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  • Introduction & ObjectivesAbiraterone acetate (AA) is the prodrug of abiraterone, which inhibits CYP17A1 and testosterone synthesis and prolongs survival of metastatic castration-resistant prostate cancer (mCRPC) patients. A low dose of prednisone (P) is given when AA is administered to mCRPC patients. Long-term use of moderate-/high-dose corticosteroids (CS) has an established adverse event (AE) profile. We investigated whether long-term use of low-dose P with or without AA led to CS-associated AEs.Material & Methods2267 mCRPC patients in COU-AA-301 and COU-AA-302 received 5 mg bid P, representing 2006 patient-years of P exposure. 1333 patients received AA + P. We used an inclusive Standardized MedDRA Queries–oriented approach to identify 112 preferred terms for known CS-associated AEs from both databases. CS-associated AEs during each 3-month exposure interval and across all exposure to P were assessed.ResultsThe overall incidence of CS-associated AEs for any P exposure was 25%, 26%, and 23% for all patients, AA + P, and P alone, respectively. The incidence of grade ≥ 3 CS-associated AEs with any P exposure was 5%, 5%, and 4% for all patients, AA + P, and P alone, respectively. The most common grade ≥ 3 CS-associated AEs occurring in ≥ 0.1% of all patients were hyperglycemia (2%), cataract (0.4%), diabetes mellitus (0.4%), gastrointestinal hemorrhage (0.3%), adrenal insufficiency (0.1%), hip fracture (0.1%), melena (0.1%), and osteoporotic spinal compression fracture (0.1%). The overall incidence of weight increase (grade 1 and 2 only) was 4%, 4%, and 5% for all patients, AA + P, and P alone, respectively. Most were grade 1 (3.4%). When assessed by duration of exposure (3-month intervals up to ≥ 30 months), grade ≥ 3 CS-associated AEs fluctuated between 1% and 2%, but no discernable trend was observed. The observed change in weight from baseline showed no apparent increase over time.ConclusionsWith more than 2000 patient-years of exposure, low-dose P given with or without AA is associated with an overall low incidence of CS-associated AEs. The occurrence of CS-associated AEs remained low with increased duration of exposure to P. Deprince K.1, De Porre P.1, Fizazi K.2, Chi K.N.3, De Bono J.S.4, Gomella L.G.5, Miller K.6, Rathkopf D.E.7, Ryan C.J.8, Scher H.I.9, Shore N.10, Londhe A.11, Mcgowan T.12, Pelhivanov N.13, Charnas R.14, Todd M.B.15, Montgomery B.16 7th European Multidisciplinary Meeting on Urological Cancers 1Janssen Research & Development, Dept. of Oncology Development, Beerse, 2Institut Gustave Roussy, University of Paris Sud, Dept. of Uro-Genitology, Villejuif, 3BC Cancer Agency, Dept. of Experimental Therapeutics, Vancouver, 4The Institute of Cancer Research and The Royal Marsden Hospital, Dept. of Cancer Therapeutics/Clinical Studies, Sutton, 5Jefferson Medical College and Kimmel Cancer Center, Dept. of Urology, Philadelphia, 6Charité-Universitätsmedizin Berlin, Dept. of Urology, Berlin, 7Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, Dept. of Oncology and Internal Medicine, New York, 8Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, Dept. of Hematology/Oncology, San Francisco, 9Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, Dept. of Genitourinary Oncology, New York, 10Carolina Urologic Research Center, Atlantic Urology Clinics, Dept. of Urology, Myrtle Beach, 11Janssen Research & Development, Dept. of Clinical Biostatistics, Horsham, 12Janssen Scientific Affairs, Dept. of Medical Group Oncology, Horsham, 13Janssen Research & Development, Dept. of Oncology, Raritan, 14Janssen Research & Development, Dept. of Oncology, Los Angeles, 15Janssen Global Services, Dept. of Oncology, Raritan, 16University of Washington, Dept. of Genitourinary Medical Oncology, Seattle 58636 EMUC15-0141 P055
