Do we need new high-risk criteria for surgically treated renal cancer patients to improve the outcome of future clinical trials in the adjuvant setting? Results of a comprehensive analysis based on the multicenter CORONA database

I. Wolff; M. May; B. Hoschke; R. Zigeuner; L. Cindolo; G. Hutterer; L. Schips; O. De Cobelli; B. Rocco; C. De Nunzio; A. Tubaro; I. Coman; B. Feciche; M. Truss; O. Dalpiaz; R. S. Figenshau; K. Madison; M. Sánchez-Chapado; M. D C Santiago Martin; L. Salzano; G. Lotrecchiano; S. F. Shariat; M. Hohenfellner; R. Waidelich; C. Stief; K. Miller; S. Pahernik; S. Brookman-May

doi:10.1016/j.ejso.2016.01.009

Do we need new high-risk criteria for surgically treated renal cancer patients to improve the outcome of future clinical trials in the adjuvant setting? Results of a comprehensive analysis based on the multicenter CORONA database

I. Wolff, M. May, B. Hoschke, R. Zigeuner, L. Cindolo, G. Hutterer, L. Schips, O. De Cobelli, B. Rocco, C. De Nunzio, A. Tubaro, I. Coman, B. Feciche, M. Truss, O. Dalpiaz, R. S. Figenshau, K. Madison, M. Sánchez-Chapado, M. D C Santiago Martin, L. SalzanoG. Lotrecchiano, S. F. Shariat, M. Hohenfellner, R. Waidelich, C. Stief, K. Miller, S. Pahernik, S. Brookman-May

Research output: Contribution to journal › Article › peer-review

Abstract

Background Since there is still an unmet need for potent adjuvant strategies for renal cancer patients with high progression risk after surgery, several targeted therapies are currently evaluated in this setting. We analyzed whether inclusion criteria of contemporary trials (ARISER, ASSURE, SORCE, EVEREST, PROTECT, S-TRAC, ATLAS) correctly identify high-risk patients. Methods The study group comprised 8873 patients of the international CORONA-database after surgery for non-metastatic renal cancer without any adjuvant treatment. Patients were divided into potentially eligible high-risk and assumable low-risk patients who didn't meet inclusion criteria of contemporary adjuvant clinical trials. The ability of various inclusion criteria for disease-free survival (DFS) prediction was evaluated by Harrell's c-index. Results During a median follow-up of 53 months 15.2% of patients experienced recurrence (5-year-DFS 84%). By application of trial inclusion criteria, 24% (S-TRAC) to 47% (SORCE) of patients would have been eligible for enrollment. Actual recurrence rates of eligible patients ranged between 29% (SORCE) and 37% (S-TRAC) opposed to

Original language	English
Pages (from-to)	744-750
Number of pages	7
Journal	European Journal of Surgical Oncology
Volume	42
Issue number	5
DOIs	https://doi.org/10.1016/j.ejso.2016.01.009
Publication status	Published - May 1 2016

Keywords

Adjuvant therapy
Disease recurrence
Nephrectomy
Phase-3-trials
Renal cell cancer
Targeted agents

ASJC Scopus subject areas

Oncology
Surgery

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Wolff, I., May, M., Hoschke, B., Zigeuner, R., Cindolo, L., Hutterer, G., Schips, L., De Cobelli, O., Rocco, B., De Nunzio, C., Tubaro, A., Coman, I., Feciche, B., Truss, M., Dalpiaz, O., Figenshau, R. S., Madison, K., Sánchez-Chapado, M., Santiago Martin, M. D. C., ... Brookman-May, S. (2016). Do we need new high-risk criteria for surgically treated renal cancer patients to improve the outcome of future clinical trials in the adjuvant setting? Results of a comprehensive analysis based on the multicenter CORONA database. European Journal of Surgical Oncology, 42(5), 744-750. https://doi.org/10.1016/j.ejso.2016.01.009

Do we need new high-risk criteria for surgically treated renal cancer patients to improve the outcome of future clinical trials in the adjuvant setting? Results of a comprehensive analysis based on the multicenter CORONA database. / Wolff, I.; May, M.; Hoschke, B.; Zigeuner, R.; Cindolo, L.; Hutterer, G.; Schips, L.; De Cobelli, O.; Rocco, B.; De Nunzio, C.; Tubaro, A.; Coman, I.; Feciche, B.; Truss, M.; Dalpiaz, O.; Figenshau, R. S.; Madison, K.; Sánchez-Chapado, M.; Santiago Martin, M. D C; Salzano, L.; Lotrecchiano, G.; Shariat, S. F.; Hohenfellner, M.; Waidelich, R.; Stief, C.; Miller, K.; Pahernik, S.; Brookman-May, S.

In: European Journal of Surgical Oncology, Vol. 42, No. 5, 01.05.2016, p. 744-750.

