Lapatinib/Trastuzumab/AI Triplet Nearly Doubles PFS in HER2+/HR+ Metastatic Breast Cancer

Excerpt:

“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).”

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The Case for Bone-Directed Adjuvant Therapy in Postmenopausal Early Breast Cancer

Excerpt:

“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.”

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Dual HER2 Blockade Superior to Single Blockade for HER2+/HR+ Breast Cancer

Excerpt:

“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.”

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Abemaciclib Improves PFS in Phase III MONARCH 3 Breast Cancer Trial

Excerpt:

“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.”

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Novartis Kisqali® (Ribociclib, LEE011) Receives FDA Approval as First-Line Treatment for HR+/HER2- Metastatic Breast Cancer in Combination with Any Aromatase Inhibitor

Excerpt:

“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.”

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Dual HER2-Blockade Plus AI Shows Promise in HER2+/ER+ Breast Cancer

Excerpt:

“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.”

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Aromatase Inhibitors Associated with Reduced Endothelial Function in Postmenopausal Breast Cancer Patients

Excerpt:

“Postmenopausal women with breast cancer who took aromatase inhibitors demonstrated endothelial dysfunction, a predictor of cardiovascular disease, according to study results presented at the 2016 San Antonio Breast Cancer Symposium, held Dec. 6–10.

“Aromatase inhibitors (AIs) are a class of drugs that lower estrogen levels, and have been shown to reduce breast cancer-related mortality in women with locally advanced curative intent estrogen receptor-positive disease, which accounts for 75 percent of breast cancer cases.

“However, estrogen also protects against heart disease, and recent research has suggested that the suppression of estrogen raises the risk of cardiovascular disease, said the study’s lead author, Anne H. Blaes, MD, MS, an associate professor in hematology and oncology at the University of Minnesota.”

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Three-Drug Breast Cancer Regimen Slows Progression

Excerpt:

“Adding a drug to a standard regimen for hormone receptor (HR)-positive and HER2-positive breast cancer improved progression-free survival, a researcher said here.

“In a Phase II randomized trial, investigators compared an aromatase inhibitor (AI) combined with pertuzumab (Perjeta) and trastuzumab (Herceptin) versus an AI just with trastuzumab in women with locally advanced or metastatic breast cancer, Grazia Arpino, MD, PhD, of the University of Naples Federico II in Italy, reported at a general session at the San Antonio Breast Cancer Symposium.

“The three-drug combination led to a median of 18.89 months without progression, compared with 15.8 months for the two drugs.”

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Hormonal Therapy Effectively Added to Dual HER2-Blockade in Phase II PERTAIN Study

Excerpt:

“The addition of an aromatase inhibitor (AI) to pertuzumab (Perjeta) and trastuzumab (Herceptin) improved progression-free survival (PFS) by 3.09 months, when compared with trastuzumab plus an AI, according to findings from the phase II PERTAIN trial presented at the 2016 San Antonio Breast Cancer Symposium.

“In the ongoing, open-label study, the median PFS was 18.89 months with the pertuzumab combination compared with 15.80 months for trastuzumab and an AI alone. Furthermore, there was a 35% reduction in the risk of progression or death with the addition of pertuzumab (HR, 0.65; 95% CI, 0.48-0.89; P = .007).”

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