评估食管切除术后锻炼对 2 年和 5 年生存率的影响:PERFECT 试验结果。

David Binyam,J K van Vulpen,R van Hillegersberg,J P Ruurda,G A P Nieuwenhuijzen,E A Kouwenhoven,E van der Wall,R P R Groenendijk,D L van der Peet,C Rosman,B P L Wijnhoven,M I van Berge Henegouwen,H W M van Laarhoven,P D Siersema,Anne M May,A E Hiensch
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We assessed 2- and 5-year (progression-free) survival. (Un)adjusted Cox Proportional-Hazards models were used to calculate hazard ratios (HRs) for comparison between the trial arms. Sensitivity analyses, excluding patients with events within the exercise intervention period, were performed.\r\n\r\nRESULTS\r\nIn total, 120 participants (EX = 61; CG = 59) were included in the PERFECT-trial. After 2-year follow-up, no significant difference in the risk of death or progression between EX and CG was found (adjusted HR = 1.65, 95% CI [0.75-3.63] and 1.38, 95% CI [0.76-2.50], respectively). After excluding patients with events during the intervention period (EX = 8; CG = 4), 2-year HRs for death (1.03, 95% CI [0.41-2.56]) and progression (1.26, 95% CI [0.64-2.48]) both decreased and remained insignificant. No significant effects were found on 5-year mortality (1.03, 95% CI [0.57-1.84]) and progression (1.21, 95% CI [0.72-2.04]) either. Sensitivity-analysis resulted in attenuated 5-year HRs for mortality (0.82, 95% CI [0.42-1.58]) and progression (1.08, 95% CI [0.61-1.92]).\r\n\r\nCONCLUSIONS\r\nThe results indicate no benefit of a 12-week exercise program in the first year post-esophagectomy on 2- and 5-year (progression-free) survival in esophageal cancer patients. 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引用次数: 0

摘要

目的:尽管食道癌的治疗取得了最新进展,但食道癌患者的生存率仍然很低,发病率也很高。探索性证据表明,运动可以降低癌症相关死亡率和复发率。在此,我们研究了食管癌治疗后体育锻炼(PERFECT)试验的参与者在食管切除术后第一年进行锻炼干预对生存的影响。在 PERFECT 试验中,接受食管切除术的食管癌患者被随机分配到为期 12 周的锻炼计划(EX)或对照组(CG)。我们评估了2年和5年(无进展)生存率。(采用(未)调整的 Cox 比例-危险模型计算危险比 (HR),以比较试验组之间的差异。结果共有 120 名参与者(EX = 61;CG = 59)参加了 PERFECT 试验。随访 2 年后,EX 和 CG 的死亡或病情恶化风险无明显差异(调整后 HR 分别为 1.65,95% CI [0.75-3.63] 和 1.38,95% CI [0.76-2.50])。在排除干预期间发生事件的患者(EX = 8;CG = 4)后,2 年死亡 HR(1.03,95% CI [0.41-2.56])和病情进展 HR(1.26,95% CI [0.64-2.48])均有所下降,但仍不显著。对 5 年死亡率(1.03,95% CI [0.57-1.84])和病情进展(1.21,95% CI [0.72-2.04])的影响也不明显。敏感性分析结果表明,死亡率(0.82,95% CI [0.42-1.58])和病情进展(1.08,95% CI [0.61-1.92])的 5 年 HR 值均有所降低。没有益处的原因可能是运动时间相对较短,而且是在治疗结束后进行的。
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Evaluating the Impact of Post-Esophagectomy Exercise on 2- and 5-Year Survival: Findings from the PERFECT Trial.
PURPOSE Despite recent treatment advances, esophageal cancer still has poor survival and a high morbidity. Exploratory evidence suggests that exercise can reduce cancer-related mortality and recurrence rates. Here, we investigated the effects of an exercise intervention in the first year after esophagectomy on survival in participants of the Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT)-trial. METHODS In the PERFECT-trial, esophageal cancer patients who had undergone esophagectomy were randomized to a 12-week exercise program (EX) or the control group (CG). We assessed 2- and 5-year (progression-free) survival. (Un)adjusted Cox Proportional-Hazards models were used to calculate hazard ratios (HRs) for comparison between the trial arms. Sensitivity analyses, excluding patients with events within the exercise intervention period, were performed. RESULTS In total, 120 participants (EX = 61; CG = 59) were included in the PERFECT-trial. After 2-year follow-up, no significant difference in the risk of death or progression between EX and CG was found (adjusted HR = 1.65, 95% CI [0.75-3.63] and 1.38, 95% CI [0.76-2.50], respectively). After excluding patients with events during the intervention period (EX = 8; CG = 4), 2-year HRs for death (1.03, 95% CI [0.41-2.56]) and progression (1.26, 95% CI [0.64-2.48]) both decreased and remained insignificant. No significant effects were found on 5-year mortality (1.03, 95% CI [0.57-1.84]) and progression (1.21, 95% CI [0.72-2.04]) either. Sensitivity-analysis resulted in attenuated 5-year HRs for mortality (0.82, 95% CI [0.42-1.58]) and progression (1.08, 95% CI [0.61-1.92]). CONCLUSIONS The results indicate no benefit of a 12-week exercise program in the first year post-esophagectomy on 2- and 5-year (progression-free) survival in esophageal cancer patients. The absence of beneficial effects may be explained by the relatively short exercise program, which was performed after treatment completion.
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