دورية أكاديمية
NSABP FB-7: A phase II randomized neoadjuvant trial with paclitaxel + trastuzumab and/or neratinib followed by chemotherapy and postoperative trastuzumab in HER2+ breast cancer
| العنوان: | NSABP FB-7: A phase II randomized neoadjuvant trial with paclitaxel + trastuzumab and/or neratinib followed by chemotherapy and postoperative trastuzumab in HER2+ breast cancer |
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| المؤلفون: | Jacobs S. A., Robidoux A., Abraham J., Perez-Garcia J. M., La Verde N., Orcutt J. M., Cazzaniga M. E., Piette F., Antolin S., Aguirre E., Cortes J., Llombart-Cussac A., Di Cosimo S., Kim R. S., Feng H., Lipchik C., Lucas P. C., Srinivasan A., Wang Y., Song N., Gavin P. G., Balousek A. D., Paik S., Allegra C. J., Wolmark N., Pogue-Geile K. L. |
| المساهمون: | Jacobs, S, Robidoux, A, Abraham, J, Perez-Garcia, J, La Verde, N, Orcutt, J, Cazzaniga, M, Piette, F, Antolin, S, Aguirre, E, Cortes, J, Llombart-Cussac, A, Di Cosimo, S, Kim, R, Feng, H, Lipchik, C, Lucas, P, Srinivasan, A, Wang, Y, Song, N, Gavin, P, Balousek, A, Paik, S, Allegra, C, Wolmark, N, Pogue-Geile, K |
| بيانات النشر: | BioMed Central Ltd. GB |
| سنة النشر: | 2019 |
| المجموعة: | Università degli Studi di Milano-Bicocca: BOA (Bicocca Open Archive) |
| مصطلحات موضوعية: | Breast cancer, Neoadjuvant, Neratinib, MED/06 - ONCOLOGIA MEDICA |
| الوصف: | Purpose: The primary aim of NSABP FB-7 was to determine the pathologic complete response (pCR) rate in locally advanced HER2-positive (HER2+) breast cancer patients treated with neoadjuvant trastuzumab or neratinib or the combination and weekly paclitaxel followed by standard doxorubicin plus cyclophosphamide. The secondary aims include biomarker analyses. Experimental design: pCR was tested for association with treatment, gene expression, and a single nucleotide polymorphism (SNP) in the Fc fragment of the IgG receptor IIIa-158V/F (FCGR3A). Pre-treatment biopsies and residual tumors were also compared to identify molecular changes. Results: The numerical pCR rate in the trastuzumab plus neratinib arm (50% [95%CI 34-66%]) was greater than that for single-targeted therapies with trastuzumab (38% [95%CI 24-54]) or neratinib (33% [95%CI 20-50]) in the overall cohort but was not statistically significant. Hormone receptor-negative (HR-) tumors had a higher pCR rate than HR+ tumors in all three treatment arms, with the highest pCR rate in the combination arm. Diarrhea was the most frequent adverse event and occurred in virtually all patients who received neratinib-based therapy. Grade 3 diarrhea was reported in 31% of patients; there were no grade 4 events. Our 8-gene signature, previously validated for trastuzumab benefit in two different clinical trials in the adjuvant setting, was correlated with pCR across all arms of NSABP FB-7. Specifically, patients predicted to receive no trastuzumab benefit had a significantly lower pCR rate than did patients predicted to receive the most benefit (P = 0.03). FCGR genotyping showed that patients who were homozygous for the Fc low-binding phenylalanine (F) allele for FCGR3A-158V/F were less likely to achieve pCR. Conclusions: Combining trastuzumab plus neratinib with paclitaxel increased the absolute pCR rate in the overall cohort and in HR- patients. The 8-gene signature, which is validated for predicting trastuzumab benefit in the adjuvant setting, was associated with pCR in ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | ELETTRONICO |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/31796073; info:eu-repo/semantics/altIdentifier/wos/WOS:000510615200002; volume:21; issue:1; journal:BREAST CANCER RESEARCH; http://hdl.handle.net/10281/259086Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85075974733; http://breast-cancer-research.comTest/ |
| DOI: | 10.1186/s13058-019-1196-y |
| الإتاحة: | https://doi.org/10.1186/s13058-019-1196-yTest http://hdl.handle.net/10281/259086Test http://breast-cancer-research.comTest/ |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.9140DC33 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1186/s13058-019-1196-y |
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