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

Eduard Vrdoljak, L. Géczi, Jozef Mardiak, Tudor Eliade Ciuleanu, Sophie Leyman, Ke Zhang, Peter Sajben, Laszlo Torday

Research output: Contribution to journalArticle

8 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)775-782
Number of pages8
JournalPathology and Oncology Research
Volume21
Issue number3
DOIs
Publication statusPublished - Jan 4 2015

Fingerprint

Compassionate Use Trials
Renal Cell Carcinoma
Neoplasms
Hand-Foot Syndrome
Cytokines
Phase III Clinical Trials
Survival
sunitinib
Standard of Care
Neutropenia
Thrombocytopenia
Nausea
Disease-Free Survival
Fatigue
Disease Progression
Diarrhea
Survival Rate
Hypertension
Safety

Keywords

  • Expanded-access
  • Metastatic
  • Renal cell carcinoma
  • Sunitinib

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pathology and Forensic Medicine

Cite this

Central and Eastern European Experience with Sunitinib in Metastatic Renal Cell Carcinoma : A Sub-analysis of the Global Expanded-Access Trial. / Vrdoljak, Eduard; Géczi, L.; Mardiak, Jozef; Ciuleanu, Tudor Eliade; Leyman, Sophie; Zhang, Ke; Sajben, Peter; Torday, Laszlo.

In: Pathology and Oncology Research, Vol. 21, No. 3, 04.01.2015, p. 775-782.

Research output: Contribution to journalArticle

Vrdoljak, Eduard ; Géczi, L. ; Mardiak, Jozef ; Ciuleanu, Tudor Eliade ; Leyman, Sophie ; Zhang, Ke ; Sajben, Peter ; Torday, Laszlo. / Central and Eastern European Experience with Sunitinib in Metastatic Renal Cell Carcinoma : A Sub-analysis of the Global Expanded-Access Trial. In: Pathology and Oncology Research. 2015 ; Vol. 21, No. 3. pp. 775-782.
@article{f94a055c5e494373a016fb1d5bc8a3c4,
title = "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-na{\"i}ve 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 = "Expanded-access, Metastatic, Renal cell carcinoma, Sunitinib",
author = "Eduard Vrdoljak and L. G{\'e}czi and Jozef Mardiak and Ciuleanu, {Tudor Eliade} and Sophie Leyman and Ke Zhang and Peter Sajben and Laszlo Torday",
year = "2015",
month = "1",
day = "4",
doi = "10.1007/s12253-014-9889-0",
language = "English",
volume = "21",
pages = "775--782",
journal = "Pathology and Oncology Research",
issn = "1219-4956",
publisher = "Springer Netherlands",
number = "3",

}

TY - JOUR

T1 - Central and Eastern European Experience with Sunitinib in Metastatic Renal Cell Carcinoma

T2 - A Sub-analysis of the Global Expanded-Access Trial

AU - Vrdoljak, Eduard

AU - Géczi, L.

AU - Mardiak, Jozef

AU - Ciuleanu, Tudor Eliade

AU - Leyman, Sophie

AU - Zhang, Ke

AU - Sajben, Peter

AU - Torday, Laszlo

PY - 2015/1/4

Y1 - 2015/1/4

N2 - 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.

AB - 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.

KW - Expanded-access

KW - Metastatic

KW - Renal cell carcinoma

KW - Sunitinib

UR - http://www.scopus.com/inward/record.url?scp=84939415820&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84939415820&partnerID=8YFLogxK

U2 - 10.1007/s12253-014-9889-0

DO - 10.1007/s12253-014-9889-0

M3 - Article

C2 - 25557271

AN - SCOPUS:84939415820

VL - 21

SP - 775

EP - 782

JO - Pathology and Oncology Research

JF - Pathology and Oncology Research

SN - 1219-4956

IS - 3

ER -