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BACKGROUND: Enfortumab vedotin shows promise as a targeted therapy for advanced urothelial carcinoma, particularly in patients who have previously received platinum-based chemotherapy and an immune-checkpoint inhibitor. The EV-301 phase III trial demonstrated significantly improved overall survival and response rates compared to standard chemotherapy. However, more data, especially from larger real-world studies, are needed to further assess its effectiveness in Japanese patients. METHODS: A total of 6007 urothelial cancer patients inducted with pembrolizumab as a second-line treatment were analyzed. Among them, 563 patients received enfortumab vedotin after pembrolizumab, while 443 patients received docetaxel or paclitaxel after pembrolizumab, and all were included in the study for efficacy as a life prolonging agent. RESULTS: The enfortumab vedotin group showed a longer overall survival than the paclitaxel/docetaxel group (p = 0.013, HR: 0.71). In multivariate analysis, enfortumab vedotin induction was the independent risk factor for overall survival (p = 0.013, HR: 0.70). There were no significant differences in cancer-specific survival. CONCLUSIONS: Enfortumab vedotin prolonged the overall survival for Japanese advanced or metastatic urothelial carcinoma patients compared to paclitaxel or docetaxel after pembrolizumab treatment.
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Background: Malignant ureteral obstruction (MUO) is often caused by advanced intra-abdominal cancers. Effective management must be attempted, but the treatment policy is unclear. Metallic ureteral stents are one of the latest options in managing MUO. Metallic ureteral stents are superior to traditional polyurethane stents. The present study retrospectively reviewed our four institutions' experiences with treating MUO using metallic ureteral stent. Methods: A total of 45 patients who required metallic ureteral stent placement for MUO at Yokohama City University Medical Center (Yokohama, JAPAN) between January 2014 and May 2016 were analyzed. We defined stent failure as having to change the ureteral stent before the scheduled ureteral stent exchange time or having to perform percutaneous nephrostomy (PCN). Complications were defined as an unscheduled hospital visit or hospitalization caused by incompatibility, infection, and pain of the metallic ureteral stent, etc., unrelated to the primary disease. We compared stent failure and the overall survival (OS) between metallic and polymeric ureteral stents. To evaluate the workload of the medical staff, we used the NASA Task Load Index (NASA-TLX) in a total of 11 urologists. Results: During the observation period, 8 (17.8%) patients in the metallic ureteral stent group and 10 (27.8%) in the control group developed stent failure. Complications were noted in 14 (31.1%) patients in the metallic ureteral stent group and 15 (41.7%) patients in the control group. A Kaplan-Meier analysis and log-rank test showed no significant differences between two groups in the overall survival (P = 0.673). One or more complications developed in 19 (32.2%) patients in the metallic ureteral stent group and 18 (38.3%) patients in the control group (P = 0.409). Renal dysfunction after the replacement of the ureteral stent developed in 9 (15.3%) patients in the metallic ureteral stent group and 14 (29.8%) patients in the control group. No patients developed a urinary tract infection (UTI) that required hospitalization in the metallic ureteral stent group, whereas 3 (6.4%) patients in the control group had a UTI that was treated with hospitalization. The average workload score in the six subscales was analyzed, and the scores for mental demand and performance were higher in the metallic ureteral stent group, although there was no significant difference between the metallic and polymeric ureteral stent groups. Conclusions: Metallic ureteral stents showed favorable ureteral stent patency and reduced the workload for urologists.
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(Purpose) Pre-treatment low lymphocyte count may result from cytokine secretion by the tumor microenvironment, in association with aggressive tumor biology. We sought to establish the prognostic impact of the absolute lymphocyte count (ALC) in advanced urothelial carcinoma. (Patients and method) We retrospectively reviewed 63 patients with unresectable or metastatic urothelial carcinoma who were treated with platinum-based first-line systemic chemotherapy between January 2011 and April 2018. We evaluated the importance of the ALC in patients who underwent systematic chemotherapy. (Results) Thirty-eight patients (60%) died from urothelial carcinoma, with a median follow-up interval of 12.2 months. The median overall survival (OS) duration was 15.3 months. The mean ALC in the stable and progressive disease group was lower than that in the complete and partial response group (1,312 /µL and 1,666 /µL, respectively, p=0.004). The ALC of 1,460 /µL was determined as the cut-off on Receiver operating characteristic curve analysis. The log-rank test revealed that the lymphocytopenia group (ALC <1,460 /µL) showed significantly poorer prognoses than the non-lymphocytopenia group (p=0.001). Multivariate analyses showed that lymphocytopenia was an independent poor prognostic factor (hazard ratios of 3.46, p=0.002). (Conclusions) Pre-treatment low lymphocyte count is an independent poor prognostic factor in patients with urothelial carcinoma who underwent platinum-based first-line systemic chemotherapy.
