Abstract
Background
This study investigated the clinical impact of carcinoma in situ (CIS) in intravesical Bacillus Calmette-Guérin (BCG) therapy for patients with non-muscle-invasive bladder cancer (NMIBC).
Methods
This study retrospectively evaluated 3035 patients who were diagnosed with NMIBC and treated by intravesical BCG therapy between 2000 and 2019 at 31 institutions. Patients were divided into six groups according to the presence of CIS as follows: low-grade Ta without concomitant CIS, high-grade Ta without concomitant CIS, high-grade Ta with concomitant CIS, high-grade T1 without concomitant CIS, high-grade T1 with concomitant CIS, and pure CIS (without any papillary lesion). The endpoints were recurrence- and progression-free survival after the initiation of BCG therapy. We analyzed to identify factors associated with recurrence and progression.
Results
At a median follow-up of 44.4 months, recurrence and progression were observed in 955 (31.5%) and 316 (10.4%) patients, respectively. Comparison of six groups using univariate and multivariate analysis showed no significant association of CIS. However, CIS in the prostatic urethra was an independent factors associated with progression.
Conclusion
Concomitant CIS did not show a significant impact in the analysis of Ta and T1 tumors which were treated using intravesical BCG. Concomitant CIS in the prostatic urethra was associated with high risk of progression. Alternative treatment approaches such as radical cystectomy should be considered for patients with NMIBC who have a risk of progression.
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The corresponding author can be contacted regarding the use of the data. The data are not publicly available.
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Data collection and analysis, and manuscript writing: RT. Data collection: RM, YS, MM, SH, SF, FH, and KH. Conceptualization: MM, RT, TK, TK, and YM. Methodology: NN. Validation CO. Formal analysis: NN. Investigation: YM. Data curation: KI. Supervision: HM. Project administration: HK and HN. Wrote the original draft of the manuscript: RT. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
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The authors declare no potential conflict of interest.
Ethical approval
The study was conducted according to the guidelines of the Declaration of Helsinki, and Approved on 23 May 2019 by the Institutional Review Board of each participating institute (Reference Protocol ID: NMU-2217) of the Japan Urological Oncology Group framework. Official names of institutional review board of each collaborating institute are listed here: the Medical ethics committee at Osaka University; the ethics committee of Kagawa University Faculty of Medicine; the Ethics Committee on Clinical Research, Kagoshima University; the Medical Ethics Committee for Kitasato University; the Kyushu University Hospital Ethics Committee; the Ethics Committee Graduate School and Faculty of Medicine Kyoto University; the Ethics committee of The Jikei University School of Medicine for Biomedical Research; the Ethics Committee of Shimane University; the Ethics Committee of Chiba University; the Ethics in Human Subject Research at the University of Tsukuba; the Ethics Committee of University of Toyama; the Ethical committee of Harasanshin Hospital; the Committee of Medical Ethics of Hirosaki University Graduate School of Medicine; the Independent Ethics Committee of Hokkaido University Graduate School of Medicine; the Ethical Review Committee of Yamagata University Faculty of Medicine; the Research Ethics Committee of University of Miyazaki; the Medical Ethics Review board of the Kyoto Prefectural University of Medicine; the Ethical committee of National Cancer Center Research Institute; the Ethical committee National Cancer Center Research Institute East; the Shikoku Cancer Center Ethics Committee; the Akita University School of Medicine Ethics Committee; Tottori University Faculty of Medicine Ethics Committee; the Tohoku University Graduate School of Medicine Ethics Committee; the Ethics Committee of Hamamatsu University School of Medicine; the Ethics Committee of Nara Prefecture General Medical Center; the Ethics Committee of Kokuho Chuo Hospital; the Ethics Committee of Nara City Hospital; the Ethics Committee of Yamato Koriyama Hospital; the Ethics Committee of Hirao Hospital; the Ethics Committee of Saiseikai Chuwa Hospital.
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Supplementary Information
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10147_2022_2127_MOESM1_ESM.docx
Supplementary Table 1: Patient characteristics and events compared Groups 2 (high-grade Ta without concomitant CIS) and 3 (high-grade Ta with concomitant CIS) (DOCX 16 KB)
10147_2022_2127_MOESM2_ESM.docx
Supplementary Table 2: Patient characteristics and events compared Groups 4 (high-grade T1 without concomitant CIS) and 5 (high-grade T1 with concomitant CIS) (DOCX 16 KB)
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Tomida, R., Miyake, M., Minato, R. et al. Impact of carcinoma in situ on the outcome of intravesical Bacillus Calmette-Guérin therapy for non-muscle-invasive bladder cancer: a comparative analysis of large real-world data. Int J Clin Oncol 27, 958–968 (2022). https://doi.org/10.1007/s10147-022-02127-7
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DOI: https://doi.org/10.1007/s10147-022-02127-7