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P344 Long-term zoledronic acid-mediated suppression of bone resorption in patients receiving an aromatase inhibitor
S84
Poster Session II. Supportive care/Psychology
FACT-ES, respectively. All patients completed compliance questionnaires and Group B provided feedback on EM. Results: Across 18 countries, 2758 patients were randomised. At 1 year, no statistically significant difference in compliance rates was observed between Groups A (81%) and B (82%). GHQ-12 (range 0−12) mean change from baseline (BL) total score for Group A and Group B was −0.7 (BL = 3.3) and −0.5 (BL = 3.1), respectively, with total FACT-ES (range 0–180) scores of 138.2 and 137.2, respectively. IN-PATSAT32 (range 0– 100) patients reported changes in satisfaction score of 0.1 for Group A (BL = 77.2) and 0.2 for Group B (BL = 77.6), while investigators reported changes of 0.5 (BL = 76.7) and 0.9 (BL = 76.6), respectively. Exploratory analysis showed a higher score in investigator IN-PATSAT32 resulted in improved overall compliance (all patients, 78% at <60; 80% at 60−75; 80% at 75−90; 84% at 90; p = 0.0325). Conclusion: EM did not improve patients’ compliance with AI and did not affect patients’ QoL. Overall, only investigator IN-PATSAT32 score was associated with improved patient compliance. Disclosure of Interest: C. Markopoulos Honoraria from: AstraZeneca, Pfizer and Novartis, Funding from Educational grants: Hellenic Society of Breast Surgeons, P. Neven: None Declared, M. Tanner Consultant for Roche Finland, Funding from AstraZeneca, Roche Finland, GlaxoSmithKline, M. Marty Consultant for Sanofi-aventis, Roche, Debiopharm, Honoraria from: Celgene, R. Kreienberg Consultant for AstraZeneca, L. Atkins Honoraria from: AstraZeneca, A. Franquet: None Declared, V. Deschamp Employee of AstraZeneca
P344
Long-term zoledronic acid-mediated suppression of bone resorption in patients receiving an aromatase inhibitor
A. Lipton1 , C. Campbell Baird1 , J.B. Kelly1 , L. Demers1 , S. Ali2 . 1 Penn State Milton S. Hershey Medical Center, Hershey, 2 Lebanon VA, Lebanon, United States Goals: Treatment with aromatase inhibitors (AIs) has been associated with increased bone loss and risk of fractures. Treatment with AIs may result in an increase in markers of bone resorption such as N-telopeptide of type I collagen (NTX) and C-telopeptide of type I collagen (CTX). Three large studies (Z-FAST, ZO-FAST and E-ZO-FAST) have demonstrated that IV zoledronic acid (ZOL) can prevent bone loss in postmenopausal women receiving an AI. Whether ZOL should be administered every 6 months or less frequently is not known. Methods: Breast cancer patients receiving adjuvant AI therapy whose urinary NTX was greater than 50 nM BCE/mM creatinine and whose bone mineral density (BMD) T-score was −1.5 or less were entered into this study. Patients received a single dose of ZOL 5 mg IV. Urinary and serum NTX and serum CTX were measured at baseline and at months 1, 2, 4, 6, 8, 10, and 12. Results: All patients (N = 18) had decreases in urinary and serum NTX and serum CTX by month 1 after ZOL treatment. Data are available from 13 patients for 1 year after ZOL treatment. At 12 months after treatment, urinary NTX in 13 of 13 patients, serum NTX in 12 of 13 patients, and serum CTX in 13 of 13 patients had not returned to baseline levels. BMD results at 1 year were available for 9 patients. BMD scores improved in 5 of 9 patients, and 4 of 9 had stable BMD. No patient had worsening BMD scores at 1 year. Conclusion: Zoledronic acid suppressed markers of bone resorption for at least 1 year in most patients receiving AI adjuvant therapy. Disclosure of Interest: A. Lipton Consultant for Amgen and Novartis, Honoraria from: Amgen, Novartis, and Genentech, Paid Instruction for Novartis, Funding from Novartis, Monogram Biosciences, and Oncogene Sciences, C. Campbell Baird: None Declared, J. Kelly: None Declared, L. Demers: None Declared, S. Ali: None Declared
Friday, 18 March 2011
P345
Updated guidance for the prevention of aromatase inhibitor (AI)-associated bone loss (AIBL) in early breast cancer (EBC)
