一项真实世界回顾性研究评估西妥昔单抗联合卡培他滨与卡培他滨作为 RAS 和 BRAF 野生型转移性结直肠癌患者维持治疗的可靠性。
A Real-World Retrospective Study to Evaluate the Reliability of Cetuximab plus Capecitabine versus Capecitabine as Maintenance Therapy in Patients with RAS and BRAF Wild-Type Metastatic Colorectal Cancer.
机构信息
The Second Department of Medical Oncology, Huizhou First Hospital, Huizhou, China.
Department of Medical Oncology, The Central People's Hospital of Huizhou, Huizhou, China.
出版信息
Med Princ Pract. 2024;33(1):31-40. doi: 10.1159/000533528. Epub 2023 Sep 19.
BACKGROUND
The optimal maintenance therapy for rat sarcoma (RAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) metastatic colorectal cancers (mCRCs) remains unclear. It is critical to evaluate the reliability of cetuximab-capecitabine (the observation group) relative to capecitabine alone (control group).
PATIENTS AND METHODS
In this retrospective analysis, patients with RAS and BRAF mCRC admitted to Huizhou Municipal Central Hospital, between January 2016 and October 2020 were enrolled and treated with cetuximab plus 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) as an initial therapy. Patients whose disease was controlled after at least six cycles of treatment were administered a maintenance therapy until disease progression. We also analyzed the prognosis of patients according to clinicopathological features. Altogether, 39 RAS and BRAF mCRC patients were recruited from January 2016 to October 2020, with 18 cases in the treatment group and 21 cases in the control group. The difference in baseline clinicopathological features between the two treatments is not obvious.
RESULTS
The median progression-free survival after maintenance treatment in observation group (9.5 months [95% confidence interval (CI) = 6.4-12.6]), was significantly better than the control group (7.3 months [95% CI = 5.8-8.8]). During maintenance treatment, there were no deaths caused by treatment-related adverse events, and the overall incidence of rash acne was different between the observation and control groups (p < 0.05). Most adverse events were mild and easily controlled. Primary tumor site, baseline carcinoembryonic antigen levels, and microsatellite instability status were independent prognostic factors.
CONCLUSION
Maintenance therapy using cetuximab plus capecitabine improved survival in patients with mCRC and was well tolerated by patients.
背景
鼠肉瘤（RAS）和 v-raf 鼠肉瘤病毒癌基因同源物 B（BRAF）转移性结直肠癌（mCRC）的最佳维持治疗仍不清楚。评估西妥昔单抗联合卡培他滨（观察组）与卡培他滨单药（对照组）的可靠性至关重要。
患者和方法
在这项回顾性分析中，纳入了 2016 年 1 月至 2020 年 10 月期间在惠州市中心医院接受治疗的 RAS 和 BRAF mCRC 患者，他们接受了西妥昔单抗联合氟尿嘧啶、亚叶酸钙和伊立替康（FOLFIRI）作为初始治疗。至少接受 6 个周期治疗后疾病得到控制的患者接受维持治疗，直至疾病进展。我们还根据临床病理特征分析了患者的预后。共有 39 例 RAS 和 BRAF mCRC 患者纳入本研究，其中治疗组 18 例，对照组 21 例。两组治疗前的基线临床病理特征差异不明显。
结果
观察组维持治疗后的中位无进展生存期为 9.5 个月（95%可信区间[CI] = 6.4-12.6），明显长于对照组的 7.3 个月（95% CI = 5.8-8.8）。维持治疗期间，无因治疗相关不良事件导致的死亡，观察组皮疹痤疮的总发生率与对照组不同（p < 0.05）。大多数不良反应为轻度，易于控制。原发肿瘤部位、基线癌胚抗原水平和微卫星不稳定性状态是独立的预后因素。
结论
西妥昔单抗联合卡培他滨维持治疗可改善 mCRC 患者的生存，且患者耐受性良好。
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