Vol 18, No 2 (2016)

Articles
Brentuximab vedotin in the treatment of relapsed and refractory forms of Hodgkin lymphoma
Demina E.A.
Abstract
About 80% of patients can be cured using modern treatment of Hodgkin lymphoma, regardless of disease stage. However, the first chemotherapy line is not effective in 10-30% of patients, and these patients need to continue treatment. The investigation of targeted drugs associated with the specific activity in Berezovsky-Reed- Sternberg cells, opens up new prospects for the treatment of Hodgkin lymphoma. This article deals with the review of studies concerning the application of new drug brentuximab vedotin in the treatment of relapsed and refractory forms of Hodgkin lymphoma.
Journal of Modern Oncology. 2016;18(2):15-18
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Dural non-Hodgkin’s lymphomas
Babicheva L.G., Baikov V.V., Leenman E.E., Vinogradova Y.N., Ilyin N.V., Ryabchikova V.V., Poddubnaya I.V.
Abstract
Primary presentation of intradural non-Hodgkin lymphoma (PDL) is rare. Most published cases of PDL are single-patient reports. This lesion occurs more often in middle-aged women, in contrast to brain parenchyma primary central nervous system lymphoma (PCNSL), which has a slight male predilection. In contrast with parenchymal PCNSL, there has been no clear association between acquired and congenital immunosuppression and the development of PDL. The pathogenesis of PDL is not well understood because the dura is devoid of any lymphoid tissue. One hypothesis is that a benign inflammatory condition of the dura could attract polyclonal lymphocytes from which a monoclonal lymphoma could arise. B-cell lymphomas of mucosa-associated lymphoid tissue (MALT) have been recognized as an important pathologic subtype. A PDL is more indolent and has a better prognosis than parenchymal PCNSL or systemic lymphoma with CNS metastasis. However, further studies with longer clinical follow up are necessary to assess the final outcome in these patients. In general, patients with marginal zone lymphoma have a favorable outcome, with a 5-year overall survival rate greater than 86%, without significant differences between gastrointestinal and nongastrointestinal and between localized and disseminated disease.
Journal of Modern Oncology. 2016;18(2):19-26
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New opportunities to improve of duration and quality of life: eribulin in the treatment of patients with advanced breast cancer
Semiglazova T.Y., Klyuge V.A., Semiglazov V.V., Teletaeva G.M., Krivorotko P.V., Dashyan G.A., Paltuev R.M., Tkachenko E.V., Donskikh R.V., Semiglazov V.F.
Abstract
Since 1990-s the efficiency of treatment of patients with metastatic/advanced breast cancer (MBC) was started to evaluate not only by overall survival but also by quality of life which is characterized by physical, social, mental and emotional condition of the patient. As there are no standards of system treatment for MBC after anthracyclines and taxanes, choice of further tactics was based on separate randomized trials and own intuition of the oncologist until recently. Eribulin mesylate (eribulin) became the first chemotherapy agent, confirmed to be effective in two large randomized trials: in first of them a significant increase of overall survival and the preservation of quality of life were shown in population of patients with MBC progressing after treatment including anthracycline antibiotics and taxanes. In second trial advantage of the drug was registered in patients with triple negative and luminal B HER2-negative MBC subtypes.
Journal of Modern Oncology. 2016;18(2):27-33
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Development of cytotoxic chemotherapy in metastatic breast cancer with a triple-negative phenotype
Karabina E.V., Zhukova L.G.
