Phase II, multicentre, randomised trial of eribulin plus gemcitabine versus paclitaxel plus gemcitabine as first-line chemotherapy in patients with HER2-negative metastatic breast cancer
Autor: | Seock-Ah Im, Se Hyun Kim, Tae Yong Kim, Ki Hyeong Lee, Soo Jung Lee, Ji-Yeon Kim, Young-Hyuck Im, Yeon Hee Park, Jee Hyun Kim, Kyung Hae Jung, Hye Sook Han, Sung-Bae Kim, Joohyuk Sohn, In Hae Park, Kyung-Hun Lee, Keun Seok Lee, Yee Soo Chae, Jin-Hee Ahn, Gun Min Kim |
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Rok vydání: | 2017 |
Předmět: |
0301 basic medicine
Eribulin Mesylate Oncology Adult Cancer Research medicine.medical_specialty Time Factors Paclitaxel Receptor ErbB-2 medicine.medical_treatment Breast Neoplasms Kaplan-Meier Estimate Deoxycytidine Disease-Free Survival 03 medical and health sciences chemistry.chemical_compound Young Adult 0302 clinical medicine Internal medicine Antineoplastic Combined Chemotherapy Protocols Republic of Korea Biomarkers Tumor Medicine Humans Prospective Studies Neoplasm Metastasis Furans Aged Proportional Hazards Models Chemotherapy Taxane business.industry Combination chemotherapy Ketones Middle Aged medicine.disease Metastatic breast cancer Gemcitabine Regimen 030104 developmental biology Treatment Outcome chemistry 030220 oncology & carcinogenesis Female business medicine.drug Eribulin |
Zdroj: | European journal of cancer (Oxford, England : 1990). 86 |
ISSN: | 1879-0852 |
Popis: | Background Paclitaxel plus gemcitabine (PG) combination chemotherapy is a preferred chemotherapeutic regimen for patients with metastatic breast cancer (MBC). Eribulin mesylate is a halichondrin non-taxane inhibitor of microtubule dynamics. A recent pooled analysis with eribulin showed improved overall survival (OS) in various MBC patient subgroups pretreated with anthracycline and taxane. Furthermore, eribulin may have less neurotoxicity than paclitaxel. Patients and methods This study was a prospective randomised phase II, open-label, two-arm, multicentre study comparing eribulin plus gemcitabine (EG) with PG chemotherapy as a first-line treatment for patients with human epidermal growth factor receptor 2-negative MBC. We hypothesised that EG chemotherapy would not be inferior to PG chemotherapy. The primary end-point was progression-free survival (PFS), which was estimated to be 70% at 6 months for each arm. The secondary end-points were as follows: OS, neuropathic scale, toxicity and clinical benefit rate. Results A total of 118 patients (median age: 50, 24–66) were enrolled between March 2015 and March 2016 and were randomly assigned to PG (n = 59) or EG (n = 59) chemotherapy. The mean number of metastatic sites was 3 (range 1–8). The 6-month PFS rates for both arms were 72% for EG and 73% for PG (P = 0.457). There was no significant difference in OS between the two groups (not reached versus 21.2 months, P = 0.2234). The median number of chemotherapy cycles for both groups was 10 for EG and 8 for PG (range 2–32). Clinical benefit rates were 44% for EG and 49% for PG. Major toxicities were neutropenia and neurotoxicity. Grade II or above neurotoxicity was more common with PG than with EG (13.6% for EG versus 45.8% for PG, P Conclusion EG chemotherapy had similar clinical benefits to PG chemotherapy in terms of PFS but less neurotoxicity. Trial registration KCSG BR13-11; ClinicalTrials.gov , NCT02263495. |
Databáze: | OpenAIRE |
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