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Specificity of hand-foot skin reaction induced by multikinase inhibitors: clinical, histological and ultrasound characteristics 多激酶抑制剂诱导手足皮肤反应的特异性:临床、组织学和超声特征
Q4 Medicine Pub Date : 2020-07-24 DOI: 10.17650/2222-1468-2020-10-2-30-37
E. A. Shatokhina, S. Potkin, P. Malkov, L. Kruglova, A. Polonskaya
Background. Multikinase inhibitors of angiogenesis are currently the most effective group of drugs in target therapy for cancer. They are associated with a high prevalence of a specific cutaneous adverse reaction, which manifests as a hand-foot skin reaction (HFSR). This side effect is quite prominent in the majority of patients, usually graded as II–III degree, which leads to the dose reduction and even discontinuation of the drug. The study objective is to evaluate clinical, histological and ultrasound characteristics of a HFSR associated with MKI treatment, and to assess the influence of a HFSR on patient’s quality of life. Materials and methods. The study included 46 patients with HFSR, who were previously treated with sorafenib or lenvatinib. Clinical characteristics of HFSR, including severity grading, were evaluated. We also performed ultrasound and histological examinations and assess the Dermatology Life Quality Index. Results. Grade III HFSR was in 5 (10.86 %) patients, grade II – in 25 (54.35 %), and grade I – in 16 (34.79 %). Dermatology Life Quality Index depended on the HFSR severity, with the mean value 24.5 ± 2.4. Pathomorphological examination revealed irregular epidermal proliferation with hypertrophic psoriasiform acanthosis, minimal keratinocyte vacuolization, few apoptotic figures, dyskeratosis, hyperkeratosis and microvessel dilation in the papillary dermis. Ultrasound examination showed increased vascularization in papillary and reticular dermis in affected skin areas, which was more prominent in patients with severe degrees of HFSR. The pronounced enhancement of vascularization was detected in fragmented hypoechogenic sites along the border of papillary and reticular dermis and in similar sites along the border of dermis and hypodermis. Conclusion. The use of multikinase inhibitors leads to pronounced changes not only in the surface layers of the skin, but also in the dermis and subcutaneous fat, which significantly worsens the quality of life of patients. This indicates the need to search for pathogenetically based methods of treatment of HFSR and create practical guidelines for supportive treatment of patients with HFSR taking multikinase inhibitors.
背景。血管生成多激酶抑制剂是目前肿瘤靶向治疗中最有效的一类药物。它们与特定皮肤不良反应的高发率有关,表现为手足皮肤反应(HFSR)。这种副作用在大多数患者中相当突出,通常分级为II-III度,导致剂量减少甚至停药。本研究目的是评估与MKI治疗相关的HFSR的临床、组织学和超声特征,并评估HFSR对患者生活质量的影响。材料和方法。该研究包括46例HFSR患者,他们之前接受过索拉非尼或lenvatinib治疗。评估HFSR的临床特征,包括严重程度分级。我们还进行了超声和组织学检查,并评估皮肤生活质量指数。结果。III级HFSR 5例(10.86%),II级25例(54.35%),I级16例(34.79%)。皮肤病生活质量指数与手足口病严重程度有关,平均值为24.5±2.4。病理形态学检查显示不规则表皮增生伴增生性牛皮癣样棘层,角质细胞空泡化极少,少量凋亡,角化异常,角化过度,乳头状真皮微血管扩张。超声检查显示受累皮肤区乳头状和网状真皮层血管化增加,在严重程度的HFSR患者中更为突出。在沿乳头状和网状真皮边界的碎片状低回声区域以及沿真皮和真皮边界的类似区域检测到明显的血管化增强。结论。多激酶抑制剂的使用不仅会导致皮肤表层的明显变化,还会导致真皮层和皮下脂肪的明显变化,从而显著恶化患者的生活质量。这表明需要寻找基于病理的HFSR治疗方法,并为服用多激酶抑制剂的HFSR患者的支持性治疗制定实用指南。
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引用次数: 0
Analysis of treatment outcomes in patients with progressive locally advanced non-resectable and disseminated medullary thyroid cancer receiving vandetanib outside of clinical trials (Russian experience) 进展性局部晚期不可切除和播散性甲状腺髓样癌患者在临床试验外接受万德替尼治疗的结果分析(俄罗斯经验)
Q4 Medicine Pub Date : 2020-07-24 DOI: 10.17650/2222-1468-2020-10-2-46-53
I. Romanov, А. M. Mudunov, S. Podvyaznikov, А. V. Ignatova, Y. Alymov
