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.

IF 6.4 1区 医学 Q1 ONCOLOGY International Journal of Radiation Oncology Biology Physics Pub Date : 2025-01-01 Epub Date: 2024-07-27 DOI:10.1016/j.ijrobp.2024.07.2315
Vanita Noronha, Vijay Patil, Nandini Menon, Ajaykumar Singh, Minit Shah, Ankush Shetake, Zoya Peelay, Vijayalakshmi Mathrudev, Kavita Nawale, Srushti Shah, Kumar Prabhash
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Abstract

Purpose: In the weekly-3-weekly study, cisplatin at 100 mg/m2 once-every-3-weeks led to superior locoregional control compared with 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.

Methods and materials: In this phase 3 open-label noninferiority study conducted between 2013 and 2017, 300 patients with LAHNSCC were randomly assigned to receive cisplatin 100 mg/m2 once-in-every-weeks or cisplatin 30 mg/m2 once-a-week, concurrently with radiation. The primary endpoint was locoregional control. Secondary outcomes were overall survival, progression-free survival, and late adverse events.

Results: The median follow-up was 6.91 years (95% CI, 6.12-7.36). The updated 2-year and 5-year locoregional control 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), whereas 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, hazard ratio = 1.44 (95% CI, 1.03-2.03), P = .034. The 5-year overall survival 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 = .19. There was no difference in any grade or grade ≥3 late adverse events between the 2 arms, except for hearing dysfunction, which was significantly more common in patients who received high-dose cisplatin.

Conclusions: 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 compared with cisplatin 30 mg/m2 once-a-week and should remain one of the standard treatment options.

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对头颈部癌症患者每周一次顺铂与每三周一次顺铂联合放射治疗进行比较的三期随机研究的长期更新。
目的:在 "每周 3 周"(W3W)研究中,与顺铂 30 mg/m2 每周 1 次联合根治性放疗治疗局部晚期头颈部鳞状细胞癌(LAHNSCC)相比,顺铂 100 mg/m2 每 3 周 1 次的局部区域控制效果更佳。我们报告了该研究的最新分析结果:在这项于2013年至2017年进行的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毫克/平方米,3周一次或顺铂30毫克/平方米,一周一次,同时接受放射治疗。主要终点是局部控制(LRC)。次要结局为总生存期(OS)、无进展生存期(PFS)和后期不良事件:中位随访时间为 6.91 年(95% CI,6.12-7.36 年)。每周一次顺铂治疗组的最新2年和5年LRC率分别为58.75%(95% CI,51.08-67.58)和48.09%(95% CI,40.26-57.43),而每3周一次顺铂治疗组的最新2年和5年LRC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。每周一次顺铂治疗组的5年OS为43.60%(95% CI,36.29-52.37),每3周一次顺铂治疗组为50.55%(95% CI,43.06-59.35);P=0.19。除听力功能障碍在接受大剂量顺铂治疗的患者中明显更常见外,两组患者在任何等级或等级≥3的后期不良事件方面均无差异:长期随访证实,与顺铂30毫克/平方米、每周一次相比,顺铂100毫克/平方米、每3周一次与根治性放射治疗LAHNSCC可获得更好的局部控制效果,应继续作为标准治疗方案之一。
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来源期刊
CiteScore
11.00
自引率
7.10%
发文量
2538
审稿时长
6.6 weeks
期刊介绍: International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field. This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.
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