  • Introduction & ObjectivesAbiraterone acetate (AA) is the prodrug of abiraterone, which inhibits CYP17A1 and testosterone synthesis and prolongs survival of metastatic castration-resistant prostate cancer (mCRPC) patients. A low dose of prednisone (P) is given when AA is administered to mCRPC patients. Long-term use of moderate-/high-dose corticosteroids (CS) has an established adverse event (AE) profile. We investigated whether long-term use of low-dose P with or without AA led to CS-associated AEs.Material & Methods2267 mCRPC patients in COU-AA-301 and COU-AA-302 received 5 mg bid P, representing 2006 patient-years of P exposure. 1333 patients received AA + P. We used an inclusive Standardized MedDRA Queries–oriented approach to identify 112 preferred terms for known CS-associated AEs from both databases. CS-associated AEs during each 3-month exposure interval and across all exposure to P were assessed.ResultsThe overall incidence of CS-associated AEs for any P exposure was 25%, 26%, and 23% for all patients, AA + P, and P alone, respectively. The incidence of grade ≥ 3 CS-associated AEs with any P exposure was 5%, 5%, and 4% for all patients, AA + P, and P alone, respectively. The most common grade ≥ 3 CS-associated AEs occurring in ≥ 0.1% of all patients were hyperglycemia (2%), cataract (0.4%), diabetes mellitus (0.4%), gastrointestinal hemorrhage (0.3%), adrenal insufficiency (0.1%), hip fracture (0.1%), melena (0.1%), and osteoporotic spinal compression fracture (0.1%). The overall incidence of weight increase (grade 1 and 2 only) was 4%, 4%, and 5% for all patients, AA + P, and P alone, respectively. Most were grade 1 (3.4%). When assessed by duration of exposure (3-month intervals up to ≥ 30 months), grade ≥ 3 CS-associated AEs fluctuated between 1% and 2%, but no discernable trend was observed. The observed change in weight from baseline showed no apparent increase over time.ConclusionsWith more than 2000 patient-years of exposure, low-dose P given with or without AA is associated with an overall low incidence of CS-associated AEs. The occurrence of CS-associated AEs remained low with increased duration of exposure to P. Deprince K.1, De Porre P.1, Fizazi K.2, Chi K.N.3, De Bono J.S.4, Gomella L.G.5, Miller K.6, Rathkopf D.E.7, Ryan C.J.8, Scher H.I.9, Shore N.10, Londhe A.11, Mcgowan T.12, Pelhivanov N.13, Charnas R.14, Todd M.B.15, Montgomery B.16 7th European Multidisciplinary Meeting on Urological Cancers 1Janssen Research & Development, Dept. of Oncology Development, Beerse, 2Institut Gustave Roussy, University of Paris Sud, Dept. of Uro-Genitology, Villejuif, 3BC Cancer Agency, Dept. of Experimental Therapeutics, Vancouver, 4The Institute of Cancer Research and The Royal Marsden Hospital, Dept. of Cancer Therapeutics/Clinical Studies, Sutton, 5Jefferson Medical College and Kimmel Cancer Center, Dept. of Urology, Philadelphia, 6Charité-Universitätsmedizin Berlin, Dept. of Urology, Berlin, 7Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, Dept. of Oncology and Internal Medicine, New York, 8Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, Dept. of Hematology/Oncology, San Francisco, 9Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, Dept. of Genitourinary Oncology, New York, 10Carolina Urologic Research Center, Atlantic Urology Clinics, Dept. of Urology, Myrtle Beach, 11Janssen Research & Development, Dept. of Clinical Biostatistics, Horsham, 12Janssen Scientific Affairs, Dept. of Medical Group Oncology, Horsham, 13Janssen Research & Development, Dept. of Oncology, Raritan, 14Janssen Research & Development, Dept. of Oncology, Los Angeles, 15Janssen Global Services, Dept. of Oncology, Raritan, 16University of Washington, Dept. of Genitourinary Medical Oncology, Seattle 58636 EMUC15-0141 P055
