1. [New options determining the success of treatment for neovascular age-related macular degeneration].
作者: A Zh Fursova.;I F Nikulich.;M A Vasilyeva.;A S Derbeneva.;Yu A Karlash.
来源: Vestn Oftalmol. 2025年141卷3期71-78页
Neovascular age-related macular degeneration (nAMD) is a progressive retinal disease that can lead to severe and irreversible vision loss despite the availability of effective anti-VEGF agents. One of the potential causes of suboptimal treatment outcomes in nAMD is undertreatment, which may result from the need for frequent injections and follow-up visits, limitations in public healthcare funding, and challenges in achieving sustained and long-term control of disease activity (DA). Aflibercept 8 mg is a novel formulation with a higher concentration and improved molecular stability, enabling a fourfold increase in the molar dose of the active substance delivered to the vitreous body. The phase III PULSAR trial, a 96-week randomized, double-masked, active-controlled study, evaluated the efficacy and safety of 8 mg aflibercept compared with the standard 2 mg dose in treatment-naïve patients with nAMD. Participants were randomized 1:1:1 into three groups: aflibercept 2 mg every 8 weeks (2q8), 8 mg every 12 weeks (8q12), or 8 mg every 16 weeks (8q16) after three initial monthly loading doses. The study demonstrated the benefits of the 8 mg dose in extending interinjection intervals. By week 96, 88% of patients achieved an interval of ≥12 weeks, 71% ≥16 weeks, and 47% ≥20 weeks; in the 8q16 group, 53% of patients reached an interval of ≥20 weeks and 31% - 24 weeks. Over the 2-year period, patients in the 8q16 group received approximately 8 injections, compared to around 13 in the 2q8 group, with comparable anatomical and functional outcomes and no additional safety concerns. Given the proven effectiveness in improving best-corrected visual acuity (BCVA), superior outcomes in resolving intra- and/or subretinal fluid (IRF/SRF), and reduced treatment burden, it appears optimal to broadly transition patients already receiving aflibercept 2 mg to the higher molar concentration (aflibercept 8 mg) regardless of treatment phase or the interinjection interval. This approach aims to achieve a longer anti-VEGF effect duration and sustained DA control with the fewest possible injections.
2. [Multiple myeloma: Maintenance therapy after autologous hematopoietic stem cell transplantation, depending on minimal residual disease].
作者: M V Solovyev.;L P Mendeleeva.;O S Pokrovskaya.;M V Nareyko.;M V Firsova.;I V Galtseva.;Yu O Davydova.;N M Kapranov.;L A Kuzmina.;E G Gemdzhian.;V G Savchenko.
来源: Ter Arkh. 2017年89卷7期25-31页
To determine the efficiency of maintenance therapy with bortezomib in patients with multiple myeloma (MM) who have achieved complete remission (CR) after autologous hematopoietic stem cell (auto-HSCT), depending on the presence of minimal residual disease (MRD).
3. [Salivation in children during anticancer chemotherapy].
The study aimed to assess the needs and options for salivation management in children treated with antileukemic chemotherapy. In a preliminary cross-sectional study the saliva flow rate and viscosity were evaluated in 75 leukemic children that received chemotherapy with methotrexate in low dose (44 people, 44 episode, group 1), or in high-dose (31 people, 42 episode, group 2), and in 25 healthy children (group 3). Then, 26 children were randomly divided into two groups in the 70 episodes course of high-dosed chemotherapy, and received acetylcysteine (A) or only standard oral management (S) for 1-10 day of treatment. Parameters of salivation and children performance (Lansky et al.) were evaluated. Mann-Whitney U-test was used for analysis. In group 1, 2 and 3 the flow rate (Me [LQ/HQ]) was 0.5 [0.3; 0.8]; 0.9 [0.6; 1.2] and 0.5 [0.3; 0.6] ml/min respectively (p1-3>0.05; p<0.01; p1-2<0.05). Viscosity levels in group 1, 2 and 3 were 2.75 [3.67; 3.67], 10.05 [5.3; 26.0] and 3.9 [2.7; 6.5] unites respectively (p1-3>0.05; p2, 3<0.01; p1, 2<0.01). In group A and S the flow rate was 2.7 [0.5; 4.1] and 0.4 [0.1; 2.2] ml/min (р<0.05); viscosity was 1.5 [1.2; 4.1] and 6.4 [5.3; 8.1] unites (р<0.001), performance Lansky index was 80 [65; 90] and 70 [60; 80] (р<0.01) respectively. Salivation dysfunction complicates the chemotherapy with high-dosed methotrexate in children: it is indicated by high viscosity combined with elevated flow rate. Acetylcysteine normalizes saliva viscosity and improves children's performance.
