A Phase 2 Study of Docetaxel and Capecitabine in Advanced Squamous Cell Carcinoma of the Head and Neck

Cancer research · Head and neck squamous cell carcinoma

The combination of docetaxel and capecitabine resulted in an objective response rate of 11%, a disease‑stability rate of 77.7%, a median progression‑free survival of 4.9 months, and a median overall survival of 8.7 months in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

This phase‑2, open‑label, single‑arm study evaluated the efficacy and safety of docetaxel (75 mg/m² IV on day 1) plus capecitabine (initially 800 mg/m² PO BID days 1‑14, escalated to 1 000 mg/m² BID if tolerated) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC). With 14 patients enrolled and 9 evaluable, the objective response rate (ORR) was 11% (1 PR) and disease‑stability rate 78%. Median progression‑free survival was 4.9 months and median overall survival 8.7 months. The regimen was well tolerated, with grade ≥3 neutropenia in 36% of patients and no ≥grade 3 hand‑foot syndrome. The trial was terminated early due to the introduction of checkpoint inhibitors as first‑line therapy. The findings suggest docetaxel plus capecitabine may be a viable option for patients who progress after immunotherapy or are unsuitable for checkpoint inhibition.

Head and neck squamous cell carcinoma that has progressed after platinum‑based therapy often has limited treatment options. This study provides evidence that a well‑tolerated, low‑dose docetaxel‑capecitabine combination can achieve clinically meaningful disease control and survival outcomes in this setting, offering a potential alternative for patients who cannot receive or have progressed on checkpoint inhibitors.

Evidence level: Sejtvonalas. Laboratóriumi sejtekben vizsgálták.

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