Induction therapy with paclitaxel and bevacizumab followed by switch maintenance therapy with eribulin in Japanese patients with HER2-negative metastatic breast cancer: a multicenter, collaborative, open-label, phase II clinical study for the SBCCSG 35 investigators
To examine the efficacy and safety of induction therapy with paclitaxel and bevacizumab followed by switch maintenance therapy with eribulin (ISMT) in Japanese patients with HER2-negative metastatic breast cancer (MBC). Patients, who had previously undergone a maximum of 2 regimens of chemotherapy,...
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Published in | BMC cancer Vol. 18; no. 1; p. 671 |
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Main Authors | , , , , |
Format | Journal Article |
Language | English |
Published |
England
BioMed Central Ltd
20.06.2018
BioMed Central BMC |
Subjects | |
Online Access | Get full text |
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Summary: | To examine the efficacy and safety of induction therapy with paclitaxel and bevacizumab followed by switch maintenance therapy with eribulin (ISMT) in Japanese patients with HER2-negative metastatic breast cancer (MBC).
Patients, who had previously undergone a maximum of 2 regimens of chemotherapy, received 3 cycles of induction therapy with paclitaxel (90 mg/m
intravenously on days 1, 8, and 15 followed by 1-week drug holiday) and bevacizumab (10 mg/kg intravenously after the completion of paclitaxel administration on days 1 and 15). Patients who had complete response, partial response, or stable disease underwent switch maintenance therapy with eribulin (1.4 mg/m
intravenously on days 1 and 8 followed by 1-week drug holiday). The primary endpoint was time to treatment failure (TTF) for ISMT.
Fifty-one eligible patients (median age: 66 years; range: 35-74) were enrolled: 19 (37.3%) and 32 (62.7%) had stage IV and recurrence, respectively, 42 (82.4%) had visceral metastases, and 45 (88.2%) received eribulin-38 of whom showed disease progression, and 40 (78.4%) underwent post therapy. Median TTF was 9.2 months (95% confidence interval [CI]: 7.3-11.1), median progression-free survival was 10.7 months (95% CI: 9.6-11.8), and median overall survival was 20.0 months (95% CI: 16.0-24.0). Relative dose intensity was 97.7% (range: 33.3-100.0) for induction therapy and was 83.3% (range: 49.3-100.6%) for eribulin maintenance therapy. The most common adverse event was alopecia (51 [100%]) in induction therapy and was peripheral sensory neuropathy (37 [82.2%]) in eribulin maintenance therapy. Eribulin was effective with manageable tolerability.
ISMT may be a promising therapeutic option for patients with MBC.
UMIN000015971 . Registration date: January 1, 2015. |
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Bibliography: | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 |
ISSN: | 1471-2407 1471-2407 |
DOI: | 10.1186/s12885-018-4556-6 |