Vancouver Prostate Centre, University of British Columbia, Vancouver, BC, Canada.
Department of Urology, MD Anderson Cancer Center, Houston, TX, USA.
World J Urol. 2017 Nov;35(11):1729-1736. doi: 10.1007/s00345-017-2065-x. Epub 2017 Jun 17.
Our primary endpoint was to assess pathological response rate (pT0N0 and ≤pT1N0) for patients with BCa treated with the accelerated or dose dense MVAC (ddMVAC) chemotherapy followed by radical cystectomy (RC) in this real-word multi-institutional cohort.
We retrospectively reviewed records of patients with urothelial cancer who underwent ddMVAC and RC at seven contributing institutions from 2000 to 2015. Patients with cT2-4a, M0 BCa were included. Presence of cT3-4 disease, hydronephrosis, lymphovascular invasion and/or existence of sarcomatoid, or micropapillary features on the initial transurethral resection of bladder tumor specimen was defined as high-risk disease. Logistic regression models for prediction of pT0N0 and ≤pT1N0 were generated for the entire cohort as well as for the cN0 subgroup. The multivariable Cox proportional hazards regression model for survival using post RC data was used to assess hazard ratios (HRs) for the variables of interest.
A total of 345 patients received ddMVAC chemotherapy during the study period; 85% had high-risk features. The median number of chemotherapy cycles was 4 (IQR 4-4); >90% of patients completed all scheduled cycles. The observed rates of pT0N0 and ≤pT1N0 were 30.4 and 49.3%, respectively, among cN0 patients. On the multivariable regression model, the presence of more than one clinical high-risk element was associated with 70% [OR 0.30 95% CI (0.10-0.86); p = 0.02] reduction in the odds of achieving partial pathological response.
A complete response (pT0N0) was observed in one-third of patients after neoadjuvant ddMVAC therapy, and a partial response (≤pT1N0) was observed in nearly half of the cases in this real-world experience with this regimen. To our knowledge, this represents the largest experience outside clinical trial settings.
我们的主要终点是评估接受加速或剂量密集 MVAC(ddMVAC)化疗联合根治性膀胱切除术(RC)治疗的膀胱癌患者的病理缓解率(pT0N0 和 ≤pT1N0),该研究为真实世界多机构队列研究。
我们回顾性分析了 2000 年至 2015 年期间在七个参与机构接受 ddMVAC 和 RC 治疗的尿路上皮癌患者的记录。纳入 cT2-4a、M0 膀胱癌患者。初始经尿道膀胱肿瘤切除术标本中存在 cT3-4 疾病、肾盂积水、脉管侵犯和/或存在肉瘤样或微乳头状特征被定义为高危疾病。为整个队列以及 cN0 亚组生成预测 pT0N0 和 ≤pT1N0 的逻辑回归模型。使用 RC 后数据的多变量 Cox 比例风险回归模型评估感兴趣变量的风险比(HRs)。
在研究期间,共有 345 例患者接受 ddMVAC 化疗;85%的患者有高危特征。化疗周期中位数为 4(IQR 4-4);>90%的患者完成了所有计划的周期。cN0 患者的 pT0N0 和 ≤pT1N0 观察率分别为 30.4%和 49.3%。在多变量回归模型中,存在一个以上临床高危因素与部分病理缓解的几率降低 70%相关(OR 0.30,95%CI(0.10-0.86);p=0.02)。
在该真实世界的经验中,在接受新辅助 ddMVAC 治疗后,三分之一的患者出现完全缓解(pT0N0),近一半的患者出现部分缓解(≤pT1N0)。据我们所知,这是该方案在临床试验之外的最大经验。