4. [Eribulin in the treatment for metastatic breast cancer].
Eribulin is a novel antimicrotubule drug, which is approved in the second line treatment of advanced breast cancer in patients who received anthracyclines and taxanes. The article presents the results of two huge phase III clinical trials (301, 305) and their pooled analysis. Eribulin monotherapy demonstates staistically significant improved overall survival compared to standart treatments (15.2 mnths vs 12.8 mnths, p = 0.03 in pooled analysis). Certain subgroups of patients--Her2-negative and triple-negative have the most survival benefit. According to own experience with Eribulin inside the clinical trials, presented in the article, the drug is effective and well tolerated even by older patients.
5. [Cardiotoxic effects of breast cancer chemotherapy and their possible correction].
作者: E A Reznikova.;V K Kosenok.;G I Nechaeva.;V N Merkulov.;A S Reznikov.
来源: Eksp Klin Farmakol. 2010年73卷7期36-9页
Clinical data are reported upon the examination of a group of 160 women aged 18-55, suffering of a breast cancer and subjected to polychemotherapy using various cytostatic schemes: (I) standard CAF scheme, course repetition each 4 weeks; (II) alternating CAF and AVCFM schemes (intermittent introductions), a total of 4 courses. For the reduction of the cardiotoxic effects of anthracyclines, one part of patients was given an antioxidant preparation of amber acid--Reamberin--whose administration substantially decreased both the frequency of cardial complaints and the expression of clinical manifestations of the astheno-neurotic syndrome and prevented the occurrence of systolic and diastolic dysfunction of myocardium and the heart rhythm and conductivity disturbances.
6. [Evaluation of fludarabine-containing regimens versus immunochemotherapy for chronic lymphocytic leukemia].
作者: T P Zagoskina.;S B Tkachenko.;M E Golubeva.;A V Kudriavtseva.;N V Isaeva.;O V Malykh.
来源: Ter Arkh. 2010年82卷1期35-9页
to analyze the efficacy of RFC (rituximab, fludarabine, and cyclophosphan), FCM (fludarabine, cyclophosphan, and mitoxantrone), and FC (fludarabine and cyclophosphan) treatment programs in patients with chronic lymphocytic leukemia (CLL) in an open-labeled comparative controlled investigation.
7. [Local hyperthermia by means of ballon-type electrodes in combined therapy of patients with locally spread cancer of the mouth mucosa and lower lip].
作者: V E Cheshuk.;A V Kravchenko.;O E Lobanova.;Iu R Medinets.;L G Maloed.
来源: Lik Sprava. 2004年1期32-4页
Modification of the standard chemo- and radiotherapy with local hyperthermia gives evident positive results in treatment of patients with local cancer of tunica mucosa of mouth and lower lip. Since this area having uneven complex surface needs to develop radiofrequency emitting special applicators. We have used catheters with ballons filled with hypertonic solution as electrodes to adapt the mouth cavity. An electric field creating between these ballons and high surface adjustability makes this system come in useful.
8. [Pilot results of using tamsulone-FS in patients with prostatic adenoma according to the results of a randomized multicenter comparative trial].
作者: N A Lopatkin.;S B Petrov.;A V Sivkov.;A V Markov.;N N Oshchepkov.;Iu N Bolokhanov.
来源: Urologiia. 2006年3期3-6, 8页
Tamsulone-FS--a novel Russian alpha1A/D-adrenoblocker (Farm-Syntez)--was studied in a randomized multicenter comparative trial in patients with prostatic adenoma. Pilot results agreed with other trials published in the literature and demonstrated tamsulone-FS efficacy and safety for management of lower urinary tract symptoms caused by prostatic adenoma. The efficacy and safety of tamsulone-FS was comparable to those of omnik. This drug can be recommended for wide clinical practice in prostatic adenoma. It is registered by Roszdravnadzor (certificate N LC-000859 of 03.11.2005) and allowed for production and sale.
9. [Results of the treatment of childhood acute lymphoblastic leukemia according to the Berlin-Moscow-91 protocol in 1991-2000].
作者: N V Miakova.;R Hartmann.;A E Rudneva.;N M Trubina.;L G Fechina.;A M Timakov.;A V Shamardina.;V V Lebedev.;S R Varfolomeeva.;S D Dudkin.;Z M Dyshlevaia.;V N Timofeeva.;A G Rumiantsev.;H Henze.;A I Karachunskiĭ.
