Hormonal Contraception Increases Breast Cancer Risk

December 28th, 2017

It is estimated that approximately 140 million women worldwide use hormonal contraception and this number accounts for approximately 13% of women between the ages of 15 and 49 years. Estrogen promotes the development of breast cancer and there is evidence to suggest that use of hormonal contraception at a young age may confer a higher risk of breast cancer than initiation of use later in life.
In a recent study (N Engl J Med 2017; 377:2228-2239), it was noted that the relative risk of breast cancer among all current and recent users of hormonal contraception was 1.20 (20% higher than average). This risk increased from 1.09 (9% higher than average) with less than 1 year of use to 1.38 (38% higher than average) with more than 10 years of hormonal contraception use (P=0.002). After discontinuation of hormonal contraception, the risk of breast cancer continued to be higher among the women who had used hormonal contraceptives for 5 years or more than among women who had not used hormonal contraceptives. Women who currently or recently used the progestin-only intrauterine system also had a higher risk of breast cancer than women who had never used hormonal contraceptives, with a relative risk of 1.21 (21% higher than average). These findings unequivocally suggest that no hormonal contraceptives are free of risk.

FDA Approves VERZENIO® for Hormone Receptor Positive, HER2-Negative Breast Cancer

November 1st, 2017

The FDA in September 2017, approved VERZENIO® (Abemaciclib) in combination with FASLODEX® (Fulvestrant) for women with Hormone Receptor positive (HR-positive), HER2-negative, advanced or metastatic breast cancer, with disease progression following endocrine therapy. In addition, VERZENIO® was approved as monotherapy for women and men with HR-positive, HER2-negative advanced or metastatic breast cancer, with disease progression following endocrine therapy and prior chemotherapy, in the metastatic setting. The approval of VERZENIO® in combination with FASLODEX® was based on MONARCH 2 study which showed that a combination of VERZENIO® plus FASLODEX® significantly improved Progression Free Survival and Objective Response Rates, with a tolerable safety profile, in patients with Hormone Receptor-positive and HER 2-negative metastatic breast cancer, who had progressed while receiving endocrine therapy.

FDA Approves NERLYNX® for Adjuvant Treatment of HER2 Positive Breast Cancer

September 25th, 2017

The FDA on July 17, 2017 approved NERLYNX® (Neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant Trastuzumab (HERCEPTIN®)-based therapy. NERLYNX® is a potent, irreversible, oral Tyrosine Kinase Inhibitor, of HER1, HER2 and HER4 (pan-HER inhibitor). NERLYNX® is the first TKI approved by the FDA, shown to reduce the risk for disease recurrence, in patients with early stage HER2-positive breast cancer and demonstrated significantly improved 2-year invasive Disease Free Survival.

Screening Mammography Starting at Age 40 years May Reduce Breast Cancer Deaths by 40 percent

September 12th, 2017

In the US, about 33 million screening mammograms are performed each year. Currently, the major national health care organizations in the US have different recommendations for screening mammography which has led to some confusion and emotional counterarguments. These several different recommendations include 1) Annual screening at ages 40 to 84 years. 2) Annual screening at ages 45 to 54 years and then biennially at ages 55 to 79 years. 3) Biennial screening at ages 50 to 74 years.

In a recently published study (CANCER,  August 21, 2017), it was noted  that the greatest breast cancer-specific mortality reduction was achieved with annual screening of women starting at age 40 years, saving 29,369 lives from breast cancer. This is the first study to compare the three most widely discussed recommendations for screening mammography, head to head.

KADCYLA® beneficial for patients with HER2-positive Advanced Breast Cancer who had previously received HERCEPTIN® and TYKERB®.

