C-ERB-B2 expression as a predictor of outcome in a randomized trial comparing adjuvant CMF vs single-agent epirubicin in stage I-II breast cancer (BC) patients

Colozza, Mariantonietta; Gori, Stefania; Mosconi, A.M.; Bucciarelli, E; Bisagni, Giancarlo; Rodinò, C.; Bian, A. Rosa; Sabbatini, Roberto; Mazzocchi,

doi:10.1016/s0959-8049(99)80719-9

Cited by 6 publications

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“…Similar retrospective analyses from two other randomized studies—National Surgical Adjuvant Breast and Bowel Project (NSABP) Study B‐11 (L‐phenylalanine mustard, doxorubicin, and 5‐FU vs. L‐phenylalanine mustard and 5‐FU) and South West Oncology Group Study 8814 (tamoxifen vs. tamoxifen plus CAF)—also indicated that the addition of an anthracycline to adjuvant therapy improved DFS only in patients with positive HER‐2 status 11, 12. However, several other studies failed to reveal a statistically significant correlation between HER‐2 overexpression and improved response to anthracycline therapy 13, 14. Retrospective evaluation of the HER‐2 status of patients who participated in NSABP Study B‐15 failed to show a statistically significantly better outcome with doxorubicin‐based therapy in patients who had HER‐2‐overexpressing tumors compared with patients who had tumors with normal HER‐2 status, although a trend toward improved DFS was observed 15.…”

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“…11,12 However, several other studies failed to reveal a statistically significant correlation between HER-2 overexpression and improved response to anthracycline therapy. 13,14 Retrospective evaluation of the HER-2 status of patients who participated in NSABP Study B-15 failed to show a statistically significantly better outcome with doxorubicin-based therapy in patients who had HER-2overexpressing tumors compared with patients who had tumors with normal HER-2 status, although a trend toward improved DFS was observed. 15 Similarly, a nonsignificant trend toward a better outcome in patients with HER-2 positive tumors who were treated with epirubicin was reported by Di Leo and his colleagues, who compared epirubicin plus cyclophosphamide with CMF adjuvant treatment.…”

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Correlation between HER‐2 expression and response to neoadjuvant chemotherapy with 5‐fluorouracil, doxorubicin, and cyclophosphamide in patients with breast carcinoma

Zhang

Yang

Smith

et al. 2003

Cancer

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BACKGROUNDThe objective of this study was to determine whether HER‐2 overexpression is associated with improved response to neoadjuvant chemotherapy with 5‐fluorouracil, doxorubicin, cyclophosphamide (FAC) in patients with breast carcinoma.METHODSNinety‐seven patients with Stage I–III breast carcinoma were included. HER‐2 expression was determined by routine clinical laboratory assessment, and tumors with 3 + immunohistochemistry staining intensity or gene amplification by fluorescent in situ hybridization were considered HER‐2 positive. Response was assessed by physical examination, imaging assessment, and pathologic assessment at the time of surgery.RESULTSThe median patient age was 45 years. At baseline, 68% of patients had lymph node positive disease, 87% had ≥ T2 tumors, and 28% of patients had HER‐2 positive tumors. Eighty‐four percent of patients received four courses of FAC, 8% of patients received 3 courses of FAC, and the remaining 8% of patients received 5–6 courses of FAC. The clinical response rate (complete response [CR] and partial response [PR]) was 78%, the imaging response rate (CR and PR) was 64%, and 15% of patients had a good pathologic response, defined as a CR or minimal residual disease (tumor measuring < 1 cm in greatest dimension and negative lymph nodes). Concordance between the three methods of response assessment (clinical, pathologic, and imaging) was modest and was best between clinical assessment and imaging assessment (64% concordance). HER‐2 status did not correlate with pathologic or clinical response (assessed by physical examination or imaging), although a nonsignificant trend was noted toward better response in patients with breast tumors that overexpressed HER‐2.CONCLUSIONSThe authors found no significant correlation between HER‐2 expression and clinical or pathologic response to neoadjuvant chemotherapy in patients with breast carcinoma. Cancer 2003;97:1758–65. © 2003 American Cancer Society.DOI 10.1002/cncr.11245

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Correlation between HER‐2 expression and response to neoadjuvant chemotherapy with 5‐fluorouracil, doxorubicin, and cyclophosphamide in patients with breast carcinoma

