Controversies in terminology associated with management of BCG‐unresponsive NMIBC in Asia‐Pacific

Author:

Kikuchi Eiji1ORCID,Ng Chi‐Fai2ORCID,Kitamura Hiroshi3,Ku Ja Hyeon4,Lee Lui Shiong5ORCID,Lin Tzu‐Ping6,Ng Junice Yi Siu7,Nishiyama Hiroyuki8,Poon Darren Ming‐Chun9,Kanesvaran Ravindran10,Seo Ho Kyung11,Spiteri Carmel12,Tan Ee Min7ORCID,Tsai Yuh‐Shyan13,Tran Ben14

Affiliation:

1. Department of Urology St. Marianna University School of Medicine Kawasaki Japan

2. Department of Surgery The Chinese University of Hong Kong Hong Kong Hong Kong

3. Department of Urology University of Toyama Toyoma Japan

4. Department of Urology Seoul National University Seoul South Korea

5. Department of Urology Seng Kang General Hospital Singapore Singapore

6. Department of Urology Taipei Veterans General Hospital Taipei Taiwan

7. Health Economics and Outcomes Research IQVIA Asia‐Pacific Singapore Singapore

8. Department of Urology University of Tsukuba Tsukuba Japan

9. Comprehensive Oncology Center Hong Kong Sanatorium & Hospital Hong Kong Hong Kong

10. Division of Medical Oncology National Cancer Centre Singapore Singapore Singapore

11. Department of Urology National Cancer Center Goyang‐si South Korea

12. Market Access Asia Pacific MSD Macquarie Park, NSW Macquarie Park Australia

13. Department of Urology National Cheng Kung University Hospital Tainan Taiwan

14. Department of Medical Oncology Peter MacCallum Cancer Centre Melbourne Australia

Abstract

ObjectivesExamine the understanding of terminologies and management patterns of bacillus Calmette‐Guérin (BCG)‐unresponsive nonmuscle invasive bladder cancer (NMIBC) in six territories in Asia‐Pacific.MethodsThis study involved two phases: (1) a survey with 32 urologists and 7 medical oncologists (MOs) and (2) a factorial experiment and in‐depth interviews with 23 urologists and 2 MOs. All clinicians had ≥8 years' experience managing NMIBC patients in Australia, Hong Kong, Japan, South Korea, Singapore, and Taiwan. Data from Phase 1 were summarized using descriptive statistics; content and thematic analyses applied in Phase 2.ResultsIn phase 1, 35% of clinicians defined BCG‐unresponsive as BCG‐refractory, ‐relapse and ‐resistant, 6% defined it as BCG‐refractory and ‐relapse; 22% classified BCG‐failure as BCG‐refractory, ‐relapse, ‐resistant, and when muscle‐invasive bladder cancer is detected. If eligible and willing, 50% (interquartile range [IQR], 50%–80%) of BCG‐unresponsive patients would undergo radical cystectomy (RC), and 50% (IQR 20%–50%) of RC‐eligible patients would receive bladder‐sparing treatment or surveillance. In phase 2, we found that 32%, 88%, and 48% of clinicians, respectively, used “BCG‐unresponsive,” “BCG‐refractory,” and “BCG‐relapse” in clinical practice but with no consistent interpretation of the terms. Compared with EAU definitions, 8%–60% of clinicians appropriately classified 9 tumor types that are persistent or recurrent after adequate BCG. Fifty percent of clinicians mentioned a lack of bladder‐preserving treatment that outperforms RC in quality of life as a reason to retreat BCG‐unresponsive patients with BCG.ConclusionsOur study revealed varied understanding and application of BCG‐unresponsive terminologies in practice. There is a need for a uniform and simple definition of BCG‐unresponsive disease in Asia‐Pacific.

Publisher

Wiley

Subject

Urology

Reference22 articles.

1. Non muscle invasive bladder cancer treatment;Cavaliere C;World Cancer Res J,2014

2. High-Risk Non-Muscle-Invasive Bladder Cancer—Therapy Options During Intravesical BCG Shortage

3. US Food and Drug Administration.BCG‐unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment guidance for industry [Internet]. Center for Drug Evaluation and Research2018. Available from:https://www.fda.gov/media/101468/download#:~:text=Patients%20with%20BCG%2Dunresponsive%20NMIBC with%20CIS%2C%20or%20CIS%20alone

4. European Association of Urology Guidelines on Non–muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ)

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