Autor: |
Jinsong Su, Jiajie Lai, Ruikun Yang, Bo Xu, Ying Zhu, Mingdong Zhao, Chen Yang, Guanzhao Liang |
Jazyk: |
angličtina |
Rok vydání: |
2019 |
Předmět: |
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Zdroj: |
BMC Gastroenterology, Vol 19, Iss 1, Pp 1-9 (2019) |
Druh dokumentu: |
article |
ISSN: |
1471-230X |
DOI: |
10.1186/s12876-018-0916-6 |
Popis: |
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 |
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