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-7121
Autoři: MD Joaquim Bellmunt; prof. MUDr. Bohuslav Melichar, Ph.D.; Sergio Bracarda; S.N. Negrier; Prof. MD Alain Ravaud, PhD; R. Laeufle; V. Sneller; MD Bernard J. Escudier
Background: Cardiac safety has recently become an important
consideration when evaluating therapies for mRCC. Rates of cardiac
toxicity with tyrosine kinase inhibitor therapy in mRCC have been
reported to be as high as 34.8% [Schmidinger et al. JCO 2008]. We
analysed the cardiac safety of BEV + IFN and IFN + placebo in the
phase III AVOREN (BO17705E) trial in patients (pts) with previously
untreated mRCC.
Methods: Eligible pts had predominantly clear-cell mRCC, prior nephrectomy, no prior systemic therapy for metastatic disease, KPS ˇÝ70%, no CNS metastases and adequate organ function. Pts were randomised to IFN (9MIU tiw) + BEV (10 mg/kg q2w) or placebo until disease progression. Listings of cardiac events were retrieved from the trial database and serious adverse event (SAE) reports from the safety database. The nature of events was compared between the two treatment arms and events were also evaluated based on type (non-serious adverse event [n-s AE] vs SAE), age, gender and recovery.
Results: Median BEV/placebo treatment duration was 42 and 22 weeks in the BEV + IFN and IFN plus placebo arms; median IFN duration was 34 and 20 weeks, respectively. 15 cardiac events, including four SAEs, were reported in 13 of 337 (4%) pts who received BEV + IFN; nine cardiac events (one SAE) were reported in eight of 304 (3%) pts who received IFN + placebo. Four of the total of five SAEs were reported as ˇ®atrial fibrillation (AF)ˇŻ and occurred in pts aged ˇÝ62 years. AF was shown to have a prevalence of 5.1% in pts aged ˇÝ60 years in general practice [Langenberg et al. BMJ 1996]. Although not directly comparable, the incidence of AF in AVOREN was not increased when grossly compared to a normal population. The other SAE was a myocardial infarction in a 78-year-old woman in the BEV + IFN arm, which resolved without sequelae; the event was judged by the investigator to be related to underlying hypertension rather than trial therapy. The most common n-s AEs were tachycardia/sinus tachycardia (n = 4) and arrhythmia (n = 4). All n-s AEs were reported to have resolved; 15 of the total 24 events were resolved between
Conclusions: The incidence of cardiac events in this trial was <5%. The majority of events were not serious, not suspected to trial medication, transient and did not require treatment interruption or discontinuation. We conclude that BEV + IFN has a favourable cardiac safety profile in pts with mRCC in the AVOREN trial.
Trial sponsored by F. Hoffmann-La Roche, Ltd.
Publikováno v: European Journal of Cancer Supplements, Vol 7 No 2, September 2009, Page 429
Methods: Eligible pts had predominantly clear-cell mRCC, prior nephrectomy, no prior systemic therapy for metastatic disease, KPS ˇÝ70%, no CNS metastases and adequate organ function. Pts were randomised to IFN (9MIU tiw) + BEV (10 mg/kg q2w) or placebo until disease progression. Listings of cardiac events were retrieved from the trial database and serious adverse event (SAE) reports from the safety database. The nature of events was compared between the two treatment arms and events were also evaluated based on type (non-serious adverse event [n-s AE] vs SAE), age, gender and recovery.
Results: Median BEV/placebo treatment duration was 42 and 22 weeks in the BEV + IFN and IFN plus placebo arms; median IFN duration was 34 and 20 weeks, respectively. 15 cardiac events, including four SAEs, were reported in 13 of 337 (4%) pts who received BEV + IFN; nine cardiac events (one SAE) were reported in eight of 304 (3%) pts who received IFN + placebo. Four of the total of five SAEs were reported as ˇ®atrial fibrillation (AF)ˇŻ and occurred in pts aged ˇÝ62 years. AF was shown to have a prevalence of 5.1% in pts aged ˇÝ60 years in general practice [Langenberg et al. BMJ 1996]. Although not directly comparable, the incidence of AF in AVOREN was not increased when grossly compared to a normal population. The other SAE was a myocardial infarction in a 78-year-old woman in the BEV + IFN arm, which resolved without sequelae; the event was judged by the investigator to be related to underlying hypertension rather than trial therapy. The most common n-s AEs were tachycardia/sinus tachycardia (n = 4) and arrhythmia (n = 4). All n-s AEs were reported to have resolved; 15 of the total 24 events were resolved between
Conclusions: The incidence of cardiac events in this trial was <5%. The majority of events were not serious, not suspected to trial medication, transient and did not require treatment interruption or discontinuation. We conclude that BEV + IFN has a favourable cardiac safety profile in pts with mRCC in the AVOREN trial.
Trial sponsored by F. Hoffmann-La Roche, Ltd.
Publikováno v: European Journal of Cancer Supplements, Vol 7 No 2, September 2009, Page 429
Datum přednesení příspěvku: 21. 9. 2009
