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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/m2 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/m2, 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.
Acknowledgements
The physicians listed below cared for the patients in this study. The authors thank them for their cooperation and support: A. Garcia Palomo. Hospital General de Leon, León; JA Arranz. Hospital General Universitario Gregorio Marañón, Madrid; M Doménech. Hospital Sant Joan de Déu, Althaia, Barcelona; JL González Larriba. Hospital Clínico San Carlos, Madrid; R López. Hospital Clínico Universitario Santiago, Santiago de Compostela; B. Mellado. Hospital Clínic Barcelona, Barcelona; A. Antón Torres. Hospital Universitario Miguel Servet, Zaragoza, Spain; R. Bastús. Mutua de Terrassa Barcelona, Spain; J. Cassinello. Hospital General de Guadalajara, Guadalajara; MA. Climent Duran. Instituto Valenciano de Oncología, Valencia; O. Juan. Hospital Arnau Vilanova, Valencia; M. López Brea. Hospital Marqués de Valdecilla, Santander; A Montesa. Hospital Carlos Haya Málaga; JL Pérez Gracia Clínica Universitaria de Navarra. Pamplona; F. Vázquez. H. Univ. Elche Alicante. The Study has been presented as Poster (P402.No. 2.895) at the European Cancer Conference 2013 (17th ECCO – 38th ESMO – 32nd ESTRO) held from 27 September - 1 October 2013 in Amsterdam, Netherlands; and as an Oral communication (#CO-16) at the XIV SEOM National Congress held from 23 to 25 October 2013 in Salamanca, Spain.