Efficacy and tolerability of adjuvant gemcitabine and capecitabine in patients with resected pancreatic cancer in US population: A single network experience.

Abstract

e15789 Background: Adjuvant chemotherapy with combination of gemcitabine and capecitabine improved overall survival (OS) with an acceptable toxicity profile in the European patient population. However, limited data is available for tolerability and efficacy of the combination regimen in the adjuvant setting in the US population. Herein, we report a single network experience with the combination regimen. Methods: We retrospectively evaluated 45 patients with pancreatic cancer who were treated at our institution from 1/1/2017 – 12/31/2018. Eligible patients were aged 18 years or older and had undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas. These patients received adjuvant combination chemotherapy with gemcitabine (1000 mg/m2) and capecitabine (1660 mg/m2). Electronic medical record was reviewed to collect patient data. Medcalc software was used for statistical analysis including Kaplan Meier analyses. Results: Median age of patients was 64.6 years (range 47-87). Majority of patients had stage II disease (73.5%). Seventy-one percent of patients were able to receive 6 cycles of chemotherapy. Median OS for all patients was 20.2 months (95% CI 11.7-22.7). Median OS for patients who received < 6 vs 6 cycles was 14.9 months (95% CI 6.6-14.9) vs 21.5 months (95% CI 11.9-22.9) (p = 0.21). Median progression free survival (PFS) for all patients was 19.3months (95% CI 13.1-25.7). Median PFS for patients with < 6 vs 6 cycles was 7.3 months versus 22.2 months (p = 0.0002). Overall, 31.1% of patients developed disease progression. Of note, 33.3% and 71.1% of patients required dose reductions for gemcitabine and capecitabine respectively. Fifteen grade 3-4 adverse events were reported of which 11 were hematologic and 4 non-hematologic. Conclusions: This single institution analysis shows a trend in improvement for PFS for patients able to complete adjuvant therapy with gemcitabine and capecitabine following pancreatic resection. It is worth noting, however, that dose reductions were required in the majority of patients. Therefore, we propose investigating a modified regimen of gemcitabine and capecitabine in the US population.