Purpose: Cetuximab (CET) combined with chemotherapy significantly improved the survival in RAS and RAF wild-type metastatic colorectal cancer (mCRC) patients, while clinical evidence was lacking on the use of maintenance therapy (MT). The study aimed to explore the role of maintenance therapy following Cetuximab + chemotherapy and the optimal Cetuximab-based maintenance therapy regimen.
Patients and Methods: We retrospectively reviewed data on the efficacy and safety of CET-based MT in patients with mCRC who achieved disease control after induction therapy.
Results: Eighty-one patients with mCRC who achieved disease control after CET + chemotherapy induction were enrolled. Overall median progression-free survival (PFS) was 10.5 (95% CI = 8.8– 12.2) months and median maintenance/observation PFS (mnPFS) was 6.0 (95% CI = 5.0– 7.0) months. Among these 81 patients, 61 patients were prescribed MT (CET alone for 21 patients and CET + chemotherapy for 40 patients). Median PFS and mnPFS in the MT group were significantly longer than those for the non-MT group. Different MT regimens did not affect PFS and mnPFS significantly. Univariate and multivariate analysis demonstrated MT, complete response/partial response during induction therapy, and absence of peritoneal metastasis to be positively associated with longer PFS and mnPFS. Treatment-related adverse events (AEs) were tolerable during MT, and AE-related deaths were not observed.
Conclusion: MT with CET or CET + chemotherapy was an appropriate option following initial induction chemotherapy for patients with RAS and RAF wild-type mCRC. This strategy endowed survival benefits and a tolerable safety profile.

Keywords: colorectal cancer, maintenance therapy, cetuximab, RAS and RAF wild-type, targeted therapy


中文翻译：

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转移性结直肠癌患者使用西妥昔单抗维持治疗的疗效和安全性：回顾性研究

目的：西妥昔单抗（CET）联合化疗显着提高RAS和RAF野生型转移性结直肠癌（mCRC）患者的生存率，而维持治疗（MT）的临床证据缺乏。该研究旨在探讨西妥昔单抗+化疗后维持治疗的作用以及基于西妥昔单抗的最佳维持治疗方案。
患者和方法：我们回顾性评价了基于 CET 的 MT 对诱导治疗后疾病控制的 mCRC 患者的疗效和安全性数据。
结果： 81 例 mCRC 患者在 CET + 化疗诱导后实现疾病控制。总体中位无进展生存期 (PFS) 为 10.5 (95% CI = 8.8–12.2) 个月，中位维持/观察 PFS (mnPFS) 为 6.0 (95% CI = 5.0–7.0) 个月。在这 81 名患者中，61 名患者接受了 MT（21 名患者仅接受 CET，40 名患者接受 CET + 化疗）。MT 组的中位 PFS 和 mnPFS 显着长于非 MT 组。不同MT方案对PFS和mnPFS没有显着影响。单变量和多变量分析表明，MT、诱导治疗期间的完全缓解/部分缓解以及无腹膜转移与较长的 PFS 和 mnPFS 呈正相关。MT 期间治疗相关的不良事件 (AE) 是可以忍受的，并且没有观察到 AE 相关的死亡。
结论：对于 RAS 和 RAF 野生型 mCRC 患者，MT 联合 CET 或 CET + 化疗是初始诱导化疗后的合适选择。该策略赋予了生存效益和可容忍的安全性。

关键词：结直肠癌，维持治疗，西妥昔单抗，RAS和RAF野生型，靶向治疗