451P - Breast Cancer Lighthouse study: 1 year follow-up results of ribociclib treatment patterns and clinical outcomes in a real-world Portuguese cohort

Background

CDK4/6 inhibitor treatment in advanced breast cancer (ABC) has shown benefit in progression-free survival (PFS) and another clinical endpoints in landmark clinical trials. This study aims to comprehend real-world use of ribociclib, effectiveness and safety in the Portuguese population.

Methods

Retrospective-prospective study of Portuguese cohort adult women with HR+/HER2- ABC treated with ribociclib through 3 years. Ribociclib treatment patterns, PFS at 1 year follow-up after ribociclib initiation and others secondary endpoints are reported. Data collection began in January 2019 with analysis cut-off in March 2023. Confidence intervals and survival analyses were performed using R® software.

Results

Of the 270 patients included, 64 (23.7%) were pre/peri-menopausal and 206 (76.3%) were post-menopausal patients. Median follow-up duration was 11.9 months. Baseline characteristics were described previously. Regarding treatment patterns, 207 (76.7%) received ribociclib as first-line [61 (22.6%) de novo patients and 146 (54.1%) after prior therapy], 40 (14.8%) as a second line and 23 (8.5%) after second line. During first year’s follow-up, mean ribociclib dose was of 488.4 [468.6; 508.2] and 114 (42.4%) patients reported dose adjustments. Of these 85 (74.6%) had a single dose adjustment. Patients had an average number of 12.1±5.3 clinical appointments, a mean of 3.4±2.5 imaging exams and 178 patients (65.9%) performed ECGs. Disease progression/death was experienced by 88 in 261 patients at a median of 407 days after ribociclib initiation, with a survival rate at 12 months of 0.782±0.027. At 12 months, complete response was achieved in 15 patients (5.6%), 80 patients (29.6%) had partial response and 52 (19.3%) remained stable. At cut-off, 175 (64.8%) patients were still being treated with ribociclib. Most common reasons for ribociclib discontinuation: disease progression (64, 67.4%) and AEs (21, 22.1%). Most common AEs were neutropenia (320, 42.3%), anemia (50, 6.6%), fatigue/asthenia (44, 5.8%), and leukopenia (42, 5.5%).

Conclusions

This is the first cohort of Portuguese patients to provide efficacy and safety data in a real-world setting, demonstrating similar clinical trial outcomes.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Novartis Farma – Produtos Farmacêuticos S.A.

Funding

Novartis Farma – Produtos Farmacêuticos S.A.

Disclosure

B.E. Gosalbez Pequeno, A.L.V. Matos, A.M. Nogal Dias, S. Braga, L.I. Pinto, A. Pêgo, C.D. Abreu, M.I.R. Ferreira, P.F. Gago, I. Faustino, I.M. Matos Pina, C.P. Marques: Financial Interests, Personal and Institutional, Principal Investigator, Author is the PI for this study in his/her center: Novartis Farma. J.L.C. Passos-Coelho, F.P. Branco, J.C.D.L. Simões: Financial Interests, Personal and Institutional, Advisory Board, Author is the PI for this study in his/her center: Novartis Farma. I.V. Vaz Luis: Financial Interests, Institutional, Invited Speaker: Amgen, Pfizer/Edimark, AstraZeneca; Financial Interests, Institutional, Writing Engagement: Pfizer/Edimark; Financial Interests, Institutional, Advisory Board, Consulting/ AB: Novartis; Financial Interests, Institutional, Advisory Board: Sandoz; Financial Interests, Institutional, Funding: Resilience; Non-Financial Interests, Member, Member of WG: ASCO. F. Schmitt, L. Costa: Financial Interests, Personal, Steering Committee Member, Author is a steering commitee member for this study: Novartis Farma. M.J.M. Vergueiro: Financial Interests, Institutional, Full or part-time Employment: Novartis Farma. D. Bras: Financial Interests, Personal, Full or part-time Employment: Novartis Farma.