LAUSR

BACKGROUND Improvement of the completion rate of postoperative adjuvant chemotherapy is a key to obtaining favorable prognosis in patients who undergo macroscopically curative pancreatectomy for pancreatic ductal adenocarcinoma (PDAC). STUDY DESIGN This study is a prospective single-center phase II trial which aimed to examine whether a supervised exercise therapy for PDAC improved the completion rate of S-1 adjuvant chemotherapy for development of a tolerable and effective exercise plan for patients undergoing adjuvant therapy. RESULTS Forty-three patients were included in the study. The completion rate of S-1 therapy, the primary endpoint, was 93%, which exceeded the threshold completion rate of 53% (P <0.001). As secondary endpoints, the relative dose intensity of S-1 was 100.0 [95.9,100.0] (median (IQR)), the median recurrence-free survival was 20.4 months, and the median overall survival was not reached, confirming the safety of the protocol treatment. Regarding frailty status, there was significant decrease in the Kihon checklist score (P = 0.002) and significant increase in G8 questionnaire score (P < 0.001), indicating that exercise therapy reduced frailty. There were no incidences of serious adverse events except for one case of grade 3 febrile neutropenia. The differences between before/after therapy (between 6 months/baseline) of mean muscle mass, mean body fat mass, mean body fat percentage, and mean controlling nutrition status (CONUT) score were 1.52 (P < 0.001), -1.18 (P = 0.007), -2.47 (P < 0.001), and -0.59 (P = 0.006) respectively. CONCLUSIONS Adjuvant chemotherapy combined with supervised exercise therapy for PDAC was confirmed to improve the completion rate of S-1 adjuvant chemotherapy.