Phase II evaluation of paclitaxel in combination with carboplatin in advanced head and neck carcinoma

BACKGROUND. Two-thirds of patients with squamous cell carcinomas of the hea d and neck (SCCHN) at diagnosis have advanced disease with projected 5-year survival rates of 30%. In those patients with distant metastatic or previo usly treated recurrent disease, response rate to the standard regimen of ci splatin and 5-fluorouracil is approximately 30%. The authors investigated t he use of paclitaxel and carboplatin in a limited Phase II study in recurre nt or metastatic SCCHN to evaluate tumor response, time to progression, sur vival, and toxicities of this regimen. METHODS. Patients with recurrent or metastatic SCCHN not amenable to furthe r surgical or radiation therapy were treated with 200 mg/m(2) by 3-hour inf usion of paclitaxel followed by carboplatin at an area under the concentrat ion time Curve of 6 mg/mL/minute via a 20-30-minute infusion every 3 weeks. RESULTS. Thirty-seven patients were enrolled. Ninety-five percent of patien ts had received prior surgery and postoperative radiotherapy. The overall r esponse rate was 27% (95% confidence interval, 13-41%) with I complete and 9 PRs. Median survival of all patients was 4.9 months, and I -year survival rate was 16%. There was a 43% response rate and 15.7-month median survival rate in patients with only distant metastatic disease and 38% response rat e and it 4.5-month median survival in patients with locoregional and metast atic disease. The response rate for patients with only locoregional recurre nce was 7% with a median Survival of 4.8 months. Grade 3-4 myelotoxicity oc curred in 24% of cycles administered. There were two treatment- related dea ths due to neutropenic fever and one additional death on study may have bee n caused by treatment-induced thrombocytopenia. CONCLUSIONS. The combination of paclitaxel and carboplatin is significantly myelotoxic and ineffective in patients with previously treated locoregiona lly recurrent SCCHN, whereas it deserves further evaluation in those patien ts with distant metastatic disease alone. In those patients with locoregion al disease, other more innovative treatments are needed. (C) 2001 American Cancer Society.