Quality of life after adjuvant intra-arterial chemotherapy and radiotherapy versus surgery alone in resectable pancreatic and periampullary cancer: a prospective randomized controlled study.

BACKGROUND: Adjuvant therapies for pancreatic and periampullary cancer reportedly achieve only a marginal survival benefit. In this randomized controlled trial, 120 patients with resected pancreatic or periampullary cancer received either adjuvant celiac axis infusion chemotherapy combined with radiotherapy (CAI/RT) or no adjuvant treatment. The objective of the study was to compare the quality of life (QoL) in patients who received CAI/RT after pancreatoduodenectomy with the QoL in patients who did not receive adjuvant treatment.
METHODS: During and after CAI/RT, QoL was assessed using the European Organization for Research and Treatment of Cancer QoL Questionnaire C30 every 3 months during the first 24 months after randomization.
RESULTS: Eighty-six percent of patients (n = 103) completed 1 or more questionnaires. In total, 355 questionnaires were completed. The results indicated that CAI/RT did not impair physical, emotional, or social functioning. During and after CAI/RT, patients had significantly less pain (P = .02) and less nausea and vomiting (P = .01). Overall QoL (global functioning) tended to be better (P = .08) after CAI/RT.
CONCLUSIONS: Over a period of 24 months, CAI/RT improved QoL compared with observation alone in patients with resected pancreatic and periampullary cancer. This beneficial effect of CAI/RT was most prominent in the latter half of the follow-up.

RCT Entities:   Population Interventions Outcomes