Perjeta (pertuzumab) is a targeted molecular biological agent and an antineoplastic, and this is the first agent in the class of dimerization inhibitors of receptor 2 of human epidermal growth factor (HER2). Perjeta in combination with Herceptin (trastuzumab) and docetaxel has beenapproved for the treatment of patients with metastatic breast cancer overexpressing HER2, when themetastatic cancer has not been previously treated with chemotherapy or anti-HER2.
For women with HER2-positive advanced or metastatic breast cancer, a form of particularly aggressive and difficult to treat malignant tumor, this is the first in a new class of biologic drugs approved by the FDA to prolong their lives. Pertuzumab, in combination with the current standard therapy, HERCEPTIN® (trastuzumab) and chemotherapy with docetaxel, has shown good results against metastatic disease.
Women with metastatic HER2-positive breast cancer are at increased risk of worsening of their disease and, ultimately, die. Therefore they need innovative and effective treatments that will prolong the time they can spend with their family and friends. This new cancer drug appears to play this role very well.
Approval of PERJETA based on the results of the Phase III CLEOPATRA (Clinical Evaluationof Pertuzumab and trastuzumab), a global, phase III, randomized, double-blind, placebo-controlled study. In this study, people who received PERJETA,Herceptin and docetaxel chemotherapy combination lived a median of 6.1 months longer without their cancer getting worse (progression-free survival, PFS) compared to the actual main treatment,Herceptin plus chemotherapy with docetaxel alone (median PFS of 18.5 months compared to 12.4 months). Indeed, this new cancer drug brings more hope, some scientists say.
Contra-indications – Perjeta is not indicated in patients with hypersensitivity to the medication or any of the ingredients used in its preparation. Pertuzumab has been authorized under the conditions described in the Product Monograph Perjeta, taking into consideration the potential risks associated with its administration. The drug is also contraindicated in patients withmetastatic cancer that have been previously treated with chemotherapy or anti-HER2 medications.
Dosage – normally 420 mg / 14 mL of Perjeta (pertuzumab) is given as a concentrated solution for infusion. In addition to the medicinal ingredient, the solution contains glacial acetic acid, L-histidine, polysorbate 20 (also known as Alkest TW 20 and Tween 20), sucrose and water for injection. For more information, please talk to your health care provider or pharmacist.
Side Effects – In patients who received the combination of Herceptin and Perjeta with docetaxel, the most common adverse reactions to the drug include diarrhea, hair loss (alopecia), abnormally low level of white blood cells (neutropenia), nausea, fatigue, skin rash, weakness, numbness and pain in the hands and feet (peripheral neuropathy).
More serious adverse reactions to the drug such as signs of infection(febrile neutropenia), painful inflammation and ulceration, neutropenia and severe diarrhea may also occur in certain patients. These signs can indicate fetal reactions; professional care is immediately required.
The combination of Perjeta with Herceptin and docetaxel does not alter the safety profile of Herceptin and docetaxel; however, there are more frequent cases of diarrhea, rash, painful inflammation and ulceration(mucositis) and febrile neutropenia in the treatment when the drugs are combined.
According to the pivotal clinical study, the addition of Perjeta to Herceptin and docetaxel does not appear to significantly increase the risk of damage to the heart muscle (cardiotoxicity).
1 Monographie de PERJETA™ datée du 12 avril 2013. Hoffmann-La Roche Limitée
2 Sondage Léger Marketing mené auprès de 1 501 Canadiennes du 4 au 6 mars 2013, avec une marge d’erreur de ±2,5 %, 19 fois sur 20.
3 Société canadienne du cancer. http://www.cancer.ca/fr-ca/cancer-information/cancer-101/cancer-statistics-at-a-glance/?region=on (March 19, 2013)
4 Mayo Clinic. HER2-positive Breast Cancer. http://www.mayoclinic.com/health/breast-cancer/AN00495 (March 19, 2013)
5 Chia et al. Human Epidermal Growth Factor Receptor 2 Overexpression As a Prognostic Factor in a Large Tissue Microarray Series of Node-Negative Breast Cancers. Journal Of Clinical Oncology 2008;26:5697-700.
6 Ross et al. The HER-2 Receptor and Breast Cancer: Ten Years of Targeted Anti-HER-2 Therapy and Personalized Medicine. The Oncologist 2009;14:320-68.
7 Baselga J, Cortes J, Sung-Bae K, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 2012;366:109-10.
8 Swain S, et al. Confirmatory overall survival analysis of CLEOPATRA: A randomized, double-blind, placebo-controlled Phase III study with pertuzumab, trastuzumab, and docetaxel in patients with HER2-positive first-line metastatic breast cancer. Affiche présentée lors de l’édition 2012 du Symposium sur le cancer du sein de San Antonio du CTRC-AARC. Résumé no P5-18-26.
9 Réseau canadien du cancer du sein. http://www.cbcn.ca/index.php?pageaction=content.page&id=125&lang=fr (March 19, 2013)
10 BC Cancer Agency. http://www.bccancer.bc.ca/HPI/CancerManagementGuidelines/Breast/Management/MetastaticBreastCancer.hm (March 19, 2013)
11 Wolff et al. American Society of Clinical Oncology/College of American Pathologists Guideline, Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer, Arch Patho Lab Med 2007;101:18-43.
12Tell Her 2 http://tellher2.ca/her2/ (March 19, 2013)