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22-09-2020

Patient-reported outcomes in non-muscle invasive bladder cancer: a mixed-methods systematic review

Auteurs: Claudia Rutherford, Manish I. Patel, Margaret-Ann Tait, David P. Smith, Daniel S. J. Costa, Shomik Sengupta, Madeleine T. King

Gepubliceerd in: Quality of Life Research | Uitgave 2/2021

Abstract

Objective

Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring repeated treatment and endoscopic examinations that can occur life-long. In this context, patient-reported outcomes (PROs) are important considerations to patients and managing clinicians. We undertook a systematic review to synthesise PRO results relevant to NMIBC treatment to explore trajectories overtime and differences between treatment options.

Methods

We searched databases AMED, MEDLINE, EMbase, PsycINFO, Web of Knowledge and Scopus (inception to 5th December 2019), reference lists and contacted key authors to identify studies that reported PROs after NMIBC treatment. Two reviewers independently applied inclusion and quality criteria and extracted findings. Results for PROs were synthesised for treatment groups across three time periods: acute/during induction therapy; during maintenance therapy; and long-term follow-up (> 1 year).

Results

Of 3193 papers screened, 29 were eligible. These provided evidence about induction treatment effects, but few reported maintenance or long-term evidence, and evidence about differences between NMIBC treatment options was lacking. A range of symptoms (pain in bladder area, urinary frequency and urgency, pain or burning during urination) were commonly experienced during and soon after treatment for NMIBC. Less common symptoms included fatigue, disrupted sleep and gastrointestinal problems.

Conclusions

Treatments for NMIBC can cause symptoms and functional impairment during the acute treatment phase and reduce quality of life. Clinicians should be aware of these impairments to prepare patients for short-term sequelae and enable those with treatment options to exercise preferences in choosing among them. However, gaps in current evidence limit our understanding of PRO trajectories from diagnosis through to long-term survivorship and treatment effects.

vorige artikel Quality of life of cancer patients at palliative care units in developing countries: systematic review of the published literature

volgende artikel The effect of cognitive behavioral therapy on the quality of life of breast cancer patients: a systematic review and meta-analysis of randomized controlled trials

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Cheluvappa, R., Smith, D. P., Cerimagic, S., & Patel, M. I. (2014). A comprehensive evaluation of bladder cancer epidemiology and outcomes in Australia. International Urology and Nephrology, 46(7), 1351–1360.CrossRef

Heney, N. M. (1992). Natural history of superficial bladder cancer Prognostic features and long-term disease course. Urologic Clinics of North America, 19(3), 429–433.

Anastasiadis, A., & de Reijke, T. M. (2012). Best practice in the treatment of nonmuscle invasive bladder cancer. Therapeutic Advances in Urology, 4(1), 13–32. https://doi.org/10.1177/1756287211431976.CrossRefPubMedPubMedCentral

US Department of Health & Human Support Food & Drug Administration. (2009). Patient reported outcome measures: Use in medical product development to support labelling claims. MD: US Department of Health & Human Support Food & Drug Administration.

Lipscomb, J., Gotay, C. C., & Snyder, C. F. (2007). Patient-reported outcomes in cancer a review of recent research and policy initiatives. CA: A Cancer Journal for Clinicians, 57(5), 278–300. https://doi.org/10.3322/ca.57.5.278.CrossRef

Metwally, M. A., Frederiksen, K. D., & Overgaard, J. (2014). Compliance and toxicity of the hypoxic radiosensitizer nimorazole in the treatment of patients with head and neck squamous cell carcinoma (HNSCC). Acta Oncologica, 53(5), 654–661. https://doi.org/10.3109/0284186x.2013.864050.CrossRefPubMed

Hendricksen, K., Gleason, D., Young, J. M., Saltzstein, D., Gershman, A., Lerner, S., et al. (2008). Safety and side effects of immediate instillation of apaziquone following transurethral resection in patients with nonmuscle invasive bladder cancer. The Journal of urology, 180(1), 116–120. https://doi.org/10.1016/j.juro.2008.03.031.CrossRefPubMed

