研究动态
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一项 3 期随机研究的长期更新,比较了每周一次与每 3 周一次的顺铂联合放疗治疗头颈癌的效果。

Long term update of a phase 3 randomized study comparing once-a-week versus once-every-3-weeks cisplatin along with radiation in head and neck cancer.

发表日期:2024 Jul 27
作者: Vanita Noronha, Vijay Patil, Nandini Menon, Ajaykumar Singh, Minit Shah, Ankush Shetake, Zoya Peelay, Vijayalakshmi Mathrudev, Kavita Nawale, Srushti Shah, Kumar Prabhash
来源: Int J Radiat Oncol

摘要:

在每周 3 周 (W3W) 研究中,与每周一次 30 mg/m2 顺铂联合根治性放射治疗局部晚期相比,每 3 周一次 100 mg/m2 顺铂可带来更好的局部区域控制头颈鳞状细胞癌(LAHNSCC)。我们报告了该研究的最新分析。在这项 2013 年至 2017 年间进行的 III 期开放标签非劣效性研究中,300 名 LAHNSCC 患者被随机分配接受顺铂 100 mg/m2 每 3 周一次或顺铂 30 mg /m2 每周一次,与辐射同时进行。主要终点是局部控制(LRC)。次要结局是总生存期 (OS)、无进展生存期 (PFS) 和晚期不良事件。中位随访时间为 6.91 年(95% CI,6.12-7.36)。每周一次顺铂组更新后的 2 年和 5 年 LRC 率为 58.75% (95% CI, 51.08-67.58) 和 48.09% (95% CI, 40.26-57.43),而每周一次顺铂组的更新后 2 年和 5 年 LRC 率为每 3 周顺铂组的发生率分别为 73.95% (95% CI, 66.93-81.70) 和 56.76% (95% CI, 48.46-66.48); HR=1.44(95% CI,1.03-2.03),P=0.034。每周一次顺铂组的 5 年 OS 为 43.60%(95% CI,36.29-52.37),每 3 周一次顺铂组为 50.55%(95% CI,43.06-59.35) ; P=0.19。两组之间的任何级别或≥3级晚期不良事件均无差异,但听力功能障碍除外,听力功能障碍在接受大剂量顺铂治疗的患者中更为常见。长期随访证实,100 mg/次顺铂治疗的患者明显更常见。与每周一次的顺铂 30 mg/m2 相比,每 3 周一次的 m2 治疗与 LAHNSCC 的根治性放疗同时进行,可实现更好的局部控制,因此应继续作为标准治疗选择之一。版权所有 © 2024。由 Elsevier 出版公司
In the weekly-3-weekly (W3W) study, cisplatin at 100 mg/m2 once-every-3-weeks led to superior locoregional control compared to cisplatin 30 mg/m2 once-a-week in combination with radical radiation for locally advanced head and neck squamous cell carcinoma (LAHNSCC). We report the updated analysis of the study.In this phase III open label non-inferiority study conducted between 2013 and 2017, 300 patients with LAHNSCC were randomly assigned to receive cisplatin 100 mg/m2 once-in-3-weeks or cisplatin 30 mg/m2 once-a-week, concurrently with radiation. The primary endpoint was locoregional control (LRC). Secondary outcomes were overall survival (OS), progression free survival (PFS) and late adverse events.The median follow-up was 6.91 years (95% CI, 6.12-7.36). The updated 2-year and 5-year LRC rates for the once-a-week cisplatin arm were 58.75% (95% CI, 51.08- 67.58) and 48.09% (95% CI, 40.26-57.43), while for the once-every-3-weeks cisplatin arm were 73.95% (95% CI, 66.93-81.70) and 56.76% (95% CI, 48.46-66.48), respectively; HR=1.44 (95% CI, 1.03-2.03), P=0.034. The 5-year OS was 43.60% (95% CI, 36.29-52.37) in the once-a-week cisplatin arm, and 50.55% (95% CI, 43.06-59.35) in the once-every-3-weeks cisplatin arm; P = 0.19. There was no difference in any grade or grade ≥ 3 late adverse events between the two arms, except for hearing dysfunction, which was significantly more common in patients who received high-dose cisplatin.Long term follow-up confirms that cisplatin at 100 mg/m2 administered once-every-3-weeks concurrently with radical radiation for LAHNSCC leads to superior locoregional control as compared to cisplatin 30 mg/m2 once-a-week and should remain one of the standard treatment options.Copyright © 2024. Published by Elsevier Inc.