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A phase 1, dose-finding and pharmacokinetic study of gemcitabine with nab-paclitaxel in patients with metastatic breast cancer
- Source :
- Cancer Chemotherapy and Pharmacology. 78:289-294
- Publication Year :
- 2016
- Publisher :
- Springer Science and Business Media LLC, 2016.
-
Abstract
- Gemcitabine (Gem) with paclitaxel (Pac) is used for patients with metastatic breast cancer who require cytoreduction with manageable toxicities. Nanoparticle albumin-bound (nab)-Pac exhibits better efficacy and reduces the risk of hypersensitivity reactions associated with solvent-based Pac. Therefore, Gem plus nab-Pac (GA) therapy may be effective for metastatic breast cancer. The purpose of this study was to determine the maximum tolerated dose for GA therapy.The subjects were patients with metastatic breast cancer with performance status 0 or 1 and normal hepatic, renal and marrow function. Leukopenia, neutropenia or thrombocytopenia of grade 4, neutropenic fever, or non-hematological toxicity of grade 3 or higher during the 1st cycle, and chemotherapy-induced peripheral neurotoxicity of grade 2 or higher at the end of the 1st cycle were defined as dose-limiting toxicities (DLTs). Gem (1250 mg/m(2)) was administered on days 1 and 8. nab-Pac was administered at a starting dose of 180 mg/m(2) (cohort 1) and escalated to 220 mg/m(2) (cohort 2) and 260 mg/m(2) (cohort 3) on day 1 of the 21-day cycle, using a 3 + 3 design.Nine patients (n = 3, 3, and 3 in cohorts 1, 2, and 3, respectively) were included in the study (median age 56 years; range 43-75 years). DLTs did not occur in any cohorts.The initial recommend dose in GA therapy is 1250 mg/m(2) Gem and 260 mg/m(2) nab-Pac. It is well known that nab-Pac has cumulative toxicities, and thus the efficacy and safety of GA therapy require validation in a phase 2 study.
- Subjects :
- Adult
0301 basic medicine
Oncology
Cancer Research
medicine.medical_specialty
Maximum Tolerated Dose
Paclitaxel
endocrine system diseases
education
Breast Neoplasms
Toxicology
Deoxycytidine
03 medical and health sciences
chemistry.chemical_compound
Dose finding
0302 clinical medicine
Pharmacokinetics
Albumins
health services administration
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Pharmacology (medical)
In patient
Neoplasm Metastasis
Aged
Pharmacology
Dose-Response Relationship, Drug
business.industry
food and beverages
Middle Aged
medicine.disease
Gemcitabine
Metastatic breast cancer
humanities
030104 developmental biology
chemistry
030220 oncology & carcinogenesis
Maximum tolerated dose
Female
business
medicine.drug
Subjects
Details
- ISSN :
- 14320843 and 03445704
- Volume :
- 78
- Database :
- OpenAIRE
- Journal :
- Cancer Chemotherapy and Pharmacology
- Accession number :
- edsair.doi.dedup.....3b16b3c8d26ffbf2934c20ed8bebfc60