There is a debate regarding the optimal chemotherapeutic regimens that can be used concurrently with radiotherapy (Rth) in muscle invasive bladder cancer (MIBC). Taxanes started to be widely used with evidence of response rates improvement when compared to cisplatin. Our aims were to evaluate the tumor response, treatment toxicity, and disease outcome in MIBC patients who treated with concurrent chemo-radiotherapy (CCRTh) either with paclitaxel and cisplatin or cisplatin alone.
Between July 2007 and December 2010, sixty T2-4a N0 M0 bladder cancer patients were enrolled, of whom 55 were eligible for analysis. We randomized our patients into two group; group I received CCRTh with weekly cisplatin (n = 30) and group II received CCRTH with weekly paclitaxel and cisplatin (n = 25). Kaplan-Meier curve used to estimate overall survival (OS) and recurrence free survival (RFS) with log rank test used to assess the significant difference between patients' subgroups.
A durable complete cure (CR) was achieved in 75% and 87% in group I and II respectively. The 2-year OS and recurrence free survival (RFS) were 60 % and 30% for group I, while, 80 % and 40% for group II, respectively. Multivariate analysis showed that tumor stage was the only survival predictor (P
Achieving high initial durable CR rates, with acceptable toxicity in both group; showed that addition of paclitaxel to cisplatin did not significantly add benefit to the treatment outcome.
Clinical trial identification
Legal entity responsible for the study
Prof. Samir Shehata
Assiut University Hospital
All authors have declared no conflicts of interest.