficient activity, and a 1-year rate of at least 77% would be considered as sufficient activity.
Key Findings
Rates of completion of planned treatment were 82% in the GC group and 62% in the CCRT group.
In the GC group, the 1-year disease-free survival rate was 88.9% (95% confidence interval [CI] = 79.5%–98.3%). The estimated 2-year disease-free survival rate was 74.8% (95% CI = 60.4%–89.2%). In the CCRT group, the 1-year disease-free survival rate was 77.8% (95% CI = 65.4%–90.2%). The estimated 2-year disease-free survival rate was 74.8% (95% CI = 59.9%–86.3%). Overall survival rate at 2 years was 88% (95% CI = 77.8%–98.2%) vs 80.6% (95% CI = 68.2%–93.0%), respectively.
The investigators concluded: “In this randomized clinical trial, GC and CCRT crossed the prespecified trial endpoints of 1-year disease-free survival in patients with resected stage II/III gallbladder cancers. The results set a baseline for a larger phase III trial evaluating both regimens in operated gallbladder cancers.”
Anant Ramaswamy, MD, DM, of the Department of Medical Oncology, Tata Memorial Hospital, Mumbai, is the corresponding author of the JAMA Oncology article.
Disclosure: For full disclosures of the study authors, visit jamanetwork.com.
