Long-term outcomes of the ESPAC-4 trial showed improved survival and slightly less toxicity with adjuvant gemcitabine plus capecitabine versus gemcitabine monotherapy for resected pancreatic cancer, according to data presented at the virtual 2020 ASCO Annual Meeting.

“The ESPAC-4 trial demonstrated that adjuvant [gemcitabine plus capecitabine] for pancreatic cancer significantly improved survival compared to [gemcitabine] monotherapy,” wrote John P. Neoptolemos, MD, PhD, University of Heidelberg, Germany, and co-investigators on the purpose of the study.

Within 12 weeks of undergoing surgery, a total of 732 patients (median age, 65 years) were randomized into this phase 3 trial between November 2008 and September 2014, with 730 included in the analysis. Patients were given 6 cycles of gemcitabine alone (n = 366) or gemcitabine plus capecitabine (n = 364), with each cycle spanning 4 weeks.

The primary end point was 5-year survival, and secondary end points were toxicity and relapse-free survival.

The median follow-up time frame was 60 months, and 5-year survival rates were 28% with adjuvant gemcitabine plus capecitabine versus 20% with gemcitabine monotherapy (hazard ratio, 0.84; 95% CI, 0.70-0.99; χ2 (1) = 3.87, P = .049). Furthermore, patients in either arm had a median survival of 27.7 months versus 26.0 months, respectively.

According to the data presented during the virtual ASCO meeting, the combination therapy showed an improvement in disease-free survival but had a P value that was not significant.

Slightly less toxicity, deemed not significant by the investigators, was observed in the gemcitabine plus capecitabine treatment arm, with 65 patients reporting 97 grade 3 and 4 serious adverse events compared with 70 patients in the monotherapy arm who reported 101 events.

“Adjuvant [gemcitabine plus capecitabine] for pancreatic cancer had a statistically significant improvement in survival compared to [gemcitabine] monotherapy,” concluded investigators.—Kaitlyn Manasterski

Neoptolemos J P, Palmer D H, Ghaneh P, et al. ESPAC-4: A multicenter, international, open-label randomized controlled phase III trial of adjuvant combination chemotherapy of gemcitabine (GEM) and capecitabine (CAP) versus monotherapy gemcitabine in patients with resected pancreatic ductal adenocarcinoma: Five year follow-up. Presented at: the 2020 ASCO Annual Meeting; May 29-31, 2020. Abstract 4516.