来源: Vopr Onkol. 2002年48卷3期340-6页
The report deals with the results of application of an original protocol--the Berlin-Moscow-91 (BM-91)--for the treatment of acute lymphoblastic leukemia (ALL) in children. The researchers' major concern was to improve survival and cut down side-effects incidence as well as to prevent and successfully manage occult neuroleukemia as a potential source of relapse. Patients aged 5 months-15 years received the BM-91 and ALL BFM-90m treatment first at one clinic and later at several centers. Out of 852 children with primary diagnosis of ALL admitted to Russian hematological hospitals (March 2, 1991-November 3, 2000), 687 were included into the study; 329 received the MB-91 protocol. Nine-year recurrence-free survival was 73% while overall survival--80%. Toxic side-effects after L-asparaginase were reported in 27 (7.9%). It is concluded that good results in childhood ALL treatment can be achieved without resorting to high-dosage chemotherapy and radiation in most cases.
10. [Nitrullin -- a new original Russian drug of the nitrosomethylurea group].
作者: V A Gorbunova.;N F Orel.;O V Semina.;N S Besova.;Z G Kadagidze.
来源: Vopr Onkol. 2001年47卷6期680-3页
Hematologic thrombopenia and leukopenia formation limits use of nitrullin as a toxic hazard. The drug showed moderate effect in treating inoperable non-small cell cancer of the lung and satisfactory end results. The treatment had marked symptomatic effect in patients with this cancer and, as a consequence, improved the quality of life. Nutrullin had immuno-modulating effect. Its application alone or in combination with VPN showed good results in the management of small-cell cancer of the lung.
11. [A comparative randomized phase-II study of Xeloda (capecitabine) and paclitaxel in patients with breast cancer progressing after anthracycline antibiotics].
作者: V M Moiseenko.;S M O'Reilly.;D C Dalbot.;S Van Belle.;R J Gordon.;T Griffin.;B Osterwalder.
来源: Vopr Onkol. 2000年46卷3期285-9页
A randomized study of the effectiveness of treatment with capecitabine (Xeloda) (22) and paclitaxel (taxol) (19) was carried out in breast cancer patients resistant to anthracycline antibiotic drugs. Capecitabine and paclitaxel showed comparable effectiveness, although the former appeared less toxic, particularly, in hematologic complication situations. Therefore, it may be administered to out-patients who previously received several courses of chemotherapy.
12. [Interferon alfa-2b treatment of adult patients during early chronic phase of Ph1-positive chronic myeloid leukemia (initial report on a cooperative study, protocol CML-MIG-97)].
作者: N D Khoroshko.;A G Turkina.;A V Zakharova.;Iu N Kobzev.;E V Domracheva.;L Iu Tikhonova.;E A Semenova.;V S Zhuravlev.;M A Sokolova.;S V Kuznetsov.
来源: Ter Arkh. 1999年71卷7期42-7页
Evaluation of clinical effectiveness of two regimens of induction therapy of an early chronic stage of Ph'-positive chronic myeloid leukemia including interferon-alpha 2b (intron-A, "Schering Plough") in a cooperative randomised trial on the protocol CML MIG-97.
13. [Results of clinical trials in the treatment of acute myeloid leukemia in adults during a 7-year period].
作者: V G Savchenko.;E N Parovichnikova.;G A Kliasova.;V G Isaev.;A V Pivnik.;N D Khoroshko.;Iu V Ol'shanskaia.;L Iu Tikhonova.;E R Maslova.;S M Kulikov.
来源: Ter Arkh. 1999年71卷7期13-20页
Comparison of effectiveness of induction regimens varying in intensity and maintenance variants in patients with acute myeloid leukemia (AML) included in a randomised multicenter trial.
14. [Results of phase II clinical trial of Tamoxifen and Toremifen in two different doses in advanced breast cancer in postmenopausal women].
作者: M L Gershanovich.;A M Garin.;D Baltinia.;A Kurvet.;L Kangas.;Iu Ellmen.
来源: Vopr Onkol. 1997年43卷6期587-95页
Efficacy and safety of toremifene 60 and 240 mg daily (TOR 60 and TOR 240) are compared to 40 mg tamoxifen daily (NFV 40) in postmenopausal women with advanced estrogen receptor (ER) positive of ER unknown breast cancer. The study is randomized in three parallel groups. Primary efficacy variables are response rate and time to progression. WHO and ECOG criteria were used for measurable and nonmeasurable disease assessment, respectively. Safely was reported according to WHO criretia. Altogether 463 patients were randomized (157 to TOR 60, 157 to TOR 240 and 149 to TAM 40). By data cut-off, after 20.5 months medianfollow-up time, over 70% of the patients had experienced disease progression. Response rates are 20.4%, 28.7% in TOR 60, TOR 240 and TAM 40, respectively. TOR 60 and TAM 40 show statistically equivalent efficacy and the difference between TOR 240 and TAM 40 is not significant (P = 0.112). Median times to progression are 4.9 (TOR 60), 6.1 (TOR 240) and 5.0 (TAM 40) months and corresponding hazard ratios (TAM:TOR) 1.015 and 1.124. Again, TOR 60 and TAM 40 are statistically equivalent and the difference between TOR 240 and TAM 40 is not significant (P = 0.374). All treatments were well tolerated. As a conclusion TOR 60 and TAM 40 show equivalent clinical efficacy and tolerability. The higher dose of toremifene slightly but not significantly improved response rate and time to progression. In postmenopausal women, toremifene (60 mg) daily is an effective and safe treatment of advanced ER positive or ER unknown breast cancer.
