研究动态
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通过食管鳞状细胞癌化疗选择优化器官保存策略:CROC 多机构 II 期临床试验结果。

Optimizing Organ Preservation Strategies through Chemotherapy-Based Selection in Esophageal Squamous Cell Carcinoma: Results from the CROC Multi-Institutional Phase II Clinical Trial.

发表日期:2024 Jul 02
作者: Chikatoshi Katada, Tetsuji Yokoyama, Akinori Watanabe, Hiroki Hara, Takako Yoshii, Hirofumi Fujii, Hironori Yamaguchi, Takako Eguchi Nakajima, Naoki Izawa, Takayuki Ando, Motoo Nomura, Takashi Kojima, Keishi Yamashita, Shogo Kawakami, Hiromichi Ishiyama, Yusuke Inoue, Yasutoshi Sakamoto, Hiroki Sasaki, Hideki Ishikawa, Ayumu Hosokawa, Yasuo Hamamoto, Manabu Muto, Makoto Tahara, Wasaburo Koizumi
来源: Int J Radiat Oncol

摘要:

本研究旨在评估根治性放化疗 (dCRT) 作为器官保存策略的可行性,适用于可切除食管鳞状细胞癌 (ESCC) 接受诱导化疗后降期至 IA 期的显着反应者。 IB-III 期(UICC,国际癌症控制第 7 版)有资格参加该研究。所有患者均接受三个周期的 DCF 治疗(第 1 天多西紫杉醇 75 mg/m2,第 1 天顺铂 75 mg/m2,第 1-5 天 5-氟尿嘧啶 [5-FU] 750 mg/m2,每三周重复一次)。显着缓解被定义为肿瘤缩小至T1,短轴上转移淋巴结小于1厘米,并且在三个周期的DCF治疗后降期至IA期。然后,反应显着的患者接受了 dCRT,其中包括在第 1-4 天进行两个疗程的顺铂 75 mg/m2 和 5-FU 1000 mg/m2,每四周重复一次,同时进行 50.4 Gy 的放射治疗。主要终点是 DCF 治疗和随后的 dCRT 后显着缓解者的 1 年无进展生存期 (PFS)。次要终点包括 3 年总生存期 (OS) 和无食管切除生存期 (EFS)。在登记的 92 名患者中,对 90 名进行了分析。 58.4% 的患者对三个疗程的 DCF 治疗有显着反应。在这些缓解者中,89.8% 在 dCRT 后达到完全缓解。在 33 个月的中位随访期间(范围:1-85 个月),1 年 PFS 为 89.8%(95% 置信区间=77.2%-95.6%,主要终点),3 年 OS 为83.7%。分析组的 3 年 OS 和 EFS 率分别为 74.1% 和 45.3%。两个疗程 DCF 治疗后的 18F-氟脱氧葡萄糖-正电子发射断层扫描反应与 OS 显着相关 (p=0.0049)。 在可切除的 ESCC 患者中,对于在三个疗程的 DCF 治疗诱导化疗后降期至 IA 期的显着反应者,dCRT 为一种可行的治疗方案,并提供基于化疗的选择的优化器官保存策略。版权所有 © 2024。由 Elsevier Inc. 出版。
This study aimed to assess the viability of definitive chemoradiotherapy (dCRT) as an organ-preservation strategy for remarkable responders who were downstaged to stage IA after receiving induction chemotherapy for resectable esophageal squamous cell carcinoma (ESCC).Chemotherapy-naïve patients with resectable ESCC (stage IB-III, UICC, International Cancer Control 7th edition) were eligible for the study. All patients received three cycles of DCF therapy (docetaxel 75 mg/m2 on day 1, cisplatin 75 mg/m2 on day 1, and 5-fluorouracil [5-FU] 750 mg/m2 on days 1-5, repeated every three weeks). A remarkable response was defined as a reduction of the tumor to T1, metastatic lymph nodes smaller than 1 cm on the short axis, and downstaging to stage IA after three cycles of DCF therapy. Remarkable responders then underwent dCRT, which included two courses of cisplatin 75 mg/m2 and 5-FU 1000 mg/m2 on days 1-4, repeated every four weeks, along with 50.4 Gy of concurrent radiotherapy. The primary endpoint was 1-year progression-free survival (PFS) in remarkable responders following DCF therapy and subsequent dCRT. Secondary endpoints included 3-year overall survival (OS) and esophagectomy-free survival (EFS).Of the 92 patients registered, 90 were analyzed. A remarkable response to three courses of DCF therapy was observed in 58.4% of patients. Among these responders, 89.8% achieved a complete response after dCRT. During the median follow-up period of 33 months (range: 1-85 months), the 1-year PFS was 89.8% (95% confidence interval = 77.2%-95.6%, primary endpoint), and the 3-year OS was 83.7%. The 3-year OS and EFS rates in the analysis group were 74.1% and 45.3%, respectively. An 18F-fluorodeoxyglucose-positron emission tomography response after two courses of DCF therapy was significantly associated with OS (p = 0.0049).In patients with resectable ESCC, dCRT for remarkable responders downstaging to stage IA after induction chemotherapy with three courses of DCF therapy is a feasible treatment option and provides an optimizing organ-preservation strategy of chemotherapy-based selection.Copyright © 2024. Published by Elsevier Inc.