Research output: Contribution to journal › Article › peer-review

Wolff, I, May, M, Hoschke, B, Zigeuner, R, Cindolo, L, Hutterer, G, Schips, L, De Cobelli, O, Rocco, B, De Nunzio, C, Tubaro, A, Coman, I, Feciche, B, Truss, M, Dalpiaz, O, Figenshau, RS, Madison, K, Sánchez-Chapado, M, Santiago Martin, MDC, Salzano, L, Lotrecchiano, G, Shariat, SF, Hohenfellner, M, Waidelich, R, Stief, C, Miller, K, Pahernik, S & Brookman-May, S 2016, 'Do we need new high-risk criteria for surgically treated renal cancer patients to improve the outcome of future clinical trials in the adjuvant setting? Results of a comprehensive analysis based on the multicenter CORONA database', European Journal of Surgical Oncology, vol. 42, no. 5, pp. 744-750. https://doi.org/10.1016/j.ejso.2016.01.009

Wolff I, May M, Hoschke B, Zigeuner R, Cindolo L, Hutterer G et al. Do we need new high-risk criteria for surgically treated renal cancer patients to improve the outcome of future clinical trials in the adjuvant setting? Results of a comprehensive analysis based on the multicenter CORONA database. European Journal of Surgical Oncology. 2016 May 1;42(5):744-750. https://doi.org/10.1016/j.ejso.2016.01.009

Wolff, I. ; May, M. ; Hoschke, B. ; Zigeuner, R. ; Cindolo, L. ; Hutterer, G. ; Schips, L. ; De Cobelli, O. ; Rocco, B. ; De Nunzio, C. ; Tubaro, A. ; Coman, I. ; Feciche, B. ; Truss, M. ; Dalpiaz, O. ; Figenshau, R. S. ; Madison, K. ; Sánchez-Chapado, M. ; Santiago Martin, M. D C ; Salzano, L. ; Lotrecchiano, G. ; Shariat, S. F. ; Hohenfellner, M. ; Waidelich, R. ; Stief, C. ; Miller, K. ; Pahernik, S. ; Brookman-May, S. / Do we need new high-risk criteria for surgically treated renal cancer patients to improve the outcome of future clinical trials in the adjuvant setting? Results of a comprehensive analysis based on the multicenter CORONA database. In: European Journal of Surgical Oncology. 2016 ; Vol. 42, No. 5. pp. 744-750.

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abstract = "Background Since there is still an unmet need for potent adjuvant strategies for renal cancer patients with high progression risk after surgery, several targeted therapies are currently evaluated in this setting. We analyzed whether inclusion criteria of contemporary trials (ARISER, ASSURE, SORCE, EVEREST, PROTECT, S-TRAC, ATLAS) correctly identify high-risk patients. Methods The study group comprised 8873 patients of the international CORONA-database after surgery for non-metastatic renal cancer without any adjuvant treatment. Patients were divided into potentially eligible high-risk and assumable low-risk patients who didn't meet inclusion criteria of contemporary adjuvant clinical trials. The ability of various inclusion criteria for disease-free survival (DFS) prediction was evaluated by Harrell's c-index. Results During a median follow-up of 53 months 15.2% of patients experienced recurrence (5-year-DFS 84%). By application of trial inclusion criteria, 24% (S-TRAC) to 47% (SORCE) of patients would have been eligible for enrollment. Actual recurrence rates of eligible patients ranged between 29% (SORCE) and 37% (S-TRAC) opposed to ",

keywords = "Adjuvant therapy, Disease recurrence, Nephrectomy, Phase-3-trials, Renal cell cancer, Targeted agents",

author = "I. Wolff and M. May and B. Hoschke and R. Zigeuner and L. Cindolo and G. Hutterer and L. Schips and {De Cobelli}, O. and B. Rocco and {De Nunzio}, C. and A. Tubaro and I. Coman and B. Feciche and M. Truss and O. Dalpiaz and Figenshau, {R. S.} and K. Madison and M. S{\'a}nchez-Chapado and {Santiago Martin}, {M. D C} and L. Salzano and G. Lotrecchiano and Shariat, {S. F.} and M. Hohenfellner and R. Waidelich and C. Stief and K. Miller and S. Pahernik and S. Brookman-May",

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AU - Wolff, I.

AU - May, M.

AU - Hoschke, B.

AU - Zigeuner, R.

AU - Cindolo, L.

AU - Hutterer, G.

AU - Schips, L.

AU - De Cobelli, O.

AU - Rocco, B.

AU - De Nunzio, C.

AU - Tubaro, A.

AU - Coman, I.

AU - Feciche, B.

AU - Truss, M.

AU - Dalpiaz, O.

AU - Figenshau, R. S.

AU - Madison, K.

AU - Sánchez-Chapado, M.

AU - Santiago Martin, M. D C

AU - Salzano, L.

AU - Lotrecchiano, G.

AU - Shariat, S. F.

AU - Hohenfellner, M.

AU - Waidelich, R.

AU - Stief, C.

AU - Miller, K.

AU - Pahernik, S.

AU - Brookman-May, S.

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KW - Disease recurrence

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KW - Renal cell cancer

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Do we need new high-risk criteria for surgically treated renal cancer patients to improve the outcome of future clinical trials in the adjuvant setting? Results of a comprehensive analysis based on the multicenter CORONA database

Abstract

Keywords

ASJC Scopus subject areas

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