Su Jinsong, Lai Jiajie, Yang Ruikun, Xu Bo, Zhu Ying, Zhao Mingdong, Yang Chen, Liang Guanzhao
Department of Colorectal and Anal Surgery, The First Affiliated Hospital of Zhengzhou University, Jianshe East Road No.1, Erqi District, Zhengzhou, 450052, Henan, China.
Department of Gynaecology and obstetrics, The First Affiliated Hospital, Sun Yat-sen University, Huangpu East Road No. 183, Huangpu District, Guangzhou, 510700, China.
BMC Gastroenterol. 2019 Jan 25;19(1):17. doi: 10.1186/s12876-018-0916-6.
Capecitabine plus bevacizumab (CAP-B) maintenance treatment after 6 cycles of capecitabine, oxaliplatin, and bevacizumab (CAPOXB) has demonstrated clinical activity and failure to compromise quality of life in patients with metastatic colorectal cancer (MCC) in a previous phase 3 CAIRO3 study. The objective of this study is to evaluate the efficacy and safety of CAP-B versus CAP in maintenance treatment after 6-cycle CAPOXB induction therapy in Chinese postmenopausal women with untreated characterised KRAS exon 2 wild-type MCC.
During 2012-2016, prospectively maintained databases were reviewed to evaluate cohorts with untreated characterised KRAS exon 2 wild-type MCC and stable disease or better after 6-cycle CAPOXB induction treatment. After induction treatment, all patients received either CAP-B or capecitabine (CAP) as maintenance treatment. Median progression-free survival (mPFS) and median overall survival (mOS) were the primary endpoints. Safety was the secondary endpoint.
A total of 263 women with untreated characterised KRAS exon 2 wild-type MCC and stable disease or better after 6-cycle CAPOXB induction treatment were included for the evaluation of efficacy and safety (CAP-B-treated cohort, n = 130 and CAP-treated cohort, n = 133). The mPFS was 11.5 months (95% confidence interval [CI], 5.6-17.4) and 9.2 months (95% CI, 3.6-14.8) for the CAP-B-treated and CAP-treated cohorts, respectively (HR 0.54, 95% CI 0.320.85; P = 0.013). The mOS was 16.2 months (95% CI, 11.4-18.7) and 12.4 months (95% CI, 10.6-15.5) for the CAP-B- and CAP-treated cohorts, respectively (HR 0.72, 95% CI 0.510.94; P = 0.022). The CAP-B-treated cohort experienced significantly more grade 3 or 4 diarrhoea (P < 0.001) than the CAP-treated cohort.
CAP-B maintenance treatment after 6-cycle CAPOX-B in Chinese postmenopausal women with untreated KRAS exon 2 wild-type MCC is poorer tolerated but has a more modest, if any, benefit compared with that of CAP maintenance treatment.
在先前的一项3期CAIRO3研究中，卡培他滨联合贝伐单抗（CAP-B）用于在接受6个周期的卡培他滨、奥沙利铂和贝伐单抗（CAPOXB）治疗后的维持治疗，已证明对转移性结直肠癌（MCC）患者具有临床活性且不影响生活质量。本研究的目的是评估在未治疗的、特征为KRAS外显子2野生型的绝经后中国MCC女性患者中，6周期CAPOXB诱导治疗后CAP-B与卡培他滨（CAP）维持治疗的疗效和安全性。
在2012年至2016年期间，回顾前瞻性维护的数据库，以评估未治疗的、特征为KRAS外显子2野生型的MCC且在6周期CAPOXB诱导治疗后病情稳定或更好的队列。诱导治疗后，所有患者接受CAP-B或卡培他滨（CAP）作为维持治疗。中位无进展生存期（mPFS）和中位总生存期（mOS）是主要终点。安全性是次要终点。
共有263例未治疗的、特征为KRAS外显子2野生型的MCC且在6周期CAPOXB诱导治疗后病情稳定或更好的女性纳入疗效和安全性评估（CAP-B治疗组，n = 130；CAP治疗组，n = 133）。CAP-B治疗组和CAP治疗组的mPFS分别为11.5个月（95%置信区间[CI]，5.6 - 17.4）和9.2个月（95% CI，3.6 - 14.8）（风险比0.54，95% CI 0.320.85；P = 0.013）。CAP-B治疗组和CAP治疗组的mOS分别为16.2个月（95% CI，11.4 - 18.7）和12.4个月（95% CI，10.6 - 15.5）（风险比0.72，95% CI 0.50.94；P = 0.022）。CAP-B治疗组3级或4级腹泻的发生率显著高于CAP治疗组（P < 0.001）。
在未治疗的KRAS外显子2野生型绝经后中国MCC女性患者中，6周期CAPOX-B后CAP-B维持治疗耐受性较差，但与CAP维持治疗相比，获益（若有）更为有限。
