Choi Dae Ro, Yoon Sang Nam, Kim Hyeong Su, Kim Jung Han, Kim Kwang Yong, Kim Byung Chun, Choi Young Kyun, Kim Jin Bae, Han Boram, Song Hun Ho, Zang Dae Young
Division of Hemato-Oncology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Shingilro1, Youngdeungpo-Gu, Seoul, 150-950, Republic of Korea.
Cancer Chemother Pharmacol. 2015 Mar;75(3):639-43. doi: 10.1007/s00280-015-2688-9. Epub 2015 Jan 29.
This study was conducted to evaluate the efficacy and safety of the combination of capecitabine and oral leucovorin (LV) as a third-line chemotherapy for patients with metastatic colorectal cancer (CRC) showing resistance to irinotecan- and oxaliplatin-containing regimens.
Patients who showed disease progression while receiving or within 6 months of discontinuing irinotecan- and oxaliplatin-containing regimens received capecitabine 825 mg/m(2) in combination with oral LV at a fixed dose of 30 mg, twice a day for 2 weeks followed by a 1-week rest.
Twenty-five patients were enrolled from July 2011 to June 2014. Three patients achieved PR, and 11 showed SD. The overall response rate was 12 %, and disease control rate was 56 %. With a median follow-up of 6.8 months, the median time to progression was 2.8 months and the median overall survival was 7.1 months. The most common non-hematologic toxicity was hand-foot syndrome (40 %), followed by mucositis (28 %) and diarrhea (12 %). Grade 3 hand-foot syndrome occurred in two patients (8 %), and grade 3 mucositis in one. Hematologic toxicities were mild, and only one patient developed grade 3 thrombocytopenia.
The combination of capecitabine and oral LV showed a modest activity and tolerable toxicity profile in metastatic CRC patients pretreated with irinotecan- and oxaliplatin-containing regimens. Oral LV seems to be able to reduce the usual dose of capecitabine when the two drugs are combined.
本研究旨在评估卡培他滨与口服亚叶酸钙（LV）联合作为三线化疗方案，用于对含伊立替康和奥沙利铂方案耐药的转移性结直肠癌（CRC）患者的疗效和安全性。
在接受含伊立替康和奥沙利铂方案治疗期间或停药后6个月内出现疾病进展的患者，接受卡培他滨825mg/m²，联合固定剂量30mg的口服LV，每日2次，共2周，随后休息1周。
2011年7月至2014年6月共纳入25例患者。3例患者达到部分缓解（PR），11例疾病稳定（SD）。总缓解率为12%，疾病控制率为56%。中位随访6.8个月，中位疾病进展时间为2.8个月，中位总生存期为7.1个月。最常见的非血液学毒性是手足综合征（40%），其次是黏膜炎（28%）和腹泻（12%）。2例患者出现3级手足综合征（8%），1例出现3级黏膜炎。血液学毒性较轻，仅1例患者出现3级血小板减少。
卡培他滨与口服LV联合方案在接受过含伊立替康和奥沙利铂方案治疗的转移性CRC患者中显示出一定活性且毒性可耐受。联合使用时，口服LV似乎能够降低卡培他滨的常用剂量。