P. Hadji1 , J. Body2 , N. Bundred3 , A. Brufsky4 , R. Coleman5 , M. Gnant6 , T. Guise7 , A. Lipton8 , M. Aapro9 . 1 Philipps-University of Marburg, Marburg, Germany, 2 Universite´ Libre de Bruxelles, Brussels, Belgium, 3 University Hospital of South Manchester, Manchester, United Kingdom, 4 University of Pittsburgh, Pittsburgh, United States, 5 University of Sheffield, Weston Park Hospital, Sheffield, United Kingdom, 6 Medical University of Vienna, Vienna, Austria, 7 University of Virginia, Charlottesville, 8 Penn State Milton S. Hershey Medical Center, Hershey, United States, 9 Institut Multidisciplinaire d’Oncology, Genolier, Switzerland Goals: ASCO guidelines on bone health in EBC recommend bisphosphonate (BP) therapy for women with osteoporosis (T-score <−2.5) to increase BMD, reduce fracture risk, and for individualized treatment for osteopenia (T-score −1 to −2.5). Because most fractures occur in osteopenic women, this threshold appears inadequate for averting fractures in EBC, particularly during AI use. Therefore, an algorithm was developed to assess fracture risk and direct treatment with or without T-scores (Ann Oncol. 2008;19:1407−16). Updated guidance is presented. Methods: Systematic literature review identified recent advances in BMD preservation during AI use. Evidence for individual agents was assessed based on trial size, design, follow-up duration, and safety. Results: Fracture risk factors in EBC are AI therapy, T-score <−1.5, age >65 yr, family history of hip fracture, history of fragility fracture after age 50, oral corticosteroid use >6 mo, smoking, or BMI < 20 kg/m2 (Ann Oncol. 2008;19:1407−16). Combined risk factors can define fracture risk independent of BMD (WHO FRAX algorithm). However, FRAX (for healthy women) does not address AIBL and may underestimate EBC fracture risk. Clinical trials show that BPs and denosumab can preserve BMD during AI therapy for EBC. However, poor compliance may reduce oral agent benefits, and long-term efficacy/safety of new drugs is unknown. Overall, BP evidence to date is strongest for zoledronic acid (ZOL; 4 mg q6mo). Recent reports of potential anticancer activity suggest ZOL might provide benefits beyond BMD (ABCSG-12, AZURE). Conclusion: Recommendations for treatment and prevention of AIBL: Patients (pts) should receive advice regarding exercise, calcium/vit D supplements, and baseline BMD monitoring. Pts initiating AI with T-score <−2.0 or 2 risk factors should receive bone-directed therapy. Pts with T-score >−2.0 and no other risk factors should have BMD reassessed at 12 mo. During oral BP therapy, BMD and compliance should be monitored at 12−24 mo, and the pt switched to an IV BP if response or compliance is inadequate. For all others, BMD monitoring should be individualized. Disclosure of Interest: P. Hadji Honoraria from: AstraZeneca, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, and Roche, Funding from AstraZeneca, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, and Roche, J. Body Consultant for Novartis and Amgen, N. Bundred Funding from Novartis and GlaxoSmithKline, A. Brufsky Funding from Novartis, R. Coleman Consultant for Novartis, Amgen, and Pfizer, Honoraria from: Novartis, Roche, Pfizer, AstraZeneca, and Amgen, Paid Instruction for Novartis, Funding from Novartis, M. Gnant Consultant for AstraZeneca, Novartis, and Pfizer, Honoraria from: AstraZeneca, Novartis, sanofi-aventis, Roche, Schering, Amgen, and Pfizer, Funding from AstraZeneca, Novartis, and Pfizer, T. Guise Consultant for Novartis and Amgen, Funding from Novartis, AstraZeneca, Scios, and Fibrogen, A. Lipton Consultant for Amgen, Novartis, and Cephalon, Paid Instruction for Novartis, Funding from Novartis, Oncogene Science, and Monogram Bioscience, M. Aapro Honoraria from: AstraZeneca, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, and Roche., Funding from AstraZeneca, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, and Roche.
P346
Real world considerations for bisphosphonate (BP) therapy in early breast cancer (EBC)
M. Aapro1 , P. Hadji2 . 1 Institut Multidisciplinaire d’Oncologie, Genolier, Switzerland, 2 Philipps-University of Marburg, Marburg, Germany Goals: Large randomized trials of BPs in EBC have shown significant benefit for bone health and improved disease outcomes. However, realworld use of BPs may have a large impact on how these effects might manifest. Methods: Bone health concerns in EBC and clinical data on BPs were retrospectively evaluated. Pooled compliance/outcomes data from realworld reports of BP therapy were applied to the EBC setting.
