Li Wenhua, Xu Jianming, Shen Lin, Liu Tianshu, Guo Weijian, Zhang Wen, Chen Zhiyu, Zhu Xiaodong, Li Jin
Department of Medical Oncology, Fudan University Shanghai Cancer Center, 270 Dong-An Road, Shanghai 200032, China.
BMC Cancer. 2014 Dec 19;14:986. doi: 10.1186/1471-2407-14-986.
The purpose of this phase II study was to evaluate the safety and efficacy of weekly irinotecan and capecitabine (wXELIRI) treatment in patients with metastatic colorectal cancer, specifically the rate of severe diarrhea.
Patients with unresectable histologically confirmed metastatic colorectal cancer with measurable disease received weekly irinotecan 90 mg/m² on day 1 and capecitabine 1200 mg/m² twice daily on days 1-5. Patients naïve to systemic chemotherapy for metastatic disease or who had failed FOLFOX (infusional 5-fluorouracil [5-FU], leucovorin, and oxaliplatin) or XELOX (capecitabine plus oxaliplatin) as first-line treatment were eligible. The primary endpoint was the rate of grade 3/4 diarrhea. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.
A total of 52 patients were enrolled, 30 of whom received wXELIRI as first-line treatment and 22 as second-line treatment. Grade 4 diarrhea was observed in one patient and the rate of grade 3/4 diarrhea was 7.7%. The other common grade 3/4 toxicities included leukopenia (9.6%), neutropenia (17.3%), nausea (3.8%), vomiting (3.8%), fatigue (1.9%), and hand-foot syndrome (1.9%). The median progression-free survival and overall survival for the 30 patients treated in the first-line setting was 8.5 and 16.3 months, while those for the 22 patients treated in the second-line setting was 5.0 and 10.7 months, respectively.
The wXELIRI regimen resulted in a low rate of severe diarrhea with an acceptable toxicity profile. This study provides a basis for a subsequent randomized controlled study of wXELIRI versus FOLFIRI (irinotecan, 5-FU, and folinic acid) to further explore the efficacy and safety of this regimen.
ClinicalTrials.gov: NCT01322152.
本II期研究旨在评估每周使用伊立替康和卡培他滨（wXELIRI）治疗转移性结直肠癌患者的安全性和疗效，特别是严重腹泻的发生率。
组织学确诊为不可切除的转移性结直肠癌且有可测量病灶的患者，在第1天接受每周一次的伊立替康90mg/m²治疗，在第1 - 5天接受卡培他滨1200mg/m²每日两次治疗。初治的转移性疾病全身化疗患者或一线治疗失败于FOLFOX（持续输注5-氟尿嘧啶[5-FU]、亚叶酸钙和奥沙利铂）或XELOX（卡培他滨加奥沙利铂）的患者符合入组条件。主要终点是3/4级腹泻的发生率。次要终点包括无进展生存期（PFS）、总生存期（OS）和安全性。
共纳入52例患者，其中30例接受wXELIRI作为一线治疗，22例作为二线治疗。1例患者出现4级腹泻，3/4级腹泻的发生率为7.7%。其他常见的3/4级毒性包括白细胞减少（9.6%）、中性粒细胞减少（17.3%）、恶心（3.8%）呕吐（3.8%）、疲劳（1.9%）和手足综合征（1.9%）。一线治疗的30例患者的中位无进展生存期和总生存期分别为8.5个月和16.3个月，而二线治疗的22例患者分别为5.0个月和10.7个月。
wXELIRI方案导致严重腹泻发生率低，毒性特征可接受。本研究为后续wXELIRI与FOLFIRI（伊立替康、5-FU和亚叶酸钙）的随机对照研究提供了基础，以进一步探索该方案的疗效和安全性。
ClinicalTrials.gov：NCT01322152。
