真实世界中R0切除术后结直肠癌患者接受卡培他滨为基础辅助化疗的预后影响因素及安全性探讨

doi:10.12092/j.issn.1009-2501.2019.06.017

摘要/Abstract

摘要：

目的:卡培他滨为基础的辅助化疗显著降低R0切除术后结直肠癌患者的术后复发风险。本研究旨在探讨真实世界中R0切除术后结直肠癌患者接受卡培他滨为基础辅助化疗的预后影响因素及安全性。方法:本研究从2010年1月到2017年12月，纳入279例R0切除术后接受卡培他滨为基础辅助化疗的结直肠癌患者。通过医院的病例系统整理患者基线临床资料。前期随访为患者在医院接受固定周期的辅助化疗期间的随访。后期对预后的随访为电话随访，每3个月一次。随访患者出现复发后接受治疗的情况，重点询问死亡状态和死亡的日期。用Kaplan-Meier生存分析方法分析患者的无疾病生存期（DFS）和总生存期（OS）。不良反应的评价标准依据CTCAE 4.0的标准进行。记录2级以上不良反应发生情况。结果:纳入研究的279例患者的中位年龄51岁，范围为19～82岁。男性167例（59.86%）。ECOG评分中0分患者180例（64.52%）。结肠癌和直肠癌分别173例和106例。肿瘤分化方面，分化较好、分化中等、分化较差患者分别为58例，192例和17例。肿瘤分期上，II期患者58例，III期患者221例。错配修复基因（MMR）状态上，错配修复基因缺失（dMMR）患者19例，错配修复基因存在（pMMR）患者176例，未做检测患者84例。T1-2和T3-4的患者分别为73例和206例。辅助化疗方面，接受卡培他滨单药辅助化疗患者71例，接受卡培他滨联合奥沙利铂辅助化疗患者208例。纳入研究的279例患者均可评价预后，整体人群的中位DFS为4.7年（95% CI:4.12～5.33），中位OS为6.6年（95% CI:5.74～7.27）。在针对OS的多变量Cox分析中年龄、ECOG评分和病理分期对OS具有独立的影响意义。不良反应方面，2级以上不良反应发生率较高的为中性粒细胞减少，手足综合征，腹泻等。总体不良事件安全可控。结论:R0切除术后的结直肠癌患者接受卡培他滨为基础辅助化疗具有较好的预后和安全性。

关键词: 结直肠癌, 辅助化疗, 卡培他滨, 预后

Abstract:

AIM: To investigate the prognostic factors and safety of R0 resection colorectal cancer patients received capecitabine based adjuvant chemotherapy in real world. METHODS: From Jan 2010 to December 2017, a total of 279 CRC patients underwent R0 surgical resection and received capecitabine based adjuvant chemotherapy were included in this study. Baseline characteristics data were collected through the hospital case system. The early follow-up was done during the fixed period of adjuvant chemotherapy in the hospital. Subsequent follow-up of the prognosis was telephone follow-up every three months. Disease-free survival (DFS) and overall survival (OS) were analyzed by Kaplan-Meier survival analysis. Adverse reactions were evaluated according to CTCAE 4.0. Adverse reactions above grade 2 were recorded. RESULTS:The median age of the 279 patients included in the study was 51, ranging from 19-82.167 cases (59.86%) were male. 180 patients (64.52%) were ECOG 0.173 cases of colon cancer and 106 cases of rectal cancer were included. In terms of tumor differentiation, 58 patients had well differentiation, 192 patients had intermediate differentiation, and 17 patients had poor differentiation. 58 cases of stage II patients and 221 cases of stage III patients were involved. In the state of mismatched repair gene (MMR), 19 patients with mismatched repair gene deletion (dMMR), 176 patients with mismatched repair gene presence (pMMR), and 84 patients was no detection. There were 73 patients with T1-2 and 206 patients with T3-4. 71 patients received capecitabine monotherapy and 208 patients received capecitabine combined with oxaliplatin adjuvant chemotherapy. All of the 279 CRC patients were of available for prognosis evaluation. The median disease-free survival (DFS) of the 265 CRC patients were 4.7 years (95%CI: 4.12-5.33), the median overall survival (OS) were 6.6 years (95%CI: 5.74-7.27). Adjusted in multivariate Cox regression analysis for OS, ECOG score and pathological staging were independent factors for OS. In terms of adverse reactions, neutropenia, hand and foot syndrome, diarrhea and other adverse reactions with a higher incidence of grade 2 or above were found. Overall adverse events were manageable and controllable. CONCLUSION:Capecitabine-based adjuvant chemotherapy has superior prognosis and safety in patients with colorectal cancer after R0 resection.

Key words: colorectal cancer, adjuvant chemotherapy, capecitabine, prognosis

中图分类号:

R735.3

李荣振，梅家转，夏云展，季节. 真实世界中R0切除术后结直肠癌患者接受卡培他滨为基础辅助化疗的预后影响因素及安全性探讨[J]. 中国临床药理学与治疗学, 2019, 24(6): 704-711.

LI Rongzhen, MEI Jiazhuan, XIA Yunzhan, JI Jie. Prognostic factors and safety study of R0 resection colorectal cancer patients received capecitabine based adjuvant chemotherapy in real world[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2019, 24(6): 704-711.

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