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

IF 1.8 4区医学 Q3 ONCOLOGY

Oncology-New York Pub Date : 2025-08-08 DOI:10.46883/2025.25921047

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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引用次数: 0

Abstract

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.

查看原文本刊更多论文

多西他赛和卡培他滨治疗晚期头颈部鳞状细胞癌的2期研究。

背景：多西他赛和卡培他滨联合治疗晚期头颈部鳞状细胞癌（HNSCC）的研究尚未开始。本研究旨在评估该组合在该人群中的安全性和有效性。材料和方法：在这项单臂2期试验中，晚期HNSCC患者在第1天静脉注射多西他赛75mg / m2，联合口服卡培他滨800至1000mg / m2，每日两次，为期3周，从第1天到第14天，直到进展或出现毒性。结果：共有14例患者入组试验。所有参与者均为男性，年龄中位数为66岁（47-80岁）。12例患者（86%）既往接受过化疗。在9例可评估的患者中，1例获得部分缓解，6例病情稳定，2例病情进展。中位无进展生存期为4.9个月（95% CI, 1.1-8.2），中位总生存期为8.7个月（95% CI, 4.8-17.0）。该方案具有可接受的安全性。由于引入免疫疗法改变了治疗标准，该试验被提前终止。结论：尽管试验提前终止，但该组合显示出良好的疾病稳定性和可接受的毒性。对于功能状态良好的患者可考虑此方案。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Oncology-New York 肿瘤学-肿瘤学

CiteScore

1.60

自引率

0.00%

发文量

审稿时长

6-12 weeks

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.