Osoba, D., Zee, B., Pater, J., Warr, D., Latreille, J., & Kaizer, L. (1997). Determinants of postchemotherapy nausea and vomiting in patients with cancer Quality of Life and Symptom Control Committees of the National Cancer Institute of Canada Clinical Trials Group. Journal of Clinical Oncology, 15(1), 116–123. https://doi.org/10.1200/jco.1997.15.1.116.CrossRefPubMed

Botteman, M. F., Pashos, C. L., Hauser, R. S., Laskin, B. L., & Redaelli, A. (2003). Quality of life aspects of bladder cancer: a review of the literature. Quality of Life Research, 12(6), 675–688.CrossRef

10.

Calvert, M., Brundage, M., Jacobsen, P. B., Schunemann, H. J., & Efficace, F. (2013). The CONSORT Patient-Reported Outcome (PRO) extension: implications for clinical trials and practice. Health Qual Life Outcomes, 11, 184. https://doi.org/10.1186/1477-7525-11-184.CrossRefPubMedPubMedCentral

11.

Kmet, L., Lee, R., Cook, L., & Alberta Heritage Foundation for Medical Research. (2004). Standard quality assessment criteria for evaluating primary research papers from a variety of fields. Edmonton: Alta Alberta Heritage Foundation for Medical Research.

12.

Centre for Reviews and Dissemination (2001). Undertaking systematic reviews of research on effectiveness. University of York. https://www.york.ac.uk/inst/crd/report4.htm.

13.

Colombo, R., Rocchini, L., Suardi, N., Benigni, F., Colciago, G., Bettiga, A., et al. (2012). Neoadjuvant short-term intensive intravesical mitomycin C regimen compared with weekly schedule for low-grade recurrent non-muscle-invasive bladder cancer: preliminary results of a randomised phase 2 study. European Urology, 62(5), 797–802. https://doi.org/10.1016/j.eururo.2012.05.032.CrossRefPubMed

14.

Johnson, M. H., Nepple, K. G., Peck, V., Trinkaus, K., Klim, A., Sandhu, G. S., et al. (2013). Randomized controlled trial of oxybutynin extended release versus placebo for urinary symptoms during intravesical Bacillus Calmette-Guerin treatment. Journal of Urology, 189(4), 1268–1274. https://doi.org/10.1016/j.juro.2012.10.070.CrossRef

15.

Mack, D., & Frick, J. (1996). Quality of life in patients undergoing bacille Calmette-Guerin therapy for superficial bladder cancer. British Journal of Urology, 78(3), 369–371.CrossRef

16.

Steinberg, R. L., Thomas, L. J., Mott, S. L., O'Donnell, M., & A., (2019). Multi-perspective tolerance evaluation of bacillus calmette-guerin with interferon in the treatment of non-muscle invasive bladder cancer. Bladder Cancer, 5(1), 39–49. https://doi.org/10.3233/BLC-180203.CrossRef

17.

Gontero, P., Oderda, M., Mehnert, A., Gurioli, A., Marson, F., Lucca, I., et al. (2013). The impact of intravesical gemcitabine and 1/3 dose Bacillus Calmette-Guerin instillation therapy on the quality of life in patients with nonmuscle invasive bladder cancer: results of a prospective, randomized, phase II trial. Journal of Urology, 190(3), 857–862.CrossRef

18.

Krajewski, W., Koscielska-Kasprzak, K., Rymaszewska, J., & Zdrojowy, R. (2017). How different cystoscopy methods influence patient sexual satisfaction, anxiety, and depression levels: a randomized prospective trial. Quality of Life Research.

19.

Van Der Aa, M. N. M., Steyerberg, E. W., Sen, E. F., Zwarthoff, E. C., Kirkels, W. J., Van Der Kwast, T. H., et al. (2007). Patients' perceived burden of cystoscopic and urinary surveillance of bladder cancer: A randomized comparison. BJU International, 101(9), 1106–1110. https://doi.org/10.1111/j.1464-410X.2007.07224.x.CrossRefPubMed

20.

