Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 4532
© 2005 American Society of Clinical Oncology

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Abstract

A phase II trial using altered fractionation irradiation with concomitant chemotherapy in the management of patients with muscle invasive bladder cancer (MIBC)

Alexandria Univ, Alexandria, Egypt

4532

Background: To identify the place of conservative treatment in patients (pts) with MIBC using concomitant cisplatin (C) and gemcitabine (G) with bifractionated split course radiotherapy. Methods: Eligible pts with stages T2-T4a, N0 M0 were entered in this study. Treatment began with transurethral resection (TUR) with complete macroscopic debulking followed by induction chemoradiation. The treatment regimen consisted of C 15 mg/m² and G 200 mg/m² on days 1–3 and 15–17 (one cycle of 6 days induction chemotherapy). On days 1, 3, 15, and 17, radiation was given immediately following chemotherapy using twice-daily 2 Gy per fraction to the whole pelvis for a total dose of 16 Gy delivered in 8 fractions over 17 days. Patients with a complete response (CR) via cystoscopy after the induction cycle received another chemoradiation cycle as consolidation. Patients who did not achieve CR underwent cystectomy. Both groups received outpatient adjuvant chemotherapy: G 1000mg/m² on days 1, 8, and 15 plus C 70 mg/m² on day 1 every 28 days for 6 cycles. Results: From July 2001 to January 2003, 36 pts were enrolled. All pts were evaluable for efficacy and toxicity. Twenty pts (55.6%) achieved CR after induction therapy and received consolidation chemoradiation. Of the pts who still had detectable tumor, 9 pts (25.0%) underwent radical cystectomy and 7 (19.4%) refused cystectomy and received the same chemoradiation. 6/16 died of progressive disease. The median follow-up is 22 months. The 2-year overall survival is 80%, and the 2-year probability of surviving with an intact bladder is 69.4%. Grade 3/4 thrombocytopenia was observed in 8 pts (22.2%), non hematologic toxicities in the form of grade 3 radiation cystitis in 3 pts (8.3%) and proctatitis in 4 pts (11.1%). Conclusions: This trial comprising of local TUR plus concurrent C/G, and hypofractionated radiation has been associated with acceptable hematologic toxicity. Both the complete response rate to induction therapy and the 2-year survival rate with an intact bladder are encouraging. Longer follow-up is needed to assess efficacy.

No significant financial relationships to disclose.

Abstract presentation from the 2005 ASCO Annual Meeting