Supervised Exercise Therapy and Adjuvant Chemotherapy for Pancreatic Cancer: A Prospective, Single-Arm, Phase II Open-Label, Nonrandomized, Historically Controlled Study.

ABSTRACT

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. STUDY DESIGN: This study is a prospective single-center phase II trial that aimed to examine whether a supervised exercise therapy for pancreatic ductal adenocarcinoma improved the completion rate of S-1 adjuvant chemotherapy in the 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 to 100.0] (median [interquartile range]), 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 1 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 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 pancreatic ductal adenocarcinoma was confirmed to improve the completion rate of S-1 adjuvant chemotherapy.