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Efficacy of ramucirumab in the second-line treatment of patients with disseminated gastric cancer in routine clinical practice in Russia (RAMSELGA observational study)
DOI: https://dx.doi.org/10.18565/pharmateca.2024.7.56-65
N.S. Besova, T.A. Titova, A.A. Tryakin, E.V. Artamonova, D.L. Stroyakovsky, E.V. Perminova, D.Yu. Yukalchuk, D.M. Ponomarenko, N.P. Belyak, R.V. Orlova, G.M. Teletaeva, E.Yu. Ratner, A.S. Mochalova, A.S. Zhabina, S.V. Gamayunov, A.V. Smolin, A.Yu. Povyshev, M.I. Andrievskikh, I.S. Stilidi
1) N.N. Blokhin National Medical Research Center of Oncology, Moscow, Russia; 2) Moscow City Oncology Hospital No. 62, Moscow Region, Russia; 3) Regional Oncology Dispensary, Irkutsk, Russia; 4) City Clinical Oncology Dispensary, Saint Petersburg, Russia; 5) N.N. Petrov National Medical Research Center of Oncology, Saint Petersburg, Russia; 6) Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan, Kazan, Russia; 7) MEDSI Group of Companies, Moscow, Russia; 8) Medical Radiological Research Center n.a. A.F. Tsyb, Branch Campus of the National Medical Research Radiological Center, Obninsk, Russia; 9) N.N. Burdenko Main Military Clinical Hospital, Moscow, Russia; 10) District Clinical Hospital, Tyumen Region, Khanty-Mansiysk, Russia; 11) Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine, Chelyabinsk, Russia
Background. Currently, ramucirumab, an inhibitor of type 2 vascular endothelial growth factor receptors, in combination with paclitaxel is the most effective second-line treatment regimen for disseminated gastric cancer (DGC). The experience of successful use of ramucirumab in real clinical practice in various countries of the world is widely presented in the literature.
Objective. Evaluation of the effectiveness of ramucirumab as monotherapy or in combination with chemotherapy as a second-line treatment for patients with DGC in routine clinical practice in Russia.
Methods. The analysis included data from 163 patients with GC from 11 oncology institutions in Russia who received ramucirumab as part of the second-line treatment: 17 patients were prescribed ramucirumab as a monotherapy, 104 – in combination with paclitaxel, 42 – in combination with irinotecan-based regimens. The treatment efficacy was assessed.
Results. The efficacy of ramucirumab as a monotherapy was: disease stabilization – 47.1%, median progression-free survival (mPFS) – 2.2 months, median overall survival (mOS) – 5.6 months. When treating with ramucirumab in combination with paclitaxel, the objective response rate (ORR) was 24.0% (3,8% complete response), disease control – 76.9%. The median PFS and OS were 6.1 and 10.6 months, respectively. As a result of treatment with ramucirumab in combination with irinotecan-based regimens, the ORR was 26.2% (4.8% complete response), disease control was 88.1%. The median PFS and OS were 7.5 and 13.3 months, respectively.
Conclusion. According to the obtained results, ramucirumab in combination with paclitaxel or the FOLFIRI regimen is an effective option for second-line therapy in DGC. The results of using ramucirumab alone or in combinations in real clinical practice in Russia are not inferior to and even numerically surpass the data from international studies and are comparable with the practical experience of other countries.
Objective. Evaluation of the effectiveness of ramucirumab as monotherapy or in combination with chemotherapy as a second-line treatment for patients with DGC in routine clinical practice in Russia.
Methods. The analysis included data from 163 patients with GC from 11 oncology institutions in Russia who received ramucirumab as part of the second-line treatment: 17 patients were prescribed ramucirumab as a monotherapy, 104 – in combination with paclitaxel, 42 – in combination with irinotecan-based regimens. The treatment efficacy was assessed.
Results. The efficacy of ramucirumab as a monotherapy was: disease stabilization – 47.1%, median progression-free survival (mPFS) – 2.2 months, median overall survival (mOS) – 5.6 months. When treating with ramucirumab in combination with paclitaxel, the objective response rate (ORR) was 24.0% (3,8% complete response), disease control – 76.9%. The median PFS and OS were 6.1 and 10.6 months, respectively. As a result of treatment with ramucirumab in combination with irinotecan-based regimens, the ORR was 26.2% (4.8% complete response), disease control was 88.1%. The median PFS and OS were 7.5 and 13.3 months, respectively.
Conclusion. According to the obtained results, ramucirumab in combination with paclitaxel or the FOLFIRI regimen is an effective option for second-line therapy in DGC. The results of using ramucirumab alone or in combinations in real clinical practice in Russia are not inferior to and even numerically surpass the data from international studies and are comparable with the practical experience of other countries.
Keywords: second line, gastric cancer and cardioesophageal junction cancer, FOLFIRI, ramucirumab, paclitaxel
About the Autors
Corresponding author: Natalia S. Besova, Cand. Sci. (Med.), Leading Researcher, Department of Antitumor Drug Therapy No. 2, Division of Drug Treatment, N.N. Blokhin National Medical Research Center of Oncology, Moscow, Russia; besovans@mail.ru
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