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2. Incidence and time course of everolimus-related adverse events in postmenopausal women with hormone receptor-positive advanced breast cancer: insights from BOLERO-2

Author

Rugo, HS, Pritchard, KI, Gnant, M, Noguchi, S, Piccart, M, Hortobagyi, G, Baselga, J, Perez, A, Geberth, M, Csoszi, T, Chouinard, E, Srimuninnimit, V, Puttawibul, P, Eakle, J, Feng, W, Bauly, H, El-Hashimy, M, Taran, T, and Burris, HA

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Clinical Research, Clinical Trials and Supportive Activities, Patient Safety, Breast Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Aged, 80 and over, Breast Neoplasms, Disease-Free Survival, Drug-Related Side Effects and Adverse Reactions, Everolimus, Female, Humans, Middle Aged, Neoplasm Staging, Postmenopause, Sirolimus, TOR Serine-Threonine Kinases, advanced breast cancer, everolimus, mammalian target of rapamycin, safety, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundIn the BOLERO-2 trial, everolimus (EVE), an inhibitor of mammalian target of rapamycin, demonstrated significant clinical benefit with an acceptable safety profile when administered with exemestane (EXE) in postmenopausal women with hormone receptor-positive (HR(+)) advanced breast cancer. We report on the incidence, time course, severity, and resolution of treatment-emergent adverse events (AEs) as well as incidence of dose modifications during the extended follow-up of this study.Patients and methodsPatients were randomized (2:1) to receive EVE 10 mg/day or placebo (PBO), with open-label EXE 25 mg/day (n = 724). The primary end point was progression-free survival. Secondary end points included overall survival, objective response rate, and safety. Safety evaluations included recording of AEs, laboratory values, dose interruptions/adjustments, and study drug discontinuations.ResultsThe safety population comprised 720 patients (EVE + EXE, 482; PBO + EXE, 238). The median follow-up was 18 months. Class-effect toxicities, including stomatitis, pneumonitis, and hyperglycemia, were generally of mild or moderate severity and occurred relatively early after treatment initiation (except pneumonitis); incidence tapered off thereafter. EVE dose reduction and interruption (360 and 705 events, respectively) required for AE management were independent of patient age. The median duration of dose interruption was 7 days. Discontinuation of both study drugs because of AEs was higher with EVE + EXE (9%) versus PBO + EXE (3%).ConclusionsMost EVE-associated AEs occur soon after initiation of therapy, are typically of mild or moderate severity, and are generally manageable with dose reduction and interruption. Discontinuation due to toxicity was uncommon. Understanding the time course of class-effect AEs will help inform preventive and monitoring strategies as well as patient education.Trial registration numberNCT00863655.

Published
2014

3. Perspektiven

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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4. Methoden und Evidenz des Fortschritts

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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5. Metastasen (Sekundärtumoren)

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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6. Weichteilsarkome

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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7. Maligne Knochen- und Knorpeltumoren

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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8. Leukämien und Lymphome

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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9. Krebs des Gehirns und des Nervensystems

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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10. Krebs der weiblichen Geschlechtsorgane

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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11. Blasen- und Nierenkrebs

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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12. Krebs der männlichen Geschlechtsorgane

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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13. Lungenkrebs (Bronchialkarzinom)

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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14. Krebs des Verdauungstraktes

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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15. Krebs im Kopf-Hals-Bereich

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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16. Brustkrebs (Mammakarzinom)

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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17. Krebstherapie

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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19. Hautkrebs

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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20. Klinische Pathologie von Krebserkrankungen

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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22. Untersuchungsmethoden zur Krebserkennung

Author

Aigner, K.R., Stephens, F.O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S.M., Sugarbaker, P., Taguchi, T., Thompson, J.F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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23. Was ist eine maligne Erkrankung?

