Elderly patients
Consistent efficacy in elderly patients (1)
MONALEESA pooled analysis: KISQALI + ET consistently achieved >5-year mOS regardless of age. (1)
Patients
* HR 0.69; 95% CI: 0.56–0.84. (1)
† HR 0.79; 95% CI: 0.58–1.07. (1)
‡ HR 0.75; 95% CI: 0.46–1.21. (1)
This was an exploratory analysis to assess PFS, OS and TTC across age groups (<65 years, 65–74 and ≥75 years) using Kaplan-Meier methods. (1)
MONALEESA-2: N=668, double-blind, placebo-controlled, 1:1 randomised, multicenter, phase III trial in postmenopausal women with HR+/HER2− ABC. As 1L in advanced disease. No prior endocrine therapy for ABC and no previous systemic chemotherapy for advanced disease. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + AI (letrozole 2.5 mg continuous). The primary endpoint was locally assessed PFS, and the key secondary endpoint was OS. Other secondary endpoints included the ORR (complete or partial response), the CBR (overall response plus stable disease lasting 24 weeks or more), safety, and QOL assessments. (2)
MONALEESA-3: N=726, double-blind, placebo-controlled, 2:1 randomised, phase III trial. As 1L and 2L in advanced disease plus those with early relapse in postmenopausal women with HR+/HER2– ABC. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + 500 mg intramuscular fulvestrant. The primary endpoint was locally assessed PFS. Secondary endpoints included OS, ORR, CBR, and safety and tolerability. 1L defined as: newly diagnosed (de novo) ABC patients or patients with relapse >12 months from completion of (neo)adjuvant ET with no treatment for ABC or metastatic disease. 2L was defined as: relapse on or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for advanced or metastatic disease (early relapse); relapse >12 months from completion of (neo)adjuvant therapy with subsequent progression after one line of endocrine therapy for advanced or metastatic disease, and advanced or metastatic breast cancer at diagnosis that progressed after one line of endocrine therapy for advanced disease with no prior (neo)adjuvant treatment for early disease. (3)
MONALEESA-7: N=672, double-blind, placebo-controlled, 1:1 randomised, phase III trial in pre- or perimenopausal women with HR+/HER2− ABC. As 1L in advanced disease and in patients who received 1 or fewer lines of chemotherapy for ABC. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + AI (letrozole 2.5 mg or anastrozole 1 mg) or tamoxifen* 20 mg orally once daily continuously + LHRH agonist (goserelin 3.6 mg subcutaneously on Day 1 of every cycle). The primary endpoint was investigator-assessed PFS. The key secondary endpoint was OS, defined as the time from randomisation to death from any cause. (4)
* KISQALI should not be co-administered with tamoxifen. (5)
Real-world analysis
KISQALI + ET delivered a consistent efficacy and safety profile independent of age. (1,2)
* Men and pre-/postmenopausal women with locally advanced or HR+/HER2- ABC not amenable to curative therapy with no prior ET for advanced disease. (2)
RIBANNA: N= 2615, an ongoing prospective, noninterventional study in Germany since October 2017 involving pre/perimenopausal and postmenopausal women with HR+, HER2– ABC who receive RIB+AI/FUL, or ET or CT, which were initiated as frontline treatments for ABC, in accordance with the German treatment guidelines. Therefore, only patients who were treatment naive for ABC were included in the trial. (3)
COMPLEEMENT-1: N=3246, single-arm, open-label, multicentre phase IIIb study investigating the safety and efficacy of ribociclib plus letrozole (RIB + LET) in a large, diverse cohort who have not received prior endocrine therapy (ET) for advanced disease. We present an exploratory analysis of male patients. Eligible patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC), who had no prior ET and ≤1 line of prior chemotherapy for advanced disease, received RIB + LET. Male patients also received goserelin or leuprolide. Primary endpoint was safety and tolerability; efficacy was a secondary endpoint. (4)