CETUXIMAB AND RADIOTHERAPY VERSUS CISPLATIN AND RADIOTHERAPY FOR LOCALLY ADVANCED HEAD AND NECK CANCER: LONG TERM SURVIVAL AND TOXICITY OUTCOMES OF A RANDOMIZED PHASE II TRIAL

Purpose: describing long-term survival and toxicity outcomes of a multicenter randomized phase II trial comparing radiotherapy (RT) plus cisplatin (CDDP) or cetuximab (CTX) as first line treatment in locally advanced head and neck cancer (LASCCHN).
Materials and methods: Between January 2011 and August 2014, 70 patients were enrolled and randomized to receive RT plus weekly CDDP (40 mg/m2) or CTX (250 mg/m2 plus a loading dose of 400 mg/m2). This updated series focuses on late toxicities (graded by using CTCAE scale version 4.0) and long-term survival outcomes in terms of local control (LC), overall survival (OS), cancer-specific survival (CSS) and metastasis free survival (MFS). A supplementary analysis based on HPV status was also performed.
Results: no statistically significant difference was found in terms of late effects (xerostomia, fibrosis, mucosal atrophy, weight loss). In the CDDP arm and in the CTX arm 5-year LC rates were 67% and 48%; 5-year MFS rates 83% and 97%; 5-years OS rates 61% and 52%; 5-year CSS rates 70% and 59%, respectively (none of these differences reached statistical significance). A subgroup analysis by HPV status and anatomical subsites revealed that in HPV+ oropharyngeal carcinoma (OPC) better survival were obtained in the CDDP arm (though statistical tests were not performed due to the small sample size). Conversely, no statistically significant differences were observed in HPV- OPC and other anatomical subsites, except for the confirmed better MFS rates of the CTX arm.
Conclusion: long-term results are in line with current literature suggesting that RT + CTX is inferior to RT + CDDP for the definitive treatment of LASCCHN. However, if not as an alternative to CDDP, CTX might still play a role in LASCCHN, particularly in HPV- cases.