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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24. Konkrete Maßnahmen zur Krebsprävention

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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25. Epidemiologie

Author

Aigner, K. R., Stephens, F. O., Allen-Mersh, T., Hortobagyi, G., Khayat, D., Picksley, S. M., Sugarbaker, P., Taguchi, T., Thompson, J. F., Aigner, Karl R., editor, and Stephens, Frederick O., editor

Published
2016
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26. Results of MDR-1 Vector Modification Trial Indicate that Granulocyte/Macrophage Colony-Forming Unit Cells Do not Contribute to Posttransplant Hematopoietic Recovery Following Intensive Systemic Therapy

Author

Hanania, E. G., Giles, R. E., Kavanagh, J., Ellerson, D., Zu, Z., Wang, T., Su, Y., Kudelka, A., Rahman, Z., Holmes, F., Hortobagyi, G., Claxton, D., Bachier, C., Thall, P., Cheng, S., Hester, J., Ostrove, J. M., Bird, R. E., Chang, A., Korbling, M., Seong, D., Cote, R., Holzmayer, T., Mechetner, E., Heimfeld, S., Berenson, R., Burtness, B., Edwards, C., Bast, R., Andreeff, M., Champlin, R., and Deisseroth, A. B.

Published
1996

28. Radiotherapy Use and Locoregional Recurrence Rates on SWOG 1007, a US Cooperative Group Trial Enrolling Patients with Favorable-Risk Node-Positive Breast Cancer

Author

Jagsi, R., primary, Barlow, W., additional, Woodward, W.A., additional, Connolly, E.P., additional, Shumway, D., additional, Speers, C., additional, Stecklein, S.R., additional, Zhang, H., additional, Sharma, P., additional, Pusztai, L., additional, Hortobagyi, G., additional, and Kalinsky, K., additional

Published
2022
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30. SWOG S0800 (NCI CDR0000636131): addition of bevacizumab to neoadjuvant nab-paclitaxel with dose-dense doxorubicin and cyclophosphamide improves pathologic complete response (pCR) rates in inflammatory or locally advanced breast cancer

Author

Nahleh, Z. A., Barlow, W. E., Hayes, D. F., Schott, A. F., Gralow, J. R., Sikov, W. M., Perez, E. A., Chennuru, S., Mirshahidi, H. R., Corso, S. W., Lew, D. L., Pusztai, L., Livingston, R. B., and Hortobagyi, G. N.

Published
2016
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32. Principles and performance of virtual CT and MRI intraluminal endoscopy

Author

Dousset, M., Buthiau, D., Dugas, C., Picard, J.-D., Piette, J.-C., Ziza, J.M., Wechsler, B., Ducolombier, A., Lapresle, P., Grosskopf, D., Bolgert, F., Michaux, G., Delépine, N., Delépine, G., Lefebvre, G., Darbois, Y., Dargent, D., Hortobagyi, G. N., Khayat, D., Buthiau, Didier, editor, and Khayat, David, editor

Published
2003
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34. Aktualisierte Ergebnisse von Tucatinib versus Placebo in Kombination mit Trastuzumab und Capecitabin bei Patienten mit vorbehandeltem, metastasierten HER2-positiven Brustkrebs mit ZNS-Metastasen (HER2CLIMB)

Author

Greil, R, additional, Lin, N U, additional, Murthy, R K, additional, Abramson, V, additional, Anders, C, additional, Bachelot, T, additional, Bedard, P L, additional, Borges, V, additional, Cameron, D, additional, Carey, L, additional, Chien, A J, additional, Curigliano, G, additional, DiGiovanna, M P, additional, Gelmon, K, additional, Hortobagyi, G, additional, Hurvitz, S, additional, Krop, I, additional, Loi, S, additional, Loibl, S, additional, Mueller, V, additional, Oliveira, M, additional, Paplomata, E, additional, Pegram, M, additional, Slamon, D, additional, Zelnak, A, additional, Ramos, J, additional, Feng, W, additional, and Winer, E., additional

Published
2022
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50. Open-label randomized clinical trial of standard neoadjuvant chemotherapy with paclitaxel followed by FEC versus the combination of paclitaxel and everolimus followed by FEC in women with triple receptor-negative breast cancer†

Author

Gonzalez-Angulo, A. M., Akcakanat, A., Liu, S., Green, M. C., Murray, J. L., Chen, H., Palla, S. L., Koenig, K. B., Brewster, A. M., Valero, V., Ibrahim, N. K., Moulder-Thompson, S., Litton, J. K., Tarco, E., Moore, J., Flores, P., Crawford, D., Dryden, M. J., Symmans, W. F., Sahin, A., Giordano, S. H., Pusztai, L., Do, K-A., Mills, G. B., Hortobagyi, G. N., and Meric-Bernstam, F.

Published
2014
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