Updated results from the phase IIIb complement-1 study of ribociclib (RIB) plus letrozole (LET) in the treatment of HR+, HER2-advanced breast cancer (ABC).

Abstract

1055 Background: Real-world evidence is important as it complements data from randomized controlled trialse report updated results from CompLEEment-1, a Phase IIIb trial evaluating RIB+LET in an expanded population, the largest CDK4/6i trial in ABC to date. Methods: Patients (pts) with HR+, HER2– ABC, ≤ 1 line of prior CT and no prior ET for ABC received RIB+LET. Study design has been reported previously (De Laurentiis, et al. ASCO 2019). Primary endpoints were safety and tolerability. Results: 3,246 pts received ≥ 1 dose of study treatment. Median duration of follow-up was 25.4 months (mos) (15 additional mos since interim analysis [De Laurentiis, et al. ABC5 2019]). Median treatment exposure was 17.8 mos. Baseline characteristics indicated a diverse population, including men (1.2%), premenopausal women (22.2%), and pts aged ≥ 70 years (19.5%); 112 (3.5%) pts had an ECOG PS of 2, 194 (6.0%) pts received prior CT for ABC, and 51 (1.6%) pts had stable CNS lesions. The most common adverse events (AEs) were neutropenia (61.1%), nausea (35.9%), and fatigue (23.4%). Grade 3/4 hematologic abnormalities ( > 5.0 %) were decreased neutrophils (54.8%), leukocytes (25.9%), and lymphocytes (12.6%). Grade 3/4 biochemical abnormalities ( > 5.0 %) were increased ALT (9.1%) and AST (6.7%). An increase of > 60 ms in QTcF interval from baseline occurred in 189 (5.9%) pts, while post-baseline QTcF of > 480 to ≤ 500 ms and > 500 ms occurred in 59 (1.8%) and 42 (1.3%) pts, respectively. Treatment-related AEs led to treatment discontinuation in 418 (12.9%) pts. Of 74 (2.3%) on treatment deaths, 38 (1.2%) were due to breast cancer. Median time to progression was 27.1 mos (95% CI, 25.7-NE), overall response rate was 43.6% (95% CI, 41.5-45.8%), and clinical benefit rate was 69.1% (95% CI, 67.1-71.1%) for pts with measurable disease at baseline. Conclusions: This analysis confirms the safety and efficacy of RIB+LET in a large, diverse cohort of pts with HR+, HER2– ABC (with no previous ET for ABC), closely resembling real-world clinical practice. Safety and efficacy data were consistent with those observed in the MONALEESA trials, supporting the use of RIB+LET in the first-line setting. NCT02941926. Clinical trial information: NCT02941926 .

Ribociclib in patient with hormone-positive HER2-negative breast cancer with brain metastases: a case report

“…Несмотря на более тяжелую популяцию пациентов, результаты исследования CompLEEment-1 соответствовали тем, которые были получены в исследованиях MONALEESA, включая медиану до прогрессирования 27,1 мес. (95% ДИ: 25,7-НД) и частоту общего ответа 43,6% (95% ДИ: 41,5-45,8%) [23]. У пациентов с метастазами в головной мозг время до прогрессирования было сопоставимо с общей исследуемой популяцией, тогда как время до прогрессирования у пациентов других подгрупп было короче (медиана колебалась от 13,7 до 19,5 мес.).…”

Don’t let it disappear: new opportunities to prolong the life of HR+ HER2- advanced breast cancer patients. Event review of the satellite symposium. RUSSCO Big Conference «Breast Cancer» (online). January 28th, 2021

“…Было установлено, что мВБП в общей популяции пациенток составила 27,1 мес, т.е. практически 2,5 года (95% ДИ 25,7-НД -не достигнуто) [9]. Непрямое сравнение с данными РКИ MONALEESA-2 и MONALEESA-7, в которых пациентки получали 1-ю линию терапии с рибоциклибом, показывает, что результаты, полученные в реальной клинической практике на популяции более тяжелых пациенток, оказались даже лучше (медиана ВБП 27,1 мес в CompLEEment-1 и 25,3/23,8 мес -в MONALEESA-2/7).…”

“…Профессор Е.В. Артамонова подчеркнула крайне важный аспект, связанный с поддержанием хорошего качества жизни пациенток при назначении рибоциклиба, что также соответствует данным, полученным в РКИ [3,6,9].…”