The study objective is to perform retrospective analysis of the efficacy and safety of vandetanib for metastatic and non-resectable medullary thyroid cancer in routine clinical practice. Materials and methods. We analyzed treatment outcomes in 46 patients treated with vandetanib. We also evaluated progression-free survival, overall survival, time to progression, and frequency of adverse events. Results. At a median follow-up time of 27.4 months (range: 2.5–106.5 months) and median duration of vandetanib therapy of 21 months, disease progression was registered in 32.6 % of cases, whereas stable disease was observed in 28.3 % of cases and 8.7 % of study participants demonstrated partial response. One patient had complete response to treatment. Almost one-third of patients (28.2 %) died, including 2 individuals whose death was not associated with cancer. The one-year and three-year progression-free survival rates were 67.3 % and 33.3 %, respectively; the two-year and five-year overall survival rates were 82.4 % and 29.4 %, respectively. The efficacy of therapy was confirmed by a 79.4 % decrease in the serum level of calcitonin after treatment initiation. Side effects were observed in 33.9 % of patients (primarily skin and gastrointestinal toxic reactions) and were easily managed in most of the cases. Eight individuals (17.4 %) required cessation of vandetanib due to adverse events. Conclusion. Our findings suggest high efficacy and acceptable safety profile of vandetanib in the treatment of progressive locally advanced non-resectable and disseminated medullary thyroid cancer
本研究的目的是回顾性分析凡德替尼在常规临床实践中治疗转移性和不可切除的甲状腺髓样癌的疗效和安全性。材料和方法。我们分析了46例接受万德替尼治疗的患者的治疗结果。我们还评估了无进展生存期、总生存期、进展时间和不良事件发生频率。结果。在中位随访时间为27.4个月(范围:2.5-106.5个月)和vandetanib治疗的中位持续时间为21个月时,32.6%的病例出现疾病进展,而28.3%的病例观察到疾病稳定,8.7%的研究参与者表现出部分反应。一名患者对治疗有完全反应。几乎三分之一的患者(28.2%)死亡,其中包括2名与癌症无关的患者。1年和3年无进展生存率分别为67.3%和33.3%;2年和5年总生存率分别为82.4%和29.4%。治疗开始后,血清降钙素水平下降79.4%,证实了治疗的有效性。在33.9%的患者中观察到副作用(主要是皮肤和胃肠道毒性反应),并且在大多数情况下很容易控制。8名患者(17.4%)因不良事件需要停用vandetanib。结论。我们的研究结果表明vandetanib在治疗进展性局部晚期不可切除和播散性甲状腺髓样癌方面具有较高的疗效和可接受的安全性
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引用次数: 0
Possibilities of magnetic resonance imaging in SWI mode in differential diagnosis of brain gliomas (G3–G4) and primary lymphomas SWI模式下磁共振成像在脑胶质瘤(G3-G4)和原发性淋巴瘤鉴别诊断中的可能性
Q4 Medicine Pub Date : 2020-07-24 DOI: 10.17650/2222-1468-2020-10-2-38-45
D. Sashin, Dolgushin Mb, E. Kobyakova, A. Bekyashev, A. Subbotin, E. Nechipay, D. Romanov, N. A. Kozlov
The study objectiveis to assess the possibilities of magnetic resonance imaging (MRI) in SWI (susceptibility weighted imaging) in the differential diagnosis of glial brain tumors and primary brain lymphomas.Materials and methods.Fifty-four patients with brain tumors were studied (men – 27 (50 %), women – 27 (50 %)). Average age 57.9 years. Histological examination of the surgical material revealed the glial nature of tumors in 41 patients (26 of them with glioblastoma, anaplastic astrocytomas – 15), primary brain lymphomas – in 13 patients. Brain MRI was performed using tomographs with a magnetic field of 3 and 1.5 T. A semi-quantitative assessment of the data obtained in the SWI mode based on the classification of ITSS (intratumoral susceptibility signals), reflecting the severity of interstitial vascular architectonics and microbleeding.Results.The degree of ITSS was 3 in glioblastomas (G4 ) in 26 (100 %) cases, in the structure of gliomas (G3 ) the ITSS values were 3 in 3 (20 %) cases, in the remaining 12 (80 %) cases – ITSS 2. In the group of primary brain lymphomas, the ITSS 1 was in 4 (30.7 %) cases, ITSS 0 was in 9 (69.3 %) cases.Conclusion.MRI in SWI mode is a promising technique that allows one to quantify the degree of pathological changes in tumor vascular architectonics and intratumoral hemorrhages and has shown high specificity in the differential diagnosis of malignant gliomas and lymphomas of the brain, accompanied by active accumulation of contrast medium.
