Cetuximab, docetaxel, and cisplatin (TPEx) as first-line treatment in patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN): Final results of phase II trial GORTEC 2008-03.

Abstract

5505 Background: Cetuximab in combination with platinum and 5FU (PFEx) has become a standard in first-line treatment of patients (pts) with R/M SCCHN. Cetuximab and taxane combinations have shown promising activity. This multicenter phase II study evaluates the efficacy and safety of cetuximab, docetaxel and cisplatin combination (TPEx) as first-line treatment in pts with R/M SCCHN. Methods: Pts were required to have WHO PS 0-1, no prior systemic therapy for R/M SCCHN, cumulative dose of cisplatin less than 300 mg/m² and no prior anti-EGFR therapy. Pts received docetaxel 75 mg/m² day 1, cisplatin 75 mg/m² day 1 and cetuximab (400 mg/m² on day 1 of cycle 1 then 250 mg/m² weekly), repeated every 21 days x 4 cycles then followed by cetuximab 500 mg/m² every 2 weeks (wks) as maintenance therapy until disease progression or unacceptable toxicity. G-CSF support with lenograstim 150 µg/m²/day was delivered after each cycle of chemotherapy. Response was assessed every 6 wks, according to RECIST. The primary endpoint was objective response rate (ORR) at 12 wks. Secondary endpoints were safety, best overall response, progression-free survival (PFS), overall survival (OS) and biomarkers. Results: 54 pts have been enrolled: 52 males, median age 57.8years (28-69), 12 (22.2%) oropharynx, 55% metastatic.48 pts could be evaluated for ORR at 12 wks: partial response, stable disease and progression were respectively found in 23 pts (PR 47.9%), 21 pts (SD 43.7%) and 4 pts (PD 8.3%). Best overall ORR was 54% (1 CR, 27 PR). The median PFS and OS were 7.1 and 15.3 months, respectively. The 1-year OS was 58.6%. Median PFS after start of maintenance therapy was 4.2 months. Toxicity was manageable with G-CSF support. Treatment related toxicities included G4 neutropenia (n=3). Grade 3 events were skin rash (n=5), hypersensitivity reaction (n=3), mucositis (n=1), fatigue (n=1) and febrile neutropenia (n=1). Alopecia was common. 1 toxic death was related to sepsis on feeding tube. Conclusions: Efficacy analysis demonstrates that TPEx regimen is effective and might be a relevant substitute for PFEx as first-line treatment in fit pts with R/M SCCHN.