Addition of Trastuzumab to Lapatinib Maintains Quality of Life While Improving Progression-Free Survival: Presented at ASCO-Breast

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Title: Addition of Trastuzumab to Lapatinib Maintains Quality of Life While Improving Progression-Free Survival: Presented at ASCO-Breast
URL: http://www.pslgroup.com/dg/22B67E.htm
Doctor's Guide
September 8, 2008

Lisa M. Cockrell, PhD

WASHINGTON, DC -- September 8, 2008 -- Patient quality of life (QOL) is comparable for patients receiving lapatinib plus trastuzumab or lapatinib alone, according to results of an analysis of phase 3 clinical data.

In addition, said lead author Harold J. Burstein, MD, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, the combination of lapatinib and trastuzumab had a better progression-free survival (PFS) than those on lapatinib monotherapy.

Dr. Burstein and colleagues presented their findings here on September 5 at the American Society for Clinical Oncology's 2008 Breast Cancer Symposium (ASCO-Breast).

The aim of this multicentre, open-label trial was to compare the effects on QOL and PFS of combination therapy with lapatinib/trastuzumab versus lapatinib monotherapy.

Lapatinib is a small-molecule tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2), while trastuzumab is a monoclonal antibody directed against the HER2 receptor.

A previous presentation at the 2008 ASCO Annual Meeting showed that the lapatinib/trastuzumab combination significantly improved PFS, with a hazard ratio of 0.73 (P = .008). This was accompanied by a significant increase in the rate of clinical benefit (complete response, partial response, and stable disease) compared with lapatinib monotherapy (24.7% vs 12.4%, respectively, P = .01).

A total of 296 women with HER2-positive metastatic breast cancer were randomised to 1 of the 2 treatments in a 1:1 design. Crossover to the combination arm was allowed after progression on single-agent lapatinib. All participants had progressed on at least 1 regimen containing trastuzumab prior to study entry.

Patient QOL was determined using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire, comprised of 37 items, which produces 5 subscores (physical well-being, social/family well-being, emotional well-being, functional well-being, and breast cancer). Each of these 5 subscores is also used to further generate the FACT-General (FACT-G) and Trial Outcome Index (TOI) scores. In all 3 scores, higher values are indicative of better QOL.

The FACT-B questionnaire was completed at baseline, weeks 4, 12, and 16, followed by every 8 weeks until therapy discontinuation, at which time patients completed a final questionnaire.

More than 95% of patients completed the QOL questionnaire at baseline. Scores on the FACT-B questionnaire were similar in the 2 treatment arms at the start of the study. The baseline mean FACT-B score was 98.7 and 97.2 points for the lapatinib/trastuzumab and lapatinib monotherapy arms, respectively.

At the follow-up QOL evaluations, scores showed a small decline over time, but remained similar between the 2 treatment groups. Differences in the QOL scores were calculated as the score in the lapatinib monotherapy arm subtracted from the score in the combination arm. Although some differences were noted in favour of the combination-therapy arm, none achieved minimum clinical importance, Dr. Burstein said.

The researchers found that addition of trastuzumab to lapatinib significantly prolonged PFS while maintaining a similar QOL compared with lapatinib alone.

This combination may have an important clinical benefit for patients with metastatic breast cancer, they concluded.

[Presentation title: Impact of Lapatinib Plus Trastuzumab Versus Single-Agent Lapatinib on Quality of Life (QOL) of Patients With Trastuzumab-Refractory HER2+ (ErbB2+) Metastatic Breast Cancer (MBC). Abstract 154]

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