The final overall survival findings from the MONALEESA-2 trial confirm the long-term benefits of combining ribociclib with first-line letrozole for postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer.

Premenopausal women with hormone receptor-positive, HER2-negative, advanced breast cancer derive a significant progression-free survival benefit from the addition of everolimus to first-line letrozole, shows the MIRACLE trial.

Extending adjuvant aromatase inhibitor therapy with letrozole to 5 years improves survival among women with hormone receptor-positive breast cancer who have already received 2 to 3 years of tamoxifen, shows the phase 3 GIM4 trial.

The final analysis of the SOLE trial has shown no significant difference in the outcomes of postmenopausal women with hormone receptor-positive breast cancer who received extended intermittent or continuous adjuvant letrozole.

The average changes from baseline in the Short Form-36 (SF-36) physical and mental component summary scores did not differ significantly between the letrozole and placebo treatment arms over the 5-year study period.

Janni W et al. Breast Cancer Res Treat 2018; 169: 469. doi:10.1007/s10549-017-4658-x

The research team recruited 5101 men or pre- or postmenopausal women with stage IIA (either N0 with additional genetic risk factors or N1), stage IIB, or stage III early breast cancer and randomly assigned them to receive letrozole or anastrozole for at least 5 years either with or without ribociclib 400 mg/day given on a 3 weeks on, 1 week off schedule for up to 3 years.

After a median follow-up of 24.1 months, the primary endpoint of investigator-assessed PFS was a median of 24.0 months for the participants who were randomly assigned to receive ribociclib 600 mg/day on a 3 weeks on, 1 week off schedule alongside letrozole or anastrozole plus goserelin.

“These findings support dalpiciclib plus letrozole or anastrozole as a new first-line treatment option,” he said.

He reported that the current, second interim analysis shows that median OS was 67.1 months with abemaciclib 150 mg twice daily plus daily anastrozole 1.0 mg or letrozole 2.5 mg versus 54.5 months with placebo and a NAI, a “numerically favorable OS difference” that gave a hazard ratio (HR) of 0.754 that supports abemaciclib use, albeit without reaching statistical significance.

PALOMA-2 study findings suggest that first-line palbociclib does not improve overall survival when added to letrozole for estrogen receptor-positive, HER2-negative advanced breast cancer, but the analysis was hindered by missing data.

The most commonly prescribed AI was letrozole (52.2%) followed by anastrozole (44.2%), and exemestane (3.6%), and the most used DOACs were rivaroxaban (53.2%) and apixaban (35.0%).

Circulating tumor DNA target mutations may represent a promising prognostic biomarker among women receiving first-line ribociclib plus letrozole for hormone receptor-positive, HER2-negative advanced breast cancer, research suggests.

The co-primary endpoint of PFS in the overall trial population was significantly improved with elacestrant 400 mg/day versus physician’s choice of fulvestrant, anastrozole, letrozole, or exemestane, at a median of 2.8 and 1.9 months, respectively, and a hazard ratio (HR) for progression or death of 0.70 favoring the oral SERD.

The meta-analysis included data on 7030 premenopausal women included in the ABCSG 12, TEXT, SOFT, or HOBOE trials that compared an AI (anastrozole, exemestane, or letrozole) with tamoxifen, both given for 3–5 years, on a background of ovarian suppression with goserelin or triptorelin.

Group B ( 18 F-FDG-PET-guided group; n=285) received 2 weeks of treatment with trastuzumab and pertuzumab plus either letrozole 2.5 mg/day if postmenopausal or tamoxifen 20 mg/day if premenopausal.

They therefore analyzed data pertaining to 538 participants of the phase 3 BIG 1–98 trial that evaluated adjuvant endocrine monotherapy with letrozole or tamoxifen versus a sequential strategy involving both agents.

Around a third (31.3%) of these patients received tamoxifen, raloxifene, nonsteroidal AIs (anastrozole or letrozole), or a steroidal AI (exemestane), the researchers say in JAMA Network Open .

A second interim analysis of the MONALEESA-2 trial indicates that the addition of ribociclib to letrozole remains beneficial for patients with hormone receptor-positive, HER2-negative advanced breast cancer over longer follow-up.