本研究的目的是评估磁共振成像(MRI)的敏感性加权成像(SWI)鉴别诊断神经胶质性脑肿瘤和原发性脑淋巴瘤的可能性。材料和方法。研究了54例脑肿瘤患者(男性27例(50%),女性27例(50%))。平均年龄57.9岁。手术材料的组织学检查显示41例患者的肿瘤为胶质细胞瘤(其中胶质母细胞瘤26例,间变性星形细胞瘤15例),原发性脑淋巴瘤13例。大脑核磁共振进行使用层析x射线摄影机3和1.5 t的磁场半定量评估获得的数据在瑞士模式分类的基础上的同期(瘤内磁化率信号),反映的严重性间质血管ITSS建筑学和microbleeding.Results.The程度的是3件(G4) 26(100%)情况下,结构的神经胶质瘤(G3)同期值在3(20%)例3,其余12(80%)例,同期2。在原发性脑淋巴瘤组中,ITSS 1为4例(30.7%),ITSS 0为9例(69.3%)。结论:mri在SWI模式下可以定量判断肿瘤血管结构和肿瘤内出血的病理改变程度,对脑恶性胶质瘤和淋巴瘤的鉴别诊断具有较高的特异性,并伴有造影剂活性积累。
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引用次数: 0
Antibiotic prophylaxis for head and neck cancer surgery 头颈癌手术的抗生素预防
Q4 Medicine Pub Date : 2020-07-24 DOI: 10.17650/2222-1468-2020-10-2-54-60
A. Guz, D. M. Fatkullin, A. Garev, A. S. Zakharov, M. I. Sokolova, A. P. Alekseeva
This review analyzes the research data concerning the problem of antibiotic prophylaxis (ABP) of wound infections after various surgeries for head and neck tumors. In patients with clean wounds, ABP should be used in exceptional cases only (for example, if the patient has any risk factors), otherwise it should be avoided. A short ABP course is recommended for patients with clean-contaminated wounds; however highrisk patients may require a prolonged course. There is some evidence of ABP efficacy in patients with non-contaminated wounds after cervical lymphadenectomy. When choosing a drug for ABP, a doctor should consider the site of surgery and the risk of wound contamination. The optimal drugs after head and neck surgeries include first- and second-generation cephalosporins, ampicillin in combination with sulbactam, metronidazole, and clindamycin. First- and second-generation cephalosporins in combination with metronidazole are preferable, but if the wound is infected with gram-positive bacteria, it is necessary to use clindamycin monotherapy. Reconstructive surgeries with a free flap require a short course of ABP with one of the following combinations: cefazolin + metronidazole, cefuroxime + metronidazole, or ampicillin + sulbactam; if the patient is allergic to beta-lactams, clindamycin can be used. Despite the availability of standard ABP regimens, a surgeon must apply a tailored approach when choosing an ABP regimen for each patient, taking into account risk factors and the volume of surgery.
本文综述了国内外有关头颈部肿瘤各种手术后伤口感染的抗生素预防问题的研究资料。对于伤口干净的患者,ABP仅在特殊情况下使用(例如,如果患者有任何危险因素),否则应避免使用。对于伤口未被污染的患者,建议进行短期ABP治疗;然而,高风险患者可能需要延长疗程。有一些证据表明,ABP对宫颈淋巴结切除术后未污染伤口的患者有效。在选择ABP药物时,医生应考虑手术部位和伤口污染的风险。头颈部手术后的最佳药物包括第一代和第二代头孢菌素、氨苄西林联合舒巴坦、甲硝唑和克林霉素。第一代和第二代头孢菌素联合甲硝唑是优选的,但如果伤口感染革兰氏阳性菌,则有必要使用克林霉素单药治疗。自由皮瓣重建手术需要短期ABP治疗,并采用以下组合之一:头孢唑林+甲硝唑,头孢呋辛+甲硝唑,或氨苄西林+舒巴坦;如果患者对-内酰胺过敏,可以使用克林霉素。尽管有标准的ABP方案,但外科医生在为每位患者选择ABP方案时,必须考虑到风险因素和手术量,采用量身定制的方法。
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引用次数: 0
Oral cancer reconstructive surgery using the free radial forearm flap (review) 应用游离前臂桡侧皮瓣进行口腔癌重建手术(综述)
Q4 Medicine Pub Date : 2020-07-24 DOI: 10.17650/2222-1468-2020-10-2-61-68
H. Chen, A. Mudunov, R. I. Azizian, I. Pustynskiy, D. K. Stelmah
This review covers the issues related to the application of radial free forearm flaps for the reconstruction of defects after surgeries for oral squamous cell carcinoma. The advantages of this method include optimal match of the flap to the tissues of the oral cavity, good adaptation to defect edges, and possibility to replace defects of almost any size and locations. Flap survival rate reaches 92.0–98.4 %. The method demonstrated good functional and aesthetic results when used for the repair of extensive defects of the tongue, oral floor, cheeks, as well as total defects of the lips, hard and soft palates. The main disadvantages of the method include aesthetic defects of the donor site and possible forearm dysfunction, but most patients are quite comfortable with these inconveniences. The death rate is 0.09 %; the incidence of complications is 15–24 %. The main cause of graft failure in this case is venous thrombosis. Advanced age is not currently considered as a contraindication for this method. Further studies evaluating free radial flaps are highly relevant, particularly those comparing this method with other ones and determining strict indications for it (such as size and location of the defect, tumor characteristics, and previous treatment).
