948 - Analysis of the USA postmarketing safety profile of cabazitaxel in the treatment of metastatic castrate-resistant prostate cancer (mCRPC) previously...

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anti-Cancer Agents & Biologic Therapy
Prostate Cancer
Presenter Leonardo Nicacio
Authors L. Nicacio1, P. Raina2, R. Sands3, S. Neibart4
  • 1Us Medical Affairs Oncology, sanofi-aventis U.S. LLC, Inc., A SANOFI COMPANY, 08807 - Bridgewater/US
  • 2Us Pharmacovigilance, sanofi-aventis U.S. LLC, Inc., A SANOFI COMPANY, 07830 - Bridgewater/US
  • 3Global Oncology, sanofi-aventis U.S. LLC, Inc., A SANOFI COMPANY, 02142 - Cambridge/US
  • 4Global Pharmacovigilance, sanofi-aventis U.S. LLC, Inc., A SANOFI COMPANY, 08807 - Bridgewater/US

Abstract

Background

Cabazitaxel (Jevtana®) in combination with prednisone was licensed in the United States (USA) in June 2010 for the treatment of mCRPC in patients (pts) previously treated with a docetaxel-containing treatment regimen. We estimate that over 13,000 patients have since been treated in the US. This research analyzes the post-marketing safety profile of cabazitaxel based on spontaneously reported pharmacovigilance (PV) Adverse Events (AEs) in the USA. As such reports depend on voluntary reporting, only a qualitative comparison to the safety profile observed in the clinical trial setting is possible.

Methods

Safety information spontaneously reported to Sanofi US PV from June 17, 2010 - March 31, 2012 was reviewed. The most frequently reported AEs are presented, using MedDRA preferred terms and compared with the safety profile observed in clinical trials.

Results

A total of 692 spontaneously reported AEs were received for 373 US men in the time period indicated, 312 (45%) serious (SAEs) and 380 (55%) non-serious. The pts were 45 to 88 years old (mean ± SD: 68.6 ± 12) and virtually all with mCRPC. The most frequently reported hematologic AEs were neutropenia [n = 27; 16 SAEs], febrile neutropenia [n = 18; 17 SAEs], anemia [n = 9; 4 SAEs] and thrombocytopenia [n = 7; 3 SAEs]. The most frequently reported non-hematologic AEs included diarrhea [n = 32; 8 SAEs], fatigue [n = 28; 1 SAEs], hematuria [n = 15; 5 SAEs], nausea [n = 14; 1 SAEs], vomiting [n = 9; 2 SAEs] and pyrexia [n = 3; 0 SAEs]. Concomitant therapies and co-morbidities were associated with most of the cases. Disease progression was reported as an event in 68 pts with 38 pts reporting increased PSA levels. A total of 57 deaths were reported: 9 due to disease progression; 3 pulmonary embolism; 2 chronic obstructive pulmonary disease; 2 febrile neutropenia; 2 sepsis; 2 septic shock; 12 other causes; and, 25 cause not specified.

Conclusion

Although subject to the limitations of the post-marketing voluntary adverse event reporting system, the emerging safety profile of Jevtana is consistent with that observed in the clinical trial setting.

Disclosure

L. Nicacio: I am an employee of Sanofi and own Sanofi stock.

P. Raina: I am an employee of Sanofi and own Sanofi stock.

R. Sands: I am an employee of Sanofi and own Sanofi stock.

S. Neibart: I am an employee of Sanofi and own Sanofi stock.