Background

Neoadjuvant chemoradiation (NACRT) improves outcomes for patients with rectal cancer; however, there are dose-limiting toxicities and only a 15% to 27% pathologic complete response (pCR) rate. Exercise may help manage toxicities and improve treatment response, but feasibility and early efficacy have not been established. EXERT was a phase II trial designed to establish the feasibility and safety of exercise and provide the first evidence of efficacy.

Materials and Methods

Patients with rectal cancer scheduled to receive NACRT were randomly assigned to usual care (n = 18) or exercise (n = 18) involving supervised exercise during NACRT and unsupervised exercise after NACRT. The primary outcome was cardiorespiratory fitness (VO₂ peak). Clinical outcomes included treatment toxicities, treatment completion, and treatment response.

Results

Median attendance at supervised exercise sessions during NACRT was 82%, and median self-reported exercise after NACRT was 90 min/wk. From baseline to post-NACRT, VO₂ peak increased by 0.4 mL·kg⁻¹·min⁻¹ in the exercise group and decreased by 0.8 mL·kg⁻¹·min⁻¹ in the usual care group (P = .47). There were no significant differences between groups for grade 3/4 toxicities or treatment completion. Of 18 patients in the exercise group, 10 (56%) achieved pCR/near pCR compared with 3 of 17 (18%) in the usual care group (P = .020).

Conclusion

Exercise during and after NACRT is feasible for many patients with rectal cancer and may improve pCR despite limited fitness improvements. Larger trials are warranted to confirm if exercise is an effective intervention for improving treatment outcomes in this clinical setting.

中文翻译：

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新辅助直肠癌治疗期间和之后运动的可行性、安全性和初步疗效：II 期随机对照试验

背景

新辅助放化疗（NACRT）可改善直肠癌患者的预后；然而，存在剂量限制性毒性，只有 15% 至 27% 的病理完全缓解 (pCR) 率。运动可能有助于控制毒性和改善治疗反应，但可行性和早期疗效尚未确定。EXERT 是一项 II 期试验，旨在确定运动的可行性和安全性，并提供第一个疗效证据。

材料和方法

计划接受 NACRT 的直肠癌患者被随机分配到常规护理组 ( n =  18) 或运动组 ( n =  18)，包括 NACRT 期间有监督的运动和 NACRT 后的无监督运动。主要结果是心肺健康（VO ₂峰值）。临床结果包括治疗毒性、治疗完成和治疗反应。

结果

NACRT 期间监督锻炼的中位出席率为 82%，NACRT 后自我报告的锻炼中位为 90 分钟/周。从基线到 NACRT 后，VO ₂峰值在运动组增加了 0.4 mL·kg ^-1 · min ^-1，在常规护理组减少了 0.8 mL·kg ^-1 ·min ^{-1 (} P = . 47) . 3/4 级毒性或治疗完成组之间没有显着差异。在运动组的 18 名患者中，10 名 (56%) 达到 pCR/接近 pCR，而常规护理组 17 名患者中有 3 名 (18%) ( P = .020)。

结论

对于许多直肠癌患者来说，在 NACRT 期间和之后进行锻炼是可行的，尽管体能改善有限，但可能会改善 pCR。有必要进行更大规模的试验来确认运动是否是在这种临床环境中改善治疗结果的有效干预措施。