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A phase II evaluation of a 3‐hour infusion of paclitaxel, cisplatin, and 5‐fluorouracil in patients with advanced or recurrent squamous cell carcinoma of the head and neck
Author(s) -
Worden Francis P.,
Moon James,
Samlowski Wolfram,
Clark Joseph I.,
Dakhil Shaker R.,
Williamson Stephen,
Urba Susan G.,
Ensley John,
Hussain Maha H.
Publication year - 2006
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.21994
Subject(s) - medicine , mucositis , regimen , neutropenia , fluorouracil , chemotherapy , chemotherapy regimen , anemia , febrile neutropenia , cisplatin , nausea , surgery , phases of clinical research , survival rate , oncology , gastroenterology
BACKGROUND. Previous data from an institutional pilot study in patients with advanced or recurrent squamous cell carcinoma of the head and neck (SCCHN) who received treated a combined chemotherapy regimen of paclitaxel, cisplatin, and 5‐fluorouracil indicated an overall response rate of 60% and a median survival of 6 months. To validate these results and to determine the feasibility of this combination, a Phase II study was conducted by the Southwest Oncology Group (SWOG S0007). METHODS. Patients with advanced or recurrent SCCHN were eligible if they had received 1 previous regimen of induction/adjuvant chemotherapy or no prior systemic therapy. Patients received treatment with paclitaxel (135 mg/m 2 on Day 1), followed by cisplatin (75 mg/m 2 on Day 1), and 5‐fluorouracil (1000 mg/m 2 per day as a 96‐hour continuous infusion on Days 1–4) every 21 days. RESULTS. Seventy‐six patients received a combined total of 286 cycles of chemotherapy. Sixty‐nine patients were evaluable for response. There were 5 complete responses (7%) and 23 partial responses (33%) partial responses, for an overall response rate of 41%. The median progression‐free survival was 4 months, and the median overall survival was 10 months. Six treatment‐related deaths were documented, including deaths in 2 patients who had a Zubrod PS of 2. Grade 3 or 4 neutropenia (according to National Cancer Institute Common Toxicity Criteria [version 2.0]) was observed in 47% of patients. Other Grade 3 or 4 adverse events included mucositis (34% of patients), nausea (20% of patients), anemia (9% of patients), and neuropathy (8% of patients). CONCLUSIONS. The combination of paclitaxel, cisplatin, and 5‐fluorouracil had efficacy similar to that of standard treatment regimens in patients with advanced or recurrent SCCHN but with increased toxicity. Cancer 2006. © 2006 American Cancer Society.