Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): a randomised, double-blind, phase 3 trial

Few treatments with a distinct mechanism of action are available for patients with platinum-refractory advanced or metastatic urothelial carcinoma. We assessed the efficacy and safety of treatment with docetaxel plus either ramucirumab-a human IgG1 VEGFR-2 antagonist-or placebo in this patient population

Arterial aneurysmal sac-ureteral fistula after aortic and common iliac aneurysmal repair: A case report

An arterioureteral fistula is the communication between the ureter and a major artery, such as the common iliac artery or aorta. Here, we report a case of a fistula between the ureter and the common iliac arterial aneurysmal sac following abdominal aortic aneurysmal repair in a 72-year-old man. He reported acute-onset abdominal pain on postoperative day 8, and computed tomography revealed a fistula. Ureterocutaneostomy was performed to prevent urine inflow into the aneurysm and to preserve kidney function

A case of Ewing sarcoma family tumor of the kidney treated with robotic-assisted partial nephrectomy

Ewing sarcoma family tumors (ESFTs) of the kidney represents less than 1% of all renal tumors. A 45-year-old Japanese woman presented with right abdominal pain. Contrast-enhanced computed tomography showed a 12 × 8-cm right cystic renal mass. The mass was diagnosed as cystic renal cell carcinoma (RCC) and right partial nephrectomy was performed. Immunohistochemical studies showed that the tumor was positive for CD99 (membranous staining in