Capecitabine plus bevacizumab versus capecitabine in maintenance treatment for untreated characterised KRAS exon 2 wild-type metastatic colorectal cancer: a retrospective analysis in Chinese postmenopausal women

Abstract Background 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...

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Main Authors: Jinsong Su, Jiajie Lai, Ruikun Yang, Bo Xu, Ying Zhu, Mingdong Zhao, Chen Yang, Guanzhao Liang
Format: Article
Language:English
Published: BMC 2019-01-01
Series:BMC Gastroenterology
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12876-018-0916-6
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author Jinsong Su
Jiajie Lai
Ruikun Yang
Bo Xu
Ying Zhu
Mingdong Zhao
Chen Yang
Guanzhao Liang
author_facet Jinsong Su
Jiajie Lai
Ruikun Yang
Bo Xu
Ying Zhu
Mingdong Zhao
Chen Yang
Guanzhao Liang
author_sort Jinsong Su
collection DOAJ
description Abstract Background 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. Methods 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. Results 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 0.32~0.85; 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 0.51~0.94; P = 0.022). The CAP-B-treated cohort experienced significantly more grade 3 or 4 diarrhoea (P < 0.001) than the CAP-treated cohort. Conclusions 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.
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spelling doaj.art-6dbf8893dab044b781ff9f25ae8ce6692022-12-21T19:30:27ZengBMCBMC Gastroenterology1471-230X2019-01-011911910.1186/s12876-018-0916-6Capecitabine plus bevacizumab versus capecitabine in maintenance treatment for untreated characterised KRAS exon 2 wild-type metastatic colorectal cancer: a retrospective analysis in Chinese postmenopausal womenJinsong Su0Jiajie Lai1Ruikun Yang2Bo Xu3Ying Zhu4Mingdong Zhao5Chen Yang6Guanzhao Liang7Department of Colorectal and Anal Surgery, The First Affiliated Hospital of Zhengzhou UniversityDepartment of Gynaecology and obstetrics, The First Affiliated Hospital, Sun Yat-sen UniversityDepartment of Pediatrics, The First Affiliated Hospital, Sun Yat-sen UniversityDepartment of thoracic surgery, The First Affiliated Hospital, Sun Yat-sen UniversityDepartment of Radiology, The First Affiliated Hospital, Sun Yat-sen UniversityDepartment of Orthopaedics, Jinshan Hospital, Fudan UniversityDepartment of Physical Examination, The First Affiliated Hospital, Sun Yat-sen UniversityEmergency Department, The First Affiliated Hospital, Sun Yat-sen UniversityAbstract Background 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. Methods 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. Results 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 0.32~0.85; 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 0.51~0.94; P = 0.022). The CAP-B-treated cohort experienced significantly more grade 3 or 4 diarrhoea (P < 0.001) than the CAP-treated cohort. Conclusions 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.http://link.springer.com/article/10.1186/s12876-018-0916-6CapecitabineBevacizumabColorectal cancerProgression-free survivalOverall survival
spellingShingle Jinsong Su
Jiajie Lai
Ruikun Yang
Bo Xu
Ying Zhu
Mingdong Zhao
Chen Yang
Guanzhao Liang
Capecitabine plus bevacizumab versus capecitabine in maintenance treatment for untreated characterised KRAS exon 2 wild-type metastatic colorectal cancer: a retrospective analysis in Chinese postmenopausal women
BMC Gastroenterology
Capecitabine
Bevacizumab
Colorectal cancer
Progression-free survival
Overall survival
title Capecitabine plus bevacizumab versus capecitabine in maintenance treatment for untreated characterised KRAS exon 2 wild-type metastatic colorectal cancer: a retrospective analysis in Chinese postmenopausal women
title_full Capecitabine plus bevacizumab versus capecitabine in maintenance treatment for untreated characterised KRAS exon 2 wild-type metastatic colorectal cancer: a retrospective analysis in Chinese postmenopausal women
title_fullStr Capecitabine plus bevacizumab versus capecitabine in maintenance treatment for untreated characterised KRAS exon 2 wild-type metastatic colorectal cancer: a retrospective analysis in Chinese postmenopausal women
title_full_unstemmed Capecitabine plus bevacizumab versus capecitabine in maintenance treatment for untreated characterised KRAS exon 2 wild-type metastatic colorectal cancer: a retrospective analysis in Chinese postmenopausal women
title_short Capecitabine plus bevacizumab versus capecitabine in maintenance treatment for untreated characterised KRAS exon 2 wild-type metastatic colorectal cancer: a retrospective analysis in Chinese postmenopausal women
title_sort capecitabine plus bevacizumab versus capecitabine in maintenance treatment for untreated characterised kras exon 2 wild type metastatic colorectal cancer a retrospective analysis in chinese postmenopausal women
topic Capecitabine
Bevacizumab
Colorectal cancer
Progression-free survival
Overall survival
url http://link.springer.com/article/10.1186/s12876-018-0916-6
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