Karacetin D, Yalcin B, Okten B, Ozturk S, Maral O, Incekara O
Radiation Oncology Clinic, Sisli Etfal Research and Training Hospital, Istanbul, Turkey.
J BUON. 2009 Oct-Dec;14(4):605-8.
For almost 40 years, 5-fluorouracil (5-FU) had been the only drug with demonstrated activity against (CRC), commonly used in combination with leucovorin (LV). Oxaliplatin and capecitabine are two relatively novel drugs used in the treatment of CRC. These drugs have been found to act synergistically, both in vivo and in vitro and their combination (XELOX) is highly active in metastatic colorectal cancer (mCRC). The aim of this study was to determine the safety and efficacy of XELOX in patients with mCRC.
The study endpoints were response rates, toxicity, progression free (PFS) and overall survival (OS). XELOX was administered as first line treatment to patients with mCRC. Patient selection criteria included histological confirmation of mCRC, ECOG performance status (PS) <or=2, and adequate bone marrow, renal and hepatic function. Patients received oxaliplatin 130 mg/m(2) i.v., day 1, and oral capecitabine 1000 mg/m(2) twice daily, days 1-14, every 3 weeks.
34 patients were treated with XELOX; males/ females 23/11, median age 53.5 years (range 42-65), ECOG PS 0/1 52%/48%. Metastatic sites were the liver (23/34; 67%), lung (7/34; 20%), and bone (4/34; 11%). No patient achieved complete response (CR), 14 patients showed partial response (PR), 8 stable disease (SD) and 11 progressed (PD). Median PFS was 5.5 months, median OS 12.9 months and 1-year survival 52%.
The combination of oral capecitabine with i.v. oxaliplatin appears to be effective and well tolerated in patients with mCRC.
近40年来，5-氟尿嘧啶（5-FU）一直是唯一被证实对结直肠癌（CRC）有活性的药物，通常与亚叶酸钙（LV）联合使用。奥沙利铂和卡培他滨是用于治疗CRC的两种相对较新的药物。已发现这些药物在体内和体外均具有协同作用，它们的联合方案（XELOX）在转移性结直肠癌（mCRC）中具有高活性。本研究的目的是确定XELOX方案在mCRC患者中的安全性和疗效。
研究终点为缓解率、毒性、无进展生存期（PFS）和总生存期（OS）。XELOX方案作为一线治疗应用于mCRC患者。患者选择标准包括mCRC的组织学确诊、东部肿瘤协作组（ECOG）体能状态（PS）≤2以及足够的骨髓、肾脏和肝功能。患者在第1天接受静脉注射奥沙利铂130mg/m²，在第1 - 14天口服卡培他滨1000mg/m²，每日两次，每3周重复一次。
34例患者接受了XELOX方案治疗；男性/女性为23/11，中位年龄53.5岁（范围42 - 65岁），ECOG PS为0/1的患者分别占52%/48%。转移部位为肝脏（23/34；67%）、肺（7/34；20%）和骨（4/34；11%）。无患者达到完全缓解（CR），14例患者显示部分缓解（PR），8例病情稳定（SD），11例病情进展（PD）。中位PFS为5.5个月，中位OS为12.9个月，1年生存率为52%。
口服卡培他滨与静脉注射奥沙利铂联合方案在mCRC患者中似乎有效且耐受性良好。
