Selective bladder-sparing protocol consisting of induction low-dose chemoradiotherapy plus partial cystectomy with pelvic lymph node dissection against muscle-invasive bladder cancer: oncological outcomes of the initial 46 patients


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Abstract

Study Type – Therapy (case series)Level of Evidence 4What's known on the subject? and What does the study add?TURBT plus full-dose chemoradiotherapy (CRT) against MIBC allow more than 40% of patients to spare the bladder while maintaining survival outcomes comparable to those of radical cystectomy (RC) series, contributing to improvement of the patients' quality of life. Limitations of these protocols, however, include 1) MIBC recurrence in the preserved bladder mainly due to subclinical residual disease in the original MIBC site, 2) potential lack of curative intervention to regional lymph nodes and 3) increased mortality of salvage RC due to previous high-dose pelvic irradiation. We propose a novel selective bladder-sparing protocol consisting of induction low-dose CRT plus consolidative partial cystectomy with pelvic lymph node dissection, which potentially contributes to overcoming the limitations of the conventional bladder-sparing protocols.OBJECTIVETo evaluate oncological outcomes of muscle-invasive bladder cancer (MIBC) patients who were treated with a selective bladder-sparing protocol consisting of induction low-dose chemoradiotherapy (LCRT) plus partial cystectomy (PC) with pelvic lymph node dissection.PATIENTS AND METHODSFrom 1997–2010, 183 consecutive patients with cT2–4aN0M0 bladder cancer (median age 70 years, women/men = 46/137, T2/3/4a = 100/69/14) underwent debulking transurethral resection followed by LCRT (radiation at 40 Gy to the small pelvis concurrently with two cycles of i.v. cisplatin at 20 mg/day for 5 days).Criteria for PC include: (i) essentially solitary MIBC or intravesically circumscribed tumours (≈25% or less of the bladder in area, excluding the bladder neck and trigone); (ii) no involvement of bladder neck or trigone; and (iii) clinically, no residual disease or minimal amounts of non-invasive disease in the original MIBC site after LCRT; otherwise, radical cystectomy (RC) is recommended.Primary and secondary endpoints were cancer-specific survival (CSS) and intravesical MIBC recurrence-free survival (MRFS) for bladder-preserved patients, respectively.RESULTSOf the 183 patients, 87 (48%) achieved a clinical complete response after LCRT and 65 (36%) met the PC criteria; 46 (25%) patients actually underwent PC, 86 (47%) had RC, and the remaining 51 (28%) had neither PC, nor RC.Histological examination of the 46 PC specimens showed residual muscle-invasive disease in three (7%).Overall, 5-year overall survival and CSS rates were 64% and 71%, respectively (median follow-up for survivors of 45 months).In the 46 PC patients, neither MIBC, nor pelvic recurrence was observed; 5-year CSS and MRFS rates were both 100%.In 13 non-PC patients who achieved a complete response after LCRT and who met PC criteria but declined PC, 5-year CSS and MRFS rates were 74% and 81%, respectively; CSS and MRFS were significantly better in the PC group than in the non-PC group (P= 0.025 and 0.002, respectively).CONCLUSIONSIn the current selective bladder-sparing protocol, one-third of MIBC patients met the PC criteria; when patients from this group underwent PC with pelvic lymph node dissection, their oncological outcomes were excellent.Consolidative PC potentially reduces MIBC recurrence in the preserved bladder, eventually improving survival in properly selected MIBC patients.

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