Cancer UrologyCancer UrologyОнкоурология1726-97761996-1812Publishing House ABV Press61110.17650/1726-9776-2016-12-3-74-81DIAGNOSIS AND TREATMENT OF URINARY SYSTEM TUMORS. URINARY BLADDER CANCERДИАГНОСТИКА И ЛЕЧЕНИЕ ОПУХОЛЕЙ МОЧЕПОЛОВОЙ СИСТЕМЫ. Рак мочевого пузыряThe efficacy and safety of vinflunine in second-line therapy of patients with disseminated transitional cell carcinoma of the urinary tract in clinical practiceЭффективность и безопасность винфлунина во 2-й линии терапии у больных распространенным переходно-клеточным раком мочевых путей в клинической практикеVolkovaM. I.ВолковаМ. И.
Russian Federation

23 Kashirskoe Shosse, Moscow, 115478

115478, Москва, Каширское шоссе, 23

mivolkova@rambler.ruChernyaevV. A.ЧерняевВ. А.
Russian Federation

23 Kashirskoe Shosse, Moscow, 115478

115478, Москва, Каширское шоссе, 23

MatveevV. B.МатвеевВ. Б.
Russian Federation

23 Kashirskoe Shosse, Moscow, 115478

115478, Москва, Каширское шоссе, 23

AlekseevB. Ya.АлексеевБ. Я.
Russian Federation

3 Second Botkinsky Passage, Moscow, 125284

125284, Москва, 2-й Боткинский проезд, 3

NyushkoK. M.НюшкоК. М.
Russian Federation

3 Second Botkinsky Passage, Moscow, 125284

125284, Москва, 2-й Боткинский проезд, 3

BolotinaL. V.БолотинаЛ. В.
Russian Federation

3 Second Botkinsky Passage, Moscow, 125284

125284, Москва, 2-й Боткинский проезд, 3

KornietskayaA. L.КорниецкаяА. Л.
Russian Federation

3 Second Botkinsky Passage, Moscow, 125284

125284, Москва, 2-й Боткинский проезд, 3

PaichadzeA. A.ПайчадзеА. А.
Russian Federation

3 Second Botkinsky Passage, Moscow, 125284

125284, Москва, 2-й Боткинский проезд, 3

MaikoparovaS. Ch.МайкопароваС. Ч.
Russian Federation

6 Second Korotkaya St., Maikop, 385000

385000, Майкоп, ул. 2-я Короткая, 6

RyadinskayaL. A.РядинскаяЛ. А.
Russian Federation

63 Fourteenth Line, Rostov-on-Don, 344037

344037, Ростов-на-Дону, 14-я линия, 63

KabanovS. N.КабановС. Н.
Russian Federation

63 Fourteenth Line, Rostov-on-Don, 344037

344037, Ростов-на-Дону, 14-я линия, 63

StorozhakovaA. E.СторожаковаА. Э.
Russian Federation

63 Fourteenth Line, Rostov-on-Don, 344037

344037, Ростов-на-Дону, 14-я линия, 63

SamanevaN. Yu.СаманеваН. Ю.
Russian Federation

63 Fourteenth Line, Rostov-on-Don, 344037

344037, Ростов-на-Дону, 14-я линия, 63

ShcherbininA. V.ЩербининА. В.
Russian Federation

15 Bauman St., Perm», 614066

614066, Пермь, ул. Баумана, 15

VarlamovS. A.ВарламовС. А.
Russian Federation

77 Nikitin St., Barnaul, 656049

656049, Барнаул, ул. Никитина, 77

VarlamovI. S.ВарламовИ. С.
Russian Federation

77 Nikitin St., Barnaul, 656049

656049, Барнаул, ул. Никитина, 77

KopyltsovE. I.КопыльцовЕ. И.
Russian Federation

6 Bolnichnyi Lane, Omsk, 644043

644043, Омск, Больничный пер., 6

LebedinetsA. A.ЛебединецА. А.
Russian Federation

46 Chugunnaya St., Saint Petersburg, 194044

194044, Санкт-Петербург, ул. Чугунная, 46

OdintsovaM. V.ОдинцоваМ. В.
Russian Federation

86 Profsoyuznaya St., GSP-7, Moscow, 117997

117997, ГСП-7, Москва, ул. Профсоюзная, 86

KolesnikovS. S.КолесниковС. С.
Russian Federation

10 Profsoyuznaya St., Pskov, 180000

180000, Псков, ул. Профсоюзная, 10

KarabinaE. V.КарабинаЕ. В.
Russian Federation

201A Plekhanov St., Proletarsky District, Tula, 300040

300040, Тула, Пролетарский р-н, ул. Плеханова, 201 А

N. N. Blokhin Russian Cancer Research Center, Ministry of Health of RussiaФГБУ «РОНЦ им. Н.Н. Блохина» Минздрава РоссииP. A. Herzen Moscow Oncology Research Institute, Branch, National Medical Radiology Research Center, Ministry of Health of RussiaМНИОИ им. П.А. Герцена – филиал ФГБУ НМИРЦ Минздрава РоссииM. Kh. Ashkhamaf Adygei Republican Clinical Oncology DispensaryГБУЗ РА «Адыгейский республиканский клинический онкологический диспансер им. М.Х. Ашхамафа»Rostov Research Institute of Oncology, Ministry of Health of RussiaФГБУ «Ростовский научно-исследовательский онкологический институт» Минздрава РоссииPerm Territorial Oncology DispensaryГБУЗ ПК «Пермский краевой онкологический диспансер»Altay Territorial Oncology DispensaryКГБУЗ «Алтайский краевой онкологический диспансер»Clinical Oncology DispensaryБУЗОО «Клинический онкологический диспансер»Saint Luke Clinical HospitalСПб ГБУЗ «Клиническая больница Святителя Луки»Russian Research Center for Radiology and Surgical Technologies, Ministry of Health of RussiaФБГУ «Российский научный центр радиологии и хирургических технологий» Минздрава РоссииPskov Regional Oncology DispensaryГБУЗ «Псковский областной онкологический диспансер»Tula Regional Oncology DispensaryГУЗ «Тульский областной онкологический диспансер»3009201612374810110201601102016https://oncourology.abvpress.ru/oncur/article/view/611

