阳性EBC的应对策略ppt课件.pptVIP

Cardiac safety Cardiac death Severe CHF (NYHA III and IV) Symptomatic CHF (II, III and IV) Confirmed significant LVEF drop 1 (0.1) 0 (0.0) 3 (0.2) 13 (0.8) 0 (0.0) 13 (0.8) 33 (2.0) 62 (3.7) 87 (5.2) No. patients (%) Observationa n=1719 1-year Herceptinn=1682 Herceptin discontinued due to cardiac problems aPatients who crossed over are censored from the date of starting Herceptin treatment CHF, congestive heart failure; NYHA, New York Heart Association; LVEF, left ventricular ejection fraction Cardiac safety: observation group Cardiac death Severe CHF (NYHA III and IV) Symptomatic CHF (II, III and IV) Confirmed significant LVEF drop 0 (0.0) 0 (0.0) 1 (0.2) 5a (1.1) 0 (0.0) 0 (0.0) 9 (1.0) 26 (2.9) 43 (4.9) Crossover n=885 Herceptin discontinued due to cardiac problems aFor 3 of the patients, the LVEF drop occurred between 16 May 05 and the date of the patient decision and may have influenced the patient decision No crossover after 16 May 05 n=469 HERA 4-year follow-up data: summary (1) The updated analysis at 4 years was limited to 1-year Herceptin vs observation as recommended by IDMC Extensive selective crossover of observation patients to active therapy biased the ITT comparison Landmark analysis of observation patients who were disease free on 16 May 2005 explored the effects of later introduction of Herceptin Lack of randomisation limits the interpretation of the landmark analysis different outcome due to drug effect or patient characteristics? HERA 4-year follow-up data: summary (2) In HERA, the DFS benefit associated with Herceptin is maintained at 4-year median follow-up 50% of patients in the observation arm crossed over to Herceptin treatment, therefore the OS benefit is no longer statistically significant Patients crossing over at a later date appear to benefit from 1 year of Herceptin HERA: conclusions and next steps 4-year follow-up data support the hypothesis that the risk of relapse in HER2-positive early breast canc