Multicenter phase II clinical study of the efficiency and safety of capecitabine plus intermittent oxaliplatin with bevacizumab as first-line therapy ... View Full Text


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Article Info

DATE

2021-08-09

AUTHORS

Chihiro Kosugi, Keiji Koda, Tadamichi Denda, Keiichiro Ishibashi, Hideyuki Ishida, Kazuhiro Seike, Haruhito Sakata, Shinji Yanagisawa, Akinari Miyazaki, Wataru Takayama, Naoto Koike, Hiroaki Shimizu, Hisahiro Matsubara

ABSTRACT

PurposeThe aim of this phase II study was to evaluate the efficacy and safety of combination therapy with five-cycle CAPOX (capecitabine plus oxaliplatin) plus bevacizumab, followed by five-cycle maintenance therapy with capecitabine plus bevacizumab and reintroduction of CAPOX plus bevacizumab for five cycles, with a preplanned intermittent oxaliplatin strategy in metastatic colorectal cancer (mCRC).MethodsPatients with untreated mCRC were administered CAPOX (130 mg/m2 oxaliplatin on day 1, 2000 mg/m2/day capecitabine on days 1–14, every 21 days) + bevacizumab (7.5 mg/kg) every 3 weeks for five cycles, maintenance treatment without oxaliplatin for five cycles, and CAPOX + bevacizumab reintroduction for five cycles or upon tumor progression. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were the time to treatment failure (TTF), overall survival, response rate (RR), and safety.ResultsForty-seven patients who fulfilled the inclusion criteria were enrolled in the evaluation of efficacy and safety. Median PFS was 14.1 months (95% confidence interval [CI], 8.6–19.5), and median TTF was 12.3 months (95% CI, 10.3–14.3). The objective RRs were 51.1% (24/47) during induction therapy, 58.3% (21/36) during maintenance therapy, and 63.6% (14/22) during reintroduction therapy. The frequency of patients with neutropenia, diarrhea, peripheral sensory neuropathy, venous thromboembolism, or grade ≥ 3 allergic reactions was 2.1%.ConclusionCAPOX plus bevacizumab therapy with a preplanned intermittent oxaliplatin strategy consisting of brief five-cycle induction therapy, five-cycle maintenance therapy with capecitabine plus bevacizumab, and five-cycle reintroduction therapy consisting of CAPOX plus bevacizumab is safe and effective for mCRC patients.Trial registrationUMIN ID: 000,005,732, date of registration: June 7, 2011. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000006695 More... »

PAGES

2637-2647

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00384-021-03995-7

DOI

http://dx.doi.org/10.1007/s00384-021-03995-7

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1140280339

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/34368890


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22 schema:description PurposeThe aim of this phase II study was to evaluate the efficacy and safety of combination therapy with five-cycle CAPOX (capecitabine plus oxaliplatin) plus bevacizumab, followed by five-cycle maintenance therapy with capecitabine plus bevacizumab and reintroduction of CAPOX plus bevacizumab for five cycles, with a preplanned intermittent oxaliplatin strategy in metastatic colorectal cancer (mCRC).MethodsPatients with untreated mCRC were administered CAPOX (130 mg/m2 oxaliplatin on day 1, 2000 mg/m2/day capecitabine on days 1–14, every 21 days) + bevacizumab (7.5 mg/kg) every 3 weeks for five cycles, maintenance treatment without oxaliplatin for five cycles, and CAPOX + bevacizumab reintroduction for five cycles or upon tumor progression. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were the time to treatment failure (TTF), overall survival, response rate (RR), and safety.ResultsForty-seven patients who fulfilled the inclusion criteria were enrolled in the evaluation of efficacy and safety. Median PFS was 14.1 months (95% confidence interval [CI], 8.6–19.5), and median TTF was 12.3 months (95% CI, 10.3–14.3). The objective RRs were 51.1% (24/47) during induction therapy, 58.3% (21/36) during maintenance therapy, and 63.6% (14/22) during reintroduction therapy. The frequency of patients with neutropenia, diarrhea, peripheral sensory neuropathy, venous thromboembolism, or grade ≥ 3 allergic reactions was 2.1%.ConclusionCAPOX plus bevacizumab therapy with a preplanned intermittent oxaliplatin strategy consisting of brief five-cycle induction therapy, five-cycle maintenance therapy with capecitabine plus bevacizumab, and five-cycle reintroduction therapy consisting of CAPOX plus bevacizumab is safe and effective for mCRC patients.Trial registrationUMIN ID: 000,005,732, date of registration: June 7, 2011. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000006695
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28 schema:keywords CAPOX
29 CGI
30 II clinical study
31 II study
32 JP
33 MethodsPatients
34 ResultsForty-seven patients
35 aim
36 allergic reactions
37 bevacizumab
38 bevacizumab therapy
39 cancer
40 capecitabine
41 clinical studies
42 colorectal cancer
43 combination therapy
44 criteria
45 cycle
46 date
47 date of registration
48 diarrhea
49 efficacy
50 efficiency
51 endpoint
52 evaluation
53 evaluation of efficacy
54 failure
55 first-line therapy
56 frequency
57 frequency of patients
58 grade
59 inclusion criteria
60 induction therapy
61 mCRC patients
62 maintenance therapy
63 maintenance treatment
64 median TTF
65 median progression-free survival
66 metastatic colorectal cancer
67 months
68 multicenter phase II clinical study
69 neutropenia
70 objective response rate
71 overall survival
72 oxaliplatin
73 patients
74 peripheral sensory
75 phase II clinical study
76 phase II study
77 primary endpoint
78 progression
79 progression-free survival
80 rate
81 reaction
82 recptno
83 registration
84 reintroduction
85 response rate
86 safety
87 safety of capecitabine
88 secondary endpoints
89 sensory
90 strategies
91 study
92 survival
93 therapy
94 thromboembolism
95 time
96 treatment
97 treatment failure
98 tumor progression
99 untreated metastatic colorectal cancer
100 venous thromboembolism
101 weeks
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