肌肉浸润性膀胱癌新辅助化疗的多中心评估
Multicenter assessment of neoadjuvant chemotherapy for muscle-invasive bladder cancer.
作者信息
Zargar Homayoun, Espiritu Patrick N, Fairey Adrian S, Mertens Laura S, Dinney Colin P, Mir Maria C, Krabbe Laura-Maria, Cookson Michael S, Jacobsen Niels-Erik, Gandhi Nilay M, Griffin Joshua, Montgomery Jeffrey S, Vasdev Nikhil, Yu Evan Y, Youssef David, Xylinas Evanguelos, Campain Nicholas J, Kassouf Wassim, Dall'Era Marc A, Seah Jo-An, Ercole Cesar E, Horenblas Simon, Sridhar Srikala S, McGrath John S, Aning Jonathan, Shariat Shahrokh F, Wright Jonathan L, Thorpe Andrew C, Morgan Todd M, Holzbeierlein Jeff M, Bivalacqua Trinity J, North Scott, Barocas Daniel A, Lotan Yair, Garcia Jorge A, Stephenson Andrew J, Shah Jay B, van Rhijn Bas W, Daneshmand Siamak, Spiess Philippe E, Black Peter C
机构信息
Vancouver Prostate Centre, Vancouver, British Columbia, Canada.
Department of Genitourinary Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
出版信息
Eur Urol. 2015 Feb;67(2):241-9. doi: 10.1016/j.eururo.2014.09.007. Epub 2014 Sep 23.
BACKGROUND
The efficacy of neoadjuvant chemotherapy (NAC) for muscle-invasive bladder cancer (BCa) was established primarily with methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC), with complete response rates (pT0) as high as 38%. However, because of the comparable efficacy with better tolerability of gemcitabine and cisplatin (GC) in patients with metastatic disease, GC has become the most commonly used regimen in the neoadjuvant setting.
OBJECTIVE
We aimed to assess real-world pathologic response rates to NAC with different regimens in a large, multicenter cohort.
DESIGN, SETTING, AND PARTICIPANTS: Data were collected retrospectively at 19 centers on patients with clinical cT2-4aN0M0 urothelial carcinoma of the bladder who received at least three cycles of NAC, followed by radical cystectomy (RC), between 2000 and 2013.
INTERVENTION
NAC and RC.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
The primary outcome was pathologic stage at cystectomy. Univariable and multivariable analyses were used to determine factors predictive of pT0N0 and ≤pT1N0 stages.
RESULTS AND LIMITATIONS
Data were collected on 935 patients who met inclusion criteria. GC was used in the majority of the patients (n=602; 64.4%), followed by MVAC (n=183; 19.6%) and other regimens (n=144; 15.4%). The rates of pT0N0 and ≤pT1N0 pathologic response were 22.7% and 40.8%, respectively. The rate of pT0N0 disease for patients receiving GC was 23.9%, compared with 24.5% for MVAC (p=0.2). There was no difference between MVAC and GC in pT0N0 on multivariable analysis (odds ratio: 0.89 [95% confidence interval, 0.61-1.34]; p=0.6).
CONCLUSIONS
Response rates to NAC were lower than those reported in prospective randomized trials, and we did not discern a difference between MVAC and GC. Without any evidence from randomized prospective trials, the best NAC regimen for invasive BCa remains to be determined.
PATIENT SUMMARY
There was no apparent difference in the response rates to the two most common presurgical chemotherapy regimens for patients with bladder cancer.
背景
新辅助化疗（NAC）对肌肉浸润性膀胱癌（BCa）的疗效最初是通过甲氨蝶呤、长春碱、阿霉素和顺铂（MVAC）确定的，完全缓解率（pT0）高达38%。然而，由于吉西他滨和顺铂（GC）在转移性疾病患者中疗效相当且耐受性更好，GC已成为新辅助治疗中最常用的方案。
目的
我们旨在评估大型多中心队列中不同方案新辅助化疗的实际病理缓解率。
设计、设置和参与者：回顾性收集了2000年至2013年间19个中心的临床cT2 - 4aN0M0膀胱尿路上皮癌患者的数据，这些患者接受了至少三个周期的新辅助化疗，随后进行根治性膀胱切除术（RC）。
干预措施
新辅助化疗和根治性膀胱切除术。
结果测量和统计分析
主要结果是膀胱切除时的病理分期。采用单变量和多变量分析来确定预测pT0N0和≤pT1N0分期的因素。
结果与局限性
收集了935例符合纳入标准患者的数据。大多数患者（n = 602；64.4%）使用GC，其次是MVAC（n = 183；19.6%）和其他方案（n = 144；15.4%）。pT0N0和≤pT1N0病理缓解率分别为22.7%和40.8%。接受GC治疗的患者pT0N0疾病发生率为23.9%，MVAC为24.5%（p = 0.2）。多变量分析显示MVAC和GC在pT0N0方面无差异（优势比：0.89 [95%置信区间，0.61 - 1.34]；p = 0.6）。
结论
新辅助化疗的缓解率低于前瞻性随机试验报告的结果，我们未发现MVAC和GC之间存在差异。在没有随机前瞻性试验证据的情况下，侵袭性BCa的最佳新辅助化疗方案仍有待确定。
患者总结
膀胱癌患者对两种最常见的术前化疗方案的缓解率没有明显差异。
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