Phase II trial of docetaxel, cisplatin, fluorouracil, and leucovorin as induction for squamous cell carcinoma of the head and neck

Purpose: To evaluate the toxicity and efficacy of a 4-day regimen of doceta xel, cisplatin, fluorouracil, and leucovorin (TPFL4) in patients with locor egionally advanced squamous cell carcinoma of the head and neck (SCCHN). Patients and Methods: Thirty previously untreated patients with stage III o r IV SCCHN and Eastern Cooperative Oncology Group functional status of 2 or less were treated with TPFL4. Postchemotherapy support included prophylact ic growth factors and antibiotics. Patients who achieved a complete respons e (CR) or partial response (PR) to three cycles of TPFL4 received definitiv e twice-daily radiation therapy. The primary end points were toxicity and r esponse to TPFL4, Results: Eighty-five cycles were administered to 30 patients, The major acu te toxicities to TPFL4 were mucositis and nausea. One patient died of neutr openic sepsis during therapy. Additional major toxicities were neutropenia, anorexia, nephropathy, neuropathy, and diarrhea. Fourteen percent of all c ycles were associated with hospitalization for toxicity. The overall clinic al response rate to TPFL4 was 93%, with 63% CRs and 30% PRs. Primary tumor site clinical and pathologic response rates were 93% and 68%, respectively. Conclusion: TPFL4 has an acceptable toxicity profile in good-performance-st atus patients. Modification of the 5-day TPFL regimen (TPFL5: shorter chemo therapy infusion time, earlier intervention with growth factors and antibio tics) led to fewer episodes of febrile neutropenia and hospitalization. Res ponse rates to TPFL justify further evaluation of combinations of these age nts in the context of formal clinical trials. (C) 1999 by American Society of Clinical Oncology.