Abstract 733
Background
Previous studies demonstrated that the combination of chemotherapy with ramucirumab allows to improve the treatment results in advanced gastric cancer (GC). The one of the available options for the second line chemotherapy is combination of irinotecan with fluoropyrimidines. As angiogenesis inhibitors can enhance the efficacy of chemotherapy, we investigated the combination of irinotecan and fluoropyrimidines with ramucirumab in metastatic GC.
Methods
Eligible patients had advancedmorphologicallyverifiedGC and disease progression during or within 4 months following first-line therapy. They received FOLFIRI plus ramucirumab(8 mg/kg on day 1) or XELIRI in combination with ramucirumab(8 mg/kg on days 1 and 8). The primary end point was progression-free survival (PFS). Secondary end-points were overall survival (OS), disease control rate (DCR) and safety.
Results
Between September 2015 and October 2018, 23 patients were enrolled. Median number of cycles was 9 (2-20). Six patients achieved a partial response (PR) for an objective response rate of 26.1%. A total of 15 (65.2%) patients had stable disease (SD) for a DCR of 91.3%. With a median follow up 8,2 months, median PFS was 7.6 months (95% CI 5.9-9.2) and the median OS was 9.5 months (95% Cl 6.74 – 12.3). Median duration of PR response was 4,5 months (2,7-5,2 +) and median duration of SD was 4,2 months (2,1-10,1+ ).The main treatment-related grade 3 or 4 adverse events were decreased neutrophil count (1/23; 4.3%), anemia (1/23; 4.3%) and diarrhea (1/23; 4.3).The most frequent adverse events of special interest (AESIs) any grade were hypertension (10/23; 43.4%), bleeding/hemorrhage (5/23; 21.7%), proteinuria (5/23; 21.7%) and venous thromboembolic events (6/23; 26%). Gastrointestinal perforationdeveloped in two patients (2/23; 8.7%). No treatment-related deaths occurred.
Conclusions
In our research ramucirumab with irinotecan and fluoropyrimidinesdemonstrate the high activity and a manageable safety profile in patients with pre-treated metastatic GC.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Besova N.S.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
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