“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.”
“In patients with hormone receptor (HR)-positive advanced breast cancer and no prior endocrine therapy who were positive for a gene signature-based biomarker indicating androgen receptor (AR)-signaling, the addition of enzalutamide (Xtandi) to exemestane was found to significantly improve progression-free survival (PFS) from 4 months to 16.5 months.
“Moreover, the phase II trial showed no effect of enzalutamide on PFS in the overall cohort of patients nor in the biomarker-positive population who received prior endocrine therapy, said Denise Yardley, MD, at the 2017 San Antonio Breast Cancer Symposium.”
“Twelve weeks of neoadjuvant T-DM1 (ado-trastuzumab emtansine; Kadcyla) with or without endocrine therapy induced superior pathologic complete response (pCR) compared with trastuzumab (Herceptin) plus endocrine therapy in patients with HER2-positive/HR-positive early breast cancer, according to findings recently published online in theJournal of Clinical Oncology.
“In the prospective, neoadjuvant phase II ADAPT trial conducted by the West German Study Group, pCR was 41.0% for patients assigned to T-DM1 alone and 41.5% for those who received T-DM1 and endocrine therapy. In contrast, 15.1% of patients assigned to trastuzumab and endocrine therapy had a pCR (P<.001).”
“At the 2017 ASCO Annual Meeting, results were presented from the phase II I-SPY 2 trial investigating pembrolizumab (Keytruda) in combination with standard therapy (paclitaxel followed by doxorubicin and cyclophosphamide) as a neoadjuvant treatment for patients with locally advanced triple-negative breast cancer or hormone receptor–positive/HER2-negative breast cancer (Abstract 506).
“Findings showed that the addition of pembrolizumab increased the estimated pathologic complete response rate nearly threefold in patients with triple-negative breast cancer (60% vs 20%) and in patients with hormone receptor–positive/HER2-negative breast cancer (34% vs 13%) compared to standard therapy. Overall, based on Bayesian predictive probability of success in a confirmatory phase III trial, pembrolizumab has graduated from the I-SPY 2 TRIAL for all signatures in which it was tested (triple-negative breast cancer, all HER2-negative, and hormone receptor–positive/HER2-negative).”
“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.”
“Eli Lilly and Company (NYSE: LLY) today announced that results from the Phase 3 MONARCH 2 study showed that abemaciclib, a cyclin-dependent kinase (CDK)4 & 6 inhibitor, in combination with fulvestrant, significantly improved progression-free survival (PFS) compared to treatment with fulvestrant alone in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer who have relapsed or progressed after endocrine therapy (median PFS, 16.4 vs. 9.3 months, respectively, HR: 0.553; 95% CI: 0.449, 0.681, P < .0000001). The data were presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #1000) and simultaneously published online in the Journal of Clinical Oncology.”
“Endocrine therapy remains an integral part of the treatment paradigm for patients with estrogen receptor (ER)–positive breast cancer; however, questions remain on which patients should continue their therapy beyond 5 years.
” ‘The idea [is] that most patients with hormone receptor (HR)-positive breast cancer who are still on endocrine therapy at 5 years are going to merit some sort of discussion about whether they should continue or not, and it is okay to individualize that decision on the basis of the patient preferences, side effects, and symptom burden,’ said Amye J. Tevaarwerk, MD.”
“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.”
“The FDA recently approved ribociclib (Kisqali) for use in combination with an aromatase inhibitor as initial therapy for treatment of postmenopausal women with HR+/HER2-negative advanced or metastatic breast cancer.
“Ribociclib, an inhibitor of CDK4/6, was approved based on data from the phase III MONALEESA-2 trial, which was ended early following the first preplanned interim analysis. In this analysis, the combination of ribociclib and the aromatase inhibitor letrozole met the trial’s primary endpoint by demonstrating statistically significant improvement in progression-free survival (PFS) compared to letrozole alone.”