Cabazitaxel for metastatic castration-resistant prostate cancer: safety data from the Spanish expanded access program

Abstract

Cabazitaxel administration, in a real-world setting, is tolerated by Spanish patients with mCRPC, and the AEs are manageable.

Cabazitaxel in patients with metastatic castration‐resistant prostate cancer: safety and quality of life data from the Australian early access program

“…The incidence of grade ≥3 diarrhoea was low in our dataset (7.7%) and was similar to that in the TROPIC trial (6%) as well as other country's analyses (0.9%, 2.8%, 4.5%, 5.2% and 8.2% in the German, Italian, United Kingdom, Spanish and Canadian cohorts, respectively) . Diarrhoea, like neutropenia, requires patient education and proactive management .…”

“…The rate of grade ≥3 neutropenia was much lower in the Australian EAP than in the TROPIC trial (20.2% vs 82.0%) . Similarly low rates of grade ≥3 neutropenia have been reported in analyses of the safety results from individual countries involved in the worldwide EAP and compassionate‐use program (CUP); 7.2%, 9.8%, 16.3% and 33.9% in the German, UK, Spanish and Italian cohorts, respectively . The lower frequency of neutropenia in the real‐world setting is most likely explained by the implementation of risk mitigation strategies including careful patient selection, patient education and proactive management including the prophylactic administration of G‐CSF …”

Metastatic castration-resistant prostate cancer in very elderly patients: challenges and solutions

“…A number of early access programs (EAPs) involving 6.2%–26.8% of patients aged ≥75 years have demonstrated that cabazitaxel is well tolerated in a real-world setting 32–35. In an Italian EAP, G-CSF was more frequently used in older patients (66.8% vs 58.0%), but the hematological tolerability of cabazitaxel seemed to be similar regardless of age 34…”

Drug treatment opportunities of the elderly patients with the metastatic castration-resistant prostate cancer

“…Ряд программ раннего доступа (EAP) с участием 6,2-26,8 % пациентов в возрасте старше 75 лет пока-зал, что кабазитаксел хорошо переносится в реальной клинической практике [30][31][32]. В итальянской EAP у пожилых пациентов чаще использовали Г-КСФ по сравнению с молодыми (66,8 % против 58,0 %), но частота гематологических нежелательных явлений не зависела от возраста больных [16].…”