本文就前臂游离桡骨皮瓣在口腔鳞状细胞癌术后缺损重建中的应用进行综述。该方法的优点是皮瓣与口腔组织的最佳匹配,对缺损边缘的适应性好,几乎可以替代任何大小和位置的缺损。皮瓣成活率达92.0 ~ 98.4%。该方法用于修复舌头、口腔底、面颊的大面积缺损,以及嘴唇、软硬腭的全部缺损,具有良好的功能和美观效果。该方法的主要缺点包括供体部位的美观缺陷和可能的前臂功能障碍,但大多数患者对这些不便都很满意。死亡率为0.09%;并发症发生率为15 - 24%。静脉血栓形成是导致移植失败的主要原因。高龄目前不被认为是这种方法的禁忌症。评价游离桡骨皮瓣的进一步研究是高度相关的,特别是将该方法与其他方法进行比较,并确定其严格的适应症(如缺损的大小和位置、肿瘤特征和既往治疗)。
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引用次数: 0
The results of using free osteomyofascial flaps in the simultaneous reconstruction of combined post-resection facial defects with an intraoral component 游离骨骼肌筋膜瓣在口腔内复合缺损术后同步重建中的应用效果
Q4 Medicine Pub Date : 2020-07-24 DOI: 10.17650/2222-1468-2020-10-2-22-29
A. S. Sharapo, V. Ivashkov, А. M. Mudunov, M. Bolotin, M. Bektemirov, A. E. Raportinova
The study objectiveis to analyze the results of the use of free osteomyofascial flaps in the reconstruction of combined post-resection facial defects with an intraoral component.Materials and methods.Fifty-three patients were operated by the proposed method. The muscle portions which were used with free flaps were: m. flexor hallucis longus with the free fibula flap (n = 27), m. vastus lateralis with anterolateral thigh flap (n = 11), m. subscapularis with the scapula free flap (n = 15). An analysis of postoperative complications was performed, as well as an analysis of the timing of dental implantation.Results.The average hospital stay was 15 days. The main complications from the recipient area were: local inflammation in the reconstruction area – 2 (3.8 %) cases, hematoma on the neck – 2 (3.8 %), fistula formation – 1 (1.9 %), full flap necrosis was noted in 1 (3.7 %) case, hypertrophic growths of granulation tissue on the muscle portions of the flaps in 3 (5.7 %). The main complications from the donor zone: hematomas – 0 cases. In 2 (13.3 %) patients after using a chimeric scapular flap, lymphorrea up to 50–70 ml was noted. Dental implantation was performed in 4 (9.5 %) cases. There were no complications or difficulties in performing dental implantation. The average time taken to form the soft tissue contour in the area of implants after installing the gingiva formers in our study was 2.5 weeks, which is 2 weeks faster than using flaps that include a skin paddle.Conclusion.This reconstruction method could be used as a main for the plastic elimination of combined facial defects with an intraoral component.