15. [Postoperative hormone therapy of breast cancer (analysis of overall survival)].
作者: V F Semiglazov.;V G Ivanov.;O A Ivanova.;V M Moiseenko.;E V Tsyrlina.;N I Barash.;R T Popova.;N S Migmanova.;I K Seleznev.;A A Bozhok.
来源: Vopr Onkol. 1996年42卷6期37-42页
A third series of randomized evaluation of postoperative (adjuvant) hormone therapy (tamoxifen, sinestrol and orimeten) was carried out in breast cancer patients. The study group involved 1.332 reproductive and postmenopausal females with stage I-III tumors. The investigation established quite a range of 10-year survival evidence versus stage and reproductive status; however, no significant differences were recorded in either of the groups. Untoward side-effects were more frequent when treating with diethyl-stilbestrol (over 30%) than with tamoxifen (3.5%). No significant differences were registered in five-year total and recurrence-free survival in the treatment with orimeten or tamoxifen.
16. [Biochemical modulation by leucovorin of the antineoplastic effect of fluorofur in disseminated colorectal cancer].
作者: L V Manziuk.;N I Perevodchikova.;V A Gorbunova.;A B Luk'ianchenko.;N A Abramova.
来源: Vopr Onkol. 1996年42卷3期33-6页 17. [Effectiveness of adjuvant hormone therapy in breast cancer].
作者: V F Semiglazov.;V G Ivanov.;O A Ivanova.;V M Moiseenko.;E V Tsyrlina.;A A Bozhok.
来源: Vopr Onkol. 1996年42卷1期56-61页
A third series of randomized tests was undertaken to evaluate the efficacy of postoperative adjuvant hormone therapy (tamoxifen, diethylstilbestrol, orimethen amino glutethymide) in breast cancer patients. Tamoxifen was studied in 176 patients with T1-2N0M0 tumors. Five-year recurrence-free survival was registered in 85.2% of menopausal patients treated with tamoxifen versus 71.1% in control (P < 0.05). Five-year recurrence-free survival in menopausal females with breast tumors, stage IIb, was 71.1% among those treated with diethylstilbestrol and as low as 57.4% in the tamoxifen group (P < 0.05). Untoward side-effect incidence was much higher in the diethylstilbestrol group (30.4%) as compared with tamoxifen (3.5%). No significant difference was found for the relationship between orimethen and tamoxifen treatment with respect to 5-year survival and recurrence-free survival.
18. [The results of a comparative clinical study of the antiestrogenic preparations toremifene and tamoxifen in locally advanced and disseminated breast cancer].
A randomized clinical trial performed in 50 female patients with advanced breast cancer showed 60 mg/day and 240 mg/day toremifene and 40 mg/day tamoxifen to be nearly equally effective. Partial, with few exceptions, response lasting 5-31 months was observed in 35-50% of cases whereas another 35-50% of patients showed no change. Toxicity was low.
19. [Combined drug treatment of far-advanced forms of breast cancer].
Seventy patients with breast cancer (stage IIIb--IV) were randomized by an "envelope" method into 2 groups, each including 35 persons. Patients of the first group were injected vincristin, 5-fluoruracil, methotrexate (once a week), cyclophosphane (3 times a week) and prednisolone daily during 3 weeks. The duration of the course of treatment was 4 weeks. The therapy course was repeated with an interval of 1--2 months. Patients of the second group in addition to the analogous treatment were subjected to ovariectomy with subsequent continuous administration of prednisolone, testosterone-propionate or synoestrol. An objective effect was noted in 24 patients of the first group (71.4%), the complete remission being gained in 4 of them. An average duration of the remission--7.6 months. An objective effect was noted in 31 patients of the second group (88.5%), the complete remission--in 4 of them. An average duration of the remission--10.7 months. Primary mammary tumors and metastases in regional lymph nodes proved to be mostly susceptible to the conducted therapy. Lung and pleural metastases were found to be less susceptible. No grave complications due to this kind of treatment were noted.
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