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Clinical Trial
. 2013;18(5):501-10.
doi: 10.1634/theoncologist.2012-0414. Epub 2013 May 7.

First-line treatment patterns and clinical outcomes in patients with HER2-positive and hormone receptor-positive metastatic breast cancer from registHER

Debu Tripathy  1 , Peter A Kaufman, Adam M Brufsky, Musa Mayer, Marianne Ulcickas Yood, Bongin Yoo, Cheng Quah, Denise Yardley, Hope S Rugo
Affiliations
Clinical Trial

First-line treatment patterns and clinical outcomes in patients with HER2-positive and hormone receptor-positive metastatic breast cancer from registHER

Debu Tripathy et al. Oncologist. 2013.

Abstract

Background: Limited data are available describing the natural history of patients with HER2-positive and hormone receptor (HR)-positive metastatic breast cancer (MBC). We examined first-line treatment patterns and clinical outcomes in patients with HER2-positive, HR-positive MBC in a real-world setting.

Methods: registHER is a prospective, observational cohort of 1,023 patients with HER2-positive MBC diagnosed within 6 months of enrollment and followed until death, disenrollment, or June 2009 (median follow-up time: 27 months). Demographics, first-line treatment patterns, and clinical outcomes were examined for 530 HER2-positive, HR-positive patients. Progression-free survival (PFS) and overall survival (OS) times were examined. Multivariate analyses adjusted for baseline demographic and prognostic factors.

Results: HER2-positive, HR-positive patients receiving first-line trastuzumab plus hormonal therapy had significantly longer PFS times than patients who received hormonal therapy only (13.8 vs. 4.8 months; adjusted hazard ratio [HR]: 0.37, 95% confidence interval [CI]: 0.22-0.60); a nonsignificant reduction in OS time was observed (adjusted HR: 0.55, 95% CI: 0.27-1.14). Compared with patients who received first-line trastuzumab plus chemotherapy, patients who received first-line trastuzumab plus chemotherapy and hormonal therapy had longer median PFS times (20.4 months vs. 9.5 months; adjusted HR: 0.53, 95% CI: 0.42-0.68); a statistically significant reduction in risk of death was observed (adjusted HR: 0.50, 95% CI: 0.36-0.70). Sequential use of chemotherapy and hormonal therapy was associated with improved OS times when compared with concurrent use (adjusted PFS HR: 0.81, 95% CI: 0.54-1.21; adjusted OS HR: 0.48, 95% CI: 0.26-0.89).

Conclusions: These real-world data in patients with HER2-positive/HR-positive MBC provide evidence that, with or without chemotherapy, dual targeting of HRs and HER2 receptors is associated with significantly prolonged PFS and OS times.

Keywords: Breast cancer; HER2; Hormone receptor; Metastatic; Trastuzumab; Treatment.

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Conflict of interest statement

Disclosures of potential conflicts of interest may be found at the end of this article.

Figures

Figure 1.
Figure 1.
Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) diagram for registHER study population and analysis cohort for first-line treatment. Abbreviations: Chemo, chemotherapy; HR, hormone receptor (estrogen receptor and/or progesterone receptor); HT, hormonal therapy; MBC, metastatic breast cancer; T, trastuzumab.
Figure 2.
Figure 2.
Kaplan-Meier estimates. (A): Kaplan-Meier estimated progression-free survival in hormone receptor (HR)-positive patients for first-line treatment with trastuzumab plus hormonal therapy versus hormonal therapy only. (B): Kaplan-Meier estimated overall survival in HR-positive patients for first-line treatment with trastuzumab plus hormonal therapy versus hormonal therapy only. Abbreviations: CI, confidence interval; HR, hazard ratio.
Figure 3.
Figure 3.
Kaplan-Meier estimates. (A): Kaplan-Meier estimated progression-free survival in hormone receptor (HR)-positive patients for first-line treatment with trastuzumab plus chemotherapy plus hormonal therapy versus trastuzumab plus chemotherapy, and sequential versus concurrent therapy. (B): Kaplan-Meier estimated overall survival in HR-positive patients for first-line treatment with trastuzumab plus chemotherapy plus hormonal therapy versus trastuzumab plus chemotherapy, and sequential versus concurrent therapy. Abbreviations: Chemo, chemotherapy; CI, confidence interval; HR, hazard ratio.
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