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

• Published in: BMC cancer Vol. 18; no. 1; p. 671
• Main Authors: Inoue, Kenichi, Ninomiya, Jun, Saito, Tsuyoshi, Kimizuka, Kei, Kurosumi, Masafumi
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 20.06.2018; BioMed Central; BMC
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Asian People; Bevacizumab; Bevacizumab - administration & dosage; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - mortality; Cancer therapies; Chemotherapy; Collaboration; Diagnosis; Dosage and administration; Drug dosages; Drug therapy; ErbB-2 protein; Eribulin; Female; Furans - therapeutic use; Health aspects; Humans; Immunotherapy; Induction Chemotherapy - methods; Induction therapy; Japanese; Kaplan-Meier Estimate; Ketones - therapeutic use; Lung cancer; Maintenance Chemotherapy - methods; Metastases; Metastasis; Metastatic breast cancer; Middle Aged; Monoclonal antibodies; Oncology; Paclitaxel; Paclitaxel - administration & dosage; Peripheral neuropathy; Switch maintenance therapy; Systematic review; Targeted cancer therapy; Treatment Outcome; Switch maintenance therapy; Metastatic breast cancer; Eribulin; Metastasis; Paclitaxel; Bevacizumab
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-018-4556-6

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.