Treatment efficacy and safety of apatinib monotherapy in patients with failed standard regimen for advanced colorectal cancer
10.3872/j.issn.1007-385x.2020.07.008
- VernacularTitle:阿帕替尼单药在标准方案治疗失败晚期结直肠癌患者中的疗效及安全性
- Author:
ZHENG Xiaoyong
1
,
2
;
BAI Yan
3
,
4
;
YANG Yage
1
,
2
;
SHI Dawei
1
,
2
;
GUO Changqing
5
Author Information
1. 1. Department of Gastroenterology, the Third Provincial People'
2. s Hospital of Henan Province, Zhengzhou 450000, Henan, China
3. 2. Department of Gastroenterology, the First People'
4. s Hospital of Zhengzhou, Zhengzhou 450004, Henan, China
5. 3. Department of Gastroenterology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, Henan, China
- Publication Type:Journal Article
- Keywords:
colorectal cancer (CRC);
apatinib;
efficacy;
adverse reaction;
safety
- From:
Chinese Journal of Cancer Biotherapy
2020;27(7):770-775
- CountryChina
- Language:Chinese
-
Abstract:
[Abstract] Objective: To investigate the efficacy and safety of apatinib monotherapy in the treatment for patients with advanced
colorectal cancer (CRC) who failed standard regimen. Methods: The required sample size in this prospective study was calculated with
the PASS 15 software. A total of 52 patients with advanced colorectal cancer who failed standard regimen from July 2017 to August
2018 were included in this study. The patients were given apatinib monotherapy with an initial dosage of 750 mg or 500 mg. The objective
remission rate (ORR) and disease control rate (DCR) were evaluated; the patients were followed up and progression-free survival (PFS)
and overall survival (OS) were evaluated, and adverse events during treatment were recorded. The primary endpoint of this study was
PFS, and secondary endpoints were ORR, DCR, OS and safety. Result: Of the 52 patients included, 45 patients, all of whom were late
stage CRC patients with at least two systematic chemotherapeutic treatments, were available for efficacy evaluation. Treatment efficacy evaluation showed complete response of 0 case, partial response of 5 cases, stable disease of 30 cases and progression disease of 10 cases; the ORR was 11.11%, and the DCR was 77.78%. The prognosis data indicated that the median PFS of the 45 CRC patients was 3.95 months (95% CI=3.16-4.74), and the median OS was 10.3 months (95% CI=5.70-14.90). In terms of adverse events evaluation, the adverse reactions with grade 3 or above were hand-foot syndrome (6 cases, 13.33%), hypertension (5 cases, 11.11%), proteinuria (3 cases, 6.67%), diarrhea (3 cases, 6.67%), fatigue (2 cases, 4.44%) and bleeding (1 case, 2.22%). Conclusion: Apatinib monotherapy for patients with advanced colorectal cancer, who failed the standard regimens, has potential clinical benefits, and the overall toxicity profile is manageable.
- Full text:202007081.pdf
