Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.
Department of Radiation Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.
J Clin Oncol. 2023 May 1;41(13):2350-2361. doi: 10.1200/JCO.22.00980. Epub 2023 Jan 27.
There is a lack of published literature on systemic therapeutic options in cisplatin-ineligible patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing chemoradiation. Docetaxel was assessed as a radiosensitizer in this situation.
This was a randomized phase II/III study. Adult patients (age ≥ 18 years) with LAHNSCC planned for chemoradiation and an Eastern Cooperative Oncology Group performance status of 0-2 and who were cisplatin-ineligible were randomly assigned in 1:1 to either radiation alone or radiation with concurrent docetaxel 15 mg/m once weekly for a maximum of seven cycles. The primary end point was 2-year disease-free survival (DFS).
The study recruited 356 patients between July 2017 and May 2021. The 2-year DFS was 30.3% (95% CI, 23.6 to 37.4) versus 42% (95% CI, 34.6 to 49.2) in the RT and Docetaxel-RT arms, respectively (hazard ratio, 0.673; 95% CI, 0.521 to 0.868; value = .002). The corresponding median overall survival (OS) was 15.3 months (95% CI, 13.1 to 22.0) and 25.5 months (95% CI, 17.6 to 32.5), respectively (log-rank value = .035). The 2-year OS was 41.7% (95% CI, 34.1 to 49.1) versus 50.8% (95% CI, 43.1 to 58.1) in the RT and Docetaxel-RT arms, respectively (hazard ratio, 0.747; 95% CI, 0.569 to 0.980; value = .035). There was a higher incidence of grade 3 or above mucositis (22.2% 49.7%; < .001), odynophagia (33.5% 52.5%; < .001), and dysphagia (33% 49.7%; = .002) with the addition of docetaxel.
The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC.[Media: see text].
在接受放化疗的局部晚期头颈部鳞状细胞癌（LAHNSCC）且不能耐受顺铂的患者中，系统治疗选择的文献报道较少。在这种情况下，多西他赛被评估为放射增敏剂。
这是一项随机的 II/III 期研究。计划接受放化疗且东部肿瘤协作组体力状况为 0-2 分的成年患者（年龄≥18 岁）且不能耐受顺铂被随机以 1:1 的比例分配至单纯放疗或放疗联合多西他赛 15mg/m2 每周一次，最多 7 个周期。主要终点为 2 年无病生存（DFS）率。
该研究于 2017 年 7 月至 2021 年 5 月间共纳入 356 例患者。在 RT 和 Docetaxel-RT 两组中，2 年 DFS 率分别为 30.3%（95%CI，23.6 至 37.4）和 42%（95%CI，34.6 至 49.2）（风险比，0.673；95%CI，0.521 至 0.868； 值=0.002）。相应的中位总生存（OS）期分别为 15.3 个月（95%CI，13.1 至 22.0）和 25.5 个月（95%CI，17.6 至 32.5）（对数秩检验 值=0.035）。在 RT 和 Docetaxel-RT 两组中，2 年 OS 率分别为 41.7%（95%CI，34.1 至 49.1）和 50.8%（95%CI，43.1 至 58.1）（风险比，0.747；95%CI，0.569 至 0.980； 值=0.035）。加用多西他赛组的 3 级或以上黏膜炎（22.2% vs. 49.7%； <.001）、咽痛（33.5% vs. 52.5%； <.001）和吞咽困难（33% vs. 49.7%； =.002）的发生率更高。
在局部晚期头颈部鳞状细胞癌且不能耐受顺铂的患者中，放疗联合多西他赛可改善 DFS 和 OS。[媒体：见正文]。
