Phase 1 Dose-Escalation Study of Triweekly Nab-Paclitaxel Combined With S-1 for HER2-Negative Metastatic Breast Cancer
| Autor: | Hiroaki Toba, Hirokazu Takechi, Mariko Aoyama, Takahiro Yoshida, Masami Morimoto, Akira Tangoku, Misako Nakagawa |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Oncology Adult Cancer Research medicine.medical_specialty Combination therapy Maximum Tolerated Dose Paclitaxel Receptor ErbB-2 Administration Oral Breast Neoplasms Drug Administration Schedule 03 medical and health sciences 0302 clinical medicine Breast cancer Internal medicine Albumins Antineoplastic Combined Chemotherapy Protocols medicine Dose escalation Humans Aged Tegafur Response rate (survey) business.industry Combination chemotherapy Middle Aged medicine.disease Metastatic breast cancer Drug Combinations Oxonic Acid 030104 developmental biology 030220 oncology & carcinogenesis Toxicity Feasibility Studies Female business Febrile neutropenia |
| Zdroj: | Clinical breast cancer. 20(6) |
| ISSN: | 1938-0666 |
| Popis: | Purpose To evaluate the efficacy, toxicity, maximum tolerated dose, and recommended dose of triweekly nab-paclitaxel (nab-PTX) and S-1 combination chemotherapy for patients with metastatic breast cancer. Patients and Methods This phase 1 study was conducted with a standard 3 + 3 dose escalation design. Every 3 weeks, the patients received nab-PTX at 180-260 mg/m2 on day 1 and S-1 at 65-80 mg/m2 daily on days 1 to 14. Results Ten HER2-negative metastatic breast cancer patients were enrolled; their median number of prior chemotherapy regimens was 3. Dose-limiting toxicity was observed in the first patient assigned to level 4; grade 4 febrile neutropenia and grade 3 neurotoxicity such as needing a wheelchair occurred. Therefore, an additional patient was not assigned to level 4. The maximum tolerated dose was considered level 4 (260 mg/m2 nab-PTX with 80 mg/m2 S-1). The recommended dose determined was level 3 (220 mg/m2 nab-PTX with 80 mg/m2 S-1). The response rate was 60.0%. The disease control rate was 70.0%. Conclusion This combination chemotherapy therapy was feasible and safe for patients with HER2-negative metastatic breast cancer. |
| Databáze: | OpenAIRE |
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