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

• Published in: Cancer investigation 2004, Vol.22 (6), p.823-831
• Main Authors: Langer, Corey J., Li, Yi, Jennings, Timothy, DeConti, Ronald C., Nair, Suresh, Cohen, Roger B., Forastiere, Arlene A.
• Format: Article
• Language: English
• Subjects: 96-Hr paclitaxel; Adult; Aged; Aged, 80 and over; Antineoplastic Agents, Phytogenic - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - pathology; Carcinoma, Squamous Cell - secondary; Cohort Studies; Female; Head and Neck Neoplasms - drug therapy; Head and Neck Neoplasms - pathology; Head and Neck Neoplasms - secondary; Humans; Infusions, Intravenous; Male; Metastatic squamous cell carcinoma of head and neck (SCCHN); Middle Aged; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - pathology; Neoplasm Recurrence, Local - secondary; Paclitaxel - administration & dosage; Relapsed SCCHN; SCCHN; Survival Rate
• ISSN: 0735-7907; 1532-4192
• DOI: 10.1081/CNV-200039628

Background: Paclitaxel (24-hour infusion) has yielded activity in advanced squamous cell carcinoma of the head and neck (SCCHN). Protracted exposure to paclitaxel may overcome resistance observed by using shorter infusions. Therefore we sought to evaluate paclitaxel by 96-hour infusion in both treatment-naïve and previously treated patients with SCCHN. Materials and Methods: Eligibility stipulated bidimensionally measurable, biopsy-documented, incurable SCCHN, Eastern Cooperative Oncology Group performance status (PS) 0-1, and adequate physiological indices. Patients were divided into three cohorts: 1) chemotherapy-naïve; 2) chemotherapy-exposed, paclitaxel-naïve; and 3) chemotherapy and paclitaxel exposed. Paclitaxel was dosed at 140 mg m2 (96-hour infusion) every 3 weeks in treatment-naïve patients and at 120 mg m2 (96 hours) every 3 weeks in previously treated patients. Results: Fifty patients were accrued between February 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-naïve patients, two responses (13%) were observed. There were no responses in treatment-exposed patients. The overall median survival was 5.5 months, and 1-year survival rate 10%. Treatment-naïve patients had a median survival of 8.2 months and 1-year survival rate of 20%. Conclusions: Paclitaxel by 96-hour infusion at a dose of 120-140 mg m2 96 hours is only marginally active in the treatment of SCCHN. This dose and schedule cannot be recommended for further evaluation.