联合运动与饮食干预对卵巢癌患者临床结局的影响：卵巢癌体力活动与饮食干预（PADOVA）随机对照试验

Effects of a combined exercise and dietary intervention on clinical outcomes in patients with ovarian cancer: the Physical Activity and Dietary intervention in OVArian cancer (PADOVA) randomized controlled trial.

作者信息

Brouwer Calvin G, Hartman Yvonne A W, Stelten Stephanie, Kenkhuis Malou-Floor, van Lonkhuijzen Luc R C W, Kenter Gemma G, Kos Milan, van de Ven Peter M, Driel Willemien J van, Winkels Renate M, Bekkers Ruud L M, Ottevanger Petronella B, Hoedjes Meeke, Buffart Laurien M

机构信息

Department of Medical BioSciences, Radboud University Medical Center, Nijmegen, The Netherlands.

Department of Gynecologic Oncology, Cancer Center Amsterdam, Amsterdam University Medical Centres, Amsterdam, The Netherlands.

出版信息

Int J Gynecol Cancer. 2024 Sep 7. doi: 10.1136/ijgc-2024-005634.

DOI:10.1136/ijgc-2024-005634

PMID:39244208

Abstract

OBJECTIVE

Chemotherapy treatment modifications can impact survival in patients with ovarian cancer, particularly when the relative dose intensity falls below 85%. Exercise and dietary interventions may benefit treatment tolerability. This study aimed to explore the effects of a combined exercise and dietary intervention on secondary outcomes of the Physical Activity and Dietary intervention in OVArian cancer (PADOVA) trial, specifically relative dose intensity and progression-free survival.

METHODS

81 patients with ovarian cancer were randomized into a combined supervised exercise and dietary intervention during (neo)adjuvant chemotherapy or a usual care control group. Relative dose intensity was calculated as the ratio of delivered dose intensity (dose per actual time) to the standard dose for six chemotherapy cycles. The effect on relative dose intensity was analyzed using logistic regression and Bayesian posterior probability of correctly identifying the best study arm. The effect on progression-free survival was examined using Cox regression.

RESULTS

The proportion of patients achieving a relative dose intensity ≥85% was 74.4% in the intervention group compared with 61.5% in the control group (OR 2.04, 95% CI 0.75 to 5.84). The Bayesian posterior probability that the intervention group had a higher proportion of patients with a relative dose intensity ≥85% was 88.4%. Intervention effect on progression-free survival was not statistically significant (HR 1.63, 95% CI 0.82 to 3.23). At 18 months, the proportion of patients without disease progression was 73% in the intervention group and 51% in the control group.

CONCLUSION

The proportions of patients with ovarian cancer with a relative dose intensity ≥85% and an 18-month progression-free survival were numerically higher in the intervention group compared with the control group, but these differences were not statistically significant. The higher proportions and the 88.4% probability that intervention is superior to usual care for clinical outcomes support future studies on exercise and dietary interventions with a focus on clinical outcomes as primary endpoints.

TRIAL REGISTRATION NUMBER

Registered in the Netherlands Trial Registry (NTR6300).

摘要

目的

化疗方案的调整会影响卵巢癌患者的生存率，尤其是当相对剂量强度低于85%时。运动和饮食干预可能有益于治疗耐受性。本研究旨在探讨运动与饮食联合干预对卵巢癌体力活动与饮食干预（PADOVA）试验次要结局的影响，特别是相对剂量强度和无进展生存期。

方法

81例卵巢癌患者被随机分为两组，一组在（新）辅助化疗期间接受有监督的运动与饮食联合干预，另一组为常规护理对照组。相对剂量强度计算为六个化疗周期的实际给药剂量强度（每实际时间的剂量）与标准剂量的比值。采用逻辑回归和正确识别最佳研究组的贝叶斯后验概率分析对相对剂量强度的影响。使用Cox回归检验对无进展生存期的影响。

结果

干预组达到相对剂量强度≥85%的患者比例为74.4%，而对照组为61.5%（比值比2.04，95%置信区间0.75至5.84）。干预组相对剂量强度≥85%的患者比例更高的贝叶斯后验概率为88.4%。干预对无进展生存期的影响无统计学意义（风险比1.63，95%置信区间0.82至3.23）。在18个月时，干预组无疾病进展的患者比例为73%，对照组为51%。