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
Abstract Background 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). Methods Patients, who had previously undergone a maximum of...
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| Format: | Article |
| Language: | English |
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BMC
2018-06-01
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| Series: | BMC Cancer |
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| Online Access: | http://link.springer.com/article/10.1186/s12885-018-4556-6 |
| _version_ | 1819103410380603392 |
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| author | Kenichi Inoue Jun Ninomiya Tsuyoshi Saito Kei Kimizuka Masafumi Kurosumi |
| author_facet | Kenichi Inoue Jun Ninomiya Tsuyoshi Saito Kei Kimizuka Masafumi Kurosumi |
| author_sort | Kenichi Inoue |
| collection | DOAJ |
| description | Abstract Background 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). Methods Patients, who had previously undergone a maximum of 2 regimens of chemotherapy, received 3 cycles of induction therapy with paclitaxel (90 mg/m2 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/m2 intravenously on days 1 and 8 followed by 1-week drug holiday). The primary endpoint was time to treatment failure (TTF) for ISMT. Results 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. Conclusions ISMT may be a promising therapeutic option for patients with MBC. Trial registration UMIN000015971. Registration date: January 1, 2015. |
| first_indexed | 2024-12-22T01:50:01Z |
| format | Article |
| id | doaj.art-6f69a6a4de23498b91dd4a4577d0b1f8 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-22T01:50:01Z |
| publishDate | 2018-06-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-6f69a6a4de23498b91dd4a4577d0b1f82022-12-21T18:42:57ZengBMCBMC Cancer1471-24072018-06-0118111110.1186/s12885-018-4556-6Induction 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 investigatorsKenichi Inoue0Jun Ninomiya1Tsuyoshi Saito2Kei Kimizuka3Masafumi Kurosumi4Division of Breast Oncology, Saitama Cancer CenterDepartment of Breast Surgery, Ninomiya HospitalDepartment of Breast Surgery, Japanese Red Cross Saitama HospitalDepartment of Breast Surgery, Kasukabe Medical CenterDepartment of Pathology, Saitama Cancer CenterAbstract Background 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). Methods Patients, who had previously undergone a maximum of 2 regimens of chemotherapy, received 3 cycles of induction therapy with paclitaxel (90 mg/m2 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/m2 intravenously on days 1 and 8 followed by 1-week drug holiday). The primary endpoint was time to treatment failure (TTF) for ISMT. Results 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. Conclusions ISMT may be a promising therapeutic option for patients with MBC. Trial registration UMIN000015971. Registration date: January 1, 2015.http://link.springer.com/article/10.1186/s12885-018-4556-6Metastatic breast cancerEribulinPaclitaxelBevacizumabSwitch maintenance therapyMetastasis |
| spellingShingle | Kenichi Inoue Jun Ninomiya Tsuyoshi Saito Kei Kimizuka Masafumi Kurosumi 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 BMC Cancer Metastatic breast cancer Eribulin Paclitaxel Bevacizumab Switch maintenance therapy Metastasis |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Metastatic breast cancer Eribulin Paclitaxel Bevacizumab Switch maintenance therapy Metastasis |
| url | http://link.springer.com/article/10.1186/s12885-018-4556-6 |
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