Ramucirumab use in patients with Advanced Gastric Cancer (AGC) or gastro-oesophageal junction (GEJ) adenocarcinoma in Spain: RAMIS observational study

Date 29 September 2019
Event ESMO 2019 Congress
Session Poster Display session 2
Topics Oesophageal Cancer
Gastric Cancer
Presenter Federico Longo Munoz
Citation Annals of Oncology (2019) 30 (suppl_5): v253-v324. 10.1093/annonc/mdz247
Authors F. Longo Munoz1, M. Jorge Fernandez2, R. Yaya Tur3, S. Diaz4, M. Ortega4, T. Dilla4, A. Molero4, J.M. Cervera4
  • 1Medical Oncology, Hospital Universitario Ramon y Cajal, 28031 - Madrid/ES
  • 2Medical Oncology, Complejo Universitario Hospitalario De Vigo, 36204 - Vigo/ES
  • 3Medical Oncology, IVO - Fundacion Instituto Valenciano de Oncologia, 46009 - Valencia/ES
  • 4Medical Department, Eli Lilly Spain, 28108 - Alcobendas/ES

Abstract

Background

Ramucirumab (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.

Methods

RAMIS 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.

Results

317 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:Table:

793P

CombinationMonotherapy
(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]).

Conclusions

Patient 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.

Clinical trial identification

Editorial acknowledgement

IQVIA.

Legal entity responsible for the study

Eli Lilly.

Funding

Eli Lilly.

Disclosure

F. 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.