Abstract
Treatment of patients with metastatic breast cancer (BC) with a triple-negative phenotype represents the most difficult challenge for clinicians. The optimal chemotherapy regimens for triple-negative BC (TNBC) have not been determined for a long time. However, in the later periods were found molecular agents of application (6 subtypes of TNBC) for the specific therapeutic agent and were performed many studies and subunit analysis, examined appropriate drugs for TNBC. Cell lines of these subtypes have different anticancer drug sensitivity. The results of further studies of targeted drugs using as monotherapy or in combination with chemotherapy in patients with TNBC, in spite of molecular genetic evidence for their application, have fallen short of expectations, although have shown increase in progression-free survival and overall survival. The development of eribulin (nontaxane microtubule dynamics inhibitor) in 2010 significantly increased the possibility of therapy in patients with locally advanced and metastatic BC who had already received chronic treatment. According to the joint analysis of the randomized phase III EMBRACE trial and Study 301, which included data about 1864 patients, it was demonstrated that eribulin statistically significant improve overall survival compared with other drugs using as monotherapy in the general population and among patients with TNBC [statistically significant differences in overall survival was associated with the subgroup of TNBC in patients who had been treated with eribulin, in comparison with the control arm: 12.9 and 8.2 months, respectively (relative risk 0.74; 95% confidence interval, 0.60 to 0.92, p=0.006)]. This article deals with the own experience of successful and long-term eribulin application in young woman with TN metastatic BC who have had already received chronic treatment.
Journal of Modern Oncology. 2016;18(2):34-38
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Bioequivalence assessment of BCD-022 (trastuzumab, manufactured by JSC BIOCAD, Russia) as compared with Herceptin® (F.Hoffmann-La Roche Ltd., Switzerland), used in combination with paclitaxel in HER2-positive metastatic breast cancer patients: findings of the international, double-blind phase III clinical study
Ignatova E.O., Burdaeva O.N., Kopp M.V., Kotiv B.N., Udovitsa D.P., Stroiakovskii D.L., Alekseev S.M., Sheveleva L.P., Khorinko A.V., Shapovalova I.S., Moiseenko V.M., Ivanov R.A.
Abstract
Objective. Within the multi-center double-blind randomized clinical study, investigate the bioequivalence (immediate efficacy, safety and pharmacokinetics) of BCD-022 (trastuzumab, JSC BIOCAD, Russia), as compared with Herceptin® (trastuzumab, F.Hoffmann-La Roche, Switzerland), used in combination with paclitaxel in HER2-positive metastatic breast cancer (HER2(+) MBC) patients. Subjects and methods. The analysis included 126 HER2(+) MBC patients aged 18 to 75 years (65 in the BCD-022 group and 61 in the Herceptin® group). The treatment was provided by scheme BCD-022 or Herceptin® 8 mg/kg intravenous drip, paclitaxel 175 mg/m2 intravenous drip in day 1 of the three-week course, then by the same scheme with trastuzumab 6 mg/kg. The treatment was continued for 6 courses or until disease progression/development of intolerable toxicity effects. The groups were randomized at 1:1 ratio. The primary endpoint for the immediate efficacy evaluating was the overall response rate (complete response rate + partial response rate), for the safety evaluating - the adverse event (AE) rate. One of the primary endpoint for the pharmacokinetics evaluating was the area under concentration-time curve (AUC0-504) of trastuzumab after a single administration. Immediate efficacy was evaluated by CT with contrast using RECIST 1.1 criteria. The safety analysis included immunogenicity evaluating of the study drugs by the formation rate and titer of binding and neutralizing antibodies to trastuzumab. Findings. Out of 126 HER2(+) MBC patients, 110 were included in the immediate efficacy analysis: 56 in BCD-022 group and 54 in Herceptin® group. It was impossible to assess the effect in 16 patients due to the lack of the necessary data: 9 in BCD-022 group and 7 in Herceptin® group (p=0.9). Of these, 2/16 patients withdrew before the start of treatment and 4/16 patients withdrew prior to the first assessment of the effect for reasons not related to confirmed progression. One patient of 16 had disturbance of trastuzumab dosing regimen, and