Zhang

Yang

Smith

et al. 2003

Cancer

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“…Por otra parte, a la vista de los datos disponibles hasta la actualidad, ninguno de ellos, no obstante, representativo de una investigación que pueda considerarse de nivel de evidencia I, los tumores c-erbB-2 positivos, más que resistentes a la quimioterapia -como se pensaba especialmente de su interacción con las variantes del CMF-serían sensibles, e incluso hipersensibles, a los tratamientos adyuvantes basados en la adriamicina. En efecto, tres grupos cooperativos han revisado los resultados de ensayos con pacientes tratadas en alguno de sus brazos con combinaciones quimioterápicas que incluían adriamicina en función del estado del c-erbB-2: el CALG-B, el NSABP y el SWOG; y los tres han publicados conclusiones acordes con esta hipótesis[58][59][60] .De tal manera que, con apoyos recientes de otros estudios 61 , y con excepciones62 , la evidencia actual, aunque incompleta, sugiere que para la mayoría de los pacientes c-erbB-2 positivos, con cánceres de mama para los que esté indicada la quimioterapia adyuvante, son apropiados esquemas terapéuticos que contengan una antraciclina. Sin embargo, son necesarios estudios prospectivos para determinar inequívocamente que la positividad del c-erbB-2 permite seleccionar regímenes específicos de quimioterapia17 .Por último, sostenida por estudios de poca calidad, la evidencia actual también parece apoyar cierta resistencia a la hormonoterapia de los cánceres de mama c-erbB-2 positivos 48 , aunque debe prevalecer la certeza de que los pacientes RE y/o RP positivos deben ser tratados hormonalmente cuando está indicado, independientemente del estado del c-erbB-213 .Otros biomarcadoresVarios biomarcadores, además de los previamente evaluados, han sido propuestos como factores predictivos para la hormonoterapia -pS2, EGFr,TGFa, marcadores de proliferación (fracción en fase S, Ki67/MiB1, PCNA, TLI), factores de metástasis (uPA, PAI-1)-y para la quimioterapia -p53, bcl2, marcadores de proliferación, proteínas del shock por calor-.…”

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Prognostic and predictive factors in early breast cancer

Domínguez

Marcos²,

Meiriño³

et al. 2009

An Sist Sanit Navar

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RESUMENSon muchos los factores pronósticos y predictivos potenciales en el cáncer de mama y su número aumenta continuamente. Las aportaciones a este incremento de las nuevas tecnologías para el estudio de los materiales genéticos, capaces de medir miles de genes simultáneamente en un único espécimen tumoral, son fundamentales; aunque su incorporación a la práctica clínica dependerá del adecuado diseño y análisis de las investigaciones.Sin embargo, los factores pronósticos validados son pocos y no han aumentado en la última década. Se mantienen como tales el estado de los ganglios axilares, el tamaño tumoral, el grado histológico y nuclear, la edad y los receptores de estrógeno (RE) y de progesterona (RP). Los factores predictivos validados aún son menos: sólo se consideran significativos los RE y RP. Con estudios adicionales, y la estandarización de los métodos de laboratorio, el c-erbB-2 podría añadirse pronto a los factores pronósticos y predictivos validados.Palabras clave: Cáncer de mama. Factor pronóstico. Factor predictivo. ABSTRACTThere are many potential prognostic and predictive factors in breast cancer and their number is growing every day. The contributions of the novel technologies for the study of genetic materials, that already have the capability of measuring thousands of genes simultaneously on a single tumor especimen, are of primary importance for this increment, but their integration into clinical practice will depend on the proper design and analysis of clinical investigations.However, the validated prognostic factors are few and has been unchanged for more than a decade. Accepted prognostic factors include axillary node status, tumor size, histological and nuclear grade, age and hormonal receptor status (ER and PR). Predective validated factors still are less: only ER and PR. With additional studies and the estandarización of the assays, the c-erbB-2 may soon be added to the list of prognostic and predictive validated factors.

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Is HER2/neu Overexpression a Predictor of Anthracycline Utility?

D'Orazio¹

2001

Clinical Breast Cancer

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C-ERB-B2 expression as a predictor of outcome in a randomized trial comparing adjuvant CMF vs single-agent epirubicin in stage I-II breast cancer (BC) patients

Cited by 6 publications

References 0 publications

Correlation between HER‐2 expression and response to neoadjuvant chemotherapy with 5‐fluorouracil, doxorubicin, and cyclophosphamide in patients with breast carcinoma

Correlation between HER‐2 expression and response to neoadjuvant chemotherapy with 5‐fluorouracil, doxorubicin, and cyclophosphamide in patients with breast carcinoma

Prognostic and predictive factors in early breast cancer

Is HER2/neu Overexpression a Predictor of Anthracycline Utility?

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