食管腺癌患者围手术期使用靶向药西妥昔单抗联合顺铂和氟尿嘧啶治疗的二期研究。
Perioperative Cetuximab with Cisplatin and 5-Fluorouracil in Esogastric Adenocarcinoma: A Phase II Study.
发表日期:2023 Apr 06
作者:
Caroline Gronnier, Christophe Mariette, Come Lepage, Carole Monterymard, Marine Jary, Aurélie Ferru, Mathieu Baconnier, Xavier Adhoute, David Tavan, Hervé Perrier, Véronique Guerin-Meyer, Cédric Lecaille, Nathalie Bonichon-Lamichhane, Didier Pillon, Oana Cojocarasu, Joëlle Egreteau, Xavier Benoit D'journo, Laétitia Dahan, Christophe Locher, Patrick Texereau, Denis Collet, Pierre Michel, Meher Ben Abdelghani, Rosine Guimbaud, Marie Muller, Olivier Bouché, Guillaume Piessen
来源:
Cancers
摘要:
手术前期化疗治疗胃和胃食管交界处(G/GEJ)腺癌比单独手术可以提供生存益处,但结果需要改进。本研究旨在评估靶向药物西妥昔单抗联合5-氟尿嘧啶和顺铂预防性化疗的疗效和安全性。患者在手术前和术后接受6个周期的西妥昔单抗、顺铂和简化LV5FU2。主要目的是对肿瘤客观反应(TOR)进行综合评估,评估方法是通过计算机断层扫描,而且无重度毒性导致预防性化疗(NCT)的中断(分别为45%和90%)。从2011年至2013年,共招募了65名患者。从64名可评估主要终点的患者中,19名(29.7%)具有形态学TOR,而61名(95.3%)由于重大毒性未在预防性化疗过程中提前停止。60名患者(92.3%)接受了手术。16名患者(56可用,占28.5%)具有组织学反应(Mandard肿瘤回归分级≤3)。经过44.5个月的中位随访后,中位无病生存期和总生存期分别为24.4个月[95%CI:16.4-39.4]和40.3个月[95%CI:27.5-NA]。在可手术的G/GEJ腺癌中添加西妥昔单抗到NCT方案中是安全的,但在本研究中并没有显示出足够的疗效来满足主要终点(NCT01360086)。
While perioperative chemotherapy provides a survival benefit over surgery alone in gastric and gastroesophageal junction (G/GEJ) adenocarcinomas, the results need to be improved. This study aimed to evaluate the efficacy and safety of perioperative cetuximab combined with 5-fluorouracil and cisplatin.Patients received six cycles of cetuximab, cisplatin, and simplified LV5FU2 before and after surgery. The primary objective was a combined evaluation of the tumor objective response (TOR), assessed by computed tomography, and the absence of major toxicities resulting in discontinuation of neoadjuvant chemotherapy (NCT) (45% and 90%, respectively).From 2011 to 2013, 65 patients were enrolled. From 64 patients evaluable for the primary endpoint, 19 (29.7%) had a morphological TOR and 61 (95.3%) did not stop NCT prematurely due to major toxicity. Sixty patients (92.3%) underwent resection. Sixteen patients (/56 available, 28.5%) had histological responses (Mandard tumor regression grade ≤3). After a median follow-up of 44.5 months, median disease-free and overall survival were 24.4 [95% CI: 16.4-39.4] and 40.3 months [95% CI: 27.5-NA], respectively.Adding cetuximab to the NCT regimen in operable G/GEJ adenocarcinomas is safe, but did not show enough efficacy in the present study to meet the primary endpoint (NCT01360086).