| Li Wang,Juan Lu,Yi Liu,Yunfei Gao,Man Kong,Jiandong Yang,Bin Kong,Xuebing Li,Xifen Huang,Wenzhong Pei. A retrospective analysis of the safety and efficacy of apatinib in treating advanced metastatic colorectal cancer. Oncol Transl Med, 2017, 3: 210-216. |
| 阿帕替尼治疗晚期转移性结直肠癌的安全性和有效性回顾性分析 |
| A retrospective analysis of the safety and efficacy of apatinib in treating advanced metastatic colorectal cancer |
| Received:July 18, 2017 Revised:October 16, 2017 |
| DOI：10.1007/s10330-017-0235-5 |
| 中文关键词: 结直肠癌;靶向治疗;阿帕替尼;VEGFR2;抗血管生成抑制剂 |
| 英文关键词: colorectal cancer; targeted therapy; apatinib; vascular endothelial growth factor receptor-2 (VEGFR-2); angiogenesis inhibitor |
| 基金项目: |
| Author Name | Affiliation | Department | | Li Wang | Department of Oncology, Beijing Luhe Hospital, Capital Medical University, Beijing 101149, China | Department of Oncology | | Juan Lu | Department of Oncology, Beijing Luhe Hospital, Capital Medical University, Beijing 101149, China | Department of Oncology | | Yi Liu | Department of Oncology, Beijing Luhe Hospital, Capital Medical University, Beijing 101149, China | Department of Oncology | | Yunfei Gao | Department of Oncology, Beijing Luhe Hospital, Capital Medical University, Beijing 101149, China | Department of Oncology | | Man Kong | Department of Oncology, Beijing Luhe Hospital, Capital Medical University, Beijing 101149, China | Department of Oncology | | Jiandong Yang | Department of Oncology, Beijing Luhe Hospital, Capital Medical University, Beijing 101149, China | Department of Oncology | | Bin Kong | Department of Oncology, Beijing Luhe Hospital, Capital Medical University, Beijing 101149, China | Department of Oncology | | Xuebing Li | Department of Oncology, Beijing Luhe Hospital, Capital Medical University, Beijing 101149, China | Department of Oncology | | Xifen Huang | Department of Oncology, Beijing Luhe Hospital, Capital Medical University, Beijing 101149, China | Department of Oncology | | Wenzhong Pei* | Department of Oncology, Beijing Luhe Hospital, Capital Medical University, Beijing 101149, China | Department of Oncology |
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| 中文摘要: |
| 摘要：
目的：结直肠癌是一种异质性疾病，表观遗传的改变或基因突变都能把正常的细胞转化成癌细胞。经过一系列的标准治疗后，延长患者生存时间，改善患者生存质量的可选择的方案就很少了。本回顾性研究的目的在于分析阿帕替尼治疗转移性结直肠癌的安全性和有效性。
方法：选取在首都医科大学附属北京潞河医院接受治疗的晚期转移性结直肠癌患者，ECOG≤3.从2015年10月到2017年2月共有17名IV期不可切除的结直肠癌患者接受至少一个周期阿帕替尼的治疗。主要研究终点是ORR，DCR。次要研究终点是PFS，OS和安全性。
结果：共有17名患者入组此项研究，70.6%男性，中位年龄62岁（34-83岁）。76%的患者ECOG评分0-2。原发于结肠的肿瘤占53%，主要的转移部位是肝脏（52.9%）。ORR=17.6%（3/17），DCR=82.4%（14/17）。mPFS=3.0月（95%CI:3.383-7.417 months）。1-2级不良反应包括：高血压（52.9%），乏力（64.7%），厌食（29.4%），声音嘶哑（23.5%），蛋白尿（23.5%），皮疹（17.6%）。3级不良反应包括：血小板减少（5.9%），蛋白尿（5.9%）。无4级不良反应发生。
结论：阿帕替尼治疗晚期转移性结直肠癌安全有效，毒性反应可耐受、可控制。还需要进一步的临床研究来证实。 |
| 英文摘要: |
| Objective Colorectal cancer (CRC) is a heterogeneous disease in which both epigenetic alterations and
gene mutations transform normal cells into cancer cells. Apart from a variety of standard treatments, there
are few options available to improve a CRC patient’s overall survival (OS) and quality of a life. The objective
of the present retrospective study was to analyze the response and toxicity associated with apatinib in
patients with metastatic CRC (mCRC).
Method Data on the use of apatinib as salvage therapy were collected from patients diagnosed with
mCRC, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3, from the Luhe Hospital. A
total of 17 patients with stage IV unresectable mCRC, who received at least one cycle of apatinib, between
October 2015 and February 2017, were involved in this study. Our primary endpoints were the overall
response rate (ORR) and disease control rate (DCR), and the secondary objectives were progression-free
survival (PFS), OS and safety.
Result Seventeen patients with a median age of 62 years (34–83 years) were enrolled. Twelve
patients were male, and the location of the primary tumor was in the colon and the rectum in 9 and 8
patients, respectively. Liver metastasis was observed in 9 patients and lung metastasis in 5. The ECOG
performance status was 0 to 2 in 13 patients. The ORR at the first evaluation was 17.6 % (3/17). The DCR
was 82.4% (14/17). The median PFS was 3.0 months (95% confidence interval (CI): 1.924–4.076 months)
and the median OS was 5.4 months (95% CI: 3.383–7.417 months). Grade 1–2 adverse events included
hypertension (52.9%), fatigue (64.7%), anorexia (29.4%), hoarseness (23.5%), proteinuria (23.5%), and
development of rashes (17.6%). Grade 3 adverse events included thrombocytopenia (5.9%) and proteinuria
(5.9%). There were no Grade 4 adverse events in our analysis.
Conclusions Apatinib was found to be both safe and effective in the treatment of advanced mCRC, and
its associated toxicities were acceptable and manageable. However, further studies are required to validate
these findings. |
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