INDUCTION CHEMOTHERAPY WITH CISPLATIN, FLUOROURACIL, AND HIGH-DOSE LEUCOVORIN FOR SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK - LONG-TERM RESULTS

Purpose: A phase II trial of cisplatin, fluorouracil, and leucovorin ( PFL) induction chemotherapy in patients with locally advanced squamous cell carcinomas of the head and neck region (HNCA). Patients and Meth ods: One hundred two patients (stage III/IV, previously untreated) wer e treated with induction PFL. Patients with resectable primary tumor s ite lesions and clinical complete response (CR) were offered radiother apy (RT) without surgery to the primary tumor site. Response, toxicity , local-regional therapy, survival, and preservation of the primary tu mor site were assessed.Results: Among 279 courses, the overall respons e rate was 81%. Nineteen (19%) failed to respond, including three who died during therapy. Sixty-seven (69%) of 97 with assessable primary l esions had a clinical CR at the primary tumor site. Pathologic CR was recorded in 46 of 55 (84%) clinical CR patients who had biopsies perfo rmed on the primary tumor site. Toxicities resulted in unexpected hosp italizations in 19% of cases. After definitive local-regional therapy, 84 (82%) were disease-free, including 71 (69%) with preserved primary tumor site anatomy. With a median follow-up time of 63 months, the ca use-specific, overall (OS), and failure-free survival (FFS) rates at 5 years are 58%, 52%, and 51%. Local failure occurred in 29 of 102 (29% ) and the local control rate at 5 years was 68%. Conclusion: PFL has s ignificant activity with acceptable toxicity in patients with advanced disease who have a good performance status. Preservation of the prima ry tumor site could be achieved without apparent loss of local control or survival. Management of neck disease by surgery or RT must be indi vidualized and separate from management of primary tumor. Survival com pares favorably with similar trials of induction chemotherapy or chemo radiotherapy. (C) 1997 by American Society of Clinical Oncology.