August 16th, 2014

KADCYLA® (Ado-Trastuzumab Emtansine, T-DM1) is an antibody-drug conjugate (ADC) comprised of the antibody HERCEPTIN® (Trastuzumab) and a chemotherapy agent Emtansine, linked together. Upon binding to the HER2 receptor, KADCYLA® not only inhibits the HER2 signaling pathways but also delivers Emtansine, a microtubule inhibitor, directly inside the tumor cells and destroys them. In the TH3RESA trial, treatment with KADCYLA® significantly improved Progression Free Survival compared to physicians choice, for those patients who had previously received HERCEPTIN® and TYKERB® (Lapatinib) and this therefore makes KADCYLA® the treatment of choice, for this patient population.

A Less Intense Schedule of ZOMETA® for Patients with Metastatic Breast Cancer

August 8th, 2014

Bisphosphonates inhibit osteoclast-mediated bone resorption and both oral and IV bisphosphonates reduce the risk of developing Skeletal Related Events (SRE’s) and delay the time to SRE’s in patients with Breast Cancer with bone metastases. In a study presented at ASCO 2014 meeting, continuing ZOMETA® (Zoledronic acid) for an additional year at the every 12 week schedule was non-inferior to ZOMETA® given every 4 weeks, among patients who had initially received IV bisphosphonates monthly, for one year or longer. This less frequent dosing of ZOMETA® compared with the standard monthly dosing, may be more convenient for the patients and result in less toxicities without compromising efficacy. More information at www.oncoprescribe.com

AFINITOR® overcomes Endocrine Resistance in Breast Cancer

May 12th, 2014

AFINITOR® can overcome endocrine resistance in patients with Metastatic Breast Cancer. This was demonstrated in the BOLERO-2 trial in which patients who had progressed on non-steroidal Aromatase Inhibitors, when treated with a combination of steroidal Aromatase Inhibitor AROMASIN® (Exemestane) and AFINITOR® (Everolimus), had significantly improved Progression Free Survival and Clinical Benefit. AFINITOR® is a mTOR inhibitor and mTOR pathway has been implicated as one of the mechanisms for endocrine resistance in Breast cancer. A recent BOLERO-2 trial update, was published in the Breast Cancer Research and Treatment 2013.

Yoga Can Improve Sense of Well Being in Breast Cancer Survivors

May 4th, 2014

It appears that Yoga can substantially reduce Inflammation, Fatigue and improve Vitality in breast cancer survivors. This was substantiated in a randomized trial, which enrolled breast cancer patients following local intervention and adjuvant chemotherapy. The authors were also able to measure and demonstrate a drop in the cytokines associated with inflammation, such as Interleukin-6 (IL-6), Interleukin-1beta (IL-1b) and Tumor Necrosis Factor-alfa (TNFa), with Yoga intervention. These interesting and intriguing findings were published in the Journal of Clinical Oncology. A summary of this study is available to review at www.oncoprescribe.com.

PERJETA® combination Improves Response Rates

October 12th, 2013

The FDA on September 30, 2013 approved PERJETA® for use in combination with HERCEPTIN® (Trastuzumab) and TAXOTERE® (Docetaxel) for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer. The accelerated approval by the FDA was based solely on the improved pCR rate with the three drug combination with no demonstrable improvement in event-free survival or overall survival. A confirmatory phase III trial is underway, with results expected in 2016. One would hope that the complete response rates would translate into improved survival. Stay tuned.

KADCYLA® (Ado-Trastuzumab Emtansine, T-DM1) now approved

February 22nd, 2013

The FDA today approved KADCYLA® for the treatment of patients  with HER2-positive metastatic breast cancer who have received prior treatment with HERCEPTIN® (Trastuzumab) and a taxane chemotherapy. In a large Phase III trial, KADCYLA® improved Progression Free Survival as well as Overall Survival compared to XELODA® (Capecitabine) and TYKERB® (Lapatinib). KADCYLA® is the fourth drug approved by the FDA, that targets the HER2 oncogene. The other  FDA-approved drugs used to treat HER2-positive breast cancer include HERCEPTIN® (1998), TYKERB® (2007) and PERJETA® (Pertuzumab) (2012).