Abstract
BackgroundRamucirumab (RAM), as a single agent, or combined with paclitaxel, is indicated for the treatment of patients with advanced gastric cancer (AGC) or gastro-esophageal junction adenocarcinoma (GEJ) with disease progression on or after prior fluoropyrimidine- or/and platinum-containing chemotherapy. Until now, there are limited published data on the use of RAM in clinical practice. MethodsRAMIS was an observational, retrospective study carried out in 20 Spanish hospitals. Patients initiating RAM between Dec 2015 and Q4 2018 were eligible if aged ≥18 years, had AGC/GEJ and a complete medical record. Main objectives: patientś characteristics, treatment patterns and effectiveness. Main analysis was descriptive; Kaplan-Meier method was used for time to event analysis. Exploratory analyses of predictors of effectiveness were performed. Results317 patients were included. Main characteristics at RAM initiation: 66.9% male, mean (SD) of 62.5 (11.3) years, 77.6% with AGC diagnosis, mean (SD) time since metastatic disease 1.0 (1.4) years. Patients had ECOG-0 (22.4%), 1 (63.1%) and 2 (10.4%), chronic comorbidities (62.5%), presented 1-2 metastatic sites (77.6%) and measurable disease (77.9%). Previous treatment was chemotherapy (97.2%). Most (93.7%) patients initiated RAM in combination with paclitaxel. Median time on treatment was 3.2 (2.8-3.4) months. Effectiveness results:Table793PTableCombinationMonotherapy(N=297)(N=20)Progression Free Survival *3.9 [3.4-4.3]2.0 [1.1-2.8]Overall Survival (OS)*7.4 [6.4-8.9]4.3 [1.9-7.3]OS rate*:6 months60.3% [54.2-65.9]33.8% [13.9-55.1]12 months34.3% [28.3-40.4]20.3% [5.4-41.9][95% CI] *Median, months. Higher hazard of progression was related to mono vs combo therapy (HR 2.1 [1.2-3.4]), non-measurable vs. measurable disease (1.8 [1.4-2.4]), ECOG1 vs ECOG0 (HR 1.6 [1.2-2.2], ECOG 2 vs ECOG0 (HR 2.4 [1.5-3.7]) and ≥3 vs≤2 metastatic sites (HR 1.5[1.1-2.0]). ConclusionsPatient profile and RAM effectiveness data were similar to previous studies in real life conditions. Combination regimen, measurable disease, ECOG 0, and few metastatic sites were associated with better effectiveness outcomes. Editorial acknowledgementIQVIA. Legal entity responsible for the studyEli Lilly. FundingEli Lilly. DisclosureF. Longo Munoz: Advisory / Consultancy, This study has been funded by Eli Lilly: Hospital Universitario Ramón y Cajal, Madrid, Spain. M. Jorge Fernandez: Advisory / Consultancy, This study has been funded by Eli Lilly: Hospital Alvaro Cunqueiro, Vigo (Pontevedra), Spain. R. Yaya Tur: Advisory / Consultancy, This study has been funded by Eli Lilly: IVO-Fundación Instituto Valenciano de Oncologia, Valencia, Spain. S. Diaz: Full / Part-time employment: Eli Lilly Spain. M. Ortega: Full / Part-time employment: Eli Lilly Spain. T. Dilla: Full / Part-time employment: Eli Lilly Spain. A. Molero: Full / Part-time employment: Eli Lilly Spain. J.M. Cervera: Full / Part-time employment: Eli Lilly Spain.
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