Department of Medicine (Hematology and Oncology), Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois, USA.
Department of Biostatistics and Computational Biology ECOG-ACRIN Cancer Research Group, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Prostate. 2022 Sep;82(12):1176-1185. doi: 10.1002/pros.24369. Epub 2022 May 10.
E3805 (CHAARTED) is a phase 3 trial demonstrating improved survival for men with metastatic hormone-sensitive prostate cancer (mHSPC) randomized to treatment with docetaxel (D) and androgen-deprivation therapy (ADT) versus ADT alone. We assessed the association of baseline body mass index (BMI) and metformin exposure with quality of life (QOL) and prostate cancer outcomes including survival in patients enrolled in the CHAARTED study.
We performed a posthoc exploratory analysis of the CHAARTED trial of men with mHSPC randomized to treatment with ADT with or without D between 2006 and 2012. Cox proportional hazards models and Kruskal-Wallis test were used to evaluate the association between BMI with QOL and prostate cancer outcomes and between metformin exposure and survival.
In 788 of 790 enrolled patients with prospectively recorded baseline BMI and metformin exposure status, lower BMI was not associated with survival, but was associated with high volume disease (p < 0.0001) and poorer baseline QOL on functional assessment of cancer therapy-prostate (p = 0.008). Only 68 patients had prevalent metformin exposure at baseline in the CHAARTED trial. Four groups were identified: ADT + D + metformin (n = 39); ADT + D (n = 357); ADT + metformin (n = 29); and ADT alone (n = 363). Baseline clinicopathologic characteristics were similar between groups. In this small exploratory multivariable analysis, metformin exposure was not associated with survival (hazard ratio: 1.15; 95% confidence interval: 0.81-1.63, p = 0.44).
There was no link between baseline BMI and survival, but lower baseline BMI was associated with features of greater cancer burden and poorer QOL.
E3805（CHAARTED）是一项 3 期临床试验，结果表明转移性去势敏感性前列腺癌（mHSPC）患者接受多西他赛（D）和雄激素剥夺疗法（ADT）联合治疗比单独 ADT 治疗的生存时间有所改善。我们评估了基线体重指数（BMI）和二甲双胍暴露与接受 CHAARTED 研究入组的患者的生活质量（QOL）和前列腺癌结局（包括生存）之间的关联。
我们对 2006 年至 2012 年间接受 ADT 联合或不联合 D 治疗的 mHSPC 男性的 CHAARTED 试验进行了一项探索性的事后分析。使用 Cox 比例风险模型和 Kruskal-Wallis 检验评估 BMI 与 QOL 和前列腺癌结局之间的关联，以及二甲双胍暴露与生存之间的关联。
在 790 名入组患者中，有 788 名患者的基线 BMI 和二甲双胍暴露状态有前瞻性记录，较低的 BMI 与生存无关，但与疾病体积较大（p<0.0001）和基线前列腺癌功能评估的癌症治疗-前列腺 QOL 较差（p=0.008）相关。在 CHAARTED 试验中，只有 68 名患者在基线时存在二甲双胍暴露。根据基线时的药物暴露情况，患者分为四组：ADT+D+二甲双胍（n=39）；ADT+D（n=357）；ADT+二甲双胍（n=29）；以及 ADT 单药治疗（n=363）。各组的基线临床病理特征相似。在这项小规模的探索性多变量分析中，二甲双胍暴露与生存无关（风险比：1.15；95%置信区间：0.81-1.63，p=0.44）。
基线 BMI 与生存之间没有联系，但较低的基线 BMI 与更大的癌症负担和较差的 QOL 特征有关。
