Omar K Abughanimeh Mbbs, Nicole A Shonka Md, Jane Meza PhD, Lynette Smith PhD, Irfan A Vaziri Md, Mehmet Sitki Copur Md, Robin High Mba, Kimberly Shields Bsn Rn, Holly DeSpiegelaere Bsn Rn, Anne Kessinger Md, Apar Kishor Ganti Md Ms
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A Phase 2 Study of Docetaxel and Capecitabine in Advanced Squamous Cell Carcinoma of the Head and Neck.
Background: Docetaxel and capecitabine combination have not previously been studied in advanced head and neck squamous cell carcinoma (HNSCC). This study aimed to evaluate the combination's safety and efficacy in this population.
Materials and methods: In this single-arm phase 2 trial, patients with advanced HNSCC received docetaxel 75 mg/m 2 intravenously on day 1 in combination with oral capecitabine 800 to 1000 mg/m 2 twice daily from days 1 to 14 of a 3-week cycle, until either progression or toxicity.
Results: A total of 14 patients were enrolled in the trial. All participants were men, with a median age of 66 years (range, 47-80). Twelve patients (86%) had received prior chemotherapy. Among the 9 evaluable patients, 1 patient achieved a partial response, 6 had stable disease, and 2 had progression. The median progression-free survival was 4.9 months (95% CI, 1.1-8.2), and the median overall survival was 8.7 months (95% CI, 4.8-17.0). The regimen had an acceptable safety profile. The trial was terminated early due to a change in the standard of care with the introduction of immunotherapy.
Conclusions: Despite the trial's early termination, the combination demonstrated a decent disease stability rate with acceptable toxicity. This regimen can be considered for patients with good functional status.
期刊介绍：
Although laboratory and clinical cancer research need to be closely linked, observations at the basic level often remain removed from medical applications. This journal works to accelerate the translation of experimental results into the clinic, and back again into the laboratory for further investigation. The fundamental purpose of this effort is to advance clinically-relevant knowledge of cancer, and improve the outcome of prevention, diagnosis and treatment of malignant disease. The journal publishes significant clinical studies from cancer programs around the world, along with important translational laboratory findings, mini-reviews (invited and submitted) and in-depth discussions of evolving and controversial topics in the oncology arena. A unique feature of the journal is a new section which focuses on rapid peer-review and subsequent publication of short reports of phase 1 and phase 2 clinical cancer trials, with a goal of insuring that high-quality clinical cancer research quickly enters the public domain, regardless of the trial’s ultimate conclusions regarding efficacy or toxicity.
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