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Disease-free survival as a surrogate for overall survival in upper tract urothelial carcinoma

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Disease-free survival as a surrogate for overall survival in upper tract urothelial carcinoma. / Fajkovic, Harun; Cha, Eugene K; Xylinas, Evanguelos; Rink, Michael; Pycha, Armin; Seitz, Christian; Bolenz, Christian; Dunning, Allison; Novara, Giacomo; Trinh, Quoc-Dien; Karakiewicz, Pierre I; Margulis, Vitaly; Raman, Jay D; Walton, Thomas J; Baba, Shiro; Carballido, Joaquin; Otto, Wolfgang; Montorsi, Francesco; Lotan, Yair; Kassouf, Wassim; Fritsche, Hans-Martin; Bensalah, Karim; Zigeuner, Richard; Scherr, Douglas S; Sonpavde, Guru; Roupret, Morgan; Shariat, Shahrokh F.

in: WORLD J UROL, Jahrgang 31, Nr. 1, 01.02.2013, S. 5-11.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Fajkovic, H, Cha, EK, Xylinas, E, Rink, M, Pycha, A, Seitz, C, Bolenz, C, Dunning, A, Novara, G, Trinh, Q-D, Karakiewicz, PI, Margulis, V, Raman, JD, Walton, TJ, Baba, S, Carballido, J, Otto, W, Montorsi, F, Lotan, Y, Kassouf, W, Fritsche, H-M, Bensalah, K, Zigeuner, R, Scherr, DS, Sonpavde, G, Roupret, M & Shariat, SF 2013, 'Disease-free survival as a surrogate for overall survival in upper tract urothelial carcinoma', WORLD J UROL, Jg. 31, Nr. 1, S. 5-11. https://doi.org/10.1007/s00345-012-0939-5

APA

Fajkovic, H., Cha, E. K., Xylinas, E., Rink, M., Pycha, A., Seitz, C., Bolenz, C., Dunning, A., Novara, G., Trinh, Q-D., Karakiewicz, P. I., Margulis, V., Raman, J. D., Walton, T. J., Baba, S., Carballido, J., Otto, W., Montorsi, F., Lotan, Y., ... Shariat, S. F. (2013). Disease-free survival as a surrogate for overall survival in upper tract urothelial carcinoma. WORLD J UROL, 31(1), 5-11. https://doi.org/10.1007/s00345-012-0939-5

Vancouver

Fajkovic H, Cha EK, Xylinas E, Rink M, Pycha A, Seitz C et al. Disease-free survival as a surrogate for overall survival in upper tract urothelial carcinoma. WORLD J UROL. 2013 Feb 1;31(1):5-11. https://doi.org/10.1007/s00345-012-0939-5

Bibtex

@article{b97279b377aa40dba64a905be4a3b3c1,
title = "Disease-free survival as a surrogate for overall survival in upper tract urothelial carcinoma",
abstract = "OBJECTIVES: The primary endpoint in trials of perioperative systemic therapy for urothelial carcinoma is 5-year overall survival (OS). A shorter-term endpoint could significantly speed the translation of advances into practice. We hypothesized that disease-free survival (DFS) could be a surrogate endpoint for OS in upper tract urothelial carcinoma (UTUC) patients treated with radical nephroureterectomy (RNU).PATIENTS AND METHODS: The study included 2,492 patients treated with RNU with curative intent for UTUC.RESULTS: 2/3-year DFS estimates were 78/73 %, and the 5-year OS estimate was 64 %. The overall agreements between 2- and 3-year DFS with 5-year OS were 85 and 87 %, respectively. Agreements were similar when analyzed in subgroups stratified by pathological stages, lymph node status, and adjuvant chemotherapy. The kappa statistic was 0.59 (95 % CI 0.55-0.63) for 2-year DFS/5-year OS and 0.64 (95 % CI 0.61-0.68) for 3-year DFS/5-year OS, indicating moderate reliability. The hazard ratio for DFS as a time-dependent variable for predicting OS was 11.5 (95 % CI 9.1-14.4), indicating a strong relationship between DFS and OS.CONCLUSIONS: In patients treated with RNU for UTUC, DFS and OS are highly correlated, regardless of tumor stage and adjuvant chemotherapy. While significant differences in DFS, assessed at 2 and 3 years, are highly likely to persist in OS at 5 years, marginal DFS advantages may not translate into OS benefit. External validation is necessary before accepting DFS as an appropriate surrogate endpoint for clinical trials investigating advanced UTUC patients.",
keywords = "Adult, Aged, Aged, 80 and over, Carcinoma, Transitional Cell, Disease-Free Survival, Female, Humans, Kidney Neoplasms, Kidney Pelvis, Male, Middle Aged, Nephrectomy, Retrospective Studies, Survival Analysis, Time Factors, Treatment Outcome, Ureter, Ureteral Neoplasms",
author = "Harun Fajkovic and Cha, {Eugene K} and Evanguelos Xylinas and Michael Rink and Armin Pycha and Christian Seitz and Christian Bolenz and Allison Dunning and Giacomo Novara and Quoc-Dien Trinh and Karakiewicz, {Pierre I} and Vitaly Margulis and Raman, {Jay D} and Walton, {Thomas J} and Shiro Baba and Joaquin Carballido and Wolfgang Otto and Francesco Montorsi and Yair Lotan and Wassim Kassouf and Hans-Martin Fritsche and Karim Bensalah and Richard Zigeuner and Scherr, {Douglas S} and Guru Sonpavde and Morgan Roupret and Shariat, {Shahrokh F}",
year = "2013",
month = feb,
day = "1",
doi = "10.1007/s00345-012-0939-5",
language = "English",
volume = "31",
pages = "5--11",
journal = "WORLD J UROL",
issn = "0724-4983",
publisher = "Springer",
number = "1",

