The DOI matches its Crossref record; 17 of the 17 references it cites were found in a registry or an index.
Randomized Phase III Trial of Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients With Localized or Locally Advanced Renal Cell Carcinoma
Open accessAbstract
Purpose: This phase III trial evaluated the efficacy and safety of pazopanib versus placebo in patients with locally advanced renal cell carcinoma (RCC) at high risk for relapse after nephrectomy. Patients and Methods: A total of 1,538 patients with resected pT2 (high grade) or ≥ pT3, including N1, clear cell RCC were randomly assigned to pazopanib or placebo for 1 year; 403 patients received a starting dose of 800 mg or placebo. To address toxicity attrition, the 800-mg starting dose was lowered to 600 mg, and the primary end point analysis was changed to disease-free survival (DFS) for pazopanib 600 mg versus placebo (n = 1,135). Primary analysis was performed after 350 DFS events in the intent-to-treat (ITT) pazopanib 600 mg group (ITT 600mg), and DFS follow-up analysis was performed 12 months later. Secondary end point analyses included DFS with ITT pazopanib 800 mg (ITT 800mg) and safety. Results: The primary analysis results of DFS ITT 600mg favored pazopanib but did not show a significant improvement over placebo (hazard ratio [HR], 0.86; 95% CI, 0.70 to 1.06; P = .165). The secondary analysis of DFS in ITT 800mg (n = 403) yielded an HR of 0.69 (95% CI, 0.51 to 0.94). Follow-up analysis in ITT 600mg yielded an HR of 0.94 (95% CI, 0.77 to 1.14). Increased ALT and AST were common adverse events leading to treatment discontinuation in the pazopanib 600 mg (ALT, 16%; AST, 5%) and 800 mg (ALT, 18%; AST, 7%) groups. Conclusion: The results of the primary DFS analysis of pazopanib 600 mg showed no benefit over placebo in the adjuvant setting.
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Pazopanib versus Sunitinib in Metastatic Renal-Cell Carcinoma
Motzer, R. J., Hutson, T. E., Cella, D., Reeves, J., Hawkins, R., Guo, J., Nathan, P., Staehler, M., de Souza, P., Merchan, J. R., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1303989 · Cited by 1,923
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Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy
Ravaud, A., Motzer, R. J., Pandha, H. S., George, D. J., Pantuck, A. J., Patel, A., Chang, Y.-H., Escudier, B., Donskov, F., Magheli, A., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1611406 · Cited by 782
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Cited by
Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Escudier, B., Porta, C., Schmidinger, M., Rioux-Leclercq, N., Bex, A., Khoo, V., Grünwald, V., Gillessen, S., & Horwich, A. (2019) · Annals of Oncology · doi:10.1093/annonc/mdz056 · Cited by 1,151
Pearson, A. D., Gaspar, N., Janeway, K., Campbell-Hewson, Q., Lawlor, E. R., Copland, C., Karres, D., Norga, K., Benzaghou, F., Weiner, S., et al. (2022) · European Journal of Cancer · doi:10.1016/j.ejca.2022.06.008 · Cited by 22
Adjuvant Therapy for Renal Cell Carcinoma: Hype or Hope?
Cosso, F., Roviello, G., Nesi, G., Shabani, S., Spatafora, P., Villari, D., & Catalano, M. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms24044243 · Cited by 18
Metadata
- Authors
- Motzer, R. J., Haas, N. B., Donskov, F., Gross-Goupil, M., Varlamov, S., Kopyltsov, E., Lee, J. L., Melichar, B., Rini, B. I., Choueiri, T. K., Zemanova, M., Wood, L. A., Reaume, M. N., Stenzl, A., Chowdhury, S., Lim, H. Y., McDermott, R., Michael, A., Bao, W., Carrasco-Alfonso, M. J., Aimone, P., Voi, M., Doehn, C., Russo, P., Sternberg, C. N., & on behalf of the PROTECT investigators
- Venue
- Journal of Clinical Oncology
- Published
- 2017-12-10
- Volume
- 35
- Issue
- 35
- Pages
- 3916-3923
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2756219586
- Cited by
- 382
- References
- 17
- FWCI
- 38.68
- Type
- journal article
- Language
- en
- Open access
- green
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- CoChat. (2026). Citation check: Randomized Phase III Trial of Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients With Localized or Locally Advanced Renal Cell Carcinoma. https://app.cochat.ai/papers/10.1200/jco.2017.73.5324
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- Motzer, R. J., Haas, N. B., Donskov, F., Gross-Goupil, M., Varlamov, S., Kopyltsov, E., Lee, J. L., Melichar, B., Rini, B. I., Choueiri, T. K., Zemanova, M., Wood, L. A., Reaume, M. N., Stenzl, A., Chowdhury, S., Lim, H. Y., McDermott, R., Michael, A., Bao, W., . . . on behalf of the PROTECT investigators. (2017). Randomized Phase III Trial of Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients With Localized or Locally Advanced Renal Cell Carcinoma. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2017.73.5324
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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
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.
