Bakula Mirko, Hudolin Tvrtko, Knezevic Nikola, Zimak Zoran, Andelic Jerko, Juric Ilija, Gamulin Marija, Gnjidic Milena, Kastelan Zeljko
Department of Urology, University Hospital Centre Zagreb, Kispaticeva 12, 10000 Zagreb, Croatia.
School of Medicine, University of Zagreb, Salata 3, 10000 Zagreb, Croatia.
Life (Basel). 2024 Jun 22;14(7):789. doi: 10.3390/life14070789.
Bacillus Calmette-Guérin (BCG) therapy for patients with non-muscle invasive bladder cancer (NMIBC) faces limitations in efficacy and significant side effects, aggravated by a recent global shortage. In this prospective clinical study, we report the outcomes of sequential intravesical administration of gemcitabine and docetaxel (Gem/Doce) as a first-line treatment for BCG-naïve patients with high-risk NMIBC (HR NMIBC). From October 2019 until April 2022, we enrolled 52 patients and followed the treatment protocol set forth by the University of Iowa. Follow-up assessments were conducted every 3 months. In this cohort, 25 (48.1%) patients were diagnosed with high-grade T1 (T1HG) bladder cancer, 10 (19.2%) patients had carcinoma in situ (CIS), and 17 (32.7%) patients had a combination of T1HG+CIS. The median time to first recurrence in the T1HG, CIS, and T1HG+CIS groups was 11, 10.5, and 8.8 months, respectively. The recurrence-free survival was 98.1%, 94.2%, and 80.8% at 6, 9, and 12 months, respectively. The rate of progression-free survival was 100%, 98.1%, and 92.3% at 6, 9, and 12 months, respectively. We demonstrated the safety and efficacy of Gem/Doce therapy in BCG-naïve patients with HR NMIBC during a one-year follow-up. Further research with extended follow-ups, as well as direct comparisons of Gem/Doce with other anticancer agents, is essential.
卡介苗（BCG）治疗非肌层浸润性膀胱癌（NMIBC）患者在疗效上面临局限性，且存在严重副作用，近期全球供应短缺更是加剧了这些问题。在这项前瞻性临床研究中，我们报告了吉西他滨和多西他赛序贯膀胱内给药（Gem/Doce）作为初治高危NMIBC（HR NMIBC）患者一线治疗的结果。从2019年10月至2022年4月，我们招募了52名患者，并遵循爱荷华大学制定的治疗方案。每3个月进行一次随访评估。在这个队列中，25名（48.1%）患者被诊断为高级别T1（T1HG）膀胱癌，10名（19.2%）患者有原位癌（CIS），17名（32.7%）患者为T1HG + CIS合并。T1HG、CIS和T1HG + CIS组首次复发的中位时间分别为11个月、10.5个月和8.8个月。6个月、9个月和12个月时的无复发生存率分别为98.1%、94.2%和80.8%。6个月、9个月和12个月时的无进展生存率分别为100%、98.1%和92.3%。我们在一年的随访中证明了Gem/Doce疗法在初治HR NMIBC患者中的安全性和有效性。进行更长时间的随访研究以及将Gem/Doce与其他抗癌药物进行直接比较至关重要。
