A phase II clinical trial was initiated in 1987 to evaluate a new induction regimen of cis‐platinum, 5‐fluorouracil, and leucovorin (PFL) for patients with stages III–IV squamous cell carcinoma of the head and neck. Ninety patients were treated and followed for a median duration of 18 months. The median age was 55 and 87% of the patients had stage IV disease. The rates of complete and overall clinical response following three cycles of PFL were 57% and 80%, respectively; the rate of complete response at the primary site was 72%. Eighty‐four percent of patients were treated to the primary site with radiation alone (median dose 68 Gy in daily 1.8‐Gy fractions) irrespective of the location of the primary site or initial T‐stage. The acute tolerance to full‐course radiation following PFL was acceptable. The actuarial rate of primary site control for patients treated, with radiation was 67% at 36 months. An important prognostic indicator for primary site control was a complete clinical response to induction PFL. For patients who achieved a complete response, radiation or surgery followed by radiation controlled primary site disease equally well at 70%. Patients with a partial response did less well. For these patients, surgery and radiation appeared slightly better than radiation alone.
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