Faculty Publications

Langer CJ, Li Y, Jennings T, DeConti RC, Nair S, Cohen RB, Forastiere AA

Phase II Evaluation of 96-Hour Paclitaxel Infusion in Advanced (Recurrent or Metastatic) Squamous Cell Carcinoma of the Head and Neck (E3395): A Trial of the Eastern Cooperative Oncology Group

Cancer Invest. 2004;22(6):823-31.

Abstract BACKGROUND: Paclitaxel (24-h infusion) has yielded activity in advanced squamous cell carcinoma of the head and neck (SCCHN). Protracted exposure to paclitaxel may overcome resistance obsd. by using shorter infusions. Therefore we sought to evaluate paclitaxel by 96-h infusion in both treatment-naive and previously treated patients with SCCHN. MATERIALS AND METHODS: Eligibility stipulated bidimensionally measurable, biopsy-documented, incurable SCCHN, Eastern Cooperative Oncol. Group performance status (PS) 0-1, and adequate physiol. indexes. Patients were divided into three cohorts: (1) chemotherapy-naive; (2) chemotherapy-exposed, paclitaxel-naive; and (3) chemotherapy and paclitaxel exposed. Paclitaxel was dosed at 140 mg/m2 (96-h infusion) every 3 wk in treatment-naive patients and at 120 mg/m2 (96 h) every 3 wk in previously treated patients. RESULTS: Fifty patients were accrued between Feb. 1997 and July 2000. The study was terminated because of low response rate. Eighty percent of patients were male, 75% PS 1. Nearly half the patients had oropharyngeal or hypopharyngeal primary sites. There was one treatment-related death due to neutropenic fever/pneumonia. Grade 4 toxicities included granulocytopenia in eight patients (20%), thrombocytopenia, and stomatitis in one patient each. Grade 3 or greater anemia occurred in 10 patients. There was no grade 2 or 3 peripheral sensory neuropathy. In 15 chemotherapy-naive patients, two responses (13%) were obsd. There were no responses in treatment-exposed patients. The overall median survival was 5.5 mo, and 1-yr survival rate 10%. Treatment-naive patients had a median survival of 8.2 mo and 1-yr survival rate of 20%. CONCLUSIONS: Paclitaxel by 96-h infusion at a dose of 120-140 mg/m2/96 h is only marginally active in the treatment of SCCHN. This dose and schedule cannot be recommended for further evaluation. [on SciFinder (R)]