目的:评估辅助治疗对中危非肌层浸润性膀胱癌(NMIBC)患者肿瘤预后的影响,由于诊断标准定义不清和重叠,因此在这些患者中,最佳决策仍然具有挑战性.
方法:在这项多中心研究中,回顾性分析经尿道膀胱肿瘤电切术治疗Ta病的患者。所有低危或高危NMIBC患者均被排除在分析之外。在Cox回归模型中评估了辅助治疗与无复发生存率(RFS)和无进展生存率(PFS)之间的关联。
结果:共2206例中危NMIBC患者纳入分析。其中,1427例患者接受了辅助治疗,例如卡介苗(n=168),或化疗药物,如丝裂霉素C或表阿霉素(n=1259),在不同的方案长达1年。中位(四分位距)随访为73.3(38.4-106.9)个月。辅助治疗和无辅助治疗的患者在1年和5年的RFS分别为72.6%和69.5%和50.8%和41.3%,分别。辅助治疗与更好的RFS相关(风险比[HR]0.79,95%置信区间[CI]0.70-0.89,P<0.001),但没有PFS(P=0.09)。在年龄≤70岁的原发性患者亚组中,单个Ta2级<3厘米肿瘤(n=328),辅助治疗与RFS无关(HR0.71,95%CI0.50-1.02,P=0.06).而在至少有一个危险因素包括患者年龄>70岁的患者亚组中,肿瘤多重性,复发性肿瘤和肿瘤大小≥3厘米(n=1878),膀胱内辅助治疗与RFS改善相关(HR0.78,95%CI0.68-0.88,P<0.001).
结论:在我们的研究中,在RFS方面,中危NMIBC患者可从膀胱内辅助治疗获益.然而,在没有危险因素的患者中,膀胱内辅助治疗未导致复发率明显降低.
OBJECTIVE: To evaluate the impact of adjuvant therapy on oncological outcomes in patients with intermediate-risk non-muscle-invasive bladder cancer (NMIBC), as due to the poorly-defined and overlapping diagnostic criteria optimal decision-making remains challenging in these patients.
METHODS: In this multicentre study, patients treated with transurethral resection of bladder tumour for Ta disease were retrospectively analysed. All patients with low- or high-risk NMIBC were excluded from the analysis. Associations between adjuvant therapy administration with recurrence-free survival (RFS) and progression-free survival (PFS) rates were assessed in Cox regression models.
RESULTS: A total of 2206 patients with intermediate-risk NMIBC were included in the analysis. Among them, 1427 patients underwent adjuvant therapy, such as bacille Calmette-Guérin (n = 168), or chemotherapeutic agents, such as mitomycin C or epirubicin (n = 1259), in different regimens up to 1 year. The median (interquartile range) follow-up was 73.3 (38.4-106.9) months. The RFS at 1 and 5 years in patients treated with adjuvant therapy and those without were 72.6% vs 69.5% and 50.8% vs 41.3%, respectively. Adjuvant therapy was associated with better RFS (hazard ratio [HR] 0.79, 95% confidence interval [CI] 0.70-0.89, P < 0.001), but not with PFS (P = 0.09). In the subgroup of patients aged ≤70 years with primary, single Ta Grade 2 <3 cm tumours (n = 328), adjuvant therapy was not associated with RFS (HR 0.71, 95% CI 0.50-1.02, P = 0.06). While in the subgroup of patients with at least one risk factor including patient age >70 years, tumour multiplicity, recurrent tumour and tumour size ≥3 cm (n = 1878), adjuvant
intravesical therapy was associated with improved RFS (HR 0.78, 95% CI 0.68-0.88, P < 0.001).
CONCLUSIONS: In our study, patients with intermediate-risk NMIBC benefit from adjuvant
intravesical therapy in terms of RFS. However, in patients without risk factors, adjuvant
intravesical therapy did not result in a clear reduction in the recurrence rate.