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Phase II trial of dose-dense paclitaxel, cisplatin, 5-fluorouracil, and leucovorin with filgrastim support in patients with squamous cell carcinoma of the head and neck

✍ Scribed by Ricardo Hitt; Antonio Jimeno; Jose María Millán; Daniel Castellano; Hernán Cortés-Funes

Publisher
John Wiley and Sons
Year
2004
Tongue
English
Weight
91 KB
Volume
101
Category
Article
ISSN
0008-543X

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✦ Synopsis

Abstract

BACKGROUND

The current study evaluated the feasibility and clinical activity of a combination of paclitaxel, cisplatin, 5‐fluorouracil (5‐FU), and leucovorin administered on a biweekly schedule to patients with recurrent or unresectable squamous cell carcinoma of the head and neck (HNSCC).

METHODS

Patients with recurrent or unresectable HNSCC were eligible if they had received a previous regimen of neoadjuvant chemotherapy, concurrent chemoradiotherapy, or no previous systemic therapy. Patients received paclitaxel (175 mg/m^2^ on Day 1), cisplatin (35 mg/m^2^ on Days 1 and 2), leucovorin (200 mg/m^2^ on Day 1), and 5‐FU (1000 mg/m^2^ per day as a 48‐hour continuous intravenous infusion on Days 1 and 2) every 2 weeks. Patients received subcutaneous filgrastim (300 μg per day) on Days 3–9 of each cycle. Treatment was administered on an outpatient basis for a maximum of six cycles.

RESULTS

Thirty‐five patients received a combined total of 194 treatment cycles. Eighteen complete responses (51%) and 12 partial responses (34%) were documented, for an overall response rate of 86% (30 of 35 patients). The median progression‐free survival duration was 14 months, and the median overall survival duration was 18 months. Two toxicity‐related deaths were documented (one due to neutropenic sepsis and the other due to catheter‐related pulmonary embolism). Grade 4 neutropenia was observed in one patient. Other severe (Grade 3 or 4) toxic effects included mucositis (14%), anemia (6%), thrombosis (6%), thrombocytopenia (3%), and neuropathy (3%).

CONCLUSIONS

The current dose‐dense, four‐agent, taxane‐containing biweekly schedule was feasible and effective in patients with recurrent or unresectable HNSCC. However, given the single‐center nature of the current study and the highly selected study population, further validation of these findings is recommended. Cancer 2004. © 2004 American Cancer Society.

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