title: Safety and efficacy of 2-weekly cabazitaxel in metastatic castration-resistant prostate cancer.
abstract: To evaluate the safety and efficacy of a 2-weekly cabazitaxel schedule in patients with metastatic castration-resistant prostate cancer (mCRPC).
  
  
  
  During the period October 2013 to February 2016, 43 patients with mCRPC were treated with cabazitaxel (16 mg/m2, on days 1 and 15 of a 4-week cycle) together with prophylactic granulocyte colony-stimulating factor (G-CSF). The safety profile and efficacy (prostate-specific antigen [PSA] response; biological, clinical or radiological progression-free survival [PFS] and overall survival [OS]) of the treatment were analysed.
  
  
  
  All patients had received prior docetaxel and 79.1% abiraterone acetate. At inclusion, 46.5% were aged >70 years and 27.9% had an Eastern Cooperative Oncology Group performance status ≥2. Six patients stopped treatment because of toxicity. Grade ≥3 toxicities were: asthenia (16.3%); neutropenia (11.6%); thrombocytopenia (9.3%); diarrhoea (7%), anaemia (4.7%), febrile neutropenia (4.7%) and haematuria (2.3%). In all, 52.4% achieved a ≥30% PSA response and 40.5% had a ≥50% PSA response. The median OS was 15.2 months.
  
  
  
  This prospective pilot study suggests that cabazitaxel 16 mg/m² given 2-weekly has a manageable toxicity profile in docetaxel- and abiraterone acetate-pretreated patients with mCRPC. A prospective phase III trial comparing this regimen with the standard cabazitaxel regimen is planned to confirm these results.
authors.affiliation: Department of Medical Oncology, Hôpital Européen Georges Pompidou, Paris, France.
authors.forename: Alice
authors.identifier: 0000-0002-3990-2576
authors.initials: A
authors.lastname: Clément-Zhao
authors.affiliation: Department of Medical Oncology, Hôpital Européen Georges Pompidou, Paris, France.
authors.forename: Marie
authors.initials: M
authors.lastname: Auvray
authors.affiliation: Pharmacy Department, Hôpital Européen Georges Pompidou, Paris, France.
authors.forename: Hail
authors.initials: H
authors.lastname: Aboudagga
authors.affiliation: Department of Medical Oncology, Hôpital Européen Georges Pompidou, Paris, France.
authors.forename: Félix
authors.initials: F
authors.lastname: Blanc-Durand
authors.affiliation: Department of Medical Oncology, Hôpital Européen Georges Pompidou, Paris, France.
authors.forename: Antoine
authors.initials: A
authors.lastname: Angelergues
authors.affiliation: Department of Medical Oncology, Hôpital Européen Georges Pompidou, Paris, France.
authors.forename: Yann Alexandre
authors.initials: YA
authors.lastname: Vano
authors.affiliation: Stat Process Society, Port-Mort, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Mercier
authors.affiliation: Department of Medical Oncology, Hôpital Européen Georges Pompidou, Paris, France.
authors.forename: Nader
authors.initials: N
authors.lastname: El Awadly
authors.affiliation: Department of Medical Oncology, Hôpital Européen Georges Pompidou, Paris, France.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Verret
authors.affiliation: Department of Medical Oncology, Hôpital Européen Georges Pompidou, Paris, France.
authors.forename: Constance
authors.initials: C
authors.lastname: Thibault
authors.affiliation: Department of Medical Oncology, Hôpital Européen Georges Pompidou, Paris, France.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Oudard
mesh_terms: D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001247:Asthenia / Q000139:chemically induced; D064146:Chemotherapy-Induced Febrile Neutropenia / Q000209:etiology; D003967:Diarrhea / Q000139:chemically induced; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006417:Hematuria / Q000139:chemically induced; D006801:Humans; D008297:Male; D009362:Neoplasm Metastasis; D010865:Pilot Projects; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects*; D013921:Thrombocytopenia / Q000139:chemically induced
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; C552428:cabazitaxel; D017430:Prostate-Specific Antigen
keywords: #ProstateCancer; cabazitaxel; metastatic castration-resistant prostate cancer; schedule; toxicity