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Phase II Study of Weekly Docetaxel and Cisplatin in Patients With Advanced Recurrent and Metastatic Head and Neck Cancer


  • This study was supported by an unrestricted grant from Sanofi-Aventis.


Objective: Response rates of presently used palliative chemotherapy for end-stage recurrent head and neck cancer are poor, but the regimes cause important toxicity.

Methods: A prospective phase II study was conducted to evaluate the activity and toxicity of a weekly combination of cisplatin and docetaxel in patients with recurrent head and neck cancer. From July 2003 to November 2004, 21 patients with metastatic neck disease were enrolled. Treatment consistent of 25 mg/m2 cisplatin and 35 mg/m2 docetaxel once a week for 3 weeks followed by 1 week without treatment for each cycle. The primary end point was median survival. Secondary end points were response rate (RECIST), time to progression, toxicity (NCI-CTC), and quality-of-life (EORTC QLQ-C30, QLQ-H&N35).

Results: Eight patients (42%) showed a partial response. Eight patients (42%) had stable disease. Progressive disease was seen in three patients (16%). The median follow-up time was 7.2 months (95% confidence interval [CI], 5.9–9.3 months). The median time to progression was 3.5 months (95% CI, 2.0–5.0 months). The median overall survival was 10.7 months (95% CI, 6.4–15.0 months). Grade 3 toxicities occurred in two patients (10%). A grade 4 adverse event was not recorded. Most global quality-of-life scores but not head and neck-specific scores are deteriorated after last chemotherapy.

Conclusion: Weekly docetaxel and cisplatin is active in recurrent head and neck cancer and shows an excellent toxicity profile. Its influence on the stabilization of quality of life is less significant.