Yokomizo, A., Kanimoto, Y., Okamura, T., Ozono, S., Koga, H., Iwamura, M., et al. (2016). Randomized Controlled Study of the Efficacy, Safety and Quality of Life with Low Dose bacillus Calmette-Guerin Instillation Therapy for Nonmuscle Invasive Bladder Cancer. Journal of Urology, 195(1), 41–46. https://doi.org/10.1016/j.juro.2015.08.075.CrossRef

21.

Wei, L., Li, Q., Liang, H., & Jianbo, L. (2014). The quality of life in patients during intravesical treatment and correlation with local symptoms. Journal of Chemotherapy, 26(3), 165–168. https://doi.org/10.1179/1973947813y.0000000126.CrossRefPubMed

22.

Smith, A. B., Daneshmand, S., Patel, S., Pohar, K., Trabulsi, E., Woods, M., et al. (2019). Patient-reported outcomes of blue-light flexible cystoscopy with hexaminolevulinate in the surveillance of bladder cancer: results from a prospective multicentre study. BJU International, 123(1), 35–41. https://doi.org/10.1111/bju.14481.CrossRefPubMed

23.

Krajewski, W., Halska, U., Poletajew, S., Piszczek, R., Biezynski, B., Matyjasek, M., et al. (2018). Influence of transurethral resection of bladder cancer on sexual function, anxiety, and depression. Advances in Experimental Medicine and Biology, 1116, 37–50. https://doi.org/10.1007/5584_2018_264.CrossRefPubMed

24.

Topazio, L., Miano, R., Maurelli, V., Gaziev, G., Gacci, M., Iacovelli, V., et al. (2014). Could hyaluronic acid (HA) reduce Bacillus Calmette-Guerin (BCG) local side effects? Results of a pilot study. BMC Urology, 14, 64. https://doi.org/10.1186/1471-2490-14-64.CrossRefPubMedPubMedCentral

25.

Bohle, A., Balck, F., von Weitersheim, J., & Jocham, D. (1996). The quality of life during intravesical bacillus Calmette-Guerin therapy. Journal of Urology, 155(4), 1221–1226.CrossRef

26.

Koga, H., Ozono, S., Tsushima, T., Tomita, K., Horiguchi, Y., Usami, M., et al. (2010). Maintenance intravesical bacillus Calmette-Guerin instillation for Ta, T1 cancer and carcinoma in situ of the bladder: randomized controlled trial by the BCG Tokyo Strain Study Group. International Journal of Urology, 17(9), 759–766. https://doi.org/10.1111/j.1442-2042.2010.02584.x.CrossRefPubMed

27.

Schmidt, S., Frances, A., Lorente Garin, J. A., Juanpere, N., Lloreta Trull, J., Bonfill, X., et al. (2015). Quality of life in patients with non-muscle-invasive bladder cancer: one-year results of a multicentre prospective cohort study. Urologic Oncology, 33(1), 19.e17–15. https://doi.org/10.1016/j.urolonc.2014.09.012.CrossRef

28.

Sabichi, A. L., Lee, J. J., Grossman, H. B., Liu, S., Richmond, E., Czerniak, B. A., et al. (2011). A randomized controlled trial of celecoxib to prevent recurrence of nonmuscle-invasive bladder cancer. Cancer Prevention Research (Philadelphia, Pa), 4(10), 1580–1589. https://doi.org/10.1158/1940-6207.capr-11-0036.CrossRefPubMedCentral

29.

Smith, A. B., Jaeger, B., Pinheiro, L. C., Edwards, L. J., Tan, H. J., Nielsen, M. E., et al. (2018). Impact of bladder cancer on health-related quality of life. BJU International, 121(4), 549–557. https://doi.org/10.1111/bju.14047.CrossRefPubMed

30.

