OBJECTIVEA phase II study was conducted to test the efficacy and toxicity of the combination of cisplatin, 5-Fu and nimotuzumab, as induction treatment of resectable head and neck squamous cell carcinoma (HNSCC).

METHODSForty cases of resectable HNSCC were treated with nimotuzumab (400 mg on day 1) combined with PF regimens (cisplatin 75 mg/m² on days 1 and 5-Fu 750 mg/m² on days 1-5 q3wks). After 2 cycles, an organ-preservation local therapy (surgery or radiotherapy) was recommended. The primary endpoints of this study were overall response rate, pathologic complete response and safety of the induction treatment. Mean age of 40 patients was 54 years old, of them 9 patients with oropharyngeal cancer (22.5%), 16 hypopharyngeal cancer (40.0%), 10 laryngeal cancer (25.0%), and 5 oral cancer (12.5%).

RESULTSWith a 2-cycle induction treatment, 34 (85.0%) patients achieved complete or partial response. Twenty-four patients (60.0%) got downstage, with T downstage in 21 (52.5%) patients and N downstage in 8 (20.0%) patients. Totally 27 patients got surgery after the induction treatment, of them 20 patients (74.1%) preserved organ functions. Four patients' primary tumors (10.0% in all 40 patients and 14.8% in operated 27 patients) showed pathologically complete responses. The toxicity was mild and manageable. The most common grade 3/4 toxicities were neutropenia (5.0%), nausea/vomiting (2.5%), stomatitis (2.5%) and thrombocytopenia (2.5%). One patient got grade 2 renal insufficiency and one patient got grade 1 skin rash.

CONCLUSIONFor resectable HNSCC, nimotuzumab plus PF regimen as induction treatment is highly effective for preserving the organ function and the toxicities are well tolerable.