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The DOI matches its Crossref record; 21 of the 21 references it cites were found in a registry or an index.

Randomized Phase II Trial of First-Line Treatment With Sorafenib Versus Interferon Alfa-2a in Patients With Metastatic Renal Cell Carcinoma

Escudier, Bernard, Szczylik, Cezary, Hutson, Thomas E., Demkow, Tomasz, Staehler, Michael, Rolland, Frédéric, Negrier, Sylvie, Laferriere, Nicole, Scheuring, Urban J., Cella, David, Shah, Sonalee, Bukowski, Ronald M.·2009·Journal of Clinical Oncology

Abstract

Purpose: An open-label, phase II study to evaluate progression-free survival (PFS), overall best response, adverse events (AEs), and patient-reported outcomes with sorafenib versus interferon alfa-2a (IFN-α-2a) in patients with untreated, advanced renal cancer. Patients and Methods: A total of 189 patients were randomly assigned to oral sorafenib 400 mg twice daily or to subcutaneous IFN-α-2a 9 million U three times weekly (period 1). Sorafenib patients who progressed were dose-escalated to 600 mg twice daily; IFN-α-2a patients who progressed were switched to sorafenib 400 mg twice daily (period 2). Results: In period 1 PFS was similar for sorafenib-treated (n = 97; 5.7 months) and IFN-α-2a–treated patients (n = 92; 5.6 months); more sorafenib-treated patients had tumor shrinkage (68.2% v 39.0%). Common drug-related AEs (Grades ≥ 3) for sorafenib were hand-foot skin reaction (11.3%), diarrhea (6.2%), and rash/desquamation (6.2%); for IFN-α-2a, these were fatigue (10.0%), nausea (3.3%), flu-like syndrome (2.2%), and anorexia (2.2%). Sorafenib-treated patients reported fewer symptoms, better quality of life (QOL), and greater treatment satisfaction. In period 2, 41.9% of patients who received sorafenib 600 mg twice daily (n = 43) experienced tumor reduction (median PFS, 3.6 months). After the switch to sorafenib 400 mg twice daily, tumors were reduced in 76.2% of 50 patients (median PFS, 5.3 months). AEs were mostly grade 1 to 2; no increase in AEs of grades ≥ 3 occurred after sorafenib dose escalation. Conclusion: In this study, sorafenib resulted in similar PFS as IFN-α-2a in patients with untreated RCC. However, sorafenib-treated patients experienced greater rates of tumor size reduction, better QOL, and improved tolerability. Both dose escalation of sorafenib after progression and a switch to sorafenib after progression on IFN-α-2a resulted in clinical benefit.

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Metadata

Authors
Escudier, B., Szczylik, C., Hutson, T. E., Demkow, T., Staehler, M., Rolland, F., Negrier, S., Laferriere, N., Scheuring, U. J., Cella, D., Shah, S., & Bukowski, R. M.
Venue
Journal of Clinical Oncology
Published
2009-03-10
Volume
27
Issue
8
Pages
1280-1289
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2147186814
Cited by
490
References
21
FWCI
48.53
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: Randomized Phase II Trial of First-Line Treatment With Sorafenib Versus Interferon Alfa-2a in Patients With Metastatic Renal Cell Carcinoma. https://app.cochat.ai/papers/10.1200/jco.2008.19.3342
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Escudier, B., Szczylik, C., Hutson, T. E., Demkow, T., Staehler, M., Rolland, F., Negrier, S., Laferriere, N., Scheuring, U. J., Cella, D., Shah, S., & Bukowski, R. M. (2009). Randomized Phase II Trial of First-Line Treatment With Sorafenib Versus Interferon Alfa-2a in Patients With Metastatic Renal Cell Carcinoma. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2008.19.3342

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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