本研究的目的是分析游离骨筋膜瓣在口腔内复合缺损术后重建中的应用效果。材料和方法。53例患者采用该方法手术。应用游离皮瓣的肌段有:长屈肌联合腓骨游离皮瓣27例,股外侧肌联合股前外侧皮瓣11例,肩胛下肌联合肩胛骨游离皮瓣15例。结果两组患者平均住院时间为15天。受体区主要并发症为:重建区局部炎症2例(3.8%),颈部血肿2例(3.8%),瘘形成1例(1.9%),皮瓣全坏死1例(3.7%),皮瓣肌肉部分肉芽组织增生3例(5.7%)。供体区主要并发症:血肿0例。在2例(13.3%)患者使用嵌合肩胛骨瓣后,淋巴组织高达50-70 ml。4例(9.5%)行种植。种植牙无并发症和困难。本研究牙龈成形术后种植体区域软组织轮廓形成的平均时间为2.5周,比带皮瓣的皮瓣修复快2周。结论该方法可作为口腔内构件复合面部缺损整形修复的主要方法。
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引用次数: 2
Glyciphon ointment for local treatment of basal cell cancer: clinical and pharmacological aspects 甘昔芬软膏局部治疗基底细胞癌:临床和药理方面
Q4 Medicine Pub Date : 2020-04-11 DOI: 10.17650/2222-1468-2020-10-1-73-83
S. Podvyaznikov, A. Mudunov, A. V. Ignatova, D. A. Vasilkin, A. N. Anisimov, P. Shchennikov
Introduction. Basal cell cancer (BCC) accounts for up to 80 % of all types of non-melanoma skin cancers. In 97 % of cases, BCC develops on bare facial skin, especially at the nose-forehead border, nose wings, corners of eyes and lips. Surgery can lead to gross cosmetic defects, therefore more and more specialists prefer conservative methods, among which local drug therapy holds a special place.The study objective is to evaluate the effectiveness and safety of glyciphon ointment for BCC local treatment as well as the economic costs. Materials and methods. The study included 114 patients who underwent BCC local drug therapy with 30 % Glyciphon ointment, where 111 (97.4 %) patients had primary BCC, and 3 (2.6 %) ones – recurrent BCC. Results. The study recorded 115 cases of use of glyciphon ointment in 114 patients. Doctors were fully satisfied with the treatment results in 101 (88.6 %) cases. In 11 (9.6 %) cases, satisfaction was partial due to severe adverse events (edema and hyperemia of the facial skin, pain), and in 2 (1.7 %) cases the treatment was found unsatisfactory. Eighty-six (93.5 %) patients with adverse events continued Glyciphon ointment therapy. The relapse rate after local drug therapy was 4.4 %, indicating its high efficacy and good tolerance. According to the study, most patients required 1 treatment course with 1 package of Glyciphon. Total cost of the treatment is approximately 17,000 rubles. Total budget expenditures are estimated at 1 billion 190 million rubles. Local BCC therapy with Glyciphon comparing to surgery may save more than 1 billion rubles for the state budget.Conclusion. Local chemotherapy with 30 % Glyciphon ointment is an effective and safe method to treat BCC. Its use increases treatment availability for patients and can significantly reduce federal expenditures. 
介绍。基底细胞癌(BCC)占所有类型的非黑色素瘤皮肤癌的80%。在97%的病例中,BCC发生在裸露的面部皮肤上,特别是在鼻前额边缘、鼻翼、眼角和嘴唇。手术可能导致严重的美容缺陷,因此越来越多的专家倾向于保守的方法,其中局部药物治疗占有特殊的地位。本研究的目的是评价甘霉素软膏用于BCC局部治疗的有效性和安全性以及经济成本。材料和方法。该研究包括114例接受30% Glyciphon软膏局部药物治疗的BCC患者,其中111例(97.4%)为原发性BCC, 3例(2.6%)为复发性BCC。结果。本研究记录了114例患者中115例使用甘霉素软膏的病例。101例(88.6%)患者对治疗结果满意。11例(9.6%)患者因严重不良事件(面部皮肤水肿充血、疼痛)而部分满意,2例(1.7%)患者治疗不满意。86例(93.5%)出现不良事件的患者继续接受甘霉素软膏治疗。局部药物治疗后复发率为4.4%,疗效高,耐受性好。根据研究,大多数患者需要1个疗程,1包甘昔芬。治疗的总费用约为17,000卢布。总预算支出估计为11.9亿卢布。与手术相比,使用Glyciphon进行局部BCC治疗可为国家预算节省超过10亿卢布。30%甘霉素软膏局部化疗是治疗BCC有效、安全的方法。它的使用增加了患者治疗的可获得性,并能显著减少联邦支出。
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引用次数: 1
Efficacy and tolerability of lenvatinib in patients with radioiodine-refractory differentiated thyroid cancer: results of a multicenter observational study in the Russian Federation lenvatinib对放射性碘难治性分化甲状腺癌患者的疗效和耐受性:俄罗斯联邦一项多中心观察性研究的结果
Q4 Medicine Pub Date : 2020-04-11 DOI: 10.17650/2222-1468-2020-10-1-65-72
