A randomized, multicenter, open phase II study of cetuximab with docetaxel, cisplatin as induction chemotherapy in unresectable, locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

Abstract

6069 Background: In this randomized phase II trial, we investigated the efficacy and safety of cetuximab in induction chemotherapy and followed by concurrent chemoradiotherapy (CCRT) in LA-HNSCC. Methods: Patients were randomized to receive 3 cycles of docetaxel (75 mg/m2) and cisplatin (75 mg/mg2) every 3 weeks with or without cetuximab (CDP vs. DP). CCRT was given as a definitive treatment. Patients in CDP arm received CCRT with weekly cetuximab (250 mg/m2) and cisplatin (30 mg/m2), while patients in DP arm received CCRT with weekly cisplatin. Primary endpoint was objective response rate (ORR) after induction chemotherapy. Results: 92 patients were randomized to receive either CDP (48) or DP (44). The median age was 59 years (range 29 – 73 years). The location of primary disease included oropharynx (41), hypopharynx (24), larynx (13) and oral cavity (14). 40 of the 48 patients in CDP arm and 40 of the 44 patients in DP arm completed 3 cycles of chemotherapy. Reason for incompletion in CDP arm included hypersensitivity (1), septic shock (1), skin rash (1), seizure (1), arterial thrombosis (1), unexplained death (1), unsatisfactory response (1), and withdrawal of informed consent (1). ORR to chemotherapy in CDP arm and DP arm was 81% (4 CR and 35 PR) and 82% (4 CR and 32 PR), respectively. 3 patients were not evaluable for response in CDP arm due to unexplained early death (1), septic shock (1), and hypersensitivity reaction after the first dose of cetuximab (1). CCRT completion rate after the completion of CDP and DP was 80% and 85%, respectively. Median PFS and OS were not reached in either arm, with a median follow-up time of 33 months. CDP arm showed 70% and 88% of PFS and OS rate, while DP arm showed 56% and 74% of PFS and OS at 3 years, when intend-to-treat analysis was performed. If we limited to the patients who received 3 cycles of CDP or DP, we saw 78% and 59% of 3-year PFS rate, respectively and 94% and 73% of 3-year OS rate, respectively. Conclusions: Addition of cetuximab during induction and CCRT phase may compromise completion rate of 3 cycles of induction chemotherapy but does not compromise completion of CCRT and shows promising survival data. Clinical trial information: NCT00623558.