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
2107 - Role of Individualized Intervention(s) on Quality of Life (QOL) and Adherence to Adjuvant Endocrine Therapy in Premenopausal Women with Early-Stage Breast Cancer (BC): MyChoice Study
Presenter: Shahid Ahmed
Session: Poster Display session 2
Resources:
Abstract
5812 - Correlation between the density of tumor-infiltrating lymphocytes, immune cell subsets in tumor stroma and response to systemic therapy in breast cancer
Presenter: Cvetka Grasic Kuhar
Session: Poster Display session 2
Resources:
Abstract
4734 - BRCA1/2 Testing in HER2- Advanced Breast Cancer (ABC): Results from the European Component of a Multi-Country Real World Study
Presenter: Michael Patrick Lux
Session: Poster Display session 2
Resources:
Abstract
1686 - In vitro and in vivo rescue of resistance to BET inhibitors by targeting PLK1 in triple negative breast cancer.
Presenter: Cristina Nieto-jiménez
Session: Poster Display session 2
Resources:
Abstract
5020 - Neoadjuvant endocrine therapy in combination with melatonin and metformin in locally advanced breast cancer
Presenter: Tatiana Semiglazova
Session: Poster Display session 2
Resources:
Abstract
5082 - Melatonin and metformin in neoadjuvant chemotherapy in locally advanced breast cancer
Presenter: Tatiana Semiglazova
Session: Poster Display session 2
Resources:
Abstract
2642 - Patient-tailored tamoxifen dosing based on an increased quantitative understanding of its complex pharmacokinetics: A novel integrative modelling approach
Presenter: Anna Mueller-Schoell
Session: Poster Display session 2
Resources:
Abstract
2461 - Lack of benefit of neoadjuvant pertuzumab in high risk HER2 positive breast cancer. A retrospective case-control study of 355 cases with biomarker analysis.
Presenter: Manuela Tiako Meyo
Session: Poster Display session 2
Resources:
Abstract
4776 - Targeting CDCA3 to improve chemotherapy response in triple-negative breast cancer patients
Presenter: Kenneth O'Byrne
Session: Poster Display session 2
Resources:
Abstract
1674 - Activity of BET-proteolysis targeting chimeric (PROTAC) compounds in triple negative breast cancer
Presenter: María Del Mar Noblejas López
Session: Poster Display session 2
Resources:
Abstract