Impact of pegfilgrastim as primary prophylaxis for metastatic castration-resistant prostate cancer patients undergoing cabazitaxel treatment: an open-label study in Japan.

BACKGROUND: Cabazitaxel is an efficacious treatment for patients with metastatic castration-resistant prostate cancer who have previously progressed on docetaxel, but febrile neutropenia during the first cycle is a frequent complication. Asian patients are at increased risk of febrile neutropenia. Although primary prophylaxis with granulocyte colony-stimulating factor can reduce the incidence, its efficacy has not been prospectively demonstrated in Japanese patients with cabazitaxel treatment. METHODS: PEGAZUS, a prospective, single-arm study conducted at eight clinical sites in Japan, enrolled 21 heavily pretreated patients with metastatic castration-resistant prostate cancer. Patients received cabazitaxel 25 mg/m2 every 3 weeks, up to 10 cycles. Oral prednisolone 10 mg was taken daily. Pegfilgrastim 3.6 mg was administered at least 24 h after the cabazitaxel infusion. The primary endpoint was the incidence of febrile neutropenia in the first cycle. RESULTS: The median number of treatment cycles was seven. The relative dose intensity of cabazitaxel was 67.4% (range, 53.2-91.3%). Two of 21 patients (9.5%) experienced febrile neutropenia in the first cycle. This rate was lower than the rate (43%) previously observed without prophylactic granulocyte colony-stimulating factor in a similar patient population. Six patients showed a prostate-specific antigen response (28.6%). Three of four patients evaluable for tumor response had stable disease and one had progressive disease. Grade ≥3 diarrhea was not observed. Primary prophylaxis with granulocyte colony-stimulating factor significantly reduced the incidence of febrile neutropenia in this study. CONCLUSIONS: Cabazitaxel plus granulocyte colony-stimulating factor is safe and effective for Japanese patients with metastatic castration-resistant prostate cancer who have previously progressed on docetaxel. Clinical trial registration: ClinicalTrials.gov (NCT02441894).

Choosing an appropriate length of loop type ureteral stent using direct ureteral length measurement.

PURPOSE: The ureteral stent is now a fundamental part of many urological procedures. To decrease ureteral stent-related symptoms, loop type ureteral stent was developed. However the most important factor to decrease urinary symptoms is choosing the optimal length of a ureteral stent. We investigated the relationship between the actual ureteral length and the loop type ureteral stent position. MATERIALS AND METHODS: A total of 226 loop type polyurethane ureteral stents (156 patients) were inserted with four options for stent length (20, 22, 24 and 26 cm). The ureteral length was measured using a ruled 5-Fr ureteral catheter. The appropriateness of stent position was defined into three groups based on kidney-ureter-bladder films. RESULTS: Nine stents (3.9%) migrated, 171 stents (75.7%) were in the appropriate position and 46 stents (19.5%) were overlong. The rate of migration rate and overlong stents closely correlated with the ureteral length when the proximal end of the stent was in the renal pelvis. CONCLUSIONS: It is appropriate to choose a loop type ureteral stent that is the same or 1 cm less than the length of the ureter when the proximal end of the stent will be in the renal pelvis.