Phase I dose-finding study of eribulin and capecitabine for metastatic breast cancer: JBCRG-18 cape study
Autor: | Norikazu Masuda, Hiroyuki Yasojima, Hiroji Iwata, Masaya Hattori, Satoshi Morita, Shinji Ohno, Akiyo Yoshimura, Hiroshi Ishiguro, Shoichiro Ohtani |
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Rok vydání: | 2017 |
Předmět: |
Adult
0301 basic medicine Oncology medicine.medical_specialty Maximum Tolerated Dose Anthracycline Breast Neoplasms Capecitabine 03 medical and health sciences chemistry.chemical_compound Dose finding 0302 clinical medicine Breast cancer Surgical oncology Internal medicine Antineoplastic Combined Chemotherapy Protocols polycyclic compounds medicine Humans Neoplasm Invasiveness Pharmacology (medical) Radiology Nuclear Medicine and imaging Neoplasm Metastasis Furans skin and connective tissue diseases neoplasms Taxane Dose-Response Relationship Drug business.industry Correction General Medicine Ketones Middle Aged Prognosis bacterial infections and mycoses medicine.disease Metastatic breast cancer Survival Rate 030104 developmental biology chemistry 030220 oncology & carcinogenesis bacteria Female business Follow-Up Studies Eribulin medicine.drug |
Zdroj: | Breast Cancer (Tokyo, Japan) |
ISSN: | 1880-4233 1340-6868 |
Popis: | Eribulin is a nontaxane microtubule inhibitor with activity in patients with metastatic breast cancer (MBC). We conducted a phase I dose-finding study of eribulin and capecitabine in patients with MBC pretreated with anthracycline and taxane.Women with MBC aged ≤70 years were enrolled. A 3 + 3 dose escalation design was used: level 0 dosing, eribulin (1.4 mg/mNine women with MBC were enrolled; six at level 0, three at level 1. One patient had grade 4 DLTs at level 0 (serum creatinine 7.65 mg/dL and uric acid 13.4 mg/dL), considered associated with study drugs. Level 1 dosing was taken as the RD. Neutropenia was the most common ≥grade 3 toxicity. Pharmacokinetic parameters of eribulin were not influenced by co-administration of capecitabine. Of three patients in level 1, one achieved partial response and one had prolonged stable disease.Eribulin with capecitabine in the level 1 dosing schedule was associated with manageable toxicities and promising clinical activity. This combination is recommended for phase II investigation. |
Databáze: | OpenAIRE |
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