Die Ergebnisse der Phase-III-Studie mit MDV3100 sind heute von Medivation bzw. Astellas bekanntgegeben worden
und werden morgen beim "2012 Genitourinary Cancers Symposium in San Francisco" präsentiert.
Fast 5 Monate beim Überleben sowie Ansprechen auch der sekundären Endpunkte und relativ gute Verträglichkeit - bei Männern, die schon HB und Chemo hinter sich haben - nicht schlecht!
und werden morgen beim "2012 Genitourinary Cancers Symposium in San Francisco" präsentiert.
Fast 5 Monate beim Überleben sowie Ansprechen auch der sekundären Endpunkte und relativ gute Verträglichkeit - bei Männern, die schon HB und Chemo hinter sich haben - nicht schlecht!
Of particular note:
"The almost five-month overall survival benefit MDV3100 showed over placebo in this trial is noteworthy, as is the fact that men with post-chemotherapy prostate cancer taking MDV3100 lived for a median of a year and a half," said Professor Johann de Bono, M.D., MSc, Ph.D., FRCP, Honorary Consultant in Medical Oncology, Professor of Experimental Cancer Medicine, The Institute of Cancer Research and The Royal Marsden Hospital, and the co-principal investigator of the AFFIRM study. "As a practicing oncologist, I am hopeful that I may be able to offer MDV3100 as a life-prolonging option to these very ill patients."
- Men taking MDV3100 lived for a median of 18.4 months, compared with 13.6 months for men taking placebo (p < 0.0001; HR=0.631).
- MDV3100 also met all secondary endpoints, including radiographic progression-free survival (8.3 versus 2.9 months; p < 0.0001; HR=0.404), soft tissue response rate (28.9% versus 3.8%; p < 0.0001) and time to prostate-specific antigen (PSA) progression (8.3 versus 3.0 months; p < 0.0001; HR=0.249).
- PSA declines of 50% or greater were more common in the MDV3100 group than in the placebo group (54.0% versus 1.5%; p < 0.0001), as were PSA declines of 90% or greater (24.8% versus 0.9%; p < 0.0001).
- MDV3100 was well tolerated. Common side effects included fatigue, diarrhea and hot flush. Serious adverse events, adverse events causing patients to stop treatment, and adverse events causing death all were lower in the MDV3100 group than in the placebo group. Grade 3 or greater side effects of interest were fatigue (6.3% in the MDV3100 group versus 7.3% in the placebo group), cardiac disorders (0.9% versus 2.0%) including myocardial infarction (0.3% versus 0.5%), seizure (0.6% versus 0.0%) and liver function test abnormalities (0.4% versus 0.8%).
"The almost five-month overall survival benefit MDV3100 showed over placebo in this trial is noteworthy, as is the fact that men with post-chemotherapy prostate cancer taking MDV3100 lived for a median of a year and a half," said Professor Johann de Bono, M.D., MSc, Ph.D., FRCP, Honorary Consultant in Medical Oncology, Professor of Experimental Cancer Medicine, The Institute of Cancer Research and The Royal Marsden Hospital, and the co-principal investigator of the AFFIRM study. "As a practicing oncologist, I am hopeful that I may be able to offer MDV3100 as a life-prolonging option to these very ill patients."
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