Email this article The efficacy and safety of vinflunine in second-line therapy of patients with disseminated transitional cell carcinoma of the urinary tract in clinical practice
- Authors: Volkova M.I.1, Chernyaev V.A.1, Matveev V.B.1, Alekseev B.Y.2, Nyushko K.M.2, Bolotina L.V.2, Kornietskaya A.L.2, Paichadze A.A.2, Maikoparova S.C.3, Ryadinskaya L.A.4, Kabanov S.N.4, Storozhakova A.E.4, Samaneva N.Y.4, Shcherbinin A.V.5, Varlamov S.A.6, Varlamov I.S.6, Kopyltsov E.I.7, Lebedinets A.A.8, Odintsova M.V.9, Kolesnikov S.S.10, Karabina E.V.11
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Affiliations:
- N. N. Blokhin Russian Cancer Research Center, Ministry of Health of Russia
- P. A. Herzen Moscow Oncology Research Institute, Branch, National Medical Radiology Research Center, Ministry of Health of Russia
- M. Kh. Ashkhamaf Adygei Republican Clinical Oncology Dispensary
- Rostov Research Institute of Oncology, Ministry of Health of Russia
- Perm Territorial Oncology Dispensary
- Altay Territorial Oncology Dispensary
- Clinical Oncology Dispensary
- Saint Luke Clinical Hospital
- Russian Research Center for Radiology and Surgical Technologies, Ministry of Health of Russia
- Pskov Regional Oncology Dispensary
- Tula Regional Oncology Dispensary
- Issue: Vol 12, No 3 (2016)
- Pages: 74-81
- Section: DIAGNOSIS AND TREATMENT OF URINARY SYSTEM TUMORS. URINARY BLADDER CANCER
- Published: 30.09.2016
- URL: https://oncourology.abvpress.ru/oncur/article/view/611
- DOI: https://doi.org/10.17650/1726-9776-2016-12-3-74-81
- ID: 611
Cite item
Abstract
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.
About the authors
M. I. Volkova
N. N. Blokhin Russian Cancer Research Center, Ministry of Health of Russia
Author for correspondence.
Email: mivolkova@rambler.ru
23 Kashirskoe Shosse, Moscow, 115478 Russian Federation
V. A. Chernyaev
N. N. Blokhin Russian Cancer Research Center, Ministry of Health of Russia23 Kashirskoe Shosse, Moscow, 115478 Russian Federation
V. B. Matveev
N. N. Blokhin Russian Cancer Research Center, Ministry of Health of Russia23 Kashirskoe Shosse, Moscow, 115478 Russian Federation
B. Ya. Alekseev
P. A. Herzen Moscow Oncology Research Institute, Branch, National Medical Radiology Research Center, Ministry of Health of Russia3 Second Botkinsky Passage, Moscow, 125284 Russian Federation
K. M. Nyushko
P. A. Herzen Moscow Oncology Research Institute, Branch, National Medical Radiology Research Center, Ministry of Health of Russia3 Second Botkinsky Passage, Moscow, 125284 Russian Federation
L. V. Bolotina
P. A. Herzen Moscow Oncology Research Institute, Branch, National Medical Radiology Research Center, Ministry of Health of Russia3 Second Botkinsky Passage, Moscow, 125284 Russian Federation
A. L. Kornietskaya
P. A. Herzen Moscow Oncology Research Institute, Branch, National Medical Radiology Research Center, Ministry of Health of Russia3 Second Botkinsky Passage, Moscow, 125284 Russian Federation
A. A. Paichadze
P. A. Herzen Moscow Oncology Research Institute, Branch, National Medical Radiology Research Center, Ministry of Health of Russia3 Second Botkinsky Passage, Moscow, 125284 Russian Federation
S. Ch. Maikoparova
M. Kh. Ashkhamaf Adygei Republican Clinical Oncology Dispensary6 Second Korotkaya St., Maikop, 385000 Russian Federation
L. A. Ryadinskaya
Rostov Research Institute of Oncology, Ministry of Health of Russia63 Fourteenth Line, Rostov-on-Don, 344037 Russian Federation
S. N. Kabanov
Rostov Research Institute of Oncology, Ministry of Health of Russia63 Fourteenth Line, Rostov-on-Don, 344037 Russian Federation
A. E. Storozhakova
Rostov Research Institute of Oncology, Ministry of Health of Russia63 Fourteenth Line, Rostov-on-Don, 344037 Russian Federation
N. Yu. Samaneva
Rostov Research Institute of Oncology, Ministry of Health of Russia63 Fourteenth Line, Rostov-on-Don, 344037 Russian Federation
A. V. Shcherbinin
Perm Territorial Oncology Dispensary15 Bauman St., Perm», 614066 Russian Federation
S. A. Varlamov
Altay Territorial Oncology Dispensary77 Nikitin St., Barnaul, 656049 Russian Federation
I. S. Varlamov
Altay Territorial Oncology Dispensary77 Nikitin St., Barnaul, 656049 Russian Federation
E. I. Kopyltsov
Clinical Oncology Dispensary6 Bolnichnyi Lane, Omsk, 644043 Russian Federation
A. A. Lebedinets
Saint Luke Clinical Hospital46 Chugunnaya St., Saint Petersburg, 194044 Russian Federation
M. V. Odintsova
Russian Research Center for Radiology and Surgical Technologies, Ministry of Health of Russia86 Profsoyuznaya St., GSP-7, Moscow, 117997 Russian Federation
S. S. Kolesnikov
Pskov Regional Oncology Dispensary10 Profsoyuznaya St., Pskov, 180000 Russian Federation
E. V. Karabina
Tula Regional Oncology Dispensary201A Plekhanov St., Proletarsky District, Tula, 300040 Russian Federation
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