医学
西妥昔单抗
伊立替康
福尔菲里
内科学
人口
结直肠癌
肿瘤科
不利影响
临床研究阶段
氟尿嘧啶
克拉斯
癌症
外科
化疗
环境卫生
作者
Carmine Pinto,Armando Orlandi,Nicola Normanno,Evaristo Maiello,Maria Alessandra Calegari,Lorenzo Antonuzzo,Roberto Bordonaro,Maria Giulia Zampino,Sara Pini,Francesca Bergamo,Giuseppe Tonini,Antonio Avallone,Tiziana Pia Latiano,Gerardo Rosati,Alessio Aligi Cogoni,Alberto Ballestrero,Alberto Zaniboni,Mario Roselli,Stefano Tamberi,Carlo Barone
摘要
PURPOSE The intensity of anti-EGFR–based first-line therapy for RAS/BRAF wild-type (wt) metastatic colorectal cancer (mCRC), once disease control is achieved, is controversial. A de-escalation strategy with anti-EGFR monotherapy represents a potential option to maintain efficacy while reducing cytotoxicity. METHODS In this multicenter, open-label, phase III trial, patients with untreated RAS/BRAF wt mCRC were randomly assigned to receive either fluorouracil, leucovorin, and irinotecan/cetuximab (FOLFIRI/Cet) until disease progression (arm A) or FOLFIRI/Cet for eight cycles followed by Cet alone (arm B). The coprimary end points were a noninferior progression-free survival (PFS) in the modified per-protocol (mPP) population (>eight cycles) and a lower incidence of grade (G) 3-4 adverse events (AEs) for arm B compared with arm A. RESULTS Overall, 606 patients were randomly assigned, with 300 assigned to arm A and 306 to arm B. The median follow-up was 22.3 months. In the mPP population, 291 events occurred with a PFS of 10 versus 12.2 months for arms B and A, respectively ( P of noninferiority = .43). In the intention-to-treatment (ITT, ≥one cycle) population, 503 events occurred with a PFS of 9 versus 10.7 months ( P = .39). The overall survival was 35.7 versus 30.7 months ( P = .119) and 31.0 versus 25.2 months ( P = .32) in the mPP and ITT population, respectively. Arm B had lower G3-4 AEs during the maintenance period than arm A (20.2% v 35.1%). CONCLUSION The ERMES study did not demonstrate noninferiority of maintenance with Cet alone. Despite a more favorable safety profile, maintenance with single-agent Cet after induction with FOLFIRI/Cet cannot be recommended for all patients but could represent an option in selected cases.
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