Does HER-2 Status Predict Only a Decreased Response to Hormone Therapy in Advanced Breast Cancer, or Does It Also Predict the Extent of Metastatic Disease?
Authors: Miquel Beltràn, Ramon Colomer, A Lipton, S.M. Ali, K. Leitzel
Journal: Journal of Clinical Oncology (2002)

Article Tools SPECIAL DEPARTMENTS Article Tools OPTIONS & TOOLS Export Citation Track Citation Add To Favorites Rights & Permissions COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2002.99.191 Journal of Clinical Oncology - published online before print September 21, 2016 PMID: 12454123 Does HER-2 Status Predict Only a Decreased Response to Hormone Therapy in Advanced Breast Cancer, or Does It Also Predict the Extent of Metastatic Disease? Miquel BeltrànxMiquel BeltrànSearch for articles by this author , Ramon ColomerxRamon ColomerSearch for articles by this author A LiptonxA LiptonSearch for articles by this author , S.M. AlixS.M. AliSearch for articles by this author , K. LeitzelxK. LeitzelSearch for articles by this author Show More Institut Català Oncologia, Girona, SpainPenn State College of Medicine, Hershey, PA https://doi.org/10.1200/JCO.2002.99.191 First Page Full Text PDF Figures and Tables © 2002 by American Society of Clinical OncologyjcoJ Clin OncolJournal of Clinical OncologyJCO0732-183X1527-7755American Society of Clinical OncologyResponse01122002In Reply:We respond to Drs Beltràn and Colomer’s important concerns regarding our article1 as follows: With regard to serum HER-2/neu and site of metastases, in response to a previous letter to the editor,2 we had performed a 2 × 2 χ2 analysis and a multivariate analysis within the two strata of visceral disease and nonvisceral disease. According to the χ2 tests, clinical benefit (complete response + partial response + stable) within each stratum was significantly less for patients with elevated serum HER-2/neu levels versus patients with normal serum HER-2/neu levels (P = .0001 and P = .0011, respectively). Likewise, according to the multivariate analyses, serum HER-2/neu remained a significant prognostic factor for response to therapy within the two strata (P = .0005 and P = .002, respectively). With regard to serum HER-2/neu and tumor burden, we have addressed the impact of tumor burden as measured by CA 15-3 on the predictive and prognostic value of serum HER-2/neu in a recent report.3 In that report, based on two phase III trials of second-line hormone therapy (n = 566 patients), we concluded that “serum HER-2/neu level is a significant independent predictive and prognostic factor in hormone receptor-positive metastatic breast cancer, even when adjusted for tumor burden as measured by CA 15-3. Furthermore, the combination of elevated serum HER-2/neu and elevated serum CA 15-3 predicts a worse prognosis compared to elevated CA 15-3 alone.” A multivariate analysis, including age, serum HER-2/neu, estrogen receptor/progesterone receptor, disease-free interval, Eastern Cooperative Oncology Group performance status, and site of metastases (visceral v nonvisceral), yielded serum HER-2/neu as a significant independent variable for clinical benefit (P < .0001; odds ratio, 0.39), time to progression (P < .0001; hazard ratio, 1.97), and overall survival (P < .0001; hazard ratio, 2.2), while serum CA 15-3 remained a significant independent variable for overall survival only. So the answer to Drs Beltràn and Colomer’s question is yes, serum HER-2 status predicts decreased response to hormone therapy when adjusted for visceral metastatic disease, tumor burden, and, in a multivariate model, other traditional covariates. 1. Lipton A, Ali SM, Leitzel K, et al: Elevated serum Her-2/neu level predicts decreased response to hormone therapy in metastatic breast cancer. J Clin Oncol 20:: 1467,2002-1472, Link, Google Scholar2. Panasci LC: HER-2/ serum levels vis-à-vis hormonal response in metastatic breast cancer. J Clin Oncol 20:: 3357,,2002 (letter)neu Google Scholar3. Ali SM, Leitzel K, Chinchilli V, et al: Relationship of serum HER-2/neu to serum CA 15-3 in patients with metastatic breast cancer. Clin Chem 48:: 1314,2002-1320, Medline, Google Scholar