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Pathology & Oncology Research
Article . 2015 . Peer-reviewed
License: Springer TDM
Data sources: Crossref
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Central and Eastern European Experience with Sunitinib in Metastatic Renal Cell Carcinoma: A Sub-analysis of the Global Expanded-Access Trial

Authors: Vrdoljak Eduard; Géczi Lajos; Mardiak Jozef; Ciuleanu Tudor-Eliade; Leyman Sophie; Zhang Ke; Sajben Peter; +1 Authors

Central and Eastern European Experience with Sunitinib in Metastatic Renal Cell Carcinoma: A Sub-analysis of the Global Expanded-Access Trial

Abstract

A global, open-label, expanded-access trial (EAT) provided sunitinib treatment on a compassionate-use basis to patients with metastatic renal cell carcinoma (mRCC) between 2005 and 2011. This retrospective analysis examines outcomes in patients from Central and East European (CEE) countries participating in the global EAT. Sunitinib (starting dose 50 mg orally once daily, with dose reduction for toxicity) was administered in repeated 6-week cycles (4 weeks on and 2 weeks off) until occurrence of disease progression or unacceptable toxicity. Tumor assessments were guided by Response Evaluation Criteria in Solid Tumors (RECIST) criteria but were performed according to local standards of care. In total, 401 CEE patients received sunitinib (median treatment duration 9.6 months), of whom 378 were evaluable for tumor response. The most frequent grade ≥3 toxicities were fatigue (7.5 %), hypertension (7.0 %), thrombocytopenia (6.5 %), diarrhea (4.2 %), nausea and hand-foot syndrome (both 3.7 %) and neutropenia (3.0 %). Median overall survival was 30.7 months (95 % CI 23.3, ‒ months). Overall survival tended to be longer in cytokine-naïve than cytokine-experienced patients (median 60.8 vs. 27.5 months; P = 0.1324). Among patients with evaluable tumors, 4.0 % achieved a complete and 14.6 % a partial response [objective response rate (ORR) 18.5 % (95 % CI 14.7, 22.8 %)]. Median progression-free survival was 11.6 months (95 % CI 10.3, 12.8 months). Sunitinib demonstrates safety and effectiveness in real-world mRCC patients in CEE countries. Expanded-access program patients showed a lower tumor response rate but similar survival outcomes to patients in the pivotal Phase III clinical trial of sunitinib in mRCC.

Keywords

Adult, Male, Indoles, ПОЧЕЧНО-КЛЕТОЧНЫЙ РАК,МЕТАСТАТИЧЕСКИЙ РАК,СУНИТИНИБ,ИССЛЕДОВАНИЕ РАСШИРЕННОГО ДОСТУПА, Antineoplastic Agents, Middle Aged, Prognosis, Kidney Neoplasms, Europe, Survival Rate, Young Adult, Lymphatic Metastasis, Sunitinib, Humans, Female, Pyrroles, Carcinoma, Renal Cell, Aged, Follow-Up Studies, Neoplasm Staging, Retrospective Studies

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    popularity
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    Average
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
8
Average
Average
Top 10%
Green
gold