  • Introduction & ObjectivesAbiraterone acetate (AA) is the prodrug of abiraterone, which inhibits CYP17A1 and testosterone synthesis and prolongs survival of metastatic castration-resistant prostate cancer (mCRPC) patients. A low dose of prednisone (P) is given when AA is administered to mCRPC patients. Long-term use of moderate-/high-dose corticosteroids (CS) has an established adverse event (AE) profile. We investigated whether long-term use of low-dose P with or without AA led to CS-associated AEs.Material & Methods2267 mCRPC patients in COU-AA-301 and COU-AA-302 received 5 mg bid P, representing 2006 patient-years of P exposure. 1333 patients received AA + P. We used an inclusive Standardized MedDRA Queries–oriented approach to identify 112 preferred terms for known CS-associated AEs from both databases. CS-associated AEs during each 3-month exposure interval and across all exposure to P were assessed.ResultsThe overall incidence of CS-associated AEs for any P exposure was 25%, 26%, and 23% for all patients, AA + P, and P alone, respectively. The incidence of grade ≥ 3 CS-associated AEs with any P exposure was 5%, 5%, and 4% for all patients, AA + P, and P alone, respectively. The most common grade ≥ 3 CS-associated AEs occurring in ≥ 0.1% of all patients were hyperglycemia (2%), cataract (0.4%), diabetes mellitus (0.4%), gastrointestinal hemorrhage (0.3%), adrenal insufficiency (0.1%), hip fracture (0.1%), melena (0.1%), and osteoporotic spinal compression fracture (0.1%). The overall incidence of weight increase (grade 1 and 2 only) was 4%, 4%, and 5% for all patients, AA + P, and P alone, respectively. Most were grade 1 (3.4%). When assessed by duration of exposure (3-month intervals up to ≥ 30 months), grade ≥ 3 CS-associated AEs fluctuated between 1% and 2%, but no discernable trend was observed. The observed change in weight from baseline showed no apparent increase over time.ConclusionsWith more than 2000 patient-years of exposure, low-dose P given with or without AA is associated with an overall low incidence of CS-associated AEs. The occurrence of CS-associated AEs remained low with increased duration of exposure to P. Deprince K.1, De Porre P.1, Fizazi K.2, Chi K.N.3, De Bono J.S.4, Gomella L.G.5, Miller K.6, Rathkopf D.E.7, Ryan C.J.8, Scher H.I.9, Shore N.10, Londhe A.11, Mcgowan T.12, Pelhivanov N.13, Charnas R.14, Todd M.B.15, Montgomery B.16 7th European Multidisciplinary Meeting on Urological Cancers 1Janssen Research & Development, Dept. of Oncology Development, Beerse, 2Institut Gustave Roussy, University of Paris Sud, Dept. of Uro-Genitology, Villejuif, 3BC Cancer Agency, Dept. of Experimental Therapeutics, Vancouver, 4The Institute of Cancer Research and The Royal Marsden Hospital, Dept. of Cancer Therapeutics/Clinical Studies, Sutton, 5Jefferson Medical College and Kimmel Cancer Center, Dept. of Urology, Philadelphia, 6Charité-Universitätsmedizin Berlin, Dept. of Urology, Berlin, 7Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, Dept. of Oncology and Internal Medicine, New York, 8Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, Dept. of Hematology/Oncology, San Francisco, 9Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, Dept. of Genitourinary Oncology, New York, 10Carolina Urologic Research Center, Atlantic Urology Clinics, Dept. of Urology, Myrtle Beach, 11Janssen Research & Development, Dept. of Clinical Biostatistics, Horsham, 12Janssen Scientific Affairs, Dept. of Medical Group Oncology, Horsham, 13Janssen Research & Development, Dept. of Oncology, Raritan, 14Janssen Research & Development, Dept. of Oncology, Los Angeles, 15Janssen Global Services, Dept. of Oncology, Raritan, 16University of Washington, Dept. of Genitourinary Medical Oncology, Seattle 58636 EMUC15-0141 P055
