多西他赛、顺铂和西妥昔单抗序贯西妥昔单抗并同步放疗治疗局部晚期头颈部鳞状细胞癌的多中心II期试验（TPEx）（CSPOR HN01：ECRIPS研究）
A Multicenter Phase II Trial of Docetaxel, Cisplatin, and Cetuximab (TPEx) Followed by Cetuximab and Concurrent Radiotherapy for Patients With Local Advanced Squamous Cell Carcinoma of the Head and Neck (CSPOR HN01: ECRIPS Study).
作者信息
Zenda Sadamoto, Ota Yosuke, Kiyota Naomi, Okano Susumu, Fujii Masato, Kitamura Morimasa, Takahashi Shunji, Ueda Tsutomu, Monden Nobuya, Yamanaka Takeharu, Tahara Makoto
机构信息
Department of Radiation Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Department of Radiation Oncology, Hyogo Cancer Center Hospital, Hyogo, Japan.
出版信息
Front Oncol. 2019 Jan 22;9:6. doi: 10.3389/fonc.2019.00006. eCollection 2019.
Induction chemotherapy (IC) is a treatment option for locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). However, treatment with docetaxel, cisplatin, and 5-FU (TPF) followed by cisplatin and radiotherapy is controversial because of toxicity concerns. The aim of this phase II study was to assess the feasibility of docetaxel, cisplatin, and cetuximab (TPEx) followed by cetuximab and concurrent radiotherapy for LA SCCHN. We enrolled patients with histological evidence of squamous cell carcinoma of the oropharynx, hypopharynx, or larynx without distant metastases. IC comprised cisplatin (75 mg/m) and docetaxel (75 mg/m) on day 1, repeated every 3 weeks for up to three courses. Cetuximab was initiated at 400 mg/m, followed by 250 mg/m doses weekly until the end of radiotherapy. Radiotherapy (70 Gy/35 fr/7 w) was initiated after the last docetaxel administration. The primary endpoint was the rate of treatment completion. We enrolled 54 patients (median age, 58 years) between August 2013 and October 2015. Our patients were 49 males and 5 females with hypopharyngeal ( = 28), oropharyngeal ( = 19), or laryngeal ( = 7) cancers, and 48 of them had stage IV disease. The overall response rate was 72.2% with a median follow-up of 36.1 months and a 3-year overall survival of 90.7%. The treatment completion rate was 76%; 50 patients (93%) received ≥2 courses of IC, and 41 (76%) completed radiotherapy. The frequencies of grade ≥3 febrile neutropenia or allergy/infusion reactions were 39% and 11%, respectively. There was one treatment-related death. IC with TPEx followed by cetuximab with concurrent radiotherapy showed acceptable compliance for the treatment of LA SCCHN. However, high frequency of febrile neutropenia remains a challenge and further improvement in the management of TPEx is necessary. UMIN000009928.
诱导化疗（IC）是局部晚期头颈部鳞状细胞癌（LA SCCHN）的一种治疗选择。然而，由于毒性问题，多西他赛、顺铂和5-氟尿嘧啶（TPF）治疗后再进行顺铂和放疗存在争议。本II期研究的目的是评估多西他赛、顺铂和西妥昔单抗（TPEx）治疗后再进行西妥昔单抗和同步放疗用于LA SCCHN的可行性。我们纳入了有口咽、下咽或喉鳞状细胞癌组织学证据且无远处转移的患者。IC方案为第1天给予顺铂（75mg/m²）和多西他赛（75mg/m²），每3周重复一次，最多进行三个疗程。西妥昔单抗起始剂量为400mg/m²，随后每周给予250mg/m²剂量直至放疗结束。放疗（70Gy/35次/7周）在最后一次多西他赛给药后开始。主要终点是治疗完成率。2013年8月至2015年10月期间，我们纳入了54例患者（中位年龄58岁）。我们的患者中，49例为男性，5例为女性，患有下咽癌（n = 28）、口咽癌（n = 19）或喉癌（n = 7），其中48例为IV期疾病。总体缓解率为72.2%，中位随访时间为36.1个月，3年总生存率为90.7%。治疗完成率为76%；50例患者（93%）接受了≥2个疗程的IC，41例（76%）完成了放疗。≥3级发热性中性粒细胞减少或过敏/输液反应的发生率分别为39%和11%。有1例与治疗相关的死亡。TPEx方案的IC治疗后再进行西妥昔单抗同步放疗显示出用于LA SCCHN治疗时可接受的依从性。然而，发热性中性粒细胞减少的高发生率仍然是一个挑战，有必要进一步改进TPEx方案的管理。UMIN000009928。
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