Cancer Management and Research (Nov 2022)

Instillation Strategies for Non-Muscle-Invasive Bladder Cancer in the Bacillus Calmette-Guerin Shortage Era: A Simple Solution for BCG Discontinuation

  • Lin PT,
  • Hsieh ML,
  • Su SH,
  • Chang YH,
  • Huang LK,
  • Chu YC,
  • Kan HC,
  • Lin PH,
  • Yu KJ,
  • Chuang CK,
  • Wu CT,
  • Pang ST,
  • Shao IH

Journal volume & issue
Vol. Volume 14
pp. 3121 – 3130

Abstract

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Po-Ting Lin1 *, Ming-Li Hsieh1,2 *, Shih-Huan Su,1 Ying-Hsu Chang,2,3 Liang-Kang Huang,1,2 Yuan-Cheng Chu,1,2 Hung-Cheng Kan,1,2 Po-Hung Lin,1,2 Kai-Jie Yu,1,2 Cheng-Keng Chuang,1,2 Chun-Te Wu,1,2,4 See-Tong Pang,1,2 I-Hung Shao1,2,5 1Division of Urology, Department of Surgery, Chang Gung Memorial Hospital, Linkou Branch, Taoyuan, Taiwan; 2Department of Medicine, Chang Gung University, Taoyuan, Taiwan; 3Department of Urology, New Taipei Municipal TuCheng Hospital, Chang Gung Memorial Hospital and Chang Gung University, New Taipei, Taiwan; 4Division of Urology, Department of Surgery, Chang Gung Memorial Hospital, Keelung Branch, Keelung, Taiwan; 5Cancer Genome Research Center, Chang Gung Memorial Hospital, Linkou Branch, Taoyuan, Taiwan*These authors contributed equally to this workCorrespondence: I-Hung Shao, Department of Medicine, Chang Gung University, No. 5, Fusing St., Gueishan Dist, Taoyuan City, Taiwan, Email [email protected]: Among intravesical instillation protocol in patients with non-muscle-invasive bladder cancer (NMIBC), chemotherapy agents have been widely used during the bacillus Calmette-Guérin (BCG) shortage era since the patient might under the risk of BCG discontinuation. This study evaluates the efficacy of incomplete BCG instillation compared with pure chemotherapy instillation protocol.Materials and Methods: Patients newly diagnosed with intermediate- and high-risk NMIBC who received incomplete BCG intravesical instillation or chemotherapy instillation were retrospectively included. Patients were divided into three groups according to different intravesical instillation schedules: [BCG only], [BCG + Chemo], and [Chemo only]. Comparisons between these three groups were performed. Bladder recurrence-free survival (RFS) was analyzed as the primary endpoint.Results: A total of 475 patients who received intravesical instillations were enrolled. Compared to the [Chemo only] group, the [BCG + Chemo] group had significantly better bladder RFS (p = 0.027). Multivariate analysis of recurrence revealed the [BCG + Chemo] regimen has a hazard ratio 0.381 (95% CI 0.154– 0.941, p = 0.037). The total instillation number > 12 was associated with better RFS (p = 0.001) compared with other instillation numbers.Conclusion: For NMIBC patients facing the risk of unexpected BCG instillation interruption, instead of starting instillation with chemotherapy agents, receiving BCG first till stoppage then shifting to chemotherapy agents is recommended.Keywords: bladder cancer, NMIBC, intravesical instillation, intravesical chemotherapy, BCG, bladder recurrence

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