Abstract 2717
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
Combination | Monotherapy | |
---|---|---|
(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 months | 60.3% [54.2-65.9] | 33.8% [13.9-55.1] |
12 months | 34.3% [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.
Resources from the same session
4947 - Pre-treatment serum 25-hydroxyvitamin D levels and survival in a Danish cohort of patients with pancreatic cancer
Presenter: Louise Rasmussen
Session: Poster Display session 2
Resources:
Abstract
5124 - STAR_PAC: Phase I clinical trial repurposing all trans retinoic acid (ATRA) as stromal targeting agent in a novel drug combination for pancreatic cancer.
Presenter: Hemant Kocher
Session: Poster Display session 2
Resources:
Abstract
5257 - Outcomes of First Line FOLFIRINOX (FFX) Versus Gemcitabine and Nab-Paclitaxel (GN) in Patients with Advanced Pancreatic Cancer: Multi-Institutional Canadian Sites Experience
Presenter: Neha Papneja
Session: Poster Display session 2
Resources:
Abstract
1166 - Effect of prior cancer on survival outcomes for patients with pancreatic adenocarcinoma
Presenter: Chaobin He
Session: Poster Display session 2
Resources:
Abstract
1169 - Association of combination of irreversible electroporation ablation and chemotherapy with outcomes of locally advanced pancreatic cancer: a large cohort study
Presenter: Chaobin He
Session: Poster Display session 2
Resources:
Abstract
1222 - Results from phase I study of the oncolytic viral immunotherapy agent Canerpaturev (C-REV) in combination with gemcitabine plus nab-paclitaxel as first-line treatment of unresectable pancreatic cancer
Presenter: Yusuke Hashimoto
Session: Poster Display session 2
Resources:
Abstract
1698 - Multicenter retrospective study of gemcitabine plus nab-paclitaxel for elderly patients with advanced pancreatic cancer
Presenter: Masato Ozaka
Session: Poster Display session 2
Resources:
Abstract
2424 - Irinotecan Combined with Oxaliplatin and S1 in Patients with Metastatic Pancreatic Adenocarcinoma
Presenter: Keke Nie
Session: Poster Display session 2
Resources:
Abstract
2885 - Cancer-associated thrombosis in patients with pancreatic cancer and its correlation with plasma tissue factor level: A Japanese prospective cohort study
Presenter: Satoshi Kobayashi
Session: Poster Display session 2
Resources:
Abstract
3702 - A Phase I/Ib, multi-center trial of ARQ-761 (Beta-Lapachone) with gemcitabine/nab-Paclitaxel in patients with advanced pancreatic cancer
Presenter: Muhammad Beg
Session: Poster Display session 2
Resources:
Abstract