Joshua Julie Mariam, Vijayan Meenu, Pooleri Ginil Kumar
Department of Pharmacy Practice, Amrita School of Pharmacy, Amrita Vishwa Vidyapeetham, AIMS Health Science Campus, Kochi, Kerala, India.
Department of Pharmacy Practice, Amrita School of Pharmacy, Amrita Vishwa Vidyapeetham, AIMS Health Science Campus, Kochi, Kerala, India
Ther Adv Urol. 2019 Mar 5;11:1756287219833056. doi: 10.1177/1756287219833056. eCollection 2019 Jan-Dec.
Adjuvant intravesical immunotherapy with Bacillus Calmette-Guerin (BCG) is considered as the first-line agent in patients with high-risk nonmuscle invasive bladder cancer (NMIBC) after surgery. There are no data in India where there is a high prevalence of tubercle bacillus and inherent immunity against sp. The present study aims to evaluate the outcomes of intravesical BCG in the Indian population.
A retrospective study of 101 patients who underwent intravesical BCG for high-risk NMIBC between January 2006 and December 2015 was carried out in a single centre. We compared the recurrence-free rate and progression rate of patients who received induction alone and induction with maintenance BCG therapy. The safety profile of intravesical BCG therapy was also assessed in the study.
After a median follow up of 2 years, the disease-free survival (DFS) rates of the induction group and maintenance group were 82% and 88% respectively ( = 0.233). There was no difference in progression-free survival (PFS) rates at 2 years in those who receive maintenance BCG (95%) and those with induction BCG (94.7%; = 0.721). A total of 69.36% of our patients had local adverse events.
Our results suggest that maintenance therapy does not enhance the therapeutic effects of BCG in patients who respond favourably to 6 weeks of induction. Additional prospective studies are warranted in those countries where tuberculosis exposure is prevalent.
卡介苗（BCG）辅助膀胱内免疫疗法被认为是高危非肌层浸润性膀胱癌（NMIBC）患者术后的一线治疗药物。在结核杆菌高流行率且对特定菌种存在固有免疫力的印度，尚无相关数据。本研究旨在评估印度人群膀胱内卡介苗治疗的效果。
对2006年1月至2015年12月期间在单一中心接受膀胱内卡介苗治疗高危NMIBC的101例患者进行回顾性研究。我们比较了单纯诱导治疗患者与诱导联合维持卡介苗治疗患者的无复发生存率和进展率。本研究还评估了膀胱内卡介苗治疗的安全性。
中位随访2年后，诱导组和维持组的无病生存率（DFS）分别为82%和88%（P = 0.233）。接受维持卡介苗治疗的患者与接受诱导卡介苗治疗的患者在2年时的无进展生存率（PFS）无差异（分别为95%和94.7%；P = 0.721）。我们的患者中共有69.36%发生局部不良事件。
我们的结果表明，维持治疗并不能增强对6周诱导治疗反应良好的患者的卡介苗治疗效果。在结核病暴露普遍的国家，有必要进行更多的前瞻性研究。
