Department of Medical Oncology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510655, China.
Guangdong Provincial Key Laboratory of Colorectal & Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510655, China.
Future Oncol. 2023 Sep;19(30):2045-2054. doi: 10.2217/fon-2023-0149. Epub 2023 Oct 10.
In patients with metastatic colorectal cancer (mCRC) exhibiting no evidence of disease (NED), this study assessed the efficacy and safety of capecitabine maintenance therapy. The single-arm, phase II CAMCO trial enrolled mCRC-NED patients after first-line treatment, administering oral capecitabine maintenance for 1 year. A total of 93 patients were enrolled. The primary end point, 3-year disease-free survival, yielded a rate of 51.6% (95% CI: 41.3-62.0%). Secondary end points included a 3-year overall survival rate of 83.9% (95% CI: 76.3-91.5%). Grade 3 adverse events (AE) were observed in seven patients (7.5%). Predominantly grade 1 and 2, the most common AE was hand-foot syndrome. In mCRC-NED patients, capecitabine maintenance demonstrated a manageable 3-year disease-free survival rate of 51.6%, accompanied by manageable AEs. NCT01880658 (ClinicalTrials.gov).
在转移性结直肠癌（mCRC）患者中，没有疾病证据（NED），本研究评估了卡培他滨维持治疗的疗效和安全性。这项单臂、II 期的 CAMCO 试验纳入了一线治疗后 NED 的 mCRC 患者，给予口服卡培他滨维持治疗 1 年。共纳入 93 例患者。主要终点，3 年无疾病生存率，达到 51.6%（95%CI：41.3-62.0%）。次要终点包括 3 年总生存率为 83.9%（95%CI：76.3-91.5%）。7 例（7.5%）患者观察到 3 级不良事件（AE）。最常见的 AE 是手足综合征，主要为 1 级和 2 级。在 mCRC-NED 患者中，卡培他滨维持治疗显示出可管理的 3 年无疾病生存率为 51.6%，同时伴有可管理的 AE。NCT01880658（ClinicalTrials.gov）。