E. Borodavina, P. Isaev, A. Shurinov, P. Rumyantsev, V. Krylov, K. Petrosyan, A. Kaprin, S. A. Ivanov, S. Podvyaznikov, I. Romanov, A. Mudunov, K. Slashchuk, R. Zhikhorev, M. Volkonsky, R. M. Chagova, I. Suslova, A. I. Khryapa, A. K. Lepshokova, N. L. Fadeeva, A. R. Safarova, L. P. Kaleykina, E. V. Lymar, E. Chernyakova, O. A. Snezhko, A. E. Zinkovskaya, F. F. Mufazalov, E. Kuzmina, Y. Druzhinina, S. Musin, M. R. Mukhitova, A. Khasanova, S. Safina, S. L. Kirienko
Background. The implementation of tyrosine kinase inhibitors into clinical practice improved treatment outcomes in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC). Lenvatinib is recommended as a first-line drug for these patients. The study objective is to analyze clinical experience with lenvatinib in patients with RR-DTC in the Russian Federation. Materials and methods. The data from 18 clinical sites in Russia was analyzed for the period December 2015 and September 2019. Seventyseven patients with histologically verified DTC, proven resistance to radioactive iodine therapy, and tumor progression (according to the Response Evaluation Criteria In Solid Tumors 1.1 criteria) were included in the study. Results.Median progression-free survival in patients included into analysis (n = 72) was 26.1 months. In patients who responded to therapy (including those with partial and complete response), median progression-free survival reached 36.2 months, which is higher than that reported in the updated results of the SELECT study (33.1 months). Lenvatinib-associated adverse events (AEs) were observed in 87 % of patients. Severe AEs were registered in 18.2 % of participants. In 6.5 % of cases, AEs lead to lenvatinib cessation; in 74 % of cases, AEs required dose reduction.Conclusion. Our findings suggest high efficacy and good tolerability of lenvatinib in patients with RR-DTC in routine clinical practice in the Russian Federation.
背景。酪氨酸激酶抑制剂在临床实践中的应用改善了放射性碘难治性分化型甲状腺癌(RR-DTC)患者的治疗效果。Lenvatinib被推荐作为这些患者的一线药物。研究目的是分析俄罗斯联邦RR-DTC患者使用lenvatinib的临床经验。材料和方法。研究人员分析了2015年12月至2019年9月期间俄罗斯18个临床站点的数据。77例经组织学证实的DTC患者,证实对放射性碘治疗有耐药性,肿瘤进展(根据实体瘤反应评价标准1.1标准)纳入研究。结果。纳入分析的患者中位无进展生存期(n = 72)为26.1个月。在对治疗有反应的患者中(包括部分和完全缓解的患者),中位无进展生存期达到36.2个月,高于SELECT研究的最新结果(33.1个月)。87%的患者观察到lenvatinib相关不良事件(ae)。18.2%的参与者出现严重不良反应。在6.5%的病例中,ae导致lenvatinib停药;在74%的病例中,ae需要减少剂量。我们的研究结果表明,在俄罗斯联邦的常规临床实践中,lenvatinib对RR-DTC患者的疗效高,耐受性好。
{"title":"Efficacy and tolerability of lenvatinib in patients with radioiodine-refractory differentiated thyroid cancer: results of a multicenter observational study in the Russian Federation","authors":"E. Borodavina, P. Isaev, A. Shurinov, P. Rumyantsev, V. Krylov, K. Petrosyan, A. Kaprin, S. A. Ivanov, S. Podvyaznikov, I. Romanov, A. Mudunov, K. Slashchuk, R. Zhikhorev, M. Volkonsky, R. M. Chagova, I. Suslova, A. I. Khryapa, A. K. Lepshokova, N. L. Fadeeva, A. R. Safarova, L. P. Kaleykina, E. V. Lymar, E. Chernyakova, O. A. Snezhko, A. E. Zinkovskaya, F. F. Mufazalov, E. Kuzmina, Y. Druzhinina, S. Musin, M. R. Mukhitova, A. Khasanova, S. Safina, S. L. Kirienko","doi":"10.17650/2222-1468-2020-10-1-65-72","DOIUrl":"https://doi.org/10.17650/2222-1468-2020-10-1-65-72","url":null,"abstract":"Background. The implementation of tyrosine kinase inhibitors into clinical practice improved treatment outcomes in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC). Lenvatinib is recommended as a first-line drug for these patients. The