therefore the comparison of immediate efficacy would be incorrect. One patient of 16 showed nonconformity to the inclusion/non-inclusion criteria, and the patient was excluded from the study. In 8/16 patients, characteristics of lesions or their visualization technique did not allow an assessment in accordance with RECIST 1.1 criteria. These patients received treatment in the amount of 6 courses on the Protocol to the achievement of clinical efficacy. Overall response rate was recorded in 30/56 (53.6%) (95% CI 40.7-65.9%) and 29/54 (53.7%) (95% CI 40.6-66.3%) patients in BCD-022 group and Herceptin® group, respectively (p=0.9). No statistically significant differences were found when comparing the other parameters of immediate efficiency: complete response was observed in 3/56 (5.4%) and 2/54 (3.7%) patients, partial response in 27/56 (48.2%) and 27/54 (50.0%), stabilization in 14/56 (25.0%) and 14/54 (25.9%), progression in 12/56 (21.4%) and 11/54 (20.4%) patients in BCD-022 and Herceptin® group, respectively (p>0.05). Comparison by all the main pharmacokinetic parameters (AUC0-504, Cmax, Tmax, T1/2 and Ctrough) showed no statistically significant differences between the groups. Out of 126 patients, 124 were included in the safety analysis: 63 in BCD-022 group and 61 in Herceptin® group. Two patients withdrew from the study prior to treatment. AEs were registered in 62/63 (98.4%) and 60/61 (98.4%) patients in BCD-022 group and Herceptin® group, respectively. Statistically significant differences between the groups were not identified in any of the AEs. The most common AEs were hematologic toxicity, myalgia and arthralgia. Most reported AEs were mild to moderate by CTCAE 4.03. Serious adverse events (SAEs) were reported in 10 patients: in 4/63 (6.4%) patients in BCD-022 group and in 7/61 (11.5%) Herceptin® group (2 SAEs were reported in 1 patient in the Herceptin® group) (p=0.2). In most cases SAEs were due to concomitant diseases, exposure to chemotherapeutic agents or other non-study therapy causes. Trastuzumab-related SAEs were reported in 5 patients: in 1/63 (1.6%) in BCD-022 group and in 4/61 (6.5%) in Herceptin® (р=0.2) group. Immunogenicity study revealed the emergence of binding antibodies to trastuzumab in 3/63 (4.7%) patients in BCD-022 group and in 1/61 (1.6%) in Herceptin® group, of them neutralizing antibodies to trastuzumab were reported in 1 patient in BCD-022 group and in 1 in the control group (p=1.0). Conclusion. BCD-022 (trastuzumab, JSC BIOCAD, Russia) is non-inferior to the original trastuzumab drug Herceptin® (F.Hoffmann-La Roche Ltd., Switzerland) on the profile of immediate efficacy, safety and pharmacokinetic properties.
Journal of Modern Oncology. 2016;18(2):39-47
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Cost-effectiveness of empegfilgrastim (Extimia®) for the prevention of severe neutropenia in patients with malignant neoplasm of female breast
Rudakova A.V., Tolkacheva D.G., Gavrilova O.N., Vaganov A.S.
Abstract
Granulocyte colony stimulating factor (G-CSF), particularly filgrastim, significantly reduces the chance of developing side effects of chemotherapy. Pegylated G-CSF products are characterized as longer-acting drugs in comparison with non-pegylated forms. The aim of the study was to assess the cost-effectiveness of pegylated filgrastim (Russia) - empegfilgrastim (Extimia®) in comparison with non-pegylated filgrastim (Leucostim®). Material and methods. The assessment was conducted from the position of health systems based on the results of double-blind randomized trial concerning the comparison between Russian preparations such as empegfilgrastim and filgrastim using for the prevention of neutropenia in patients with breast cancer. Costs for G-CSF have been calculated on the basis of registered cost for non-pegylated filgrastim (Leucostim®) and anticipated costs for empegfilgrastim (in both cases - including VAT with 10% markup). Horizon scanning is first cycle of chemotherapy. Results. Empegfilgrastim (Extimia®), used for the prevention of severe neutropenia, reduces the impacts on budget by 9.2% in comparison with filgrastim (Leucostim®). Costs for each patient without grade 4 neutropenia were 62.5% lower on using empegfilgrastim in comparison with filgrastim. Conclusions. Empegfilgrastim has the same therapeutic efficacy, as well as pharmacoeconomic advantages in comparison with non-pegylated filgrastim, reducing impacts on a budget and can be recommended to be used in clinical practice.