Poster Session II. Supportive care/Psychology
FACT-ES, respectively. All patients completed compliance questionnaires and Group B provided feedback on EM. Results: Across 18 countries, 2758 patients were randomised. At 1 year, no statistically significant difference in compliance rates was observed between Groups A (81%) and B (82%). GHQ-12 (range 0−12) mean change from baseline (BL) total score for Group A and Group B was −0.7 (BL = 3.3) and −0.5 (BL = 3.1), respectively, with total FACT-ES (range 0–180) scores of 138.2 and 137.2, respectively. IN-PATSAT32 (range 0– 100) patients reported changes in satisfaction score of 0.1 for Group A (BL = 77.2) and 0.2 for Group B (BL = 77.6), while investigators reported changes of 0.5 (BL = 76.7) and 0.9 (BL = 76.6), respectively. Exploratory analysis showed a higher score in investigator IN-PATSAT32 resulted in improved overall compliance (all patients, 78% at <60; 80% at 60−75; 80% at 75−90; 84% at 90; p = 0.0325). Conclusion: EM did not improve patients’ compliance with AI and did not affect patients’ QoL. Overall, only investigator IN-PATSAT32 score was associated with improved patient compliance. Disclosure of Interest: C. Markopoulos Honoraria from: AstraZeneca, Pfizer and Novartis, Funding from Educational grants: Hellenic Society of Breast Surgeons, P. Neven: None Declared, M. Tanner Consultant for Roche Finland, Funding from AstraZeneca, Roche Finland, GlaxoSmithKline, M. Marty Consultant for Sanofi-aventis, Roche, Debiopharm, Honoraria from: Celgene, R. Kreienberg Consultant for AstraZeneca, L. Atkins Honoraria from: AstraZeneca, A. Franquet: None Declared, V. Deschamp Employee of AstraZeneca
P344
Long-term zoledronic acid-mediated suppression of bone resorption in patients receiving an aromatase inhibitor
A. Lipton1 , C. Campbell Baird1 , J.B. Kelly1 , L. Demers1 , S. Ali2 . 1 Penn State Milton S. Hershey Medical Center, Hershey, 2 Lebanon VA, Lebanon, United States Goals: Treatment with aromatase inhibitors (AIs) has been associated with increased bone loss and risk of fractures. Treatment with AIs may result in an increase in markers of bone resorption such as N-telopeptide of type I collagen (NTX) and C-telopeptide of type I collagen (CTX). Three large studies (Z-FAST, ZO-FAST and E-ZO-FAST) have demonstrated that IV zoledronic acid (ZOL) can prevent bone loss in postmenopausal women receiving an AI. Whether ZOL should be administered every 6 months or less frequently is not known. Methods: Breast cancer patients receiving adjuvant AI therapy whose urinary NTX was greater than 50 nM BCE/mM creatinine and whose bone mineral density (BMD) T-score was −1.5 or less were entered into this study. Patients received a single dose of ZOL 5 mg IV. Urinary and serum NTX and serum CTX were measured at baseline and at months 1, 2, 4, 6, 8, 10, and 12. Results: All patients (N = 18) had decreases in urinary and serum NTX and serum CTX by month 1 after ZOL treatment. Data are available from 13 patients for 1 year after ZOL treatment. At 12 months after treatment, urinary NTX in 13 of 13 patients, serum NTX in 12 of 13 patients, and serum CTX in 13 of 13 patients had not returned to baseline levels. BMD results at 1 year were available for 9 patients. BMD scores improved in 5 of 9 patients, and 4 of 9 had stable BMD. No patient had worsening BMD scores at 1 year. Conclusion: Zoledronic acid suppressed markers of bone resorption for at least 1 year in most patients receiving AI adjuvant therapy. Disclosure of Interest: A. Lipton Consultant for Amgen and Novartis, Honoraria from: Amgen, Novartis, and Genentech, Paid Instruction for Novartis, Funding from Novartis, Monogram Biosciences, and Oncogene Sciences, C. Campbell Baird: None Declared, J. Kelly: None Declared, L. Demers: None Declared, S. Ali: None Declared
Friday, 18 March 2011
P345
Updated guidance for the prevention of aromatase inhibitor (AI)-associated bone loss (AIBL) in early breast cancer (EBC)
