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Breast Cancer
May 15, 2003

Serum HER-2/neu and Response to the Aromatase Inhibitor Letrozole Versus Tamoxifen

Publication: Journal of Clinical Oncology

Abstract

Purpose: To determine the effect of elevated serum HER-2/neu on the response of metastatic breast cancer patients to an aromatase inhibitor versus an antiestrogen.
Patients and Methods: Five hundred sixty-two estrogen receptor–positive metastatic breast cancer patients were randomized to first-line hormone therapy with either letrozole or tamoxifen. An automated enzyme-linked immunosorbent assay was used to detect serum HER-2/neu.
Results: For patients with normal serum HER-2/neu (70.5%), objective response rate (ORR; 39% in letrozole-treated patients v 26% in tamoxifen-treated patients; P = .008), clinical benefit (CB; 57% v 45%; P = .016), time to progression (TTP; median, 12.2 v 8.5 months; P = .0019), and time to treatment failure (TTF; median, 11.6 v 6.2 months; P = .0066) were significantly better in patients treated with letrozole. In the elevated HER-2/neu group (29.5%), there was no significant difference in ORR (17% in letrozole-treated patients v 13% in tamoxifen-treated patients; P = .45) or CB (33% v 26%; P = .31), but there was a strong trend in favor of a longer TTP with letrozole (median, 6.1 v 3.3 months; P = .0596) and a significantly longer TTF with letrozole (median, 6.0 v 3.2 months; P = .0418). Multivariate analysis revealed that elevated serum HER-2/neu was a negative predictor for ORR and TTP.
Conclusion: Patients with normal serum HER-2/neu receiving letrozole demonstrated a significantly greater ORR and CB and longer TTP and TTF than patients receiving tamoxifen. Although in patients with elevated serum HER-2/neu there was no significant difference between letrozole and tamoxifen in ORR or CB, there was a strong trend favoring longer TTP and significantly longer TTF with letrozole.

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Information

Published In

Journal of Clinical Oncology
Pages: 1967 - 1972
PubMed: 12743150

History

Published in print: May 15, 2003
Published online: November 01, 2016

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A. Lipton
From the Milton S. Hershey Medical Center, Hershey, PA; Veterans Affairs Medical Center, Lebanon, PA; Novartis Pharmaceutical Corporation, East Hanover, NJ; Bayer Corporation, Tarrytown, New York; and Novartis Pharma AG, Basel, Switzerland.
S.M. Ali
From the Milton S. Hershey Medical Center, Hershey, PA; Veterans Affairs Medical Center, Lebanon, PA; Novartis Pharmaceutical Corporation, East Hanover, NJ; Bayer Corporation, Tarrytown, New York; and Novartis Pharma AG, Basel, Switzerland.
K. Leitzel
From the Milton S. Hershey Medical Center, Hershey, PA; Veterans Affairs Medical Center, Lebanon, PA; Novartis Pharmaceutical Corporation, East Hanover, NJ; Bayer Corporation, Tarrytown, New York; and Novartis Pharma AG, Basel, Switzerland.
L. Demers
From the Milton S. Hershey Medical Center, Hershey, PA; Veterans Affairs Medical Center, Lebanon, PA; Novartis Pharmaceutical Corporation, East Hanover, NJ; Bayer Corporation, Tarrytown, New York; and Novartis Pharma AG, Basel, Switzerland.
H.A. Harvey
From the Milton S. Hershey Medical Center, Hershey, PA; Veterans Affairs Medical Center, Lebanon, PA; Novartis Pharmaceutical Corporation, East Hanover, NJ; Bayer Corporation, Tarrytown, New York; and Novartis Pharma AG, Basel, Switzerland.
H.A. Chaudri-Ross
From the Milton S. Hershey Medical Center, Hershey, PA; Veterans Affairs Medical Center, Lebanon, PA; Novartis Pharmaceutical Corporation, East Hanover, NJ; Bayer Corporation, Tarrytown, New York; and Novartis Pharma AG, Basel, Switzerland.
C. Brady
From the Milton S. Hershey Medical Center, Hershey, PA; Veterans Affairs Medical Center, Lebanon, PA; Novartis Pharmaceutical Corporation, East Hanover, NJ; Bayer Corporation, Tarrytown, New York; and Novartis Pharma AG, Basel, Switzerland.
P. Wyld
From the Milton S. Hershey Medical Center, Hershey, PA; Veterans Affairs Medical Center, Lebanon, PA; Novartis Pharmaceutical Corporation, East Hanover, NJ; Bayer Corporation, Tarrytown, New York; and Novartis Pharma AG, Basel, Switzerland.
W. Carney
From the Milton S. Hershey Medical Center, Hershey, PA; Veterans Affairs Medical Center, Lebanon, PA; Novartis Pharmaceutical Corporation, East Hanover, NJ; Bayer Corporation, Tarrytown, New York; and Novartis Pharma AG, Basel, Switzerland.

Notes

Address reprint requests to Allan Lipton, MD, Penn State Milton S. Hershey Medical Center, Department of Medicine, Division of Hematology/Oncology HO46, 500 University Dr, PO Box 850, Hershey, PA 17033; email: [email protected].

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A. Lipton, S.M. Ali, K. Leitzel, L. Demers, H.A. Harvey, H.A. Chaudri-Ross, C. Brady, P. Wyld, W. Carney
Journal of Clinical Oncology 2003 21:10, 1967-1972

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