study objective is to analyze clinical experience with lenvatinib in patients with RR-DTC in the Russian Federation. Materials and methods. The data from 18 clinical sites in Russia was analyzed for the period December 2015 and September 2019. Seventyseven patients with histologically verified DTC, proven resistance to radioactive iodine therapy, and tumor progression (according to the Response Evaluation Criteria In Solid Tumors 1.1 criteria) were included in the study. Results.Median progression-free survival in patients included into analysis (n = 72) was 26.1 months. In patients who responded to therapy (including those with partial and complete response), median progression-free survival reached 36.2 months, which is higher than that reported in the updated results of the SELECT study (33.1 months). Lenvatinib-associated adverse events (AEs) were observed in 87 % of patients. Severe AEs were registered in 18.2 % of participants. In 6.5 % of cases, AEs lead to lenvatinib cessation; in 74 % of cases, AEs required dose reduction.Conclusion. Our findings suggest high efficacy and good tolerability of lenvatinib in patients with RR-DTC in routine clinical practice in the Russian Federation.","PeriodicalId":36598,"journal":{"name":"Opuholi Golovy i Sei","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67782125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Psychological assistance to patients after laryngectomy 喉切除术后患者的心理援助
Q4 Medicine Pub Date : 2020-04-11 DOI: 10.17650/2222-1468-2020-10-1-101-106
G. Tkachenko, S. Podvyaznikov, A. Mudunov, Е. V. Gusakova
The study objective is to assess the effectiveness of psychological support to patients with laryngeal cancer after laryngectomy. Materials and methods.This study included 36 male patients aged between 45 and 62 years with morphologically verified stage II–IV (Т3–4N0–2М0) laryngeal cancer treated in the Department of Head and Neck Tumors, N. N. Blokhin National Medical Research Center of Oncology in 2011–2016. Patients were randomized into two groups. Group 1 included 14 patients who received antitumor therapy alone. Group 2 comprised 22 patients who additionally received psychological support. Patients’ mental state was assessed before treatment and 6 months after its completion using the Hospital Anxiety and Depression Scale and Symptom Check List-90 Revised. Two patients from Group 1 and 1 patient from Group 2 were excluded from the study at the first stage. Results. We found that patients in both groups had severe psychopathological symptoms (including depression, interpersonal sensitivity, and severe distress) six month after treatment completion (according to the Symptom Check List-90 Revised). Patients who received psychological support demonstrated higher level of depression than healthy controls, but it was still significantly lower than that in patients who received no psychological assistance. Similar results were obtained by the Hospital Anxiety and Depression Scale: patients who received psychological support had significantly lower level of depression than patients who had no psychological support (8.3 ± 0.9 vs 10.2 ± 0.6 points respectively). Conclusion. Patients with laryngeal cancer who received psychological assistance (including cognitive behavioral psychotherapy) demonstrated significantly lower level of depression 6 months after treatment completion compared to those who received no psychological support.
