Real world clinical outcomes of adjuvant sequential chemoradiation in patients with gallbladder carcinomas with poor performance status.

Purpose: The purpose of the study is to analyze the overall survival, relapse-free survival, and relapse patterns of adjuvant sequential chemoradiation for gallbladder cancers after curative resection in patients with poor performance status.

Materials and methods: We retrospectively reviewed clinical records of gallbladder patients with pathologic stage T2-4 or node positivity treated with sequential chemoradiation at our institute between January 2015 and January 2019. Sequential chemoradiotherapy protocol consisted of six cycles of gemcitabine 1,000 mg/m2 and oxaliplatin 100 mg/m2 administered every 2 weekly and postoperative radiation therapy (45 Gy in 25 fractions over 5 weeks) by three-dimensional conformal technique.

Results: A total of 36 patients were included. The median overall survival and relapse-free survival was 26 months (95% confidence interval [CI], 21.4-30.5) and 21 months (95% CI, 11.8-30.1), respectively. The 2-year overall and relapse-free survival rates were 55.1% (95% CI, 37.9%-72.3%) and 44.7% (95% CI, 27.5%-61.9%), respectively. Locoregional, systemic, and combined recurrence were noted in 2 (5.5%), 14 (38.8%), and 3 (8.3%) patients, respectively. On univariate analysis, tumour grading significantly influenced relapse free survival; nodal stage and overall stage demonstrated a statistically significant influence on overall survival (p < 0.05) with a trend towards significance for lymphovascular invasion. On multivariate analysis, no significant factors were found. Grade 3 and 4 haematological adverse events were observed only in 2 (5.5%) with chemotherapy. No grade 3 and 4 adverse events were observed due to radiation therapy.

Conclusion: Sequential chemoradiation is feasible and tolerable with acceptable efficacy in the adjuvant setting in patients unfit for concurrent chemoradiotherapy.