  • Introduction & ObjectivesAbiraterone acetate (AA) is the prodrug of abiraterone, which inhibits CYP17A1 and testosterone synthesis and prolongs survival of metastatic castration-resistant prostate cancer (mCRPC) patients. A low dose of prednisone (P) is given when AA is administered to mCRPC patients. Long-term use of moderate-/high-dose corticosteroids (CS) has an established adverse event (AE) profile. We investigated whether long-term use of low-dose P with or without AA led to CS-associated AEs.Material & Methods2267 mCRPC patients in COU-AA-301 and COU-AA-302 received 5 mg bid P, representing 2006 patient-years of P exposure. 1333 patients received AA + P. We used an inclusive Standardized MedDRA Queries–oriented approach to identify 112 preferred terms for known CS-associated AEs from both databases. CS-associated AEs during each 3-month exposure interval and across all exposure to P were assessed.ResultsThe overall incidence of CS-associated AEs for any P exposure was 25%, 26%, and 23% for all patients, AA + P, and P alone, respectively. The incidence of grade ≥ 3 CS-associated AEs with any P exposure was 5%, 5%, and 4% for all patients, AA + P, and P alone, respectively. The most common grade ≥ 3 CS-associated AEs occurring in ≥ 0.1% of all patients were hyperglycemia (2%), cataract (0.4%), diabetes mellitus (0.4%), gastrointestinal hemorrhage (0.3%), adrenal insufficiency (0.1%), hip fracture (0.1%), melena (0.1%), and osteoporotic spinal compression fracture (0.1%). The overall incidence of weight increase (grade 1 and 2 only) was 4%, 4%, and 5% for all patients, AA + P, and P alone, respectively. Most were grade 1 (3.4%). When assessed by duration of exposure (3-month intervals up to ≥ 30 months), grade ≥ 3 CS-associated AEs fluctuated between 1% and 2%, but no discernable trend was observed. The observed change in weight from baseline showed no apparent increase over time.ConclusionsWith more than 2000 patient-years of exposure, low-dose P given with or without AA is associated with an overall low incidence of CS-associated AEs. The occurrence of CS-associated AEs remained low with increased duration of exposure to P. Deprince K.1, De Porre P.1, Fizazi K.2, Chi K.N.3, De Bono J.S.4, Gomella L.G.5, Miller K.6, Rathkopf D.E.7, Ryan C.J.8, Scher H.I.9, Shore N.10, Londhe A.11, Mcgowan T.12, Pelhivanov N.13, Charnas R.14, Todd M.B.15, Montgomery B.16 7th European Multidisciplinary Meeting on Urological Cancers 1Janssen Research & Development, Dept. of Oncology Development, Beerse, 2Institut Gustave Roussy, University of Paris Sud, Dept. of Uro-Genitology, Villejuif, 3BC Cancer Agency, Dept. of Experimental Therapeutics, Vancouver, 4The Institute of Cancer Research and The Royal Marsden Hospital, Dept. of Cancer Therapeutics/Clinical Studies, Sutton, 5Jefferson Medical College and Kimmel Cancer Center, Dept. of Urology, Philadelphia, 6Charité-Universitätsmedizin Berlin, Dept. of Urology, Berlin, 7Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, Dept. of Oncology and Internal Medicine, New York, 8Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, Dept. of Hematology/Oncology, San Francisco, 9Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, Dept. of Genitourinary Oncology, New York, 10Carolina Urologic Research Center, Atlantic Urology Clinics, Dept. of Urology, Myrtle Beach, 11Janssen Research & Development, Dept. of Clinical Biostatistics, Horsham, 12Janssen Scientific Affairs, Dept. of Medical Group Oncology, Horsham, 13Janssen Research & Development, Dept. of Oncology, Raritan, 14Janssen Research & Development, Dept. of Oncology, Los Angeles, 15Janssen Global Services, Dept. of Oncology, Raritan, 16University of Washington, Dept. of Genitourinary Medical Oncology, Seattle 58636 EMUC15-0141 P055
