Barlow Lamont J, McKiernan James M, Benson Mitchell C
Department of Urology, Columbia University College of Physicians and Surgeons, Columbia University Medical Center, Herbert Irving Pavilion - 11th Floor, 161 Fort Washington Ave., New York, NY 10032, USA.
World J Urol. 2009 Jun;27(3):331-5. doi: 10.1007/s00345-009-0377-1. Epub 2009 Feb 13.
Since the success of our Phase I trial of intravesical docetaxel for treatment-refractory non-muscle invasive bladder cancer (NMIBC), we have found this agent to be a favorable alternative for BCG-refractory patients unable or unwilling to undergo cystectomy. This study analyzes the safety and efficacy of intravesical docetaxel in a larger patient population with extended follow-up.
A retrospective analysis of all patients who received salvage intravesical docetaxel at our institution was conducted, including 18 patients treated during the Phase I trial and 15 patients treated after the trial's completion. Toxicity, efficacy and recurrence-free survival were analyzed.
Thirty-three patients with refractory NMIBC received salvage intravesical docetaxel therapy between 2003 and 2008 at a single institution. Twenty of thirty-three (61%) patients had a complete response (CR) after six weekly induction treatments. Ten patients with CRs were given maintenance docetaxel therapy, and one patient received maintenance BCG and interferon. With a median follow-up of 29 months, 1 and 2-year recurrence-free survival rates were and 45 and 32%, respectively. Twelve of thirty-three patients (36%) had Grade 1 or 2 local toxicities. No patients experienced Grade 3 or 4 toxicities.
Docetaxel is a promising intravesical agent with minimal toxicity and significant efficacy and durability for the management of BCG-refractory NMIBC.
自我们开展的多西他赛膀胱内灌注治疗难治性非肌层浸润性膀胱癌（NMIBC）的I期试验取得成功以来，我们发现该药物对于无法或不愿接受膀胱切除术的卡介苗（BCG）难治性患者而言是一种不错的选择。本研究分析了在更大患者群体中进行更长时间随访的膀胱内灌注多西他赛的安全性和疗效。
对在我们机构接受挽救性膀胱内灌注多西他赛治疗的所有患者进行回顾性分析，包括I期试验期间治疗的18例患者和试验完成后治疗的15例患者。分析毒性、疗效和无复发生存率。
2003年至2008年期间，在单一机构有33例难治性NMIBC患者接受了挽救性膀胱内灌注多西他赛治疗。33例患者中有20例（61%）在每周一次的诱导治疗6次后获得完全缓解（CR）。10例获得CR的患者接受了多西他赛维持治疗，1例患者接受了BCG和干扰素维持治疗。中位随访29个月，1年和2年无复发生存率分别为45%和32%。33例患者中有12例（36%）出现1级或2级局部毒性。无患者出现3级或4级毒性。
多西他赛是一种有前景的膀胱内用药，对于治疗BCG难治性NMIBC具有最小的毒性、显著的疗效和持久性。
