PREDICT (Patient characteristics in Renal cell carcinoma and Daily practice Treatment with Nexavar) global non-interventional study: first interim results

Konference: 2009 34st Congress ESMO a 15th Congress ECCO - účast ČR

Kategorie: Genitourinární nádory

Téma: Poster session II: Genitourinary malignancies - Renal cancer

Číslo abstraktu: P-7128

Autoři: Prof. Dr. Dirk Jäger; J.H. Ma; MD Ernesto Korbenfeld; Doc. MUDr. Milada Zemanová, Ph.D.; Nicolai Leonhartsberger; Kathrin Stauch; A. Bockenhoff; J. Yu; MD Bernard J. Escudier

Background: Sorafenib was shown to be effective for the treatment of metastatic renal cell carcinoma (mRCC) in randomized controlled trials (RCT). Because pts treated under daily-practice conditions have heterogeneous characteristics that may differ from RCT populations, the PREDICT (Patient characteristics in REnal cell carcinoma and Daily practICe Treatment with Nexavar) non-interventional study was undertaken to record baseline characteristics of mRCC pts and their potential influence on the efficacy and safety of sorafenib in community practice settings. PREDICT is ongoing in 14 countries throughout Europe, Latin America, and Asia, and thus encompasses a broad multi-ethnic population. Results of the first analysis (cutoff: Feb 25, 2009) categorizing the baseline characteristics and adverse events (AEs) of this population are compared to those in the pivotal Phase 3 TARGET study (Escudier, N Engl J Med 2007).

Methods: Clinicians follow mRCC pts, for whom they have prescribed sorafenib, for the length of therapy, up to 12 months. Baseline characteristics are recorded and at pts' normally scheduled follow-up visits, tumor status, pt status, and adverse events (AEs) are noted.

Results: Currently 1529 pts are valid for baseline characteristics; 91% were prescribed sorafenib 400 mg bid. The table shows baseline characteristics in PREDICT compared to TARGET. While the most frequently reported AEs were similar in the two sorafenib-treated populations, incidences were lower in PREDICT (valid for safety: N = 1606) vs TARGET (N = 451), ie, hand-foot skin reaction (22% vs 30%), diarrhea (18% vs 43%), rash (10% vs 40%), and alopecia (7% vs 27%).

Conclusions: These initial findings of PREDICT show that the safety profile of sorafenib is similar to that seen in the research setting of TARGET. However, pts in the real-world setting of PREDICT have a somewhat worse baseline tumor/disease condition and prognosis.

Publikováno v: European Journal of Cancer Supplements, Vol 7 No 2, September 2009, Page 431

Datum přednesení příspěvku: 21. 9. 2009