Docetaxel plus cisplatin in recurrent and/or metastatic non-squamous-cell head and neck cancer: a multicenter phase II trial
Docetaxel plus cisplatin in recurrent and/or metastatic non-squamous-cell head and neck cancer: a multicenter phase II trial
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DOI：
10.1007/s12032-021-01581-z
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发表时间：
2021-11-01
期刊：
影响因子：
3.4
通讯作者：
Minami, Hironobu
中科院分区：
文献类型：
--
作者：
Imamura, Yoshinori;Tanaka, Kaoru;Minami, Hironobu
非鳞状细胞头颈癌（NSCHNC）的全身治疗和基因组分析的临床应用尚未完全阐明。这项II期试验评估了多西他赛和顺铂联合治疗一线患者的有效性和安全性。入选标准：复发性和/或转移性NSCHNC；最近6个月内疾病进展；既往无全身治疗；ECOG性能状态为0-1。患者接受多西他赛（75 mg/m(2)，第1天）和顺铂（75 mg/m(2)，第1天），每21天重复6个周期。主要终点为客观有效率（ORR）。次要终点包括无进展生存期（PFS）、总生存期（OS）和不良事件。使用Ion AmpliSeq Cancer Hotspot Panel v2进行下一代测序（NGS）。2012年11月至2016年10月共纳入23例患者，其中男性8例。中位年龄为57岁。96%的病例有转移。在22名可评估的患者中，确诊的ORR为45%（95%保密区间24-68%）。中位随访期为18.8个月，中位PFS和OS分别为6.7和20.1个月。3/4级不良事件包括发热性中性粒细胞减少症（39%）和贫血（22%）。未观察到与治疗相关的死亡。NGS分析揭示了潜在的治疗靶点，包括ERBB2、KIT和ALK。多西他赛和顺铂联合方案可以被认为是复发性和/或转移性NSCHNC的一种新的治疗选择，尽管应该考虑对发热性中性粒细胞减少症进行初级预防。不同的基因组改变可能带来新的治疗选择。该试验于2012年9月1日在UMIN临床试验注册中心注册，注册号为UMIN000008333。
The clinical utility of systemic therapy and genomic profiling in non-squamous-cell head and neck cancer (NSCHNC) has not been fully elucidated. This phase II trial evaluated the efficacy and safety of docetaxel and cisplatin combination in the first-line setting. Eligibility criteria were recurrent and/or metastatic NSCHNC; progressive disease within the last 6 months; no prior systemic therapy; and ECOG performance status of 0-1. Patients received docetaxel (75 mg/m(2) on day 1) and cisplatin (75 mg/m(2) on day 1), repeated every 21 days for 6 cycles. The primary endpoint was confirmed objective response rate (ORR). The secondary endpoints included progression-free survival (PFS), overall survival (OS), and adverse events. Next-generation sequencing (NGS) was performed using the Ion AmpliSeq Cancer Hotspot Panel v2. Twenty-three patients were enrolled from November 2012 to October 2016, of whom 8 were male. Median age was 57 years. Ninety-six percent of cases were metastatic. Among 22 evaluable patients, confirmed ORR was 45% (95% confidential interval 24-68%). With a median follow-up period of 18.8 months, median PFS and OS were 6.7 and 20.1 months, respectively. Grade 3/4 adverse events included febrile neutropenia (39%) and anemia (22%). No treatment-related deaths were observed. NGS analysis revealed potential treatment targets, including ERBB2, KIT, and ALK. The docetaxel and cisplatin combination regimen can be considered a new treatment option in recurrent and/or metastatic NSCHNC, although primary prophylaxis for febrile neutropenia should be considered. Diverse genomic alterations may lead novel treatment options. This trial was registered with the UMIN Clinical Trials Registry as UMIN000008333 on [September 1st, 2012].