Journal of Modern Oncology. 2016;18(2):48-51
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The role of regorafenib in the treatment of metastatic colorectal cancer
Tryakin A.A.
Abstract
Regorafenib is a multi-tyrosine kinase inhibitor, associated with the activity in metastatic colorectal cancer (mCRC) and gastrointestinal stromal tumors. Regorafenib application in patients with mCRC after exhausting all available drug therapies have resulted in statistically significant increase in life expectancy in comparison with best supportive therapy. This article discusses the issues concerning the efficacy, tolerability and the role of the drug in the treatment of refractory mCRC.
Journal of Modern Oncology. 2016;18(2):52-56
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Long-term treatment of neuroendocrine tumor of the pancreas
Khvastunov R.A., Egorov S.V., Kargin A.V., Kim A.Y.
Abstract
Most neuroendocrine tumors (NET) grow slower than other epithelial malignant neoplasms, but they can be aggressive and resistant to treatment. NET of the pancreas account for only 0.55% in the structure of these formations. From this point of view, we present the description of a clinical case and the treatment of a NET of the pancreas. It demonstrates the possibility of long-term combined treatment of NET of this localization.
Journal of Modern Oncology. 2016;18(2):58-60
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Predictive biomarkers in chemotherapy of pancreatic duct adenocarcinoma: rewiew of the literature
Kovalenko Z.A., Kekeeva T.V., Lyadov V.K.
Abstract
This is a literature rewiew on predictive biomarkers in pancreatic duct adenocarcinoma. The main point of this rewiew is to identify prognostic role of different biomarkers in adjuvant and palliative chemotherapy of pancreatic cancer.
Journal of Modern Oncology. 2016;18(2):61-66
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Prognostic factors in patients with disseminated gastrointestinal stromal tumors
Arkhiri P.P., Stilidi I.S., Poddubnaya I.V., Nered S.N., Nikulin M.P., Abu-Khaydar O.B.
Abstract
The main method of treatment of patients with metastatic GIST is targeted therapy using tyrosine kinase inhibitors in contrast to localized forms of the disease. The efficiency and the duration of targeted therapy efficiency are the main prognostic factors in patients with metastatic gastrointestinal stromal tumors (GIST). Targeted therapy was ineffective among patients with the median survival of only 12-19 months, whereas in cases of effective targeted therapy the median survival was incomparably higher - 60-72 months. The main prognostic factors in patients with primary localized gastrointestinal stromal tumors are: the size of the primary tumor, mitotic index, the localization of tumors, mutation status and morphological characteristics of GIST. Taking into consideration that the main method of treatment in patients with disseminated GIST is drug therapy, the predictive values of several mentioned factors have lost the value, but other factors such as mutation status, morphological characteristics, the number and size of tumors and the localization of metastatic nodes have become more important.
Journal of Modern Oncology. 2016;18(2):67-71
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Improved technique thyroidectomy with lateral modified radical neck dissection
Shabunin A.V., Dolidze D.D., Podvyaznikov S.O., Melnik K.V., Mumladze R.B., Vardanyan A.V., Lebedinskiy I.N., Grachev P.V.
