Cabazitaxel can now be used at a dose of 20 mg/m2 every 3 weeks in combination with prednisone in patients with metastatic castration-resistant prostate cancer who have received a docetaxel-based treatment regimen.
Cabazitaxel can now be used at a dose of 20 mg/m2 every 3 weeks in combination with prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received a docetaxel-based treatment regimen. The approval followed an FDA review of a post-marketing study to evaluate a lower dose of the drug against the 25 mg/m2 dose, which was approved for cabazitaxel in 2010.
The approval was based on data from a noninferiority, multicenter, randomized open-label trial (PROSELICA) of 1200 docetaxel-treated patients with mCRPC. Patients received either cabazitaxel 25 mg/m2 (n = 602) or the 20 mg/m2 (n = 598) dose.
The 2 doses were deemed at par in an intent-to-treat population: median overall survival (OS) was 13.4 months for patients administered 20 mg/m2 cabazitaxel, compared with 14.5 months for patients administered the higher dose (hazard ratio [HR], 1.024; 97.78% CI, 0.886-1.184). The estimated median OS was 15.1 and 15.9 months for the low and the high dose, respectively (HR, 1.042; 97.78% CI, 0.886-1.224).
The higher dose, however, yielded safety concerns at a higher frequency than the lower dose of cabazitaxel. Major safety findings included myelosuppression, infections, and increased toxicity:
Results from the FIRSTANA trial have also indicated that the lower dose is equally effective in ensuring survival and is relatively less toxic. The trial, results of which were published in the Journal of Clinical Oncology in July, evaluated the 2 doses of cabazitaxel in addition to 75 mg/m2 docetaxel in an mCRPC population, administered every 3 weeks along with daily prednisone. While the median OS was 24.5 months in the low-dose arm, it was 25.2 months in the high-dose arm. However, grade 3/4 adverse events were much different: 41.2% vs 60.1%, respectively.
Current management strategies for cabazitaxel-associated toxicities include:
Standard Criteria for Loss of Ambulation Needed in DMD
April 19th 2024A recent study suggests the differences between ambulation definitions for patients with Duchenne muscular dystrophy (DMD) can impact the identification of ambulant vs nonambulant individuals, and standard criteria across settings are needed.
Read More
Government agencies have created an online portal for the public to report potential anticompetitive practices in health care; there are changes coming to the “boxed warning” section for chimeric antigen receptor T-cell therapies (CAR T) to highlight T-cell blood cancer risk; questions about the safety of obesity medications during pregnancy have arisen in women on them who previously struggled with fertility issues.
Read More
Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
Listen
Gene, Light Therapy Combo Shows Promise Against Prostate Cancer Cells in Proof-of-Concept Study
April 18th 2024In their preclinical model, the researchers found efficacy both in vitro and in vivo by using CRISPR-Cas9 to mimic porphyria and combining the technology with light therapy.
Read More
Pegcetacoplan for PNH More Cost-Effective Than Anti-C5 Monoclonal Antibodies
April 18th 2024A cost-utility analysis conducted from the perspective of the Italian health system found that pegcetacoplan was more effective and less costly than 2 complement 5 (C5) inhibitors for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
Read More