Meta-analysis of Lapatinib plus Capecitabine versus Capecitabine in the Treatment of HER2- Positive Breast Cancer

Lynda Smith, St Cloud State University

I dedicate my thesis work to my family who has taught me to apply an immense amount of work for the things that I aspire to achieve while continually offering love and support. I will appreciate all they have done; you are my best cheerleaders. A special gratitude to my sibling, Pamela, Janice, Sharon, Scott, Andrea, and Jenny, whose support and words of encouragement kept me motivated and driven to succeed.

To my mother, Marion, though absent, you are ever near, still missed, still loved, and ever dear. Your memory is my gift with which I’ll never part. I have you forever in my heart.

Abstract

PROBLEM:

Systemic review of randomized controlled clinical trials to compare treatment outcomes for human epidermal growth factor receptor (HER)-2 positive metastatic breast cancer patients receiving combination therapy lapatinib plus capecitabine versus monotherapy with capecitabine. Meta-analysis was performed to assess the odds of tumor progression between combination therapy lapatinib plus capecitabine versus capecitabine monotherapy in women with metastatic breast cancer.

METHODS:

Several randomized clinical trials are identified comparing combination therapy lapatinib plus capecitabine versus capecitabine monotherapy in women with metastatic HER-2 positive breast cancer that had disease progression after treatment with regimens that included an anthracycline, a taxane, and trastuzumab. Patients in the treatment arm received lapatinib dosed at 1,500 mg per day continuously plus capecitabine 2,000 mg per square meter of body surface area on days 1 through 14 of a 21 day cycle. Patients in the control arm received capecitabine at a dose of 2,500 mg per square meter of body surface area on days 1 through 14 of a 21 day cycle. Mantel–Haenszel fixed-effect meta-analysis was used to combine the data to evaluate time to tumor progression in a heavily pre-treated breast cancer population.

CONCLUSION:

Three eligible clinical trials were identified, reporting outcomes on 1,131 women. Mantel–Haenszel fixed-effect analysis showed an 26.7 percent reduction in the odds of tumor progression for lapatinib plus capecitabine treated patients (odds ratio [OR], 0.733; 95 percent confidence interval [CI], 0.565 to 0.952) than patients treated with capecitabine monotherapy. The use of lapatinib plus capecitabine should be evaluated in a clinical trial for newly diagnosed HER – 2 positive patients or older patients who might otherwise be exposed to potential serious adverse side effects as a result of the current first line treatment or patients that have a pre-existing heart condition.