Abstract
Background. According to World Health Organization thyroid cancer (TC) is the most common endocrine malignancy. The frequency of regional lymph node (LN) lesions in this disease may be up to 80%, which requires advanced operations. In cases when metastasis develop in the II-V group cervical LN, should be perfomed thyroidectomy with functional neck dissection. Life expectancy and life quality of this severe category of patients depends on perfomed intervention. Extent and operation technique tend to move to functionally sparing methods, which aimed to preserve oncological principles with anatomical structures damage prevention and to promote better cosmetic effects. However, existing nowadays interventions do not always combine these requirements. The foregoing calls for further improvement of the operation - thyroidectomy with lateral modified radical neck dissection with the achievement of the maximum radicalism, optimal safety and the desired cosmetic result of intervention. Aim. Improving the results of surgical treatment of patients with TC with metastases in the LN group II-V operation areas by improving methodology, with a decrease in the number of complications and achieving the desired cosmetic effect without prejudice radical intervention. Materials and methods. Study based on results of treatment of 46 patients with different forms of cancer which were examined and operated in department of endocrine surgery of S.P.Botkin City Clinical Hospital of the Department of Health of Moscow. Patients were divided on 2 groups. In first group were included 22 (47.8%) patients operated in the period from 2008 to 2011 and in second group 24 (52.2%) patients who received treatment with 2012 by 2015. Here with cancer forms in first group were distributed as follows: papillary cancer - 18 (81.8%) cases, follicular - 3 (13.6%) and medullary - 1 (4.5%) follow up. In second group papillary cancer has been identified in 18 (75.0%) patients, follicular in 3 (12.5%) and medullary - in 2 (8.3%). Extent of process was assessed and in first group: T1bN1bM0 - in 2 (9.1%) cases, and in second group - in 3 (12.5%) cases, T2N1bM0 - in 7 (31.8%) and 9 (37.5%), a T3N1bM0 - in 13 (59.1%) and 12 (50.0%) surveillances respectively. Age ratio ranged from 35 to 65 years. Mean age in first group was 50 years for men and 52 for women, while in the second group - 45 years for men and 48 years. Sex ratio in both groups - 1:9; 21 (95.5%) and 22 (91.7%) patients with differentiated cancer forms underwent radioiodine therapy. Conclusion. Proposed improved method of thyroidectomy with functional neck dissection using in patients with TC allows to perform a radical operation achieving required safety of intervention and preserve patients life quality.
Journal of Modern Oncology. 2016;18(2):72-77
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Second primary cancer in patients with head and neck squamous cell carcinoma: case report
Agabekyan G.O., Stelmakh D.K., Aydarbekova A.A.
Abstract
We report a clinical case of metachronous multiple primary squamous cell carcinoma with three successive defeats of the head and neck for 32 years - the language, hypopharynx, oropharynx.
Journal of Modern Oncology. 2016;18(2):78-80
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Supportive therapy for ovarian cancer
Pokataev I.A., Tyulyandin S.A.
Abstract
Surgery is the main treatment for patients suffering from ovarian cancer. But, the therapy successes of this pathology have been primarily associated with the effective drug treatment in recent years. New drugs and chemotherapy regimens have significantly changed the principles of medicinal treatment of the disease and helped to add supportive part of therapy. Supportive therapy was considered inappropriate due to limited efficacy and high toxicity 5 years ago.
Journal of Modern Oncology. 2016;18(2):81-87
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Passive smoking prevalence among patients of krasnoyarsk regional oncologic dispensary
Kutumova O.Y., Kononova L.I., Dobretsova E.A., Shulmin A.B., Korotkova K.M., Rossiyeva T.V.
Abstract
There was conducted a questionnaire survey aimed at defining prevalence of passive smoking among the patients that were undergoing medical treatment at Krasnoyarsk Regional Oncological Dispensary at the time of the survey. The data received were statistically processed. Answering the question “Do you breathe environmental tobacco smoke?” 46,1% of the patients responded that they breathe tobacco smoke contaminated air and 53.9% of the patients do not breathe environmental tobacco smoke. Passive smoking is more common for men (50%) than for women (38.7%). Representatives of age groups “fewer than 30 years old” and “30-39 years old” breathe environmental tobacco smoke more often than others (50% and 53% respectively). They are mostly patients of the thoracic surgical oncology department (72.7%) diagnosed with lung cancer. A half (50%) of passively smoking patients breathe tobacco smoke contaminated air 7 days a week for up to 10 minutes per day (65.4%). It is shown that nearly 285 (73, 3) patients of an oncological clinic, are active and passive smokers. Thus, the conducted researches allow to draw a conclusion that passive inhalation of a tobacco smoke is one of major factors of the increased risk of cancer cases of lungs, and not less significant, than active smoking.
Journal of Modern Oncology. 2016;18(2):88-90
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