“The first-ever direct comparison of three adjuvant aromatase inhibitors for the treatment of postmenopausal hormone receptor–positive early breast cancer shows no significant differences in clinical efficacy or safety, according to an Italian research team.
“In the randomized, open-label phase 3 FATA-GIM3 trial of almost 3700 women, the 5-year disease-free survival for patients treated with anastrozole (Arimidex, Novartis), exemestane (Aromasin, Pfizer), or letrozole (Femara, Novartis) was 90.0%, 88.0% and 89.4%, respectively.”
“The U.S. Food and Drug Administration has given another approval for a breast cancer treatment developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY). The announcement marks the third FDA approval for Verzenio in five months.
“The most recent ruling approves Verzenio, also known as abemaciclib, for use in combination with an aromatase inhibitor as an initial endocrine-based therapy for the treatment of postmenopausal women with advanced or metastatic breast cancer. Lilly says the approval follows the results of a successful Phase 3 clinical trial.”
“Undergoing acupuncture significantly reduced joint pain related to treatment with aromatase inhibitors (AIs) in postmenopausal women with early-stage breast cancer compared with both sham acupuncture and no treatment at all, according to data from the Southwest Oncology Group (SWOG) S1200 trial presented at the 2017 San Antonio Breast Cancer Symposium, held December 5–9.”
“The triplet combination of HER2-targeted therapy and an aromatase inhibitor (AI) improved progression-free survival (PFS) by more than 5 months compared with the combination of trastuzumab (Herceptin) and an AI in patients with HER2+/HR+ breast cancer.
“In phase III results from the ALTERNATIVE trial presented at the 2017 ASCO Annual Meeting, the median PFS was 11 months (95% CI, 8.3-13.8) for postmenopausal women with HER2+/HR+ metastatic breast cancer assigned to lapatinib (Tykerb) plus trastuzumab plus an AI compared with 5.7 months (95% CI, 5.5-8.4) for patients assigned to trastuzumab plus an AI. Lead study author William J. Gradishar MD, interim chief of hematology and oncology at Northwestern University’s Feinberg School of Medicine, said that represented a 38% reduction in the risk of progression (HR, 0.62; 95% CI, 0.45-0.88; P = .0064).”
“A duration of endocrine therapy beyond 5 years has gained traction in the treatment of endocrine receptor (ER)-positive early-stage breast cancer. Long-term use of aromatase inhibitors (AIs), however, may increase the risk of bone loss and bone fracture. Data suggest that the use of bone-targeted agents can substantially reduce the risk of osteoporotic complications associated with AI use, and even reduce the risk of bone recurrence in postmenopausal women with early-stage breast cancer.”
“Dual blockade of HER2 with lapatinib plus trastuzumab and an aromatase inhibitor (AI) was superior to single blockade with trastuzumab plus an AI in postmenopausal women with HER2-positive, hormone receptor (HR)-positive metastatic breast cancer, according to the results of the phase III ALTERNATIVE study (abstract 1004) presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2–6 in Chicago.
” ‘Dual HER2 blockade with this triplet of lapatinib/trastuzumab and an AI can offer an effective and well-tolerated chemotherapy-sparing option for patients who are not intended or appropriate for chemotherapy,’ said researcher William J. Gradishar, MD, of the Robert H. Lurie Comprehensive Cancer Center at Northwestern University in Chicago, who presented the results.”
“Adding abemaciclib to letrozole or anastrozole improved progression-free survival (PFS) compared with either aromatase inhibitor alone in women with HR+/HER2-negative breast cancer enrolled in the phase III MONARCH 3 study, according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor.
“MONARCH 3 (NCT02246621) is the second phase III trial of abemaciclib to demonstrate improved PFS in patients with HR+/HER2-negative breast cancer. In March, Lilly announced that in the MONARCH 2 study, combining abemaciclib with fulvestrant extended PFS compared with fulvestrant alone in patients who had progressed during or within 1 year of receiving endocrine therapy in the neoadjuvant or adjuvant setting, or during frontline endocrine treatment for metastatic disease.”
“The US Food and Drug Administration (FDA) has approved Kisqali®(ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
“Kisqali is a CDK4/6 inhibitor approved based on a first-line Phase III trial that met its primary endpoint early, demonstrating statistically significant improvement in progression-free survival (PFS) compared to letrozole alone at the first pre-planned interim analysis. Kisqali was reviewed and approved under the FDA Breakthrough Therapy designation and Priority Review programs.”
“Data from the phase II PERTAIN trial presented late last year at the 2016 San Antonio Breast Cancer Symposium (SABCS) showed that adding an aromatase inhibitor (AI) to pertuzumab (Perjeta) and trastuzumab (Herceptin) extended progression-free survival (PFS) by over 3 months versus trastuzumab plus an AI in patients with HER2-positive, HR-positive locally advanced or metastatic breast cancer.
“The median PFS was 18.89 months with the pertuzumab triplet compared with 15.80 months for trastuzumab and an AI alone (HR, 0.65; 95% CI, 0.48-0.89; P = .007). The objective response rates were 63.3% versus 55.7%, respectively.”