Neoadjuvant Gemcitabine-Cisplatin Plus Radical Cystectomy-Pelvic Lymph Node Dissection for Muscle-invasive Bladder Cancer: A 12-year Experience.
Neoadjuvant Gemcitabine-Cisplatin Plus Radical Cystectomy-Pelvic Lymph Node Dissection for Muscle-invasive Bladder Cancer: A 12-year Experience.
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DOI：
10.1016/j.clgc.2020.02.014
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发表时间：
2020-10
影响因子：
3.2
通讯作者：
Bajorin DF
中科院分区：
文献类型：
--
作者：
Iyer G;Tully CM;Zabor EC;Bochner BH;Dalbagni G;Herr HW;Donat SM;Russo P;Ostrovnaya I;Regazzi AM;Milowsky MI;Rosenberg JE;Bajorin DF
目的探讨肌肉浸润性膀胱癌(MIBC)患者接受新辅助化疗吉西他滨-顺铂(GC)联合根治性膀胱切除-盆腔淋巴清扫术(RC-PLND)的药物释放/毒性及病理/手术结果。在转诊中心对化疗和手术/病理结果进行了回顾性分析，并进行了5年生存随访。新辅助化疗后病理终点包括完全缓解(PT0N0)、残留的非MIBC(Pta/Tis/T1N0)和≥MIBC(≥Pt2和/或N+)。分析病理/手术结果与总生存期(OS)、无病生存期(DFS)和手术治疗与RC-PLND的关系(COX回归)。2000年1月至2012年10月，临床T2a-T4aN0M0 MIBC患者(154例)接受GC加RC-PLND治疗。患者(117例，76%)接受GCx4治疗，136例(88%)接受GCx3治疗。5年OS为61%(95%可信区间53-71)。中位淋巴结清扫数(LN)为19个，pT0N0为21%，PTA/Tis/T1N0为25%，5年OS相似(分别为85%和89%)。PT2与≥PT2残留病的5年OS分别为87%(95%CI，78%−98%)和38%(95%CI，27%−53%)；P<；0.001。NAC分期后≥PT2(HR6.79；95%CI2.63-17.53；p<；0.001)、阳性LN(HR3.64；95%CI1.84-7.19；p<；0.001)和阳性切缘(HR4.15；95%CI1.68-10.25；p=0.002)与全因死亡风险增加相关(多因素分析)。每切除一个新的结节，危险比为0.97(95%CI：0.94-1.00)，但这种影响没有统计学意义(p=0.056)。新佐剂GC实现了有意义的病理反应。≥pt2残留病、切缘阳性或化疗后LN阳性的患者生存率较低。我们试图确定常用的新辅助方案吉西他滨和顺铂(GC)的有效性和耐受性，然后在单一中心进行手术。对154名接受新辅助GC治疗的患者进行了回顾分析，结果显示病理降级率为46%，肌肉侵犯导致的任何程度降级的5年总存活率为87%。服用GC后没有明显的手术延迟或手术并发症发生率，顺铂分成第1天和第8天的应答率也没有差异。这些数据支持GC作为一种有效的、可耐受的方案用于肌肉浸润性膀胱癌的治疗。
To determine drug delivery/toxicity, and pathological/surgical outcomes of muscle-invasive bladder cancer (MIBC) patients receiving neoadjuvant gemcitabine-cisplatin (GC) plus radical cystectomy-pelvic lymph node dissection (RC-PLND). Chemotherapy and surgical/pathologic outcomes were retrospectively analyzed with 5-year survival follow-up at a referral center. Post-neoadjuvant chemotherapy (NAC) pathologic endpoints included complete response (pT0N0), residual non-MIBC (pTa/Tis/T1N0) and ≥MIBC (≥pT2 and/or N+). Associations of pathologic/surgical findings with overall survival (OS), disease-free survival (DFS), and surgical management with RC-PLND were analyzed (Cox regression). Clinical T2a-T4aN0M0 MIBC patients (154) from 1/2000–10/2012 received GC plus RC-PLND. Patients (117, 76%) received GCx4 and 136 (88%) GCx3. Five-year OS was 61% (95% CI 53–71). Median number of resected lymph nodes (LN) was 19. Down-staging was observed as follows: pT0N0: 21%; pTa/Tis/T1N0: 25%, with similar 5-yr OS (85% and 89%, respectively). Five-year OS for <pT2 vs. ≥pT2 residual disease was 87% (95% CI, 78%−98%) vs. 38% (95% CI, 27%−53%); p<0.001. Post-NAC stage ≥pT2 (HR 6.79; 95% CI 2.63–17.53; p<0.001), positive LN (HR 3.64; 95% CI 1.84–7.19; p<0.001) and positive margins (HR 4.15; 95% CI 1.68–10.25; p=0.002) were associated with increased risk of all-cause death (multivariable analysis). A hazard ratio of 0.97 (95% CI: 0.94–1.00) was observed for each additional node removed, but this effect was not statistically significant (p=0.056). Neoadjuvant GC achieves meaningful pathologic responses. Patients with ≥pT2 residual disease, positive margins, or positive LN post-chemotherapy have inferior survival. We sought to define the efficacy and tolerability of the commonly used regimen of neoadjuvant gemcitabine and cisplatin (GC) followed by surgery at a single center. Retrospective analysis of 154 patients who received neoadjuvant GC revealed a pathologic downstaging rate of 46% and a 5-year overall survival of 87% with any degree of downstaging from muscle invasion. No significant delay to surgery or surgical complication rates were observed following GC administration, and no difference in response rates were observed when cisplatin was split over days 1 and 8. These data support the use of GC as an effective, tolerable regimen in the management of muscle-invasive bladder cancer.
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影响因子：
3.2
作者：
Maughan, Benjamin L.;Agarwal, Neeraj;Sonpavde, Guru
通讯作者：
Sonpavde, Guru
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作者：
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