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Annals of Oncology 13:1665-1673, 2002
© 2002 European Society for Medical Oncology

Original Paper

Induction chemotherapy with paclitaxel, cisplatin and 5-fluorouracil for squamous cell carcinoma of the head and neck: long-term results of a phase II trial

R. Hitt1,+, L. Paz-Ares1, A. Brandáriz2, D. Castellano1, C. Peña3, J. M. Millán4, F. Calvo5, D. Ortiz de Urbina5, E. López6, J. J. Álvarez-Vicent2 and H. Cortés-Funes1,§

1 Medical Oncology Division, 2 Otorhinolaryngology Service, 3 Radiation Oncology Division, 4 Radiology Department, Hospital Universitario 12 de Octubre, Madrid; 5 Radiotherapy Department, Hospital Gregorio Marañón, Madrid; 6 Bristol-Myers Squibb, Madrid, Spain

Received 17 October 2001; revised 21 February 2002; accepted 27 March 2002

Background:

The aim of this study was to evaluate the efficacy and toxicity of a combination of paclitaxel, cisplatin and 5-fluorouracil (PPF) as induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).

Methods:

Seventy patients with previously untreated stage III–IV SCCHN were included in this phase II trial. Induction treatment consisted of a maximum of three outpatient courses of paclitaxel 175 mg/m2 as a 3-h infusion on day 1, cisplatin 100 mg/m2 on day 2, and 5-fluorouracil (5-FU) 500–750 mg/m2/day as a 24-h continuous infusion on days 2–6, repeated every 3 weeks. The 5-FU dose was reduced from 750 mg/m2/day to 500 mg/m2/day due to the excessive toxicity observed in the first 14 patients enrolled. Local treatment consisted of radiotherapy and/or surgery.

Results:

Two-hundred-and-one cycles were administered to 70 patients. The main toxicities of PPF were neutropenia (grade 4, 14%; febrile neutropenia, 4%), peripheral neuropathy (grade 2–3, 14%) and catheter-associated venous thrombosis (7%). There were three early deaths (two from neutropenic sepsis and one from pulmonary embolism), and 13 patients required hospitalization due to toxicity. Other side effects included mucositis, anorexia, diarrhea, myalgias and alopecia. The overall response rate to PPF was 88%, including 59% complete responses (CR) and 29% partial responses. The CR rates at the primary tumor and neck lymph nodes were 74% and 62%, respectively. With a median follow-up of 51 months (range 40–63 months), the estimated 5-year time-to-disease progression and overall survival rates were 56% and 44%, respectively.

Conclusions:

The PPF regimen has major antitumor activity and is associated with manageable toxicity as induction treatment in SCCHN patients. The high complete response rate and favorable long-term outcome justify further evaluation of this chemotherapy combination.

Key words: chemotherapy, cisplatin, 5-fluorouracil, head and neck cancer, paclitaxel, phase II


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