Objective: to investigate the safety of vinflunine, the rate and duration of its treatment response, progression-free and overall survival rates in patients receiving this drug in routine clinical practice for first-line chemotherapy (CT) – resistant disseminated transitional cell carcinoma of the urinary tract.

Materials and methods. This retrospective observational multicenter study included data on 25 patients with verified disseminated transitional cell carcinoma of the urinary tract who took vinflunine for tumor progression after first-line CT performed in 11 Russian clinical centers in 23 March 2013 to 26 June 2016. The median age of the patients was 60 (44‒81) years. Their baseline somatic status was rated as ECOG 0 in 1 (4.0 %) patient, ECOG 1 in 13 (52.0 %) patients, EGOG 2 in 9 (36.0 %), and ECOG 3 in 2 (8.0 %). The most common sites of tumor foci were bones (n = 14, 56.0 %), lymph nodes of different groups (n = 14; 56.0 %), and lung (n = 9; 36.0 %).

Results. Adverse reactions were recorded in 24 (96.0 %) cases. The most common types of toxicity were asthenia (n = 19; 76.0 %), anemia (n = 18; 72.0 %), neutropenia (n = 13; 52 %), and nausea (n = 12; 48.0 %). Most adverse events were grades I–II and well controlled. There were no deaths due to adverse events. The best treatment response was regarded as partial in 6 (24.0 %) patients; stabilization and progression were observed in 10 (40.0 %) and 9 (36.0 %) patients, respectively. The median duration of partial response was 5.1 (95 % confidence interval (CI), 0.6–15.0) months; that of stabilization was 3.4 (95 % CI, 1.2–6.3) months. In all the 25 cases, the median progression-free and overall survival rates were 3.7 (95 % CI, 2.1‒5.3) and 6.5 (95 % CI, 5.2‒7.8) months, respectively. The somatic status was a predictor of overall survival (p < 0.0001).

Conclusion. The efficacy and safety of vinflunine in second-line therapy for first-line CT-resistant disseminated transitional cell carcinoma of the urinary tract in unselected patients agree with those previously observed in Phase III randomized trial.

Цель исследования – изучение безопасности, частоты и длительности ответов, беспрогрессивной и общей выживаемости у больных, получавших винфлунин в рутинной клинической практике по поводу распространенного переходно-клеточного рака мочевых путей, резистентного к 1-й линии химиотерапии (ХТ).

Материалы и методы. В ретроспективное наблюдательное многоцентровое исследование включены данные 25 больных верифицированным распространенным переходно-клеточным раком мочевых путей, получавших винфлунин по поводу прогрессии опухоли после проведения ХТ 1-й линии с 23.03.2013 по 26.06.2016 в 11 клинических центрах России. Медиана возраста – 60 (44–81) лет. Исходный соматический статус по шкале ECOG был расценен как 0 у 1 (4,0 %), 1 – у 13 (52,0 %), 2 – у 9 (36,0 %), 3 – у 2 (8,0 %) больных. Наиболее распространенными локализациями опухолевых очагов были кости (n =14; 56,0 %), лимфатические узлы различных групп (n =14; 56,0 %) и легкие (n = 9; 36,0 %).

Результаты. Нежелательные явления были зарегистрированы в 24 (96,0 %) случаях. Наиболее распространенными видами токсичности являлись астения (n =19; 76,0 %), анемия (n =18; 72,0 %), нейтропения (n =13; 52,0 %), тошнота (n = 12; 48,0 %). Нежелательные явления в большинстве наблюдений имели I–II степени тяжести и хорошо контролировались. Смертности, обусловленной нежелательными явлениями, не зарегистрировано. Наилучший ответ на лечение расценен как частичный у 6 (24,0 %), стабилизация – у 10 (40,0 %), прогрессирование – у 9 (36,0 %) больных. Медиана длительности частичного ответа составила 5,1 (95 % доверительный интервал (ДИ) 0,6–15,0) мес, стабилизации – 3,4 (95 % ДИ 1,2–6,3) мес. Медиана беспрогрессивной и общей выживаемости всех 25 больных составила 3,7 (95 % ДИ 2,1–5,3) и 6,5 (95 % ДИ 5,2–7,8) мес соответствен- но. Соматический статус являлся фактором прогноза общей выживаемости (p < 0,0001).

Заключение. Эффективность и безопасность применения винфлунина во 2-й линии терапии распространенного переходно-клеточного рака мочевых путей, резистентного к 1-й линии ХТ, у неотобранных больных соответствуют ранее полученным результатам рандомизированного исследования III фазы. 

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