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
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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1 retracted
Immunotherapy for advanced renal cell cancer
Coppin, C., Porzsolt, F., Autenrieth, M., Kumpf, J., Coldman, A., & Wilt, T. (2004) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd001425.pub2 · Cited by 589
RetractedSorafenib in Advanced Clear-Cell Renal-Cell Carcinoma
Escudier, B., Eisen, T., Stadler, W. M., Szczylik, C., Oudard, S., Siebels, M., Negrier, S., Chevreau, C., Solska, E., Desai, A. A., et al. (2007) · New England Journal of Medicine · doi:10.1056/nejmoa060655 · Cited by 4,802
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Survival and Prognostic Stratification of 670 Patients With Advanced Renal Cell Carcinoma
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Self-citationClassification of renal cell carcinoma: Workgroup No. 1
St�rkel, S., Eble, J. N., Adlakha, K., Amin, M., Blute, M. L., Bostwick, D. G., Darson, M., Delahunt, B., & Iczkowski, K. (1997) · Cancer · doi:10.1002/(sici)1097-0142(19970901)80:5<987::aid-cncr24>3.0.co;2-r · Cited by 864
BAY 43-9006 Inhibition of Oncogenic RET Mutants
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Motzer, R. J., Tannir, N. M., McDermott, D. F., Arén Frontera, O., Melichar, B., Choueiri, T. K., Plimack, E. R., Barthélémy, P., Porta, C., George, S., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1712126 · Cited by 4,656
Self-citationPembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma
Rini, B. I., Plimack, E. R., Stus, V., Gafanov, R., Hawkins, R., Nosov, D., Pouliot, F., Alekseev, B., Soulières, D., Melichar, B., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1816714 · Cited by 3,403
Self-citationRini, B. I., Campbell, S. C., & Escudier, B. (2009) · The Lancet · doi:10.1016/s0140-6736(09)60229-4 · Cited by 1,621
Self-citationMotzer, R. J., Nosov, D., Eisen, T., Bondarenko, I., Lesovoy, V., Lipatov, O., Tomczak, P., Lyulko, O., Alyasova, A., Harza, M., et al. (2013) · Journal of Clinical Oncology · doi:10.1200/jco.2012.47.4940 · Cited by 445
Self-citationHow much is life worth: cetuximab, non-small cell lung cancer, and the $440 billion question
Fojo, T., & Grady, C. (2009) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djp177 · Cited by 349
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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- 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).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.