LAUSR

AIM Dose-Banding (DB) consists in approximating the theoretical dose of anticancer drugs calculated according to the body surface area (Dose-BSA) of patients. This concept is supported by pharmacokinetic but not by clinical data. The aim of this study was to assess the clinical outcome of DB defined as dose-fitting up to +/-10%. METHOD This was a retrospective study conducted in patients receiving weekly paclitaxel in neoadjuvant (NAT) and metastatic (M+) settings. Three groups of patients were considered according to type of paclitaxel dosing: Dose-BSA, DB approximated down (DB-Low) and DB approximated up (DB-High). Efficacy was evaluated by the rate of pathological complete response (pCR) for patients in NAT setting and by the median of progression free survival (PFS) plus overall survival (OS) for those in M+ setting. Toxicity and efficacy were compared in the 3 groups. RESULTS A total of 224 and 209 patients were assessable in the M+ and NAT settings respectively. A toxic event was observed for 31.7% and 27.3% in M+ and NAT respectively. The rate of pCR was 41.6% in NAT. The median PFS was 5.2 [4.1-5.8] and OS was 16.3 [14.6-18.4] months for patients in M+. Efficacy and toxicity were not different in DB-Low and DB-High group compared to Dose-BSA group. CONCLUSION DB with approximated doses up to +/-10% does not seem to influence clinical outcome of patients treated with weekly paclitaxel. This is the first study to include clinical observations which lends support to DB as a safe and effective dosing method.