The DOI matches its Crossref record; 24 of the 24 references it cites were found in a registry or an index.
Cardiac Safety Analysis of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With or Without Trastuzumab in the North Central Cancer Treatment Group N9831 Adjuvant Breast Cancer Trial
Open accessAbstract
Purpose: To assess cardiac safety and potential cardiac risk factors associated with trastuzumab in the NCCTG N9831 Intergroup adjuvant breast cancer trial. Patients and Methods: Patients with HER2-positive operable breast cancer were randomly assigned to doxorubicin plus cyclophosphamide (AC) followed by either weekly paclitaxel (arm A); paclitaxel then trastuzumab (arm B); or paclitaxel plus trastuzumab then trastuzumab alone (arm C). Left ventricular ejection fraction (LVEF) was evaluated at registration and 3, 6, 9, and 18 to 21 months. Results: Of 2,992 patients completing AC, 5.0% had LVEF decreases disallowing trastuzumab (decrease below normal: 2.4%, decrease > 15%: 2.6%). There were 1,944 patients with satisfactory or no LVEF evaluation who proceeded to post-AC therapy. Cardiac events (congestive heart failure [CHF] or cardiac death [CD]): arm A, n = 3 (2 CHF, 1 CD); arm B, n = 19 (18 CHF, 1 CD); arm C, n = 19 (all CHF); 3-year cumulative incidence: 0.3%, 2.8%, and 3.3%, respectively. Cardiac function improved in most CHF cases following trastuzumab discontinuation and cardiac medication. Factors associated with increased risk of a cardiac event in arms B and C: older age (P < .003), prior/current antihypertensive agents (P = .005), and lower registration LVEF (P = .033). Incidence of asymptomatic LVEF decreases requiring holding trastuzumab was 8% to 10%; LVEF recovered and trastuzumab was restarted in approximately 50%. Conclusion: The cumulative incidence of post-AC cardiac events at 3 years was higher in the trastuzumab-containing arms versus the control arm, but by less than 4%. Older age, lower registration LVEF, and antihypertensive medications are associated with increased risk of cardiac dysfunction in patients receiving trastuzumab following AC.
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Studies of the HER-2/ neu Proto-Oncogene in Human Breast and Ovarian Cancer
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Trastuzumab plus Adjuvant Chemotherapy for Operable HER2-Positive Breast Cancer
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Self-citationTrastuzumab-Induced Hepatotoxicity: A Case Report
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Risk Factors for Doxorubicin-lnduced Congestive Heart Failure
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Self-citationSmith, I., Procter, M., Gelber, R. D., Guillaume, S., Feyereislova, A., Dowsett, M., Goldhirsch, A., Untch, M., Mariani, G., Baselga, J., et al. (2007) · The Lancet · doi:10.1016/s0140-6736(07)60028-2 · Cited by 1,507
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Wolff, A. C., Hammond, M. E. H., Hicks, D. G., Dowsett, M., McShane, L. M., Allison, K. H., Allred, D. C., Bartlett, J. M. S., Bilous, M., Fitzgibbons, P., et al. (2014) · Archives of Pathology and Laboratory Medicine · doi:10.5858/arpa.2013-0953-sa · Cited by 1,762
Self-citationGianni, L., Eiermann, W., Semiglazov, V., Manikhas, A., Lluch, A., Tjulandin, S., Zambetti, M., Vazquez, F., Byakhow, M., Lichinitser, M., et al. (2010) · The Lancet · doi:10.1016/s0140-6736(09)61964-4 · Cited by 1,255
Curigliano, G., Lenihan, D., Fradley, M., Ganatra, S., Barac, A., Blaes, A., Herrmann, J., Porter, C., Lyon, A. R., Lancellotti, P., et al. (2020) · Annals of Oncology · doi:10.1016/j.annonc.2019.10.023 · Cited by 1,031
Bowles, E. J. A., Wellman, R., Feigelson, H. S., Onitilo, A. A., Freedman, A. N., Delate, T., Allen, L. A., Nekhlyudov, L., Goddard, K. A. B., Davis, R. L., et al. (2012) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djs317 · Cited by 566
Bodai, B. I., & Tuso, P. (2015) · The Permanente Journal · doi:10.7812/tpp/14-241 · Cited by 397
Metadata
- Authors
- Perez, E. A., Suman, V. J., Davidson, N. E., Sledge, G. W., Kaufman, P. A., Hudis, C. A., Martino, S., Gralow, J. R., Dakhil, S. R., Ingle, J. N., Winer, E. P., Gelmon, K. A., Gersh, B. J., Jaffe, A. S., & Rodeheffer, R. J.
- Venue
- Journal of Clinical Oncology
- Published
- 2008-03-10
- Volume
- 26
- Issue
- 8
- Pages
- 1231-1238
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2152647863
- Cited by
- 538
- References
- 24
- FWCI
- 38.72
- Type
- journal article
- Language
- en
- Open access
- green
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- Perez, E. A., Suman, V. J., Davidson, N. E., Sledge, G. W., Kaufman, P. A., Hudis, C. A., Martino, S., Gralow, J. R., Dakhil, S. R., Ingle, J. N., Winer, E. P., Gelmon, K. A., Gersh, B. J., Jaffe, A. S., & Rodeheffer, R. J. (2008). Cardiac Safety Analysis of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With or Without Trastuzumab in the North Central Cancer Treatment Group N9831 Adjuvant Breast Cancer Trial. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2007.13.5467
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