Real-world efficacy and safety of two doses of cabazitaxel (20 or 25 mg/m


Journal

BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800

Informations de publication

Date de publication:
13 Jul 2020
Historique:
received: 12 03 2020
accepted: 02 07 2020
entrez: 15 7 2020
pubmed: 15 7 2020
medline: 28 1 2021
Statut: epublish

Résumé

The recommended starting dose of cabazitaxel for castration-resistant prostate cancer (CRPC) is 25 mg/m We compared the safety and efficacy of cabazitaxel between patients who received cabazitaxel at starting doses of 25 and 20 mg/m The C20 and C25 groups comprised 190 and 159 patients without matching and 112 patients per group after matching. In unmatched patients, any-grade (C25 vs C20: 89.3% vs 78.4%, Fisher's p < 0.01) and grade ≥ 3 (81.1% vs 61.1%) ADRs were more frequent in the C25 group. Neutropenia (any grade: 61.6% vs 54.2%; grade ≥ 3: 55.3% vs 42.6%) and febrile neutropenia (grade ≥ 3: 30.2% vs 14.7%) were more frequent in the C25 group. In matched patients, the PSA response rate (reduction in PSA ≥30% from a baseline ≥5 ng/mL) was 26.4 and 32.0% in the C20 and C25 groups, respectively, median OS was 291 days (95% CI 230-not reached) versus not reached (hazard ratio 0.73, 95% CI 0.50-1.08), and TTF favored C25 (hazard ratio 0.75, 95% CI 0.57-0.99). Clinicians should consider the patient's risk of clinically significant ADRs and prophylactic granulocyte colony stimulating factor when selecting the starting dose of cabazitaxel for CRPC. Some patients at high risk of ADRs or unfit patients may benefit from a lower starting dose of 20 mg/m Not applicable.

Sections du résumé

BACKGROUND BACKGROUND
The recommended starting dose of cabazitaxel for castration-resistant prostate cancer (CRPC) is 25 mg/m
METHODS METHODS
We compared the safety and efficacy of cabazitaxel between patients who received cabazitaxel at starting doses of 25 and 20 mg/m
RESULTS RESULTS
The C20 and C25 groups comprised 190 and 159 patients without matching and 112 patients per group after matching. In unmatched patients, any-grade (C25 vs C20: 89.3% vs 78.4%, Fisher's p < 0.01) and grade ≥ 3 (81.1% vs 61.1%) ADRs were more frequent in the C25 group. Neutropenia (any grade: 61.6% vs 54.2%; grade ≥ 3: 55.3% vs 42.6%) and febrile neutropenia (grade ≥ 3: 30.2% vs 14.7%) were more frequent in the C25 group. In matched patients, the PSA response rate (reduction in PSA ≥30% from a baseline ≥5 ng/mL) was 26.4 and 32.0% in the C20 and C25 groups, respectively, median OS was 291 days (95% CI 230-not reached) versus not reached (hazard ratio 0.73, 95% CI 0.50-1.08), and TTF favored C25 (hazard ratio 0.75, 95% CI 0.57-0.99).
CONCLUSIONS CONCLUSIONS
Clinicians should consider the patient's risk of clinically significant ADRs and prophylactic granulocyte colony stimulating factor when selecting the starting dose of cabazitaxel for CRPC. Some patients at high risk of ADRs or unfit patients may benefit from a lower starting dose of 20 mg/m
TRIAL REGISTRATION BACKGROUND
Not applicable.

Identifiants

pubmed: 32660451
doi: 10.1186/s12885-020-07131-6
pii: 10.1186/s12885-020-07131-6
pmc: PMC7359263
doi:

Substances chimiques

Taxoids 0
cabazitaxel 51F690397J

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

649

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Auteurs

Hideyasu Matsuyama (H)

Department of Urology, Graduate School of Medicine, Yamaguchi University, Yamaguchi, Japan. hidde@yamaguchi-u.ac.jp.

Nobuaki Matsubara (N)

Department of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

Hirotaka Kazama (H)

Sanofi Genzyme Oncology Medical, Sanofi K.K., Tokyo, Japan.

Takeshi Seto (T)

Medical Affairs, Sanofi K.K., Tokyo, Japan.

Shoko Tsukube (S)

Sanofi Genzyme Oncology Medical, Sanofi K.K., Tokyo, Japan.
Medical Affairs, Sanofi K.K., Tokyo, Japan.

Kazuhiro Suzuki (K)

Department of Urology, Gunma University Graduate School of Medicine, Maebashi, Japan.

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Classifications MeSH