Cancer Treatment Today

In June 11, 2012, U.S. Food and Drug Administration (FDA) has approved PerjetaTM (pertuzumab). Perjeta is approved in combination with Herceptin® (trastuzumab) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. This approval is based on data from a Phase III study which showed that people with previously untreated HER2-positive metastatic breast cancer who received the combination of Perjeta, Herceptin and docetaxel chemotherapy lived a median of 6.1 months longer without their cancer getting worse (progression-free survival, or PFS) compared to Herceptin plus docetaxel chemotherapy (median PFS 18.5 vs. 12.4 months).

The regimen using paclitaxel, is much less studied. There are some small phase II studies, but it is still in clinical trials. Taxol causes more neuropathy than docetaxel and this regimen is not medically necesary.

With Taxol. there is on ongoing study: Paclitaxel, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer, NCT01276041. This renders it an experimental treatment.

With anasrozole, the phase II PERTAIN study of locally advanced or metastatic hormone receptorpositive, HER2-positive breast cancer patients, the addition of pertuzumab (Perjeta) to a regimen of trastuzumab (Herceptin) and an aromatase inhibitor in the first-line setting significantly improved progression-free survival by 3 months. This study has not been published or included in guidelines.

Baselga J, Cortes J, Sung-Bae K, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med.2012; 366:109119.

Fabi A, Malaguti P, Vari S, Cognetti F. First-line therapy in HER2 positive metastatic breast cancer: is the mosaic fully completed or are we missing additional pieces?. J Exp Clin Cancer Res. 2016;35:104. Published 2016 Jun 30.

José Baselga, Karen A. Gelmon, Shailendra Verma, Andrew Wardley, PierFranco Conte, David Miles, Giulia Bianchi, Javier Cortes, Virginia A. McNally, Graham A. Ross, Pierre Fumoleau and Luca Gianni Phase II Trial of Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2Positive Metastatic Breast Cancer That Progressed During Prior Trastuzumab Therapy JCO March 1, 2010 vol. 28 no. 7 1138-1144

Smyth LM et al, Weekly paclitaxel with trastuzumab and pertuzumab in patients with HER2-overexpressing metastatic breast cancer: overall survival and updated progression-free survival results from a phase II study. Breast Cancer Res Treat. 2016 Jul;158(1):91-7.

Arpino G, Ferrero J-M, de la Haba-Rodriguez J, et al: Primary analysis of PERTAIN: A randomized, two-arm, open-label, multicenter phase II trial assessing the efficacy and safety of pertuzumab given in combination with trastuzumab plus an aromatase inhibitor in first-line patients with HER2-positive and hormone receptor-positive metastatic or locally advanced breast cancer. 2016 San Antonio Breast Cancer Symposium. Abstract S3-04. Presented December 8, 2016.

Kaufman B, Mackey JR, Clemens MR, et al: Trastuzumab plus anastrozole versus anastrozole alone for the treatment of postmenopausal women with human epidermal growth factor receptor 2-positive, hormone receptor-positive metastatic breast cancer: Results from the randomized phase III TAnDEM study. J Clin Oncol 27:5529-5537, 2009.