دورية أكاديمية
Cabazitaxel for metastatic castration-resistant prostate cancer: safety data from the Spanish expanded access program
| العنوان: | Cabazitaxel for metastatic castration-resistant prostate cancer: safety data from the Spanish expanded access program |
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| المؤلفون: | Castellano, Daniel, Antón-Aparicio, Luis M., Esteban, Emilio, Sánchez-Hernández, Alfredo, Germá, José Ramón, Batista, Norberto, Maroto, Pablo, Pérez-Valderrama, Begoña, Luque, Raquel, Méndez-Vidal, María José |
| بيانات النشر: | Taylor & Francis |
| سنة النشر: | 2014 |
| المجموعة: | RUC - Repositorio Universidade Coruña |
| مصطلحات موضوعية: | Cabazitaxel, Compassionate use studies, Docetaxel, Prostatic neoplasms, Safety |
| الوصف: | [Abstract] BACKGROUND: Based on the TROPIC study results, cabazitaxel was approved for the management of metastatic castration-resistant prostate cancer (mCRPC) progressing on or after docetaxel. METHODS: This multi-centre program provided early access to cabazitaxel to patients with mCRPC before its commercialization. Safety data from 153 Spanish patients receiving cabazitaxel 25 mg/m(2) i.v. Q3W, plus oral prednisone/prednisolone 10 mg daily, are reported. RESULTS: Median age of patients was 70 years (26.8% ≥ 75 years), 94.1 and 26.8% had bone and visceral metastasis, respectively. Most had an Eastern Cooperative Oncology Group ≤ 1 (88.9%) and had received a median of 8.0 cycles of last docetaxel treatment. The median of cabazitaxel cycles and cumulative dose were 6.0 (Interquartile range [IQR]: 4.0; 8.0) and 148.9 (IQR: 98.2; 201.4) mg/m(2), respectively. Adverse events (AEs) possibly related to cabazitaxel occurred in 143 (93.5%) patients. The most frequent grade ≥ 3 AEs were neutropenia (n = 25, 16.3%) and asthenia (n = 17, 11.1%). Febrile neutropenia and grade ≥ 3 diarrhea occurred in 5.2% of the patients each. There were five (3.3%) possibly treatment-related deaths, mainly infection-related. G-CSFs were used in 114 (74.5%) patients, generally as prophylaxis (n = 107; 69.9%). Grade ≥ 3 peripheral neuropathy and nail disorders were uncommon. CONCLUSIONS: Cabazitaxel administration, in a real-world setting, is tolerated by Spanish patients with mCRPC, and the AEs are manageable. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 1474-0338 |
| العلاقة: | https://doi.org/10.1517/14740338.2014.939583Test; Castellano D, Antón Aparicio LM, Sánchez Hernández A, et al. Cabazitaxel for metastatic castration-resistant prostate cancer: safety data from the Spanish expanded access program. Expert Opin Drug Saf. 2014; 13(9): 1165-1173; http://hdl.handle.net/2183/21608Test |
| الإتاحة: | https://doi.org/10.1517/14740338.2014.939583Test http://hdl.handle.net/2183/21608Test |
| حقوق: | Thsi is an accepted manuscript of an article published by Taylor & Francis in Expert Opinion on Drug Safety, avaliable online at Taylor & Francis Online. ; info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.98C39BF2 |
| قاعدة البيانات: | BASE |
| تدمد: | 14740338 |
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