}

RIS

TY - JOUR

T1 - Disease-free survival as a surrogate for overall survival in upper tract urothelial carcinoma

AU - Fajkovic, Harun

AU - Cha, Eugene K

AU - Xylinas, Evanguelos

AU - Rink, Michael

AU - Pycha, Armin

AU - Seitz, Christian

AU - Bolenz, Christian

AU - Dunning, Allison

AU - Novara, Giacomo

AU - Trinh, Quoc-Dien

AU - Karakiewicz, Pierre I

AU - Margulis, Vitaly

AU - Raman, Jay D

AU - Walton, Thomas J

AU - Baba, Shiro

AU - Carballido, Joaquin

AU - Otto, Wolfgang

AU - Montorsi, Francesco

AU - Lotan, Yair

AU - Kassouf, Wassim

AU - Fritsche, Hans-Martin

AU - Bensalah, Karim

AU - Zigeuner, Richard

AU - Scherr, Douglas S

AU - Sonpavde, Guru

AU - Roupret, Morgan

AU - Shariat, Shahrokh F

PY - 2013/2/1

Y1 - 2013/2/1

N2 - OBJECTIVES: The primary endpoint in trials of perioperative systemic therapy for urothelial carcinoma is 5-year overall survival (OS). A shorter-term endpoint could significantly speed the translation of advances into practice. We hypothesized that disease-free survival (DFS) could be a surrogate endpoint for OS in upper tract urothelial carcinoma (UTUC) patients treated with radical nephroureterectomy (RNU).PATIENTS AND METHODS: The study included 2,492 patients treated with RNU with curative intent for UTUC.RESULTS: 2/3-year DFS estimates were 78/73 %, and the 5-year OS estimate was 64 %. The overall agreements between 2- and 3-year DFS with 5-year OS were 85 and 87 %, respectively. Agreements were similar when analyzed in subgroups stratified by pathological stages, lymph node status, and adjuvant chemotherapy. The kappa statistic was 0.59 (95 % CI 0.55-0.63) for 2-year DFS/5-year OS and 0.64 (95 % CI 0.61-0.68) for 3-year DFS/5-year OS, indicating moderate reliability. The hazard ratio for DFS as a time-dependent variable for predicting OS was 11.5 (95 % CI 9.1-14.4), indicating a strong relationship between DFS and OS.CONCLUSIONS: In patients treated with RNU for UTUC, DFS and OS are highly correlated, regardless of tumor stage and adjuvant chemotherapy. While significant differences in DFS, assessed at 2 and 3 years, are highly likely to persist in OS at 5 years, marginal DFS advantages may not translate into OS benefit. External validation is necessary before accepting DFS as an appropriate surrogate endpoint for clinical trials investigating advanced UTUC patients.

AB - OBJECTIVES: The primary endpoint in trials of perioperative systemic therapy for urothelial carcinoma is 5-year overall survival (OS). A shorter-term endpoint could significantly speed the translation of advances into practice. We hypothesized that disease-free survival (DFS) could be a surrogate endpoint for OS in upper tract urothelial carcinoma (UTUC) patients treated with radical nephroureterectomy (RNU).PATIENTS AND METHODS: The study included 2,492 patients treated with RNU with curative intent for UTUC.RESULTS: 2/3-year DFS estimates were 78/73 %, and the 5-year OS estimate was 64 %. The overall agreements between 2- and 3-year DFS with 5-year OS were 85 and 87 %, respectively. Agreements were similar when analyzed in subgroups stratified by pathological stages, lymph node status, and adjuvant chemotherapy. The kappa statistic was 0.59 (95 % CI 0.55-0.63) for 2-year DFS/5-year OS and 0.64 (95 % CI 0.61-0.68) for 3-year DFS/5-year OS, indicating moderate reliability. The hazard ratio for DFS as a time-dependent variable for predicting OS was 11.5 (95 % CI 9.1-14.4), indicating a strong relationship between DFS and OS.CONCLUSIONS: In patients treated with RNU for UTUC, DFS and OS are highly correlated, regardless of tumor stage and adjuvant chemotherapy. While significant differences in DFS, assessed at 2 and 3 years, are highly likely to persist in OS at 5 years, marginal DFS advantages may not translate into OS benefit. External validation is necessary before accepting DFS as an appropriate surrogate endpoint for clinical trials investigating advanced UTUC patients.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Carcinoma, Transitional Cell

KW - Disease-Free Survival

KW - Female

KW - Humans

KW - Kidney Neoplasms

KW - Kidney Pelvis

KW - Male

KW - Middle Aged

KW - Nephrectomy

KW - Retrospective Studies

KW - Survival Analysis

KW - Time Factors

KW - Treatment Outcome

KW - Ureter

KW - Ureteral Neoplasms

U2 - 10.1007/s00345-012-0939-5

DO - 10.1007/s00345-012-0939-5

M3 - SCORING: Journal article

C2 - 23011256

VL - 31

SP - 5

EP - 11

JO - WORLD J UROL

JF - WORLD J UROL

SN - 0724-4983

IS - 1

ER -