REVIEWS AND ANALYSIS
Objective. To perform literature review of clinical trials reporting on the use of single-agent brentuximab vedotin (BV) 1.8 mg/kg therapy in adult patients with relapsed/refractory (R/R) CD30-positive Hodgkin lymphoma (HL).
Methods. A literature search was performed in Pubmed and eLIBRARY. RU databases to identify all studies published from 1 July 2007 until 1 July 2017. We used the key words “brentuximab vedotin” and “Hodgkin lymphoma” simultaneously. The inclusion criteria required that study population included ≥ 20 adult patients with R/R HL. We included clinical trials, systematic reviews, meta-analysis, pharmacoeconomic studies: total 25 publications met inclusion criteria. Publications were grouped by 3 BV indications in instruction for use: adult patient with relapsed/refractory CD30-positive Hodgkin lymphoma post-autologous stem cell transplantation (postASCT), adult patient with refractory CD30-positive HL after failure of at least 2 prior multiagent chemotherapy regimens in patients who are not candidates for ASCT, adult patient with classical HL at high risk of relapse or progression post-ASCT.
Results. Overall response rate (ORR) and complete rate (CR) were 75% and 34% respectively in adult patients with R/R CD30-positive HL post-ASCT in SGN35–0003 study. In patients with refractory HL after failure of at least 2 prior multiagent chemotherapy regimens who are not candidates for auto-SCT ORR and CR were 40% and 30% respectively. In mixed population ORR were 56-80%, CR – 10-46.5%. In patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT ORR was not evaluated, median progression-free survival was improved in patients in BV group compared with those in placebo group (42.9 and 24.1 months respectively). Overall survival in both group was similar. In patients with R/R CD30-positive HL the incremental cost-effectiveness ratio per quality-adjusted life year (ICER/QALY) was 6.7 million rub. и 3 million rub. from a Russian and a Scottish healthcare payer respectively. ICER/QALY when BV compared with best supportive care was 9.79 million rubles. In patients who were at risk for HL repapse after ASCT if BV consolidation compared with active surveillance ICER/QALY was 8.86 million rub.
Conclusion. As a result of the literature review, it was found that the response rate, the complete response to BV therapy, and the overall survival and progression-free survival with use of BV in different patient populations differ; in most cases, the result of effectiveness favors BV. The found safety data indicated a good tolerability of the drug. The results of the found pharmacoeconomic studies differ depending on the comparison therapy and the accepted pharmacoeconomic indicator.DIAGNOSTICS AND TREATMENT OF TUMORS. CURRENT STATUS OF THE PROBLEM
The article shows the possibilities of the usage of cytological material for diagnostics of lung cancer at the example of work of an oncological outpatient clinic during one year. Light microscopy was used to study of cytological specimens of various material of 721 patients. The method has allowed to determine the diagnosis of lung cancer in majority of the observed cases with definition of histological type in 89%. When comparing the results of cytology with the final diagnosis the difference of determination of the tumor histological types is less than 1%. The immunocytochemical test is used at the examination of pleural fluid of 40 patients without determined primary locus. The immunocytochemical research has allowed specifying the inhering of the tumor cells to the metastasis from the lung, elevating the precision of the diagnostics to 96%. The cytological material of 62 patients obtained during the bronchoscopic examination, puncture of lymphatic nodules, pleural fluid and sputum with presence of a sufficient quantity of tumor cells (not less than 200) represents appropriate material for molecular-genetic research. The usage of cytological material for search of somatic mutations is justified for oncological patients with locally advanced or disseminated process, whose cytological material is the unique accessible morphological material for research.
OWN INVESTIGATIONS
Background: Eribulin mesylate was initially approved in 2010 by FDA as a third-line treatment for women with advanced breast cancer (ABC) pretreated with at least two lines of chemotherapy, and then in 2011 it was approved by EMA as a second-line therapy. Patients should have received an anthracycline and a taxane in either the adjuvant or metastatic setting. Since then, several studies have been conducted confirming its efficacy and safety. We report our experience of using eribulin in our centre in a real-life clinical setting.
Materials and methods: 34 patients with ABC were enrolled to receive eribulin. From February 2016 to February 2017, patients were treated with standard doses of eribulin and evaluated for toxicity and responses. All of them had previously received anthracyclines and taxanes in either the adjuvant or metastatic setting. Median age was 60 years (range: 39–79). ECOG performance status was 1 or 2 at the time of enrollment. Median number of cycles of eribulin was 5 (range 2–10). Patients received eribulin from first-line chemotherapy to seventh-line chemotherapy for ABC. Median number of envolved visceral organs was 2 (range 1–4).
Results: There were no complete responses. Partial responses were achieved in 26.4% (9/34), stabilization of the disease in 32.4% (11/34) and progression of the disease in 41.2% (14/34) of patients. The median progression-free survival was 4.09 months (range: 2.6–6.53). Main toxicities (grade 3–4) included peripheral neuropathy and neutropenia. Neuropathy was marked in 14.7% (5/34) and neutropenia in 14.7% (5/34) of patients. Dose reductions were required in 14.7% (5/34) of patients because of neutropenia.
Conclusion: Our experience shows that eribulin has clinical activity as well as satisfactory tolerability in unselected patients in a reallife clinical setting. Thus, in our opinion, eribulin can represent a new option in treatment of ABC patients.
ISSN 2587-6813 (Online)