Abstract 1113
Background
Ribociclib in combination with endocrine therapy (ET) is the current standard of care in first-line for HR+/HER2- aBC. An increasing proportion of patients who are candidates for ribociclib are older (≥70 years of age). The number of older patients who have participated thus far in ribocicib trials is, however, small, and little data is available on the tolerability of ribociclib in this population, particularly among frail older patients. Previous trials, moreover, do not usually include older patient-specific methods of evaluation (comprehensive geriatric assessment). RIBOB addresses the issue of efficacy and tolerability of ribociclib in older patients, including frail patients and patients with multiple comorbidities as is frequent in clinical practice.
Trial design
Ribob is a prospective, open lable, single arm trial which will evaluate the clinical efficacy, overall safety and tolerability of ribociclib in combination with letrozole in older women (≥70 years) with HR+/HER2- aBC and no prior hormonal treatment for advanced disease (as per approved indication). Frail patients, patients with comorbidities and patients with altered laboratory tests for whom treatment is deemed adequate and safe by the local investigator are eligible. Exclusion criteria include patients with uncontrolled brain lesions and QTc interval prolongation. A total of 150 patients will be enrolled for treatment with Letrozole (2.5 mg once daily) + ribociclib 600 mg (day 1 to 21 in a 28 day cycle) until progression, intolerable toxicity or patient/physician decision to withdraw. Study end-points include PFS, OS, safety and functionality, which will be evaluated through EORTC QLQ-C30 (modified) and EORTC IL15 questionnaires as well comprehensive geriatric assessment at baseline, 3 months and 1 year. Translational research will include the collection of plasma samples which will be obtained to evaluate aging biomarkers and thymidine kinase and their impact on efficacy and toxicity. Recruitment is open since January/2019.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
UZ Leuven.
Funding
Novartis.
Disclosure
N.F. Ponde: Research grant / Funding (self), Travel Grant: Novartis. L. Decoster: Research grant / Funding (self): Boehringer-Ingelheim; Research grant / Funding (self): Roche; Research grant / Funding (self): BMS. E. de Azambuja: Speaker Bureau / Expert testimony, Research grant / Funding (self): Roche; Research grant / Funding (self): GSK. G. Jerusalem: Honoraria (self), Research grant / Funding (self): Novartis; Honoraria (self), Research grant / Funding (self): Roche; Honoraria (self), Research grant / Funding (self): Amgen; Honoraria (self), Research grant / Funding (self): BMS; Honoraria (self): Pfizer; Honoraria (self): Puma; Honoraria (self): Daiichi-Sankyo; Honoraria (self): AZ; Honoraria (self): Lilly; Honoraria (self): Celgene; Research grant / Funding (self): MSD. P. Vuylsteke: Research grant / Funding (self): Roche. H. Wildiers: Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Novartis; Advisory / Consultancy, Research grant / Funding (self): Roche; Advisory / Consultancy: Celldex; Advisory / Consultancy, Research grant / Funding (self): Pfizer; Advisory / Consultancy, Research grant / Funding (self): PUMA. All other authors have declared no conflicts of interest.
Resources from the same session
4906 - Tumor-infiltrating lymphocytes (TILs) in patients with epithelial ovarian cancer undergoing neoadjuvant chemotherapy: A restrospective study
Presenter: Sara Giovannoni
Session: Poster Display session 2
Resources:
Abstract
3919 - Prognostic significance of elements of the adaptive immunity in the microenvironment of epithelial ovarian cancer.
Presenter: Periklis Foukas
Session: Poster Display session 2
Resources:
Abstract
5139 - Neutrophil-to-lymphocyte ratio predicts platinum sensitivity in epithelial ovarian cancer patients: a MITO24 retrospective study
Presenter: Alberto Farolfi
Session: Poster Display session 2
Resources:
Abstract
4212 - The prognostic impact of monocyte to lymphocyte ratio (MLR) in advanced epithelial ovarian cancer (EOC)
Presenter: Marc Cucurull Salamero
Session: Poster Display session 2
Resources:
Abstract
5123 - TP53 Hotspot mutations as immunoreactive neoantigens define a signature with differential survival outcomes in advanced ovarian cancer
Presenter: Marica Garziera
Session: Poster Display session 2
Resources:
Abstract
3795 - Use of bevacizumab (Bev) in real life for first-line (fl) treatment of ovarian cancer (OC)/ The GINECO ENCOURAGE cohort of 500 French patients
Presenter: Dominique Berton-Rigaud
Session: Poster Display session 2
Resources:
Abstract
2359 - Phase II study: Letrozole maintenance therapy after first line chemotherapy in patients with advanced serous and endometrioid ovarian cancer
Presenter: Alexandra Tyulyandina
Session: Poster Display session 2
Resources:
Abstract
3619 - Baseline IPI (Immune Prognostic Index) predicts survival in patients with advanced cervical cancer treated with immune checkpoint inhibitors (ICI).
Presenter: Felix Blanc-Durand
Session: Poster Display session 2
Resources:
Abstract
3474 - Preselecting tumor-infiltrating lymphocyte subsets to implement adoptive inmmunotherapy in ovarian cancer
Presenter: Diego Salas-Benito
Session: Poster Display session 2
Resources:
Abstract
5134 - Early prediction of the platinum-resistant relapse risk using the CA125 modeled kinetic parameter KELIM: a pooled analysis of AGO-OVAR 7 & 9; ICON 7 (AGO/GINECO/ MRC CTU/GCIG trials).
Presenter: OLIVIER COLOMBAN
Session: Poster Display session 2
Resources:
Abstract