Survival, quality of life and quality-adjusted survival of patients in the ESPAC-1 trial: a European randomized trial to assess the roles of adjuvant chemotherapy and chemoradiation in resectable pancreatic cancer.

Aims: To assess the roles of adjuvant chemotherapy and chemoradiation in resectable pancreatic cancer. Methods: ESPAC-1 is the largest randomized adjuvant pancreatic study aiming to answer two questions: (i) is there a role for chemoradiation (40Gy + 5-fluorouracil); (ii) is there a role for chemotherapy (5-fluorouracil + folinic acid). 541 patients with pancreatic ductal adenocarcinoma were randomized from 83 clinicians in 11 countries. Quality of life (QoL) was assessed by patient questionnaires (EORTC QLQ-C30/ESPAC-QLQ32) completed at 3-monthly intervals. Additional QoL-related information was collected by the clinician (performance status, weight, diabetes and enzyme supplements). Changes in dimension scores within 6 months from entry were compared between treatments. Calculation of the quality adjusted life months (QALM) for the global QoL score enabled the length of survival and QoL to be combined. Results: Two hundred and twenty-seven patients (42 per cent) are alive with median follow-up of 10 months (interquartile range 1–25). Preliminary results show no evidence of a survival benefit for chemoradiation treatment (median survival 15.5 months with chemoradiation versus 16.1 months without, P = 0.24). There is evidence of a benefit for patients having chemotherapy (median survival 19.7 months with chemotherapy versus 14.0 months without, P < 0.001). A total of 296 patients have completed 789 QoL questionnaires within 1 year of entry. Initial analysis suggests there is a slight detriment with chemotherapy for social functioning (P = 0.03), role functioning (P = 0.02) and constipation (P = 0.05), within the 6 months from entry. However, with adjustment for multiple comparisons these differences become non-significant (P > 0.05). There are no significant differences in the QALM between either treatment comparisons within the first 12 months from entry to trial (no chemotherapy versus chemotherapy, P = 0.37; no chemoradiation versus chemoradiatio... [ABSTRACT FROM AUTHOR]