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.
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.
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:
|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|
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
Legal entity responsible for the study
Russian Society of Clinical Oncology (RUSSCO).
Has not received any funding.
A. Tryakin: Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Eli Lilly and Company. All other authors have declared no conflicts of interest.