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New Data Offers Insights Into the Potential Role for TYKERB(R) (Lapatinib) in Non-Cytotoxic Chemotherapy-Based Treatment Regimens
Date:6/1/2008

ents receiving the combination had a 36.2

percent response rate (90 percent CI 26.7-45.8) at 12 weeks vs. a 22.2

percent response rate (90 percent CI 14.2-30.3) for those in the

monotherapy arm.

A retrospective analysis of response rate at any time up to 12 weeks was also performed:

-- By investigator assessment, patients receiving the combination had a

56.5 percent response rate (90 percent CI 46.7 - 66.3) vs. a 31.9

percent response rate (90 percent CI 22.9 - 41.0) for those in the

monotherapy arm.

-- By independent assessment patients receiving the combination had a 43.5

percent response rate (90 percent CI 33.7 - 53.3) vs. a 23.6 percent

response rate (90 percent CI 15.4 - 31.8) for those in the monotherapy

arm.

"Data outcomes from this study are important because they demonstrate that these two targeted therapies can be combined and may provide a potential, future treatment option for HER2-positive breast cancer," said Dr. Dennis Slamon, UCLA Jonsson Comprehensive Cancer Center. "In addition, both drugs are taken orally once daily."

Treatment continued until tumor progression, patients withdrew due to an adverse event (AE) or withdrawal of consent.(1) Three patients in the combination arm had an asymptomatic decrease (greater than or equal to 20 percent) in left ventricular ejection fraction (LVEF) that was below the lower limit of normal. One patient had a smaller decline (< 20 percent) in LVEF that was symptomatic. The most common adverse events (AEs) in the combination arm versus the monotherapy arm were diarrhea (67 percent vs. 58 percent), rash (28 percent vs. 29 percent), AST increase (32 percent vs. 16 percent), ALT increase (30 percent vs. 16 percent), nausea (29 percent vs. 16 percent), hypertension (26 percent vs. 4 percent), respectively (all grades).(1) There was one death in the monotherapy arm due to hepatic failure and one dea
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SOURCE GlaxoSmithKline
Copyright©2008 PR Newswire.
All rights reserved

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