Abstract No 1997
| Phase
III study comparing cisplatin (P) & 5-fluoruracil (F) versus P,
F and paclitaxel (T) as induction therapy in locally advanced head
& neck cancer (LAHNC) Abstract:: Based on our previous phase II experience with PFT (Ann Oncol, Oct 2002), we decided to perform a phase III trial comparing this triplet with standard PF, as induction chemotherapy. Methods: Eligibility included: untreated LAHNC, measurable or evaluable disease, adequate organ function, & ECOG Performance Status (PS) 0-1. Treatment arms were: Arm A: P 100mg/m2 day (d) 1 & F 1 gm/m2 CI d1-5 q21d. Arm B: P 100 mg/m2 d2, F 500 mg/m2 CI d1-5 q21d; & T 175mg/m2 d1 q21d. Patients were stratified according to center, PS, resectability and tumor location. The primary endpoint was the complete response rate (CRR) to induction treatment. Other objectives were: organ preservation rate (OPR), disease free survival, overall survival and toxicity. After 3 cycles of induction treatment, pts with complete response (CR) or partial response (PR) > 80% were treated with chemoradiotherapy (cisplatin 100 mg/m2 d 1, 22 and 43, RT 70 Gy). An independent review of the CT scans was performed. Results: Between Dec 98 and Dec 01, 387 pts were randomized, 384 were eligible (Arm A: 192, Arm B: 192). Pretreatment characteristics were well balanced between the two arms: 35.1% of the pts were considered resectable; median age: 56 y (31-75); males: 93.2%; PS 1: 76.9%; stage IV: 84.1%; oropharynx: 28.8%, larynx: 24.9%, oral cavity: 10.6%. (table) Molecular pathological assessment was performed in 118 paraffin samples: Epidermal growth factor receptor positivity was significantly associated with better clinical response in arm B (p=0.003). Conclusions: PFT is more active and better tolerated than standard PF. Further follow-up analysis is currently ongoing.
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