Original article
Quality of life in patients with non–muscle-invasive bladder cancer: One-year results of a multicentre prospective cohort study,☆☆

https://doi.org/10.1016/j.urolonc.2014.09.012Get rights and content

Abstract

Objective

Few studies describe the effect of non–muscle-invasive bladder cancer (NMIBC) on health-related quality of life (HRQL), although patients are mostly diagnosed at this stage of the disease. Taking into account this current evidence gap and the high incidence rates in Spain, we aimed to describe the evolution over time of HRQL in Spanish patients with NMIBC and to examine the clinical and treatment-related factors associated with HRQL change during the first year of management.

Methods and materials

Observational multicenter prospective inception cohort study conducted in urology departments of 7 Spanish hospitals. A consecutive sample of 244 patients with anatomopathologically confirmed NMIBC, recruited from October 2010 to September 2011, was followed during the diagnostic process, and 6 and 12 months later. HRQL was assessed by generic and disease-specific instruments: the Short Form-36 (covering physical and mental health) and the Bladder Cancer Index, measuring urinary, bowel, and sexual domains (summary scores: 0–100). Bivariate analysis was performed and generalized estimating equation models were constructed to assess HRQL score change.

Results

Almost 52% of the patients were diagnosed at stage I, and 84% were men. The number of patients treated only with transurethral resection (TUR) was 144, and 82 also received intravesical therapy with bacillus Calmette-Guérin (BCG) or mitomycin C. Mental health was significantly worse than Short Form-36 reference norms at diagnosis (mean of 49.7 vs. 53.3, 95% CI: 52.5–54.2). Urinary domain improved significantly from diagnosis (85.2, 95% CI: 82.9–87.4) to 12-month evaluation (90.2, 95% CI: 87.7–92.8), whereas sexual domain showed deterioration from 56.4 (95% CI: 52.8–59.9) to 53.7 (95% CI: 50.0–57.4). Adjusted HRQL score changes from baseline to 12-month follow-up estimated with generalized estimating equation models showed improvement on the following parameters: urinary domain after TUR with or without intravesical therapy (+3.9, 95% CI: 0.1–7.7), bowel domain among patients treated with TUR and BCG (+7.0, 95% CI: 2.4–11.5), and sexual domain among those treated with TUR and mitomycin C (+13.1, 95% CI: 5.9–20.2).

Conclusions

For the first time, a distinctive HRQL pattern of bladder cancer treatment benefits emerges for TUR alone, and in combination with BCG or mitomycin C, which deserves further research. Treatment differences cannot be interpreted in terms of efficacy but can be useful to generate hypotheses to test in future studies.

Introduction

Bladder cancer has the fourth highest incidence of cancer cases in men in the USA and Europe [1], [2]. The reported age-adjusted incidence rates in Europe have been highest for Spain (39.0 per 100,000 against 29.1 in European Union-27) [2]. It is 3 to 4 times more frequent in men than in women [3], and 1 in 26 men develop bladder cancer during their lifetime [1]. Burden is high at all phases of treatment and surveillance owing to the frequent tumor recurrence and progression, which leads to long-term clinical monitoring [4].

Health-related quality-of-life (HRQL) evaluation is crucial because patients with bladder cancer continue experiencing treatment-related concern over a long period of cancer monitoring [5], [6]. However, systematic reviews [7], [8] show that HRQL of patients with bladder cancer is poorly known, with scarce information compared with other cancers. The literature has consistently identified urinary and sexual domains as the patients׳ greatest concern [9]. However, quality of the available information on the effect of bladder cancer on HRQL is mainly affected by retrospective or cross-sectional study designs, nonvalidated HRQL instruments, or failure to adjust for confounder variables [8], [10].

Most literature on HRQL addressed patients with muscle-invasive bladder cancer who had undergone radical cystectomy, focusing on the effect of different urinary diversion methods [6], [7]. Currently, there are only a few published studies regarding HRQL in patients with non–muscle-invasive bladder cancer (NMIBC) [5], [11], [12], [13], [14], [15], [16], [17], [18] although patients are mostly diagnosed at this stage of the disease. Taking into account the current evidence gaps regarding HRQL of patients with bladder cancer and its high incidence rates in Spain, we aimed to describe the evolution over time of HRQL (measured by generic and bladder cancer–specific instruments) of Spanish patients with NMIBC and to examine the clinical and treatment-related factors associated with HRQL changes during the first year of disease management.

