The 56.5-month overall survival for women with HER2-positive metastatic breast cancer receiving first-line treatment with pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and docetaxel in the CLEOPATRA trial represents a 15.7-month survival advantage for those receiving pertuzumab vs placebo.1 Those results have already generated extensive media coverage not only in the medical press, but by major media reaching large numbers of patients.
Patients asking about the use of pertuzumab should know that the U.S. Food and Drug Administration (FDA) has already approved pertuzumab in combination with trastuzumab and docetaxel for the treatment of patients with metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. In addition, an ASCO clinical practice guideline issued this past summer recommends (with some exceptions) trastuzumab, pertuzumab, and taxane for the first-line treatment of HER2-positive advanced breast cancer.2
The CLEOPATRA trial was limited to patients with metastatic breast cancer and tested pertuzumab as part of front-line treatment. However, the FDA has also approved pertuzumab in combination with trastuzumab and docetaxel for neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer.
The prescribing information includes a boxed warning concerning cardiomyopathy and embryo-fetal toxicity. The cardiomyopathy warning is based on an increased rate of left-ventricular ejection fraction decline observed in the neoadjuvant trials, according to a National Cancer Institute (NCI) drug information summary concerning pertuzumab.3
“Cardiac function should be evaluated prior to and during treatment with pertuzumab. The embryo-fetal toxicity warning is based on observations of oligohydramnios, delayed renal development, and embryo-fetal death in animal studies. Patients should be advised of these risks and the need for effective contraception prior to starting pertuzumab,” states the NCI summary. ■
1. Swain S, Kim S, Cortes J, et al: Final overall survival analysis from the CLEOPATRA study of first-line pertuzumab, trastuzumab, and docetaxel in patients with HER2-positive metastatic breast cancer. ESMO 2014 Congress. Abstract 350O. Presented September 28, 2014.
2. Giordano SH, Temin S, Kirshner JJ, et al: Systemic therapy for patients with advanced human epidermal growth factor receptor 2-positive breast cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol 32:2078-2099, 2014.
3. National Cancer Institute: FDA Approval for Pertuzumab. Updated October 1, 2013. Available at www.cancer.gov/cancertopics/druginfo/fda-pertuzumab. Accessed October 29, 2014.
"Impressive,” “outstanding,” and “unprecedented” are among the terms used to describe the 56.5-month overall survival for women with HER2-positive metastatic breast cancer receiving first-line treatment with pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and docetaxel in the...