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
1049 - The Effect Of Multiple Interventions For Women At Risk For Cervical Cancer On Their Health Responsibility, Beliefs Regarding Cervical Cancer, And Having Screening: A Randomized Controlled Experiment
Presenter: Busra Altinel
Session: Poster Display session 2
Resources:
Abstract
1309 - Quantifying the Effects of the Korean National Cancer Screening Program on Cervical Cancer Mortality
Presenter: Nhung Bui
Session: Poster Display session 2
Resources:
Abstract
1346 - Spread of tumor and adverse events after modified radical hysterectomy for FIGO Stage IB1 cervical cancer patients with tumor diameter preoperatively estimated 2 cm or less: Japan Clinical Oncology Group trial (JCOG1101); exploratory analysis before primary analysis.
Presenter: Takahide Arimoto
Session: Poster Display session 2
Resources:
Abstract
5352 - Impact of Combined Interstitial and Intracavitary Brachytherapy in locally advanced Cervical cancer: A Survival and toxicity profile assessment
Presenter: Vibhay Pareek
Session: Poster Display session 2
Resources:
Abstract
2049 - Chemoradiotherapy response prediction model by proteomic expressional profiling in patients with locally advanced cervical cancer
Presenter: Chel Hun Choi
Session: Poster Display session 2
Resources:
Abstract
1923 - Disparities starting adjuvant chemotherapy for locally advanced cervix cancer in the international, academic, randomised, phase 3 OUTBACK trial (ANZGOG 0902, RTOG 1174, NRG 0274)
Presenter: Linda Mileshkin
Session: Poster Display session 2
Resources:
Abstract
3284 - Primary results from CECILIA, a global single-arm phase 2 study evaluating bevacizumab (BEV), carboplatin (C) and paclitaxel (P) for advanced cervical cancer (aCC)
Presenter: Andres Redondo
Session: Poster Display session 2
Resources:
Abstract
843 - Prognostic and clinicopathological significance of PD-L1 in patients with cervical cancer: a meta-analysis
Presenter: Xiaobin Gu
Session: Poster Display session 2
Resources:
Abstract
1020 - Clinical impact of molecular profiling of cervical cancer (CC) patients (pts) in a dedicated Phase I (P1) unit
Presenter: Mariana Scaranti
Session: Poster Display session 2
Resources:
Abstract
872 - Comparative proteomic profiles of cervical cancer and paried paracancerous tissue and the potential effects of DUSP7 over-expression through inhibiting RAS pathway on the biological characteristics of human cervical cancer cell line SIHA
Presenter: Xuan Jiang
Session: Poster Display session 2
Resources:
Abstract