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
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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