研究动态
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用于可切除晚期胃癌的新辅助多西他赛、奥沙利铂和 S-1 Plus 手术以及辅助 S-1:更新的 III 期 PRODIGY 总体生存结果。

Neoadjuvant Docetaxel, Oxaliplatin, and S-1 Plus Surgery and Adjuvant S-1 for Resectable Advanced Gastric Cancer: Updated Overall Survival Outcomes From Phase III PRODIGY.

发表日期:2024 Jul 12
作者: Yoon-Koo Kang, Hyung-Don Kim, Jeong Hwan Yook, Young-Kyu Park, Jong Seok Lee, Young-Woo Kim, Jin Young Kim, Min-Hee Ryu, Sun Young Rha, Ik Joo Chung, In-Ho Kim, Sang Cheul Oh, Young Soo Park, Jae-Ho Cheong, Oh Jeong, Mi Hwa Heo, Hark Kyun Kim, ChoHyun Park, Chang Hak Yoo, Seok Yun Kang, Dae Young Zang, You Jin Jang, Ji Young Sul, Jong Gwang Kim, Beom Su Kim, Seung-Hoon Beom, Jun-Eul Hwang, Seung Wan Ryu, Myeong-Cherl Kook, Baek-Yeol Ryoo, Hyunki Kim, Moon-Won Yoo, Nam Su Lee, Sang Ho Lee, Sung Hoon Noh
来源: HEART & LUNG

摘要:

临床试验经常包括在不同时间成熟的多个终点。当关键计划的联合主要或次要分析尚未可用时,通常基于主要终点的初始报告可能会发布。临床试验更新提供了传播在 JCO 或其他地方发表的研究的更多结果的机会,这些研究的主要终点已经报告。III 期 PRODIGY 研究表明,使用多西他赛、奥沙利铂和 S-1 (DOS对于临床 T2-3N 或 T2-3N 或可切除的局部晚期胃癌 (LAGC) 患者,与手术后接受 S-1 辅助化疗 (SC) 相比,随后进行手术和辅助 S-1 化疗 (CSC) 改善了无进展生存期 (PFS) T4Nany疾病。主要终点是 PFS。总生存期(OS)是次要终点。我们在此报告该试验的长期随访结果,包括 OS。总共 238 名和 246 名患者分别被随机分配到 CSC 组和 SCC 组并接受治疗(完整分析集)。截至数据截止(2022 年 9 月),存活患者的中位随访时间为 99.5 个月。与 SC 相比,CSC 显着提高了 OS(调整后风险比 [HR],0.72;分层对数秩 P = .027),CSC 和 SC 组的 8 年 OS 率分别为 63.0% 和 55.1%。 CSC 还显着改善了 PFS(HR,0.70;分层对数秩 P = .016)。总之,新辅助 DOS 化疗作为围手术期化疗的一部分,相对于接受手术和辅助 S-1 治疗的患者而言,延长了亚洲 LAGC 患者的 OS。它应被视为亚洲 LAGC 患者的标准治疗选择之一。
Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.The phase III PRODIGY study demonstrated that neoadjuvant chemotherapy with docetaxel, oxaliplatin, and S-1 (DOS) followed by surgery and adjuvant S-1 chemotherapy (CSC) improved progression-free survival (PFS) compared with surgery followed by adjuvant S-1 (SC) for patients with resectable locally advanced gastric cancer (LAGC) with clinical T2-3N+ or T4Nany disease. The primary end point was PFS. Overall survival (OS) was the secondary end point. We herein report the long-term follow-up outcomes, including OS, from this trial. A total of 238 and 246 patients were randomly assigned to the CSC and SC arms, respectively, and were treated (full analysis set). As of the data cutoff (September 2022), the median follow-up duration of the surviving patients was 99.5 months. Compared with SC, CSC significantly increased the OS (adjusted hazard ratio [HR], 0.72; stratified log-rank P = .027) with an 8-year OS rate of 63.0% and 55.1% for the CSC and SC arms, respectively. CSC also significantly improved the PFS (HR, 0.70; stratified log-rank P = .016). In conclusion, neoadjuvant DOS chemotherapy, as part of perioperative chemotherapy, prolonged the OS of Asian patients with LAGC relative to patients treated with surgery and adjuvant S-1. It should be considered one of the standard treatment options for patients with LAGC in Asia.