Cabazitaxel for metastatic castration-resistant prostate cancer: safety data from the Spanish expanded access program. (September 2014)

• Record Type: Journal Article
• Authors: Castellano, Daniel; Antón Aparicio, Luis M; Esteban, Emilio; Sánchez-Hernández, Alfredo; Germà, Jose Ramón; Batista, Norberto; Maroto, Pablo; Pérez-Valderrama, Begoña; Luque, Raquel; Méndez-Vidal, María José
• Is Part Of: Expert opinion on drug safety. Volume 13:Number 9(2014)
• Page Start: 1165
• Page End: 1173
• Publication Date: 2014-09
• Subjects: Drugs -- Side effects -- Periodicals; Drugs -- Toxicology -- Periodicals; Chemotherapy -- Periodicals; 615.704
• DOI: 10.1517/14740338.2014.939583
• Languages: English
• ISSNs: 1474-0338

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <p> <bold> <italic>Background:</italic> </bold> Based on the TROPIC study results, cabazitaxel was approved for the management of metastatic castration-resistant prostate cancer (mCRPC) progressing on or after docetaxel.</p> <p> <bold> <italic>Methods:</italic> </bold> 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<sup>2</sup> i.v. Q3W, plus oral prednisone/prednisolone 10 mg daily, are reported.</p> <p> <bold> <italic>Results:</italic> </bold> 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<sup>2</sup>, 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.</p> <p> <bold> <italic>Conclusions:</italic> </bold> Cabazitaxel administration, in a real-world setting, is tolerated by Spanish patients with mCRPC, and the AEs are manageable.</p> </abstract>