Randomized Phase Ii Study Of Cabazitaxel Versus Methotrexate In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck (Scchn) Previously Treated With Platinum-Based Therapy

6051 Background: Cabazitaxel (caba) is a second-generation taxane that improves overall survival (OS) of patients with metastatic castrate resistant prostate cancer who progress on/after docetaxel. Caba has activity in SCCHN cell lines as well as in taxanes-resistant cell lines. We investigated cabazitaxel in recurrent SCCHN patients. Methods: Patients with non-curable SCCHN with an ECOG 0-2 and progressive disease within 1 year after platinum-based therapy were randomized between caba every 3 weeks (1st cycle : 20 mg/m2, increased to 25mg/m2 for the subsequent cycles, if no adverse event (AE) u003e grade 3 during the 1st cycle) and methotrexate (MTX) (40 mg/m2/week). Stratification parameters were ECOG PS (0-1vs 2) and prior chemotherapy given for palliation versus the curative treatment. The primary endpoint was the progression free survival rate (PFSR) at 18 weeks (central review). This trial was a randomized phase II trial (P0 = 0.15, P1 = 0.3, a = 0.1, b = 0.1; Fleming one stage). Results: 101 patients (...