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Vinflunine as second-line therapy for advanced urothelial carcinoma: Russian observational study
- 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, Maykoparova 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, Kopyl’tsov 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 National Medical Research Oncology Center, Ministry of Health of Russia
- P.A. Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Center, Ministry of Health of Russia
- M.Kh. Ashkhamaf Adygea Republican Clinical Oncology Dispensary
- Rostov Research Institute of Oncology, Ministry of Health of Russia
- Perm Regional Oncology Dispensary
- Altay Territorial Oncology Dispensary
- Clnical Oncology Dispensary
- Saint Luke Clinical Hospital
- Russian Research Center for Radiology and Surgical Technologies
- Pskov Regional Oncology Dispensary
- Tula Regional Oncology Dispensary
- Issue: Vol 13, No 3 (2017)
- Pages: 110-118
- Section: DIAGNOSIS AND TREATMENT OF URINARY SYSTEM TUMORS. URINARY BLADDER CANCER
- Published: 30.09.2017
- URL: https://oncourology.abvpress.ru/oncur/article/view/736
- DOI: https://doi.org/10.17650/1726-9776-2017-13-3-110-118
- ID: 736
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Abstract
Objective: to assess safety, responses rate and duration, progression-free and overall survival in patients with advanced urothelial carcinoma receiving vinflunine as second-line therapy in routine clinical practice, after additional patient recruitment.
Materials and methods. This retrospective observational multicenter study included medical data of 34 patients with verified advanced urothelial carcinoma receiving vinflunine for tumor progression after first-line chemotherapy in 11 Russian clinical centers from March 23, 2013 to June 3, 2017. The median age of the patients was 60 (44–81) years. ECOG performance status was 0 in 2 (5.9 %), ECOG 1 – in 21 (61.7 %), ECOG 2 – in 9 (26.5 %), and ECOG 3 – in 2 (5.9 %) patients. Visceral metastases were present in 14 (41.2 %), non-visceral – in 20 (58.8 %) cases. Anemia was recorded in 20 (58.8 %) patients. According to Bellmunt scale 2 (5.9 %) patients had none risk factors, 6 (17.6 %) had 1 risk factor, 18 (52.9 %) and 8 (23.5 %) had 2 and 3 risk factors, respectively. Initial vinflunine dosage was 320 mg/m2 in 6 (17.6 %) patients, 280 mg/m2 in 22 (64.8 %) or 250 mg/m2 in 6 (17.6 %). Patient received a median of 4 (1–10) cycles of therapy.
Results. Adverse events (AE) were recorded in 33 (97.1 %) cases. The most frequent were general (70.6 %), hematologic (58.8 %), and gastrointestinal AE (41.1 %). Most AE were grades I–II and well-controlled. There were no deaths caused by adverse events. The best response was assessed as complete in 1 (2.9 %), partial – in 5 (14.7 %), stabilization – in 19 (55.9 %), and progression – in 9 (26.5 %) of the 34 patients. Complete response duration was 9.0 months, median partial response duration was 8.0 months (95 % confidence interval (CI) 5.5–13.0); median stabilization duration – 3.5 months (95 % CI 0.7–12.8). Median progression-free and overall survival were 3.9 (95 % CI 3.5‒4.3) and 6.4 (95 % CI 0.1–17.0) months, respectively. Univariate analysis indicated that the low somatic ECOG status and the initial vinflunine dosage of 250 mg/m2 had adverse impact on overall survival.
Conclusion. The efficacy and safety of vinflunine as second-line therapy for first-line chemotherapy-resistant advanced urothelial carcinoma in unselected patients are similar to the results of Phase III randomized trial and early results of the Russian observational study.
About the authors
M. I. Volkova
N.N. Blokhin National Medical Research Oncology Center, Ministry of Health of Russia
Author for correspondence.
Email: mivolkova6@gmail.com
24 Kashirskoe Shosse, Moscow 115478, Russia Russian Federation
V. A. Chernyaev
N.N. Blokhin National Medical Research Oncology Center, Ministry of Health of Russia24 Kashirskoe Shosse, Moscow 115478, Russia Russian Federation
V. B. Matveev
N.N. Blokhin National Medical Research Oncology Center, Ministry of Health of Russia24 Kashirskoe Shosse, Moscow 115478, Russia Russian Federation
B. Ya. Alekseev
P.A. Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Center, Ministry of Health of Russia3 2nd Botkinskiy Proezd, Moscow 125284, Russia Russian Federation
K. M. Nyushko
P.A. Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Center, Ministry of Health of Russia3 2nd Botkinskiy Proezd, Moscow 125284, Russia Russian Federation
L. V. Bolotina
P.A. Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Center, Ministry of Health of Russia3 2nd Botkinskiy Proezd, Moscow 125284, Russia Russian Federation
A. L. Kornietskaya
P.A. Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Center, Ministry of Health of Russia3 2nd Botkinskiy Proezd, Moscow 125284, Russia Russian Federation
A. A. Paichadze
P.A. Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Center, Ministry of Health of Russia3 2nd Botkinskiy Proezd, Moscow 125284, Russia Russian Federation
S. Ch. Maykoparova
M.Kh. Ashkhamaf Adygea Republican Clinical Oncology Dispensary6 2nd Korotkaya St., Maykop 385012, Republic of Adygea Austria
L. A. Ryadinskaya
Rostov Research Institute of Oncology, Ministry of Health of Russia63 14th Liniya St., Rostov-on-Don 344037, Russia Russian Federation
S. N. Kabanov
Rostov Research Institute of Oncology, Ministry of Health of Russia63 14th Liniya St., Rostov-on-Don 344037, Russia Russian Federation
A. E. Storozhakova
Rostov Research Institute of Oncology, Ministry of Health of Russia63 14th Liniya St., Rostov-on-Don 344037, Russia Russian Federation
N. Yu. Samaneva
Rostov Research Institute of Oncology, Ministry of Health of Russia63 14th Liniya St., Rostov-on-Don 344037, Russia Russian Federation
A. V. Shcherbinin
Perm Regional Oncology Dispensary15 Baumana St., Perm’ 614066, Russia Russian Federation
S. A. Varlamov
Altay Territorial Oncology Dispensary110 Zmeinogorskiy Trakt, Barnaul 656045, Russia Russian Federation
I. S. Varlamov
Altay Territorial Oncology Dispensary110 Zmeinogorskiy Trakt, Barnaul 656045, Russia Russian Federation
E. I. Kopyl’tsov
Clnical Oncology DispensaryBuild. 1, 9 Zavertyaeva St., Omsk 644013, Russia Russian Federation
A. A. Lebedinets
Saint Luke Clinical Hospital46 Chugunnaya St., Saint Petersburg 194044, Russia Russian Federation
M. V. Odintsova
Russian Research Center for Radiology and Surgical Technologies
70 Leningradskaya St., Pesochnyy, Saint Petersburg 197758, Russia
Russian FederationS. S. Kolesnikov
Pskov Regional Oncology Dispensary15a Vokzal’naya St., Pskov 180000, Russia Russian Federation
E. V. Karabina
Tula Regional Oncology Dispensary201A Plekhanova St., Tula 300040, Russia Russian Federation
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