口服替加氟/尿嘧啶、亚叶酸钙联合贝伐单抗作为老年晚期或转移性结直肠癌一线治疗的II期研究

Phase II Study of Oral Tegafur/Uracil and Leucovorin plus Bevacizumab as a First-Line Therapy for Elderly Patients with Advanced or Metastatic Colorectal Cancer.

作者信息

Mizushima Tsunekazu, Tamagawa Hiroshi, Matsuda Chu, Murata Kohei, Fukunaga Mutsumi, Ota Hirofumi, Hasegawa Junichi, Tsujie Masaki, Fukuzaki Takayuki, Hata Taishi, Takemasa Ichiro, Ikeda Masataka, Yamamoto Hirofumi, Sekimoto Mitsugu, Nezu Riichiro, Doki Yuichiro, Mori Masaki

机构信息

Department of Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.

出版信息

Oncology. 2015;89(3):152-8. doi: 10.1159/000381718. Epub 2015 May 8.

DOI:10.1159/000381718

PMID:25967649

Abstract

BACKGROUND/OBJECTIVE: Oral tegafur/uracil and leucovorin (UFT/LV) therapy is effective and safe for elderly patients with advanced or metastatic colorectal cancer (CRC). However, there are few studies on the combination of bevacizumab with UFT/LV. This clinical study evaluated the efficacy and safety of UFT/LV plus bevacizumab as a first-line therapy for elderly patients with advanced or metastatic CRC.

METHODS

Forty patients with advanced or metastatic CRC aged ≥ 75 years were enrolled in this multicenter, open-label, single-arm phase II study. All patients received oral UFT (300-600 mg) and LV (50 mg) twice daily on days 1-21 and intravenous bevacizumab (5 mg/kg) on days 1 and 15 of a 4-week cycle (University Hospital Medical Information Network No. UMIN000003447).

RESULTS

The median follow-up period was 14.7 months. The response rate was 20.0% [95% confidence interval (CI): 9.1-35.6], median progression-free survival was 8.9 months (95% CI: 5.3-11), and median overall survival was 21.7 months (95% CI: 13.7-23.4). The only grade 3 hematological toxicity was neutropenia (3.0%), and the incidence rates of grade 3 nonhematological toxicity were low at ≤ 10%.

CONCLUSION

UFT/LV plus bevacizumab is a promising first-line regimen for elderly patients with advanced or metastatic CRC. The combination is well tolerated and efficacious.

摘要

背景/目的：口服替加氟/尿嘧啶和亚叶酸钙（UFT/LV）疗法对老年晚期或转移性结直肠癌（CRC）患者有效且安全。然而，关于贝伐单抗与UFT/LV联合使用的研究较少。本临床研究评估了UFT/LV联合贝伐单抗作为老年晚期或转移性CRC患者一线治疗的疗效和安全性。

方法

40例年龄≥75岁的晚期或转移性CRC患者纳入了这项多中心、开放标签、单臂II期研究。所有患者在4周周期的第1 - 21天每天口服两次UFT（300 - 600 mg）和LV（50 mg），并在第1天和第15天静脉注射贝伐单抗（5 mg/kg）（大学医院医学信息网络编号UMIN000003447）。

结果

中位随访期为14.7个月。缓解率为20.0%[95%置信区间（CI）：9.1 - 35.6]，中位无进展生存期为8.9个月（95%CI：5.3 - 11），中位总生存期为21.7个月（95%CI：13.7 - 23.4）。唯一的3级血液学毒性是中性粒细胞减少（3.0%），3级非血液学毒性的发生率较低，≤10%。