BCG分株Tice用於治療表淺性膀胱尿路上皮癌是否與Connaught效果相當?
陳昱光1、黃逸修1,2,3、張延驊1,2,3、郭俊逸1,2,3、黃志賢1,2,3、鍾孝仁1,2,3、吳宏豪1,2,3、盧星華1,2,3、林子平1,2,3、林志杰1,2,3、范玉華1,2,3、黃子豪1,2,3、魏子鈞1,2,3、黃奕燊1,2,3林登龍1,2,3, 陳光國1,2,3
台北榮民總醫院泌尿部1；國立陽明大學醫學院泌尿學科2；書田泌尿科學研究中心3
Is BCG substrain of tice intravesical instillation therapy comparable to connaught in treating non-muscle invasive urothelial carcinoma of urinary bladder?
Yu-Kuang Chen1, Eric Yi-Hsiu Huang1,2,3, Yen-Hwa Chang1,2,3, Junne Yih Kuo 1,2,3, William J.S. Huang1,2,3, Hsiao-Jen Chung1,2,3, Howard H.H Wu1,2,3, Shing-Hwa Lu1,2,3, Tzu-Ping Lin1,2,3, Chi-Cheh Lin1,2,3, Y.H. Fan1,2,3, Tzu-Hao Huang1,2,3, Zi-jun Wei1,2,3, I-shen Huang1, 2,3 Alex T.L. Lin1,2,3, Kuang-Kuo Chen1,2,3
Department of Urology, Taipei Veterans General Hospital1,
Department of Urology, School of Medicine2, and Shu-Tien Urological Science Research Center, National Yang-Ming University3
Purpose
Bacillus Calmette-Guérin (BCG) has been well recognized as the first line therapy for high risk Non-muscle invasive bladder cancer (NMIBC). There are many substrains of BCG. ImmuCyst®, the Connaught substrain of BCG, has been widely accepted. OncoTICE®, another Tice substrain of BCG, has been introduced due to the worldwide shortage of the Connaught substrain. There is few evidence to attest the clinical efficacy of this surrogate of Connaught strain.
We retrospectively compared these two BCG substrains in terms of adverse effects (AE) and efficacy for those who underwent at least 1 induction along with 1 maintenance course, i.e. 9 times of intravesical instillation.
Materials and Methods
From November 2013 to February 2017, 111 patients diagnosed as NMIBC were on Tice. The patients on Connaught during June 2007 to August 2012 were enrolled for comparison. Patients with history of renal transplantation and MIBC were excluded. The SWOG regimen was followed for intravesical instillation (6-week induction followed by 3 weekly maintenance instillations at months 3,6,12,18,24,30,36). Adverse events were recorded and categorized as grade 1 to 3 according to Cleveland Clinic Approach of BCG Toxicity. Recurrence is defined as pathologic finding of PUNLMP (papillary urothelial neoplasm of low malignant potential), pTa, pT1 and TIS during followed up. Progression is defined as pathology reporting of higher than pT2, metastasis or death caused by urothelial carcinoma of urinary bladder.
Results
Thirty-six and 49 patients have undergone at least 1 induction and 1 maintenance course of Tice and Connaught, respectively. (mean instillation 12.7 vs 11.6 times, p=0.83) There were no significant differences in the demographic variables including sex, smoking status or medical comorbidity between the two groups except age (67.4 vs 72.2 yrs, p=0.0276). AE in the Connaught group was 40.81% and 41.17% in the Tice group (p=0.97). No patient experienced grade 2 or 3 toxicity with Tice but one patient withdrawal due to intolerance. Four patients receiving Connaught experienced grade 2 toxicity and two were hospitalized.
The mean follow up period of Tice group was 19.8 months. Recurrence occurred in 3 (8.82%) patients and progression in 4 (11.76%) patients. The mean recurrence free survival (RFS) was 18.29 months and progression free survival (PFS) was 17.94.
If we limited the follow up period of Connaught to 20 months, recurrence occurred in 6 patients (12.2%) and progression in 2 patients (4.1%). The mean RFS was 18.9 months and PFS was 19.4 months. All of which showed no significant difference compared to the Tice group.
Conclusion
The AE and efficacy of Tice and Connaught in treating NMIBC were comparable in our series with short-term follow up.