研究动态
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基于IChoice-01相2期单臂试验的初步结果,对于HPV相关咽峡部鳞状细胞癌,在诱导化疗后根据治疗反应,通过减少辐射剂量和省略同期化疗进行选择性治疗减弱的方法。

Selective treatment de-intensification by reducing radiation dose and omitting concurrent chemotherapy based on response to induction chemotherapy in HPV-associated oropharyngeal squamous cell carcinoma: the preliminary results of a single-arm, phase II trial (IChoice-01).

发表日期:2023 Aug 11
作者: Tingting Xu, Chunying Shen, Zhou Xin, Lin Zhu, Jun Xiang, Yulong Wang, Yongxue Zhu, Xiayun He, Hongmei Ying, Yu Wang, Qinghai Ji, Chaosu Hu, Xueguan Lu
来源: Int J Radiat Oncol

摘要:

为了展示在人乳头状瘤病毒(HPV)相关的咽峡部鳞状细胞癌(OPSCC)诱导化疗(IC)反应方面,去强化方案的可行性。在2019年1月至2021年7月期间,招募了T1-2 / N1-3M0(不包括单个和≤3cm淋巴结的T1N1M0)或T3-4N0-3M0的p16 + OPSCC患者。所有患者都接受了docetaxel 75mg/m2 d1和顺铂75mg/m2 d1每隔3周进行两个疗程的IC。对于那些对IC有显著反应(原发病灶和淋巴结均下降≥50%)的患者,进入去强化队列(队列D),采用调强放射治疗(IMRT)独立给予降低剂量的60Gy/30次疗程。对于未能达到显著反应的患者,作为联合放化疗队列(队列C),剂量同时被集成增强到标准的70Gy/35次疗程,与顺铂80mg/m2 d1,22同时进行。使用MD Anderson Dysphagia Inventory(MDADI)记录患者报告的吞咽功能。主要终点是使用Simon的两级设计测量的2年无进展生存率(PFS)。48名参与者中,有26名(54.2%)满足弱化治疗的条件,而22名(45.8%)患者进入Cohort C。在中位随访时间为29.7个月(6.9-48.0个月)的情况下,所有参与患者的2年PFS率和总生存率分别为85.4%和93.6%。在D队列中,2年PFS和总生存率均为100%。IC相关的3/4级毒性包括41.7%的白细胞减少/中性粒细胞减少和4.2%的低钠血症。观察到C队列中3/4级口腔炎发生率较高(61.9% vs 23.1% P=0.022)。在放疗后第3个月,两个队列都观察到MDADI分数的持续下降,并发现在第12个月恢复到基线水平。在HPV+ OPSCC中根据IC反应选择性减少放疗剂量和移除联合化疗是可行和有希望的。进一步的研究以平衡疗效和毒性在前瞻性对照试验中值得进行。版权所有 © 2023 Elsevier Inc.已出版。
To demonstrate the feasibility of de-intensification regimen in the light of the response to induction chemotherapy (IC) in human papillomavirus (HPV)associated oropharyngeal squamous cell carcinoma (OPSCC).Patients with p16+ OPSCC, T1-2/N1-3M0 (excluding T1N1M0 with single and ≤3cm lymph node) or T3-4N0-3M0 were enrolled between January 2019 and July 2021. All patients received two cycles IC with docetaxel 75mg/m2 d1 and cisplatin 75mg/m2 d1 every 3 weeks. Those with major responses (≥50% decrease in both primary and lymph nodes) to IC entered the de-intensification cohort (Cohort D), in which intensity modulated radiation therapy (IMRT) alone was given to a reduced dose of 60Gy/30fractions. For those failed to meet major responses, as concurrent chemoradiotherapy cohort (Cohort C), dose was simultaneously integrated boosted to a standard 70Gy/35fractions to non-major response sites, concurrently with cisplatin 80mg/m2 d1,22. Patient-reported swallow function was documented using MD Anderson Dysphagia Inventory (MDADI). The primary endpoint was 2-year progression-free survival (PFS) using Simon's twostage design.A total of 26/48 (54.2%) participants met the criteria of treatment deintensification while 22/48 (45.8%) patients entered Cohort C. With a median follow-up time of 29.7 months (6.9-48.0 months), two-year PFS and OS rates were 85.4% and 93.6%, respectively for all enrolled patients. In cohort D, two-year PFS and OS rates were both 100%. Grade 3/4 IC-related toxicities included leukopenia/neutropenia occurring in 41.7% and hyponatremia in 4.2% of patients. A higher incidence of grade 3/4 mucositis (61.9% vs 23.1% P=0.022) was observed in cohort C. Consistent decline in longitudinal MDADI scores were observed at month 3 after radiotherapy between cohorts and both were found to recover to baseline at month 12.Selective radiotherapy dose reduction and concurrent chemotherapy removal based on IC response in HPV+ OPSCC was feasible and promising. Further study of this strategy to balance the efficacy and toxicity is warranted in a prospective controlled trial.Copyright © 2023. Published by Elsevier Inc.