“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.”
“An intermittent dosing schedule with extended adjuvant letrozole did not improve disease-free survival (DFS) over continuous treatment with the agent in postmenopausal women with hormone receptor–positive breast cancer, according to the randomized phase III SOLE trial.
” ‘The magnitude of the beneficial effect of 5 years of extended letrozole use in postmenopausal women who have previously received an aromatase inhibitor for 5 years is low,’ wrote study authors led by Marco Colleoni, MD, of the European Institute of Oncology in Milan, Italy. That small effect may be partially due to acquired resistance, and animal studies suggest that such resistance can be reversed by discontinuing treatment.”
“Previously the drug was approved as second-line monotherapy for women failing anti-estrogen therapy, and as second-line combination therapy with palbociclib (Ibrance). It was first approved by the FDA in 2002.”
“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).”
“Appropriately selected postmenopausal women with breast cancer warrant consideration for adjuvant bisphosphonate therapy, according to an updated clinical guideline.
“Either zoledronic acid (Zometa) or clodronate may be considered for adjuvant therapy, as data supporting use of other bisphosphonates remain limited. The RANK ligand-targeted monoclonal antibody denosumab (Xgeva) did not make the cut as recommended therapy because of a lack of long-term survival data to support its use.
” ‘Data for adjuvant denosumab look promising but are currently insufficient to make any recommendation,’ concluded a panel of experts representing the American Society of Clinical Oncology (ASCO) and Cancer Care Ontario.”
“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.”
“The FDA has approved co-packaging of the oral medications ribociclib (Kisqali) and letrozole (Femara) for the treatment of postmenopausal women with HR-positive, HER2-negative advanced breast cancer.
“With the new Kisqali Femara Co-Pack, patients can obtain a full 28-day cycle of the 2 medicines in 1 package with 1 prescription and 1 copay, and the cost will be the same as that for Kisqali alone, according to Novartis, which manufactures both medications.”