A Sequential Treatment Approach to Myoinvasive Urothelial Cancer: A Phase II Southwest Oncology Group Trial (S0219)
- 30 June 2009
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Journal of Urology
- Vol. 181 (6), 2476-2481
- https://doi.org/10.1016/j.juro.2009.01.115
Abstract
Purpose: We conducted a phase II trial of neoadjuvant paclitaxel, carboplatin and gemcitabine as well as transurethral resection of bladder tumor to evaluate the clinical T0 (cT0) rate with paclitaxel, carboplatin and gemcitabine, and to study cystoscopic surveillance or immediate cystectomy for patients with cT0 status following chemotherapy. Materials and Methods: Patients with T2-T4a chemotherapy and radiation naive urothelial cancer were eligible. T2+ tumor had to be diagnosed by transurethral bladder tumor resection followed by a second transurethral bladder tumor resection to confirm persistent disease within 16 weeks of the first resection. Three cycles of paclitaxel, carboplatin and gemcitabine were administered within 8 weeks of the second transurethral bladder tumor resection. Patients with cT0 status after paclitaxel, carboplatin and gemcitabine therapy could elect immediate cystectomy or cystoscopic surveillance, and those with greater than cT0 status were to undergo immediate cystectomy. Results: Of 77 patients 74 were assessable, and cT0 status after paclitaxel, carboplatin and gemcitabine was achieved in 34 of 74 patients (46%). Of the 34 patients with cT0 status 10 underwent immediate cystectomy, 6 of whom had persistent cancer. Persistent tumor at transurethral bladder tumor resection was seen in 28 patients (38%) and 21 underwent cystectomy. Thus, 35 of 74 patients underwent cystectomy. With a median followup of 22 months 2-year overall survival was 59% (95% CI 45, 72) and among cT0 cases it was 75% (95% CI 57, 93). Conclusions: Although neoadjuvant paclitaxel, carboplatin and gemcitabine had a promising 46% cT0 rate, the study failed to meet the primary objective as there was an unacceptably high rate (60%) of persistent cancer at cystectomy in patients presumed to have pT0 status. Patients completing neoadjuvant chemotherapy should strongly consider definitive local therapy rather than cystoscopic surveillance regardless of post-chemotherapy cT0 status.Keywords
This publication has 13 references indexed in Scilit:
- Defining Optimal Therapy for Muscle Invasive Bladder CancerJournal of Urology, 2007
- Muscle-Invasive Urothelial Carcinoma of the BladderUrology, 2007
- Neoadjuvant Chemotherapy plus Cystectomy Compared with Cystectomy Alone for Locally Advanced Bladder CancerNew England Journal of Medicine, 2003
- Integrated Therapy for Locally Advanced Bladder Cancer: Final Report of a Randomized Trial of Cystectomy Plus Adjuvant M-VAC Versus Cystectomy With Both Preoperative and Postoperative M-VACJournal of Clinical Oncology, 2001
- Combination Paclitaxel, Carboplatin, and Gemcitabine Is an Active Treatment for Advanced Urothelial CancerJournal of Clinical Oncology, 2001
- Radical transurethral resection and chemotherapy inBJU International, 1999
- Predicting prognosis in patients with superficial bladder cancer.1998
- Neoadjuvant chemotherapy and bladder-sparing surgery for invasive bladder cancer: ten-year outcome.Journal of Clinical Oncology, 1998
- FEASIBILITY OF TRANSURETHRAL RESECTION FOR MUSCLE INFILTRATING CARCINOMA OF THE BLADDER: LONG-TERM FOLLOWUP OF A PROSPECTIVE STUDYJournal of Urology, 1998
- Nonparametric Estimation from Incomplete ObservationsJournal of the American Statistical Association, 1958