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
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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