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CME/CE

FDA Approval: Pertuzumab for Neoadjuvant Treatment of Breast Cancer

  • Authors: News Author: Nick Mulcahy
    CME Author: Laurie Barclay, MD
  • CME/CE Released: 10/28/2013
  • THIS ACTIVITY HAS EXPIRED
  • Valid for credit through: 10/28/2014
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Target Audience and Goal Statement

This article is intended for primary care clinicians, gynecologists, oncologists, and other specialists who care for patients with breast cancer.

The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  1. Describe a new FDA-approved indication for pertuzumab.
  2. Describe data underlying the new FDA-approved indication for pertuzumab.
  3. Distinguish adverse effects associated with pertuzumab.


Disclosures

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Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.


Author(s)

  • Nick Mulcahy

    Nick Mulcahy is a senior journalist for Medscape Medical News and covers oncology. He was a recipient of a journalism fellowship from the National Press Foundation in 2010. Formerly, Nick was a freelance medical news reporter for 15 years. His byline appeared on washingtonpost.com, usnews.com, yahoo.com, and many other Web sites. He previously reported for International Medical News Group (Elsevier), MedPage Today, and HealthDay. Nick is also the former managing editor of breastcancer.org. A graduate of the University of Pennsylvania, Nick is based in Philadelphia. He can be contacted at [email protected]

    Disclosures

    Disclosure: Nick Mulcahy has disclosed no relevant financial relationships.

Editor(s)

  • Amy Nadel

    Disclosures

    Disclosure: Amy Nadel has disclosed no relevant financial relationships.

CME Author(s)

  • Laurie Barclay, MD

    Freelance writer and reviewer, Medscape, LLC

    Disclosures

    Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.

CME Reviewer(s)

  • Yullee C. Chui

    Program Manager, Medscape, LLC

    Disclosures

    Disclosure: Yullee C. Chui has disclosed no relevant financial relationships.


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CME/CE

FDA Approval: Pertuzumab for Neoadjuvant Treatment of Breast Cancer

Authors: News Author: Nick Mulcahy CME Author: Laurie Barclay, MDFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED

CME/CE Released: 10/28/2013

Valid for credit through: 10/28/2014

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Clinical Context

Among women, breast cancer is the second leading cause of cancer-related death, according to the National Cancer Institute. The human epidermal growth factor receptor 2 (HER2) protein is increased in nearly 20% of breast cancers.

In 2012, the US Food and Drug Administration (FDA) approved pertuzumab as a targeted therapy for patients with metastatic HER2-positive breast cancer. The current FDA approval of pertuzumab for the neoadjuvant treatment of breast cancer is said to be a "landmark" approval. Treating high-risk patients in the earliest disease setting may help to delay or prevent cancer recurrences.

Synopsis and Perspective

The FDA approved pertuzumab (Perjeta) to be used in combination with other agents before surgery in women with HER2-positive early-stage breast cancer.

Pertuzumab is the first medicine approved by the FDA for the neoadjuvant treatment of breast cancer. As such, it is a "landmark" approval, said David Steensma, MD, from Harvard Medical School in Boston, Massachusetts, when he and other members of the FDA's Oncologic Drugs Advisory Committee reviewed and recommended the drug.

The targeted therapy was previously approved for use in 2012 in patients with metastatic HER2-positive breast cancer.

The FDA's endorsement of pertuzumab comes under the agency's accelerated approval program. Confirmatory evidence from additional clinical trials will be needed eventually for the approval to be permanent.

Pertuzumab is now specifically indicated for the neoadjuvant treatment of breast cancer, in combination with trastuzumab and docetaxel, for patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (> 2 cm in diameter) that is high risk, as part of a complete early breast cancer regimen also containing fluorouracil, epirubicin, and cyclophosphamide or carboplatin. As part of this regimen, patients will receive trastuzumab after surgery to complete 1 year of treatment.

"We are seeing a significant shift in the treatment paradigm for early stage breast cancer," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, in a press statement. "By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences.''

The accelerated approval of pertuzumab for neoadjuvant treatment is based on a study designed to measure pathologic complete response (pCR), defined as the absence of invasive cancer in the breast and lymph nodes. In May 2012, the FDA issued a draft guidance on the use of the measure in this setting.

pCR is being used in lieu of the traditional measures of event-free or overall survival. The FDA has admitted that pCR has not been proven to predict either event-free or overall survival. However, an FDA official recently said that this high-risk early breast cancer population "justifies the risk" of considering pertuzumab on the basis of its pCR.

The main study supporting the new application is the Neoadjuvant Study of Pertuzumab and Herceptin in an Early Regimen Evaluation (NEOSPHERE), a randomized trial that compared a number of regimens with and without pertuzumab in women with HER2-positive breast cancer. In that trial, 39.3% of patients treated with pertuzumab, trastuzumab, and docetaxel (n = 107) had a pCR compared with 21.5% of patients treated with trastuzumab and docetaxel (n = 107).

The most common severe (≥ grade 3) adverse events for pertuzumab plus trastuzumab and docetaxel were neutropenia (44.9%), febrile neutropenia (8.4%), leukopenia (4.7%), and diarrhea (5.6%).

Other significant adverse effects included decreased cardiac function, infusion-related reactions, hypersensitivity reactions, and anaphylaxis.

The confirmatory trial is known as Adjuvant Pertuzumab and Herceptin in Initial Therapy of Breast Cancer (APHINITY) and will provide further data on efficacy, safety, and long-term outcomes. Results are expected in 2016, according to the FDA.

More information on the new FDA approval of pertuzumab is available on the FDA Web site.

Clinical Implications

  • The FDA has approved pertuzumab for the neoadjuvant treatment of breast cancer in patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (> 2 cm in diameter) that is high risk. It is to be given in combination with trastuzumab and docetaxel, as part of a complete early breast cancer regimen also containing fluorouracil, epirubicin, and cyclophosphamide or carboplatin. After surgery, patients should receive the trastuzumab-containing regimen for 1 year.
  • The new FDA approval is primarily based on the randomized NEOSPHERE, which compared a number of regimens with and without pertuzumab in women with HER2-positive breast cancer. pCR occurred in 39.3% of patients treated with pertuzumab, trastuzumab, and docetaxel, but in only 21.5% of patients treated with trastuzumab and docetaxel without pertuzumab.
  • For pertuzumab plus trastuzumab and docetaxel, the most common severe (≥ grade 3) adverse events were neutropenia in 44.9% of patients, febrile neutropenia in 8.4%, leukopenia in 4.7%, and diarrhea in 5.6%.Other significant adverse effects included reduced cardiac function, infusion-related reactions, hypersensitivity reactions, and anaphylaxis.

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