  • Introduction & ObjectivesAbiraterone acetate (AA) is the prodrug of abiraterone, which inhibits CYP17A1 and testosterone synthesis and prolongs survival of metastatic castration-resistant prostate cancer (mCRPC) patients. A low dose of prednisone (P) is given when AA is administered to mCRPC patients. Long-term use of moderate-/high-dose corticosteroids (CS) has an established adverse event (AE) profile. We investigated whether long-term use of low-dose P with or without AA led to CS-associated AEs.Material & Methods2267 mCRPC patients in COU-AA-301 and COU-AA-302 received 5 mg bid P, representing 2006 patient-years of P exposure. 1333 patients received AA + P. We used an inclusive Standardized MedDRA Queries–oriented approach to identify 112 preferred terms for known CS-associated AEs from both databases. CS-associated AEs during each 3-month exposure interval and across all exposure to P were assessed.ResultsThe overall incidence of CS-associated AEs for any P exposure was 25%, 26%, and 23% for all patients, AA + P, and P alone, respectively. The incidence of grade ≥ 3 CS-associated AEs with any P exposure was 5%, 5%, and 4% for all patients, AA + P, and P alone, respectively. The most common grade ≥ 3 CS-associated AEs occurring in ≥ 0.1% of all patients were hyperglycemia (2%), cataract (0.4%), diabetes mellitus (0.4%), gastrointestinal hemorrhage (0.3%), adrenal insufficiency (0.1%), hip fracture (0.1%), melena (0.1%), and osteoporotic spinal compression fracture (0.1%). The overall incidence of weight increase (grade 1 and 2 only) was 4%, 4%, and 5% for all patients, AA + P, and P alone, respectively. Most were grade 1 (3.4%). When assessed by duration of exposure (3-month intervals up to ≥ 30 months), grade ≥ 3 CS-associated AEs fluctuated between 1% and 2%, but no discernable trend was observed. The observed change in weight from baseline showed no apparent increase over time.ConclusionsWith more than 2000 patient-years of exposure, low-dose P given with or without AA is associated with an overall low incidence of CS-associated AEs. The occurrence of CS-associated AEs remained low with increased duration of exposure to P. Deprince K.1, De Porre P.1, Fizazi K.2, Chi K.N.3, De Bono J.S.4, Gomella L.G.5, Miller K.6, Rathkopf D.E.7, Ryan C.J.8, Scher H.I.9, Shore N.10, Londhe A.11, Mcgowan T.12, Pelhivanov N.13, Charnas R.14, Todd M.B.15, Montgomery B.16 7th European Multidisciplinary Meeting on Urological Cancers 1Janssen Research & Development, Dept. of Oncology Development, Beerse, 2Institut Gustave Roussy, University of Paris Sud, Dept. of Uro-Genitology, Villejuif, 3BC Cancer Agency, Dept. of Experimental Therapeutics, Vancouver, 4The Institute of Cancer Research and The Royal Marsden Hospital, Dept. of Cancer Therapeutics/Clinical Studies, Sutton, 5Jefferson Medical College and Kimmel Cancer Center, Dept. of Urology, Philadelphia, 6Charité-Universitätsmedizin Berlin, Dept. of Urology, Berlin, 7Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, Dept. of Oncology and Internal Medicine, New York, 8Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, Dept. of Hematology/Oncology, San Francisco, 9Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, Dept. of Genitourinary Oncology, New York, 10Carolina Urologic Research Center, Atlantic Urology Clinics, Dept. of Urology, Myrtle Beach, 11Janssen Research & Development, Dept. of Clinical Biostatistics, Horsham, 12Janssen Scientific Affairs, Dept. of Medical Group Oncology, Horsham, 13Janssen Research & Development, Dept. of Oncology, Raritan, 14Janssen Research & Development, Dept. of Oncology, Los Angeles, 15Janssen Global Services, Dept. of Oncology, Raritan, 16University of Washington, Dept. of Genitourinary Medical Oncology, Seattle 58636 EMUC15-0141 P055
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