Supervised Exercise Therapy and Adjuvant Chemotherapy for Pancreatic Cancer: A Prospective, Single-Arm, Phase II Open-Label, Nonrandomized, Historically Controlled Study.
Supervised Exercise Therapy and Adjuvant Chemotherapy for Pancreatic Cancer: A Prospective, Single-Arm, Phase II Open-Label, Nonrandomized, Historically Controlled Study.
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胰腺癌的监督运动疗法和辅助化疗：一项前瞻性、单臂、II 期开放标签、非随机、历史对照研究。
DOI：
10.1097/xcs.0000000000000408
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发表时间：
2022
影响因子：
5.2
通讯作者：
H.
中科院分区：
文献类型：
--
作者：
Okada KI;Kouda K;Kawai M;Hirono;S;Miyazawa M;Kitahata Y;Kawanishi M;Natsume Y;Wan K;Yamaue;H.
背景：提高术后辅助化疗的完成率是胰管腺癌行宏观根治性胰腺切除术患者获得良好预后的关键。研究设计：本研究是一项前瞻性单中心II期试验，旨在研究在为接受辅助治疗的患者制定可耐受和有效的运动计划时，监督运动治疗胰腺导管腺癌是否能提高S-1辅助化疗的完成率。结果：43例患者纳入研究。主要终点S-1治疗的完成率为93%，超过了53%的阈值完成率（p< 0.001）。作为次要终点，S-1的相对剂量强度为100.0[95.9 ~ 100.0]（中位数[四分位数范围]），中位无复发生存期为20.4个月，中位总生存期未达到，证实了该方案治疗的安全性。在虚弱状态方面，Kihon检查表得分显著降低（p= 0.002）， G8问卷得分显著升高（p< 0.001），表明运动治疗降低了虚弱状态。除1例3级发热性中性粒细胞减少症外，未发生严重不良事件。治疗前后（6个月/基线）平均肌肉质量、平均体脂质量、平均体脂百分比和平均控制营养状态评分的差异分别为1.52 （p< 0.001）、-1.18 （p= 0.007）、-2.47 （p< 0.001）和0.59 （p= 0.006）。结论：辅助化疗联合监督运动治疗胰管腺癌可提高S-1辅助化疗的完成率。
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.