Background NTZ is approved in Russia for the treatment of highly active relapsing remitting multiple sclerosis and is reimbursed via federal budget program. However, no data about NTZ treatment in Russia and the effect of federal reimbursement have been performed so far. Objective To characterize the population of patients receiving natalizumab and assess the efficacy and risk-management plan (RMP) implementation of NTZ therapy in routine clinical practice in Russia. Methods We analyzed data for 334 patients, who received at least one infusion of NTZ. Relapse rate, MRI activity, NEDA-3 status after 2 years were assessed. Anti-JC virus antibodies status and RMP implementation were evaluated. Drop-out rate and reasons for therapy discontinuation were analyzed. Results Patients switched to natalizumab in Russia are mainly female (63%), with median EDSS score of 3.5 and high disease activity: 93% had at least 1 relapse and 58% had both T1Gd+ and new T2 lesion a year before therapy initiation. Introduction of federal reimbursement allowed patients with less relapses to start therapy with natalizumab. The only predictor of 6-month progression was EDSS score at the baseline of therapy (HR = 2.1375, 95%CI 1.0026–4.5570, p = 0.0492). 82% patients reached NEDA-3 at 24 month of therapy. 25% of patients discontinued NTZ for reasons: tolerability (14.5%), JCV antibody status (61%), and patient’s decision (17%). RMP was implemented in only 36% patients. Conclusion Natalizumab appeared to have high efficacy in Russian clinical practice. Federal reimbursement allowed less active patients to start natalizumab. More efforts should be done to improve RMP implementation.

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BACKGROUND AND PURPOSE: Recent studies showed thalamic atrophy in the early stages of MS. We investigated the impact of intracortical lesions on the volumes of subcortical structures (especially the thalamus) compared with other lesions in MS. MATERIALS AND METHODS:Seventy-one patients with MS were included. The volumes of intracortical lesions and white matter lesions were identified on double inversion recovery and FLAIR, respectively, by using 3D Slicer. Volumes of white matter T1 hypointensities and subcortical gray matter, thalamus, caudate, putamen, and pallidum volumes were calculated using FreeSurfer. Age, MS duration, and the Expanded Disability Status Scale score were assessed. RESULTS:Patients with intracortical lesions were older (P ¼ .003), had longer disease duration (P , .001), and higher Expanded Disability Status Scale scores (P ¼ .02). The presence of intracortical lesions was associated with a significant decrease of subcortical gray matter volume (P ¼ .02). In our multiple regression model, intracortical lesion volume was the only predictor of thalamic volume (R 2 ¼ 0.4, b* ¼ -0.28, P ¼ .03) independent of white matter lesion volume and T1 hypointensity volume. White matter lesion volume showed an impact on subcortical gray matter volume in patients with relapsing-remitting MS (P ¼ .04) and those with disease duration of ,5 years (P ¼ .04) and on thalamic volume in patients with Expanded Disability Status Scale scores of ,4.0 (P ¼ .01). By contrast, intracortical lesion volume showed an impact on subcortical gray matter and thalamic volumes in the secondary-progressive MS subgroup (P ¼ .02 and P , .001) in patients with a long-standing disease course (P , .001 and P ¼ .001) and more profound disability (P , .001 and P , .001).CONCLUSIONS: Thalamic atrophy was explained better by intracortical lesions than by white matter lesion and T1 hypointensity volumes, especially in patients with more profound disability. ABBREVIATIONS: DIR ¼ double inversion recovery; EDSS ¼ Expanded Disability Status Scale; iCL ¼ intracortical lesion; ICV ¼ intracranial volume; PPMS ¼ primary-progressive MS; RRMS ¼ relapsing-remitting MS; SPMS ¼ secondary-progressive MS; T1H ¼ T1 hypointensities; WMH ¼ white matter hypointensities; WML ¼ white matter lesions; SGMS ¼ subcortical grey matter structures; b* ¼ standartized regression coefficients

Objective: Cognitive dysfunction is common in multiple sclerosis (MS). The Brief International Cognitive Assessment for MS (BICAMS) battery of tests has been suggested as a measure for the evaluation of the cognitive status of MS patients. This study aims to validate the BICAMS battery in the Russian population of MS patients. Methods: Age- and sex-matched MS patients (n = 98) and healthy individuals (n = 86) were included in the study. Symbol Digit Modalities Test (SDMT), California Verbal Learning Test, 2nd edition (CVLT-II) and the Brief Visuospatial Memory Test – Revised (BVMT-R) were administered to all participants. The battery was readministered 1 month later to 44 MS patients to investigate the test–retest reliability. Results: MS patients exhibited a significantly lower performance in testing with BICAMS than the control group in all three neuropsychological tests. Test–retest reliability was good for SDMT and CVLT-II (r = .82 and r = .85, respectively) and adequate for BVMT-R (r = .70). Based on the proposed criterion for impairment as z score below 1.5 SD the mean of the control group, we found that 34/98 (35%) of MS patients were found impaired at least in one cognitive domain. Patients with Expanded Disability Status Scale score ≥3.5 performed significantly worse than controls (SDMT, p < .0001; CVLT–II, p = .03; BVMT-R, p = .0004), while those with ≤3.0 scores did not. Conclusion: This study demonstrates that the BICAMS battery is a valid instrument to identify cognitive impairment in MS patients and it can be recommended for routine use in the Russian Federation.

Background. Comprehensive treatment of breast cancer includes surgery, radiation therapy and systemic treatment. Radiation therapy plays an integral role in the treatment of early breast cancer. The appointment of a targeted dose of radiation to the bed of the primary tumor reduces the risk of local recurrence.Objective: to evaluate the effectiveness of intraoperative radiation therapy in the treatment of early breast cancer.Materials and methods. A retrospective study was conducted on the basis of the St. Petersburg City Clinical Oncology Center. Patients with organ-preserving surgery and intraoperative radiation therapy were selected. Of the 352 patients, 273 patients met the inclusion/non-inclusion criteria. Inclusion criteria were verified breast cancer, clinical stage I–IIA, tumor size no more than 3 cm, absence of visible axillary lymph nodes and monocentric nature of tumor growth. All patients underwent sectoral resection of the mammary gland with a biopsy of the sentinel lymph nodes and intraoperative radiation therapy.Results. The mean age of the patients was 59 years. For 273 patients, the median follow-up was 59.1 months. During this period, 18 (6.6 %) local recurrences of the disease were noted, of which 7 (39 %) patients with luminal A, 6 (33 %) patients with luminal B, 1 (6 %) patient with luminal B HER2/neu 3+, and 4 (22 %) patients with triple negative breast cancer. Within 3 years of follow-up, recurrence-free survival was 98.5 %, within 5 years – 96.4 %.Conclusion. The use of intraoperative radiation therapy for early breast cancer is an effective and safe treatment method.