This study aimed to evaluate the effectiveness of granulocyte colony-stimulating factor (G-CSF) and ciprofloxacin in the prophylaxis of hematological complications in mCRPC patients treated with cabazitaxel after docetaxel failure and at risk for neutropenia.
Phase IV, non-randomized, open-label, single-arm interventional study, with men aged ≥65 years (or 12 weeks, that provided informed consent. Cabazitaxel 25 mg/m2 was given with prednisone on day1 every 21 days. G-CSF was administered on days 2 to 8 of each cycle or until ANC >2,000/mm3 and ciprofloxacin 1000mg on days 5 to 12. Primary endpoint was the rate of neutropenia grade ≥3 during the first cycle; secondary endpoints were the rate of neutropenia grade ≥3, febrile neutropenia, diarrhea grade ≥3, PSA response and quality of life (FACT-P) during treatment. Statistical significance was set at 0.05 and 95% confidence intervals were determined.
46 patients with median age 71.5 years (mean: 71.8 years) and 69.0 months on median since diagnosis (mean: 75.2 months) of prostatic cancer were included. Among the 45 treated patients, exposed to a median of 9.0 cycles (mean: 9.5 cycles) during 210 days, 40.0% (95% CI, 25.7%-54.3%) presented one episode of neutropenia grade ≥3 during the first cycle. During treatment, 42.2% patients presented at least one neutropenia grade ≥3; febrile neutropenia occurred in one patient (2.2%) as well as diarrhea grade ≥3. Twenty-nine patients (64.4%) achieved PSA response and 77.2% improved FACT-P score in at least one visit. Three patients (6.7%) had a serious TEAEs leading to death (none related to treatment), and 13.3% had 7 TEAEs leading to treatment discontinuation (3 related to treatment).
Prophylactic G-CSF and ciprofloxacin was effective in the prevention of neutropenia grade ≥3 and other hematological complications during the mCRPC treatment with cabazitaxel 25 mg/m2 in patients who were at risk for neutropenia.
Clinical trial identification
NCT01649635 - Global Statitic Report: January 26th 2017.
Legal entity responsible for the study
F.C. Maluf: Speaker at Sanofi-Aventis, Janssen, Bayer, AstraZeneca, Astellas, Ferring, Ache. Clinical trial investigator at Sanofi-Aventis, GSK, Janssen, Astellas, Bayer. Member of advisory board at Sanofi-Aventis, Janssen, Bayer, Astellas. F.A.M. de Oliveira: Speaker at Janssen. P.E.R. Liedke: Grants from Roche, Pfizer, Sanofi. L. Brust: Advisory Board Boheringer, Janssen, Agendia. F.S.M. Monteiro: Speaker at Sanofi, BMS, Pfizer, Janssen, Astellas e Merck Serono. Advisory Board at Janssen. Chair LACOG GU (Latin America Cooperative Oncology Group - Genito–Urinary Tumors). All other authors have declared no conflicts of interest.