Prognostic factors and risk groups in T1G3 non-muscle-invasive bladder cancer patients initially treated with Bacillus Calmette-Guérin: results of a retrospective multicenter study of 2451 patients
Paolo Gontero, Richard Sylvester, Francesca Pisano, Steven Joniau, Kathy Vander Eeckt, Vincenzo Serretta, Stéphane Larré, Savino Di Stasi, Bas Van Rhijn, Alfred J Witjes, Anne J Grotenhuis, Lambertus A Kiemeney, Renzo Colombo, Alberto Briganti, Marek Babjuk, Per-Uno Malmström, Marco Oderda, Jacques Irani, Nuria Malats, Jack Baniel, Roy Mano, Tommaso Cai, Eugene K Cha, Peter Ardelt, John Varkarakis, Riccardo Bartoletti, Martin Spahn, Robert Johansson, Bruno Frea, Viktor Soukup, Evanguelos Xylinas, Guido Dalbagni, R Jeffrey Karnes, Shahrokh F Shariat, Joan Palou, Paolo Gontero, Richard Sylvester, Francesca Pisano, Steven Joniau, Kathy Vander Eeckt, Vincenzo Serretta, Stéphane Larré, Savino Di Stasi, Bas Van Rhijn, Alfred J Witjes, Anne J Grotenhuis, Lambertus A Kiemeney, Renzo Colombo, Alberto Briganti, Marek Babjuk, Per-Uno Malmström, Marco Oderda, Jacques Irani, Nuria Malats, Jack Baniel, Roy Mano, Tommaso Cai, Eugene K Cha, Peter Ardelt, John Varkarakis, Riccardo Bartoletti, Martin Spahn, Robert Johansson, Bruno Frea, Viktor Soukup, Evanguelos Xylinas, Guido Dalbagni, R Jeffrey Karnes, Shahrokh F Shariat, Joan Palou
Abstract
Background: The impact of prognostic factors in T1G3 non-muscle-invasive bladder cancer (BCa) patients is critical for proper treatment decision making.
Objective: To assess prognostic factors in patients who received bacillus Calmette-Guérin (BCG) as initial intravesical treatment of T1G3 tumors and to identify a subgroup of high-risk patients who should be considered for more aggressive treatment.
Design, setting, and participants: Individual patient data were collected for 2451 T1G3 patients from 23 centers who received BCG between 1990 and 2011.
Outcome measurements and statistical analysis: Using Cox multivariable regression, the prognostic importance of several clinical variables was assessed for time to recurrence, progression, BCa-specific survival, and overall survival (OS).
Results and limitations: With a median follow-up of 5.2 yr, 465 patients (19%) progressed, 509 (21%) underwent cystectomy, and 221 (9%) died because of BCa. In multivariable analyses, the most important prognostic factors for progression were age, tumor size, and concomitant carcinoma in situ (CIS); the most important prognostic factors for BCa-specific survival and OS were age and tumor size. Patients were divided into four risk groups for progression according to the number of adverse factors among age ≥ 70 yr, size ≥ 3 cm, and presence of CIS. Progression rates at 10 yr ranged from 17% to 52%. BCa-specific death rates at 10 yr were 32% in patients ≥ 70 yr with tumor size ≥ 3 cm and 13% otherwise.
Conclusions: T1G3 patients ≥ 70 yr with tumors ≥ 3 cm and concomitant CIS should be treated more aggressively because of the high risk of progression.
Patient summary: Although the majority of T1G3 patients can be safely treated with intravesical bacillus Calmette-Guérin, there is a subgroup of T1G3 patients with age ≥ 70 yr, tumor size ≥ 3 cm, and concomitant CIS who have a high risk of progression and thus require aggressive treatment.
Keywords: BCG; Bacillus Calmette-Guérin; Non–muscle-invasive bladder cancer; Prognostic factors; T1G3.
Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Source: PubMed