Aim. To study the quality of life and symptoms, to assess the clinical effect and treatment safety in relapsed/refractory classical Hodgkin’s lymphoma (r/r cHL) patients treated with brentuximab vedotin (BV) as > 3rd-line therapy in the context of real clinical practice. Materials & Methods. The study enrolled 62 r/r cHL patients after the second- and subsequent-line chemotherapies, who are either ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) at the time of their enrollment into the study or after the failure of high-dose chemotherapy (HDCT) with auto-HSCT. The median age was 31 years; 46.8 % of patients were women. The patients received BV 1.8 mg/kg intravenously every 3 weeks. Clinical parameters, quality of life, and symptoms were assessed prior to BV therapy and in 3, 6, 9, 12, and 15 months after therapy onset. The RAND SF-36 form was used to assess the quality of life, and the ESAS-R tool was applied to report on symptoms. Results. Objective response was observed in 68.3 % of patients, 40 % out of them showed complete response. The median progression-free survival was 10.6 months (95% confidence interval 7.4-12.9 months). Safety profile corresponded to the published data. Adverse events of grade 3/4 were identified in 1.6 % of patients. In the period of 15 months after therapy onset, quality of life improvement or stabilization was reported based on all the scales of RAND SF-36 (GEE, p < 0.001), and symptom relief was shown based on ESAS-R total score (GEE, p < 0.001). Conclusion. In the context of real clinical practice, BV appeared to be effective in r/r cHL patients either after the second- or subsequent-line chemotherapies or after the failure of HDCT with auto-HSCT. The study demonstrated that BV was well tolerated by the patients. BV therapy contributes to the improvement of r/r cHL patients’ quality of life. Positive changes in quality of life and symptoms on BV therapy testify to its patient-assessed efficacy and safety.
Background. Ramucirumab is a monoclonal antibody that inhibits the vascular endothelial growth factor receptor-2 (VEGFR2). The study is aimed to analyse prognostic factors for survival in patients with disseminated gastric cancer who received ramucirumab in the second-line therapy in ’real-life’ clinical setting of Russia (RAMSELGA). Methods. We retrospectively analysed the outcome of 163 patients aged 20–78 years from 11 oncological centres in Russia. Survival analysis was performed using the Kaplan – Meier model, and regression analysis was performed using the Cox model. Results. In a univariate analysis of overall survival, 5 factors were identified as independent factors of an unfavourable prognosis: 1) age <65 years (RR 0.542; 95% CI 0.302–0.971; p = 0.039); 2) time to tumour progression on the first-line therapy is not more than four months. (RR 0.161; 95% CI 0.105–0.246; p = 0.0000); 3) a low grade tumour or colloid cancer (RR 1,868; 95% CI 1,063–3,284; p = 0,030); 4) peritoneal metastasis (RR 1.549; 95% CI 1.026–2.339; p = 0.037); 5) ascites or pleurisy (RR 0.624; 95% CI 0.424–0.920; p = 0.017). In a multivariate analysis, favourable prognostic factors of overall survival of patients included age – 65 years or older (OS 2.288; 95% CI 1.240–4.220; p = 0.008) and time to tumour progression on the first-line therapy – more than 4 months (OS 6.650; 95% CI 4.221–10.477; p = 0.000). Conclusion. Despite an active search, prognostic factors for survival in patients that are universal for dGC have not yet been found. To build a universal prognostic model, a very thoughtful analysis considering not only clinical and laboratory, but also pathomorphological and molecular genetic characteristics is required.
Резюме Введение. Рамуцирумаб-моноклональное антитело, ингибирующее рецепторы фактора роста эндотелия сосудов 2-го типа (VEGFR2). Целью исследования являлся анализ результатов применения рамуцирумаба во 2-й линии лечения больных диссеминированным раком желудка в реальной клинической практике России. Методы. В анализ были включены ретроспективные данные из 11 онкологических центров. Оценена специфическая токсичность. Результаты: во второй линии лечения рамуцирумаб был назначен 163 больным: в монорежиме-17, в комбинации с паклитакселом-104, в комбинации с режимами на основе иринотекана-42 пациентам. Специфическая для рамуцирумаба токсичность (любой степени) была представлена: носовыми кровотечениями (39,2%), протеинурией > 1 г/день (4,9%), артериальной гипертензией (68%), токсичность 3-4-й степени-кровотечением (4,3%), гастроинтестинальными перфорациями (2,4%), венозными тромбозами (3,6%) и ишемией головного мозга (0,6%), лечение прекращено из-за токсичности у 15 больных (9,2%). Заключение. Полученные данные соответствуют результатам рандомизированных исследований. Рамуцирумаб в комбинации с иринотеканом и фторпиримидинами демонстрирует высокую активность, приемлемую токсичность, может быть рекомендован для практического применения и дальнейшего изучения в сравнительных рандомизированных исследованиях.
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