Section snippets

Study design

The Multicenter Study on Healthcare Process and Outcomes Observed in Urologic Cancer (EMPARO-CU, from the Spanish “Estudio Multicéntrico sobre el Proceso Asistencial y los Resultados Observados en Cáncer Urológico”) is an observational prospective inception cohort study focused on the clinical care and health outcomes of patients with urologic tumors in Spain. Participants were consecutively enrolled from October 2010 to September 2011 in the urology departments of 7 hospitals located in 5

Descriptive and bivariate analyses

Means, standard deviations, and 95% CI of HRQL scores were calculated. We compared SF-36 score means with USA general population norms [20] to examine the effect of bladder cancer on patients׳ HRQL. Differences in HRQL score changes (from baseline to 12 mo) among groups defined by sociodemographic, clinical, and treatment variables were tested with 1-way analysis of variance.

Generalized estimating equation models

To estimate the HRQL changes over time according to treatment, generalized estimating equation (GEE) models were

Patient characteristics

We recruited 347 patients, but biopsy did not confirm bladder cancer in 21 cases. After excluding patients with muscle-invasive bladder cancer (47 of stage II, 5 of stage III, and 8 of stage IV) or unknown stage (21 patients), and 1 stage I patient treated with cystectomy, the sample was composed of 244 participants with NMIBC undergoing TUR with or without intravesical therapy. Of those, 220 (90.2%) completed HRQL questionnaires at baseline, 167 (68.4%) at 6-month follow-up, and 183 (75.0%) at

Discussion

As Spain shows one of the highest incidence rates of bladder cancer among European countries, HRQL evaluation is important to optimize health care services and to quantify the burden of disease. This multicentre prospective cohort study showed that bladder cancer diagnosis might have a relevant effect on mental health, and after treatment, patients perceived urinary concern relief but sexual functioning deterioration. Our results should help clinicians to better inform patients of possible

Study limitations

Our study has certain limitations that deserve further discussion. First, loss to follow-up and missing data are the main limitations of longitudinal studies with repeated measurements. Our average missing HRQL data in the 3 evaluations were 22.1%, and GEE allows the presence of missing values in the repeated measurements of the dependent variable, without having to exclude individuals with incomplete data and with no need of imputation methods (even when the assumption of missing completely at

Conclusion

Our study provides novel multicenter, prospective 1-year follow-up results for patients diagnosed at NMIBC stages, using generic and disease-specific validated HRQL instruments. General health results were compared with population norms to assess bladder cancer effect, and disease-specific HRQL evolution was estimated for standard treatments. Our results highlight the effect of bladder cancer on mental health at diagnosis, which clinicians should be aware of. A distinctive treatment pattern of

Acknowledgments

We would like to thank the whole EMPARO-CU study group for the realization of this project:

Barcelona: Virginia Becerra, Stefanie Schmidt, Yolanda Pardo, Montserrat Ferrer Fores, and Olatz Garin (IMIM Hospital del Mar Medical Research Institute); Albert Frances (Hospital del Mar); Carola Orrego Villagran and Rosa Suñol (Instituo U. Avedis Donabedian); Dimelza Osorio, Xavier Bonfill Cosp, Esther Canovas, Gemma Sancho Pardo. Ignasi Bolívar, Jordi Bachs, José Pablo Maroto, Mª Jesús Quintana, Mª

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    The study was approved by the ethic committees of all the participating centers (Fundació Puigvert-Hospital de la Santa Creu i Sant Pau, Hospital del Mar, Hospital Universitario 12 de Octubre, Hospital Universitario Ramón y Cajal, Hospital Universitario Donostia, Hospital General Universitario de Valencia, and Hospital Universitario Virgen de las Nieves, and Hospital Universitario Cruces).

    ☆☆

    The study was supported by Instituto Carlos III FEDER (PS09/02139, PS09/01204, PS09/01619, and PS09/02555) and by AGAUR (2014 SGR 748, 2009 SGR 1095 and 2012FI_B 100177). None of these organizations had any role in the design or execution of the study; in the data collection, management, or interpretation; or in the writing, reviewing, or approval of the manuscript.

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