| Autor: |
O.O. Gordeeva, E. Ratner, D.M. Ponomarenko, E. Perminova, A. Smolin, T. Titova, G.M. Teletaeva, S. Gamayunov, A. A. Meshcheryakov, D. Yukalchuk, M. Andrievsckih, A. Mochalova, Anton Yurievich Povyshev, Mikhail Fedyanin, D. Stroyakovsky, N. Besova, N. Beliak, Alexey Tryakin, Ilya Tsimafeyeu, A.S. Zhabina |
| Rok vydání: |
2019 |
| Předmět: |
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| Zdroj: |
Web of Science |
| ISSN: |
0923-7534 |
| Popis: |
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. 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. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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