Abstract 5197
Background
Ramucirumab is a preferred second-line treatment option for patients with chemorefractory metastatic gastric cancer (mGC). RamSelGa study was conducted by the Russian Society of Clinical Oncology and assessed real-world data on the use of ramucirumab in this population.
Methods
To be included in the study patients had to progress on previous platinum and fluoropyrimidine-based chemotherapy and receive ramucirumab-based therapy in second or later lines. Primary end-point was overall survival (OS). Secondary end-points included progression-free survival (PFS) and safety.
Results
One hundred forty-five pts with mGA were enrolled in 14 centers. ECOG performance status 0, 1 and 2 had 19 (13%), 102 (70%) and 24 (17%) patients. Ramucirumab was used in second- and later-lines in 126 and 19 patients, respectively. Ramucirumab was combined with weekly paclitaxel in 109 (75%) patients or irinotecan-based chemotherapy (mostly FOLFIRI) in 24 (17%) patients. Median duration of second-line ramucirumab was 4.7 (range, 0.5-34.1) months, 17 (13%) patients received therapy for ≥12 months. Median OS was 9.2 months in patients treated with ramucirumab in the second-line setting. OS and PFS data are summarized in the table. VEGF-related toxicity (all grades) included epistaxis (36%), proteinuria >1g/day (4.2%), and arterial hypertension (30%); grade 3-5 toxicity was bleeding (4.1%) and brain ischemia (0.7%, grade 5). Three patients (2%) discontinued therapy due to toxicity.Table:
797P
Regimens | Second- line, n = 126 | Median PFS, months | Median OS, months | Later- lines, n = 19 | Median PFS, months | Median OS, months |
---|---|---|---|---|---|---|
ramucirumab + paclitaxel | 95 | 5.5 | 9.2 | 14 | 3.1 | 5.5 |
ramucirumab + irinotecan-based | 24 | 7.0 | 10.3 | 0 | - | - |
others + ramucirumab | 4 | 5.5 | 10.1 | 3 | 5.2 | 5.6 |
ramucirumab alone | 3 | 2.4 | 2.5 | 2 | - | - |
Conclusions
These "real-life" efficacy data of ramucirumab in patients with mGC are in line with previous randomized trials. Ramucirumab is well tolerated in daily clinical practice. Irinotecan-based regimens could be effective and warrant further investigation.
Clinical trial identification
russco25072017.
Editorial acknowledgement
Legal entity responsible for the study
Russian Society of Clinical Oncology (RUSSCO).
Funding
Has not received any funding.
Disclosure
A. Tryakin: Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Eli Lilly and Company. All other authors have declared no conflicts of interest.
Resources from the same session
3159 - Anlotinib for advanced hepatocellular carcinoma: interim results from the phase II ALTER0802 study
Presenter: AiPing Zhou
Session: Poster Display session 2
Resources:
Abstract
3191 - The efficacy and safety of lenvatinib in patients who did not meet the inclusion criteria of the phase 3 trial (REFLECT trial) and those with BCLC Stage B hepatocellular carcinoma - A nationwide multicenter study in Japan-
Presenter: Azusa Sakamoto
Session: Poster Display session 2
Resources:
Abstract
1529 - Prognostic and predictive value of baseline alpha-fetoprotein (AFP) in patients with advanced hepatocellular carcinoma (HCC) treated with ramucirumab from two phase 3 studies (REACH, REACH-2)
Presenter: Andrew Zhu
Session: Poster Display session 2
Resources:
Abstract
2767 - Effect of second-line cabozantinib on health states for patients with advanced hepatocellular carcinoma (aHCC) after sorafenib: QTWiST analysis from the CELESTIAL study
Presenter: Nicholas Freemantle
Session: Poster Display session 2
Resources:
Abstract
2150 - Alpha-fetoprotein (AFP) response in patients with unresectable hepatocellular carcinoma (HCC) in the phase 3 RESORCE trial
Presenter: Jordi Bruix
Session: Poster Display session 2
Resources:
Abstract
3437 - Phase I/II trial of NBTXR3 activated by SBRT in patients with hepatocellular carcinoma or liver metastasis
Presenter: Marc Pracht
Session: Poster Display session 2
Resources:
Abstract
1758 - Efficacy and safety of ramucirumab (RAM) for advanced hepatocellular carcinoma (HCC) with elevated alpha-fetoprotein (AFP) following first-line sorafenib across age subgroups in two global phase 3 trials (REACH and REACH-2)
Presenter: Masatoshi Kudo
Session: Poster Display session 2
Resources:
Abstract
1192 - Ramucirumab in patients with advanced hepatocellular carcinoma (HCC) and elevated alpha fetoprotein (AFP): An exposure–response analysis
Presenter: Josep Llovet
Session: Poster Display session 2
Resources:
Abstract
1600 - Outcomes of Hepatocellular Carcinoma (HCC) Patients Treated with Nivolumab: The Mount Sinai Hospital Experience.
Presenter: Sirish Dharmapuri
Session: Poster Display session 2
Resources:
Abstract
2364 - Pembrolizumab vs Chemotherapy in Patients With Advanced/Metastatic Adenocarcinoma (AC) or Squamous Cell Carcinoma (SCC) of the Esophagus as Second-Line Therapy: Analysis of the Chinese Subgroup in KEYNOTE-181
Presenter: Jia Chen
Session: Poster Display session 2
Resources:
Abstract