本研究的目的是评估心理支持对喉癌患者喉切除术后的效果。材料和方法。本研究纳入2011-2016年在N. N. Blokhin国家肿瘤医学研究中心头颈部肿瘤科治疗的36例经形态学证实的II-IV期(Т3-4N0-2М0)喉癌男性患者,年龄在45 - 62岁之间。患者随机分为两组。第1组14例患者单独接受抗肿瘤治疗。第二组22例患者接受心理支持。采用医院焦虑抑郁量表及症状检查表-90修订版对患者治疗前及治疗结束后6个月的精神状态进行评估。第一组2例患者和第二组1例患者在第一阶段被排除在研究之外。结果。我们发现两组患者在治疗结束6个月后都有严重的精神病理症状(包括抑郁、人际关系敏感和严重的痛苦)(根据症状检查表-90修订版)。接受心理支持的患者抑郁水平高于健康对照组,但仍显著低于未接受心理支持的患者。医院焦虑抑郁量表也得出类似的结果:接受心理支持的患者抑郁水平明显低于未接受心理支持的患者(分别为8.3±0.9分和10.2±0.6分)。结论。接受心理援助(包括认知行为心理治疗)的喉癌患者在治疗结束后6个月的抑郁水平明显低于未接受心理支持的患者。
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引用次数: 1
Free radial forearm flap for reconstruction of postoperative defects in combined and complex treatment of patients with locally-advanced squamous cell carcinoma of the oral cavity 游离前臂桡侧皮瓣重建口腔局部晚期鳞状细胞癌术后缺损的综合综合治疗
Q4 Medicine Pub Date : 2020-04-11 DOI: 10.17650/2222-1468-2020-10-1-55-64
H. Chen, A. Mudunov, R. I. Azizian, I. Pustynskiy, O. A. Saprina, M. Bolotin
The study objectiveis to assess immediate and long-term results of replacing complex defects with a free radial forearm flap in the multimodal treatment of patients with locally advanced oral cavity squamous cell carcinoma.Materials and methods.Twenty eight patients (20 women and 8 men aged 23 to 71 years) with locally advanced oral cavity squamous cell carcinoma (including 10 buccal cancers, 8 carcinomas of tongue, 6 carcinomas of the floor of the mouth, 2 retromolar area carcinomas, 1 carcinoma of the hard palate and 1 carcinoma of alveolar region of the lower jaw) underwent tumor surgery with simultaneous plastic reconstruction of the defect using radial forearm free flap at the department of head and neck tumors of N. N. Blokhin National Medical Research Center of Oncology within 2010–2018. Primary tumors were detected in 2 patients and 11 patients had residual (n = 7) or recurrent (n = 4) tumors after radiotherapy or chemoradiotherapy.Results.An overall success rate was 96.4 %. Postoperative histology revealed that there were no tumor cells at the resection edges. Postoperative complications included: complete flap necrosis in 1 patient with severe concomitant diseases, marginal flap necrosis in 2 patients (in both cases after the necrotic tissue had rejected, wounds were healed by secondary intention), sural veins thrombosis in 1 patient, acute peptic ulcer bleeding on the 6th day after surgery in 1 patient treated with emergency endoscopic hemostasis. No lethal outcomes were reported. Postoperative period lasted in average 14 days. Upon subsequent observation tumor relapse in the oral cavity occurred in 4 (14.3 %) patients, relapses of regional metastases – in 2 (7.1 %). Good aesthetic and functional results were noted. Adequate restoration of breathing, chewing, swallowing and speaking resulted in a full patients’ rehabilitation. In all cases, the radial flap adapted well to the oral cavity organs and corresponded to the surrounding tissues in thickness and consistency.Conclusion.Use of a radial forearm free flap makes it possible to successfully reconstruct extensive and complex defects after surgery of locally advanced primary and recurrent forms of oral cavity squamous cell cancer of various locations. Due to flap’s high regenerative capabilities, preoperative radiation therapy does not affect the frequency of local complications. It allows restoring vital functions of the oral cavity and achieving good aesthetic and functional results.
本研究的目的是评估用前臂游离桡侧皮瓣替代复杂缺损在多模式治疗局部晚期口腔鳞状细胞癌患者中的近期和长期效果。材料和方法。局部进展期口腔鳞状细胞癌28例(女20例,男8例,年龄23 ~ 71岁),其中颊部癌10例,舌部癌8例,口腔底部癌6例,磨牙后区癌2例。2010-2018年,N. N. Blokhin国家肿瘤医学研究中心头颈部肿瘤科采用前臂桡骨游离皮瓣同时进行缺损整形重建的肿瘤手术,其中硬腭癌1例,下颌骨牙槽区癌1例。经放疗或放化疗后发现原发肿瘤2例,残留肿瘤11例(n = 7)或复发肿瘤11例(n = 4)。术后组织学显示切除边缘未见肿瘤细胞。术后并发症包括:皮瓣完全坏死1例伴严重并发症,皮瓣边缘坏死2例(均为坏死组织发生排斥反应后,创面二次愈合),腓肠静脉血栓形成1例,急诊内镜止血1例术后第6天急性消化性溃疡出血。没有致命结果的报道。术后平均14 d。经随访观察,口腔肿瘤复发4例(14.3%),局部转移复发2例(7.1%)。良好的美观和功能效果。充分恢复呼吸、咀嚼、吞咽和说话,使患者完全康复。结论:前臂桡侧游离皮瓣可以成功地修复局部晚期和复发口腔鳞状细胞癌术后广泛复杂的缺损。由于皮瓣的高再生能力,术前放疗不影响局部并发症的发生频率。它可以恢复口腔的重要功能,达到良好的审美和功能效果。
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引用次数: 2
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Opuholi Golovy i Sei
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