Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Afinitor® in HR+ Advanced Breast Cancer How does it work? • Afinitor® (everolimus) targets the mTOR pathway, which is hyperactivated in many types of cancer cells and acts as an important regulator of tumor cell division, blood vessel growth and cell metabolism2 • Endocrine therapy remains the cornerstone of treatment for women with HR+ advanced breast cancer, but most will eventually develop treatment resistance2,3 • Therapeutic resistance has been associated with overactivation of the PI3K/AKT/mTOR pathway2 The approval of Afinitor in HR+ advanced breast cancer was based on the pivotal Phase III data from the randomized, double-blind, placebo-controlled, multi-center BOLERO-2 (Breast cancer trials of OraL EveROlimus-2) trial1. • Worldwide a total of 724 women with HR+/HER2negative advanced breast cancer from 195 sites participated in the trial • All women received exemestane and were randomized 2:1 to Afinitor or placebo • 485 women received Afinitor and exemestane; 239 women received placebo and exemestane Results of BOLERO-2 1 • Afinitor plus exemestane more than doubled median progression-free survival (PFS) ›› 7.8 months with Afinitor and exemestane vs 3.2 months with placebo and exemestane alone (hazard ratio=0.45 [95% CL: 0.38 to 0.54; p<0.0001) by local investigator assessment ›› 11.0 months with Afinitor and exemestane vs 4.1 month with placebo and exemestane alone (hazard ratio=0.38 [95% CI: 0.31 to 0.48]; p<0.0001) by independent central radiology review Please see Important Safety Information on reverse. Afinitor (everolimus)* is approved in more than 80 countries for the treatment of hormone receptorpositive (HR+), HER2/neu-negative (HER2-) advanced breast cancer (HR+ advanced breast cancer), in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor1. • A finitor is the only mTOR inhibitor approved to treat advanced breast cancer • A finitor has been approved in the European Union since 2009 to treat various tumors; approximately 150,000 patients have been treated with Afinitor to date1 Dosing1 The recommended dose of Afinitor for the treatment of HR+ advanced breast cancer is 10mg, to be taken once daily at the same time every day, consistently either with or without food in combination with exemestane. Adverse Events1 The most common adverse reactions (incidence ≥ 30%) were stomatitis, infections, rash, fatigue, diarrhea and decreased appetite. The most common grade 3-4 adverse reactions (incidence ≥ 2%) were stomatitis, infections, hyperglycemia, fatigue, dyspnea, pneumonitis and diarrhea. *Known as Votubia® (everolimus) tablets for certain patients with SEGA associated with TSC in the EU and Switzerland. Afinitor ® Important Safety Information Afinitor/Votubia can cause serious side effects including lung or breathing problems, infections (including sepsis), and kidney failure, which can lead to death. Mouth ulcers and mouth sores are common side effects. Afinitor/Votubia can affect blood cell counts, kidney and liver function, and blood sugar, cholesterol, and triglyceride levels. Afinitor/Votubia may cause fetal harm in pregnant women. Highly effective contraception is recommended for women of child-bearing potential while receiving Afinitor/Votubia and for up to eight weeks after ending treatment. Women taking Afinitor/Votubia should not breast feed. Fertility in women and men may be affected by treatment with Afinitor/Votubia. The most common adverse drug reactions (incidence ≥10 percent) are mouth ulcers, skin rash, feeling tired or weak, diarrhea, nausea, decreased appetite, infections (including upper respiratory tract infection, low level of red blood cells, abnormal taste, inflammation of lung tissue, weight loss, swelling of extremities or other parts of the body, nose bleeds, itching, vomiting, high level of blood cholesterol, headache, high level of blood sugar, cough, spontaneous bleeding or bruising, and breathlessness. The most common Grade 3-4 adverse drug reactions (incidence ≥2 percent) are mouth ulcers, feeling tired or weak, infections, inflammation of lung tissue, diarrhea, spontaneous bleeding or bruising, low white blood cells (a type of blood cell that fights infection), and breathlessness. Cases of hepatitis B reactivation, blood clots in the lung or legs, and menstruation disorders such as absence of periods have been reported. Abnormalities were observed in hematology and clinical chemistry laboratory tests. References 1 Novartis Data on File. 2 Baselga, J. Everolimus in Postmenopausal Hormone-Receptor-Positive Advanced Breast Cancer. New England Journal of Medicine. February 9, 2012. 3 Ellis M. Overcoming Endocrine Therapy Resistance by Signal Transduction Inhibition. The Oncologist. April 15, 2004. ©Novartis 2014 Printed in U.S.A. G-AFI-1084413 3/14