P. Hadji1 , J. Body2 , N. Bundred3 , A. Brufsky4 , R. Coleman5 , M. Gnant6 , T. Guise7 , A. Lipton8 , M. Aapro9 . 1 Philipps-University of Marburg, Marburg, Germany, 2 Universite´ Libre de Bruxelles, Brussels, Belgium, 3 University Hospital of South Manchester, Manchester, United Kingdom, 4 University of Pittsburgh, Pittsburgh, United States, 5 University of Sheffield, Weston Park Hospital, Sheffield, United Kingdom, 6 Medical University of Vienna, Vienna, Austria, 7 University of Virginia, Charlottesville, 8 Penn State Milton S. Hershey Medical Center, Hershey, United States, 9 Institut Multidisciplinaire d’Oncology, Genolier, Switzerland Goals: ASCO guidelines on bone health in EBC recommend bisphosphonate (BP) therapy for women with osteoporosis (T-score <−2.5) to increase BMD, reduce fracture risk, and for individualized treatment for osteopenia (T-score −1 to −2.5). Because most fractures occur in osteopenic women, this threshold appears inadequate for averting fractures in EBC, particularly during AI use. Therefore, an algorithm was developed to assess fracture risk and direct treatment with or without T-scores (Ann Oncol. 2008;19:1407−16). Updated guidance is presented. Methods: Systematic literature review identified recent advances in BMD preservation during AI use. Evidence for individual agents was assessed based on trial size, design, follow-up duration, and safety. Results: Fracture risk factors in EBC are AI therapy, T-score <−1.5, age >65 yr, family history of hip fracture, history of fragility fracture after age 50, oral corticosteroid use >6 mo, smoking, or BMI < 20 kg/m2 (Ann Oncol. 2008;19:1407−16). Combined risk factors can define fracture risk independent of BMD (WHO FRAX algorithm). However, FRAX (for healthy women) does not address AIBL and may underestimate EBC fracture risk. Clinical trials show that BPs and denosumab can preserve BMD during AI therapy for EBC. However, poor compliance may reduce oral agent benefits, and long-term efficacy/safety of new drugs is unknown. Overall, BP evidence to date is strongest for zoledronic acid (ZOL; 4 mg q6mo). Recent reports of potential anticancer activity suggest ZOL might provide benefits beyond BMD (ABCSG-12, AZURE). Conclusion: Recommendations for treatment and prevention of AIBL: Patients (pts) should receive advice regarding exercise, calcium/vit D supplements, and baseline BMD monitoring. Pts initiating AI with T-score <−2.0 or 2 risk factors should receive bone-directed therapy. Pts with T-score >−2.0 and no other risk factors should have BMD reassessed at 12 mo. During oral BP therapy, BMD and compliance should be monitored at 12−24 mo, and the pt switched to an IV BP if response or compliance is inadequate. For all others, BMD monitoring should be individualized. Disclosure of Interest: P. Hadji Honoraria from: AstraZeneca, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, and Roche, Funding from AstraZeneca, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, and Roche, J. Body Consultant for Novartis and Amgen, N. Bundred Funding from Novartis and GlaxoSmithKline, A. Brufsky Funding from Novartis, R. Coleman Consultant for Novartis, Amgen, and Pfizer, Honoraria from: Novartis, Roche, Pfizer, AstraZeneca, and Amgen, Paid Instruction for Novartis, Funding from Novartis, M. Gnant Consultant for AstraZeneca, Novartis, and Pfizer, Honoraria from: AstraZeneca, Novartis, sanofi-aventis, Roche, Schering, Amgen, and Pfizer, Funding from AstraZeneca, Novartis, and Pfizer, T. Guise Consultant for Novartis and Amgen, Funding from Novartis, AstraZeneca, Scios, and Fibrogen, A. Lipton Consultant for Amgen, Novartis, and Cephalon, Paid Instruction for Novartis, Funding from Novartis, Oncogene Science, and Monogram Bioscience, M. Aapro Honoraria from: AstraZeneca, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, and Roche., Funding from AstraZeneca, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, and Roche.
P346
Real world considerations for bisphosphonate (BP) therapy in early breast cancer (EBC)
M. Aapro1 , P. Hadji2 . 1 Institut Multidisciplinaire d’Oncologie, Genolier, Switzerland, 2 Philipps-University of Marburg, Marburg, Germany Goals: Large randomized trials of BPs in EBC have shown significant benefit for bone health and improved disease outcomes. However, realworld use of BPs may have a large impact on how these effects might manifest. Methods: Bone health concerns in EBC and clinical data on BPs were retrospectively evaluated. Pooled compliance/outcomes data from realworld reports of BP therapy were applied to the EBC setting.