Brisbane, W. G., Holt, S. K., Winters, B. R., Gore, J. L., Walsh, T. J., Wright, J. L., et al. (2019). Nonmuscle Invasive Bladder Cancer Influences Physical Health Related Quality of Life and Urinary Incontinence. Urology, 125, 146–153. https://doi.org/10.1016/j.urology.2018.11.038.CrossRefPubMed

31.

Danielsson, G., Malmstrom, P. U., Jahnson, S., Wijkstrom, H., Nyberg, T., & Thulin, H. (2018). Bladder health in patients treated with BCG instillations for T1G2-G3 bladder cancer-a follow-up five years after the start of treatment. Scandinavian Journal of Urology, 52(5–6), 377–384. https://doi.org/10.1080/21681805.2018.1538162.CrossRefPubMed

32.

Yoshimura, K., Utsunomiya, N., Ichioka, K., Matsui, Y., Terai, A., & Arai, Y. (2005). Impact of superficial bladder cancer and transurethral resection on general health-related quality of life: an SF-36 survey. Urology, 65(2), 290–294.CrossRef

33.

Chung, J., Kulkarni, G. S., Morash, R., Matthew, A., Papadakos, J., Breau, R. H., et al. (2019). Assessment of quality of life, information, and supportive care needs in patients with muscle and non-muscle invasive bladder cancer across the illness trajectory. Supportive Care in Cancer, 27(10), 3877–3885. https://doi.org/10.1007/s00520-019-4649-z.CrossRefPubMedPubMedCentral

34.

Hermann, G. G., Mogensen, K., & Rosthoj, S. (2018). Outpatient diode laser treatment of intermediate-risk non-invasive bladder tumors without sedation: efficacy, safety and economic analysis. Scandinavian Journal of Urology. https://doi.org/10.1080/21681805.2018.1450782.CrossRefPubMed

35.

Jung, A., Nielsen, M. E., Crandell, J. L., Palmer, M. H., Smith, S. K., Bryant, A. L., et al. (2019). Health-related quality of life among non-muscle-invasive bladder cancer survivors: a population-based study. BJU International.. https://doi.org/10.1111/bju.14888.CrossRefPubMedPubMedCentral

36.

Hinojosa-Lindsey, M. (2011). Understanding treatment-related symptoms, symptom management techniques, and symptom management self-efficacy in a sample of non-muscle invasive bladder cancer patients. Dissertation Abstracts International Section B The Sciences and Engineering, 72(1), 214.

37.

Koo, K., Zubkoff, L., Sirovich, B., River, W., Seigne, J., Goodney, P., et al. (2017). The burden of cystoscopic bladder cancer surveillance-anxiety, discomfort, and patient preferences for decision making. Journal of Urology, 197(4), e123.

38.

Kowalkowski, M. A., Chandrashekar, A., Amiel, G. E., Lerner, S. P., Wittmann, D. A., Latini, D. M., et al. (2014). Examining sexual dysfunction in non-muscle-invasive bladder cancer: results of cross-sectional mixed-methods research. Sex Med, 2(3), 141–151. https://doi.org/10.1002/sm2.24.CrossRefPubMedPubMedCentral

39.

Mogensen, K., Christensen, K. B., Vrang, M. L., & Hermann, G. G. (2016). Hospitalization for transurethral bladder resection reduces quality of life in Danish patients with non-muscle-invasive bladder tumour. Scand J Urol, 50(3), 170–174. https://doi.org/10.3109/21681805.2015.1132762.CrossRefPubMed

40.

Singer, S., Ziegler, C., Schwalenberg, T., Hinz, A., Gotze, H., & Schulte, T. (2013). Quality of life in patients with muscle invasive and non-muscle invasive bladder cancer. Supportive Care in Cancer, 21(5), 1383–1393. https://doi.org/10.1007/s00520-012-1680-8.CrossRefPubMed

41.

Rutherford, C., Costa, D. S. J., King, M. T., Smith, D. P., & Patel, M. I. (2017). A conceptual framework for patient-reported outcomes in non-muscle invasive bladder cancer. Supportive Care in Cancer, 25, 3095–3102. https://doi.org/10.1007/s00520-017-3717-5.CrossRefPubMed

42.

Brenner, M. H., Curbow, B., & Legro, M. W. (1995). The proximal-distal continuum of multiple health outcome measures: the case of cataract surgery. Medical Care, 33(4), 236–244.

43.

Rutherford, C., Patel, M. I., Tait, M. A., Smith, D. P., Costa, D. S. J., & King, M. T. (2018). Assessment of content validity for patient-reported outcome measures used in patients with non-muscle invasive bladder cancer: a systematic review. Supportive Care in Cancer, 26(4), 1061–1076. https://doi.org/10.1007/s00520-018-4058-8.CrossRefPubMed

44.

Lamm, D. L., Blumenstein, B. A., Crissman, J. D., Montie, J. E., Gottesman, J. E., Lowe, B. A., et al. (2000). Maintenance bacillus Calmette-Guerin immunotherapy for recurrent TA, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group Study. Journal of Urology, 163(4), 1124–1129.CrossRef

45.

Brausi, M., Oddens, J., Sylvester, R., Bono, A., van de Beek, C., van Andel, G., et al. (2014). Side effects of Bacillus Calmette-Guerin (BCG) in the treatment of intermediate- and high-risk Ta, T1 papillary carcinoma of the bladder: results of the EORTC genito-urinary cancers group randomised phase 3 study comparing one-third dose with full dose and 1 year with 3 years of maintenance BCG. European Urology, 65(1), 69–76.CrossRef

46.

Mercieca-Bebber, R. L., Price, M. A., Bell, M. L., King, M. T., Webb, P. M., Butow, P. N., et al. (2017). Ovarian cancer study dropouts had worse health-related quality of life and psychosocial symptoms at baseline and over time. Asia-Pacific Journal of Clinical Oncology, 13(5), e381–e388. https://doi.org/10.1111/ajco.12580.CrossRefPubMed

47.

Feuerstein, M. A., Jacobs, M., Piciocchi, A., Bochner, B., Pusic, A., Fayers, P., et al. (2015). Quality of life and symptom assessment in randomized clinical trials of bladder cancer: A systematic review. Urologic Oncology, 33(7), 331.e317–323. https://doi.org/10.1016/j.urolonc.2015.04.002.CrossRef

48.

Kamat, A. M., Sylvester, R. J., Bohle, A., Palou, J., Lamm, D. L., Brausi, M., et al. (2016). Definitions, End Points, and Clinical Trial Designs for Non-Muscle-Invasive Bladder Cancer: Recommendations From the International Bladder Cancer Group. Journal of Clinical Oncology, 34(16), 1935–1944. https://doi.org/10.1200/jco.2015.64.4070.CrossRefPubMedPubMedCentral

49.

Coens, C., Pe, M., Dueck, A. C., Sloan, J., Basch, E., Calvert, M., et al. (2020). International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium. Lancet Oncology, 21(2), e83–e96. https://doi.org/10.1016/s1470-2045(19)30790-9.CrossRefPubMed

50.

Calvert, M., Kyte, D., Mercieca-Bebber, R., Slade, A., Chan, A. W., King, M. T., et al. (2018). Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension. JAMA, 319(5), 483–494. https://doi.org/10.1001/jama.2017.21903.CrossRefPubMed

Titel: Patient-reported outcomes in non-muscle invasive bladder cancer: a mixed-methods systematic review
Auteurs: Claudia Rutherford
Manish I. Patel
Margaret-Ann Tait
David P. Smith
Daniel S. J. Costa
Shomik Sengupta
Madeleine T. King
Publicatiedatum: 22-09-2020
Uitgeverij: Springer International Publishing
Gepubliceerd in: Quality of Life Research / Uitgave 2/2021
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-020-02637-9

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Patient-reported outcomes in non-muscle invasive bladder cancer: a mixed-methods systematic review

Abstract

Objective

Methods

Results

Conclusions

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