797P - Ramucirumab in the treatment of refractory metastatic gastric cancer: Results from the RamSelGa trial

Abstract

BackgroundRamucirumab 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. MethodsTo 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. ResultsOne 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.Table797PTableRegimensSecond- line, n=126Median PFS, monthsMedian OS, monthsLater- lines, n=19Median PFS, monthsMedian OS, monthsramucirumab + paclitaxel955.59.2143.15.5ramucirumab + irinotecan-based247.010.30--others + ramucirumab45.510.135.25.6ramucirumab alone32.42.52-- ConclusionsThese "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 identificationrussco25072017. Legal entity responsible for the studyRussian Society of Clinical Oncology (RUSSCO). FundingHas not received any funding. DisclosureA. Tryakin: Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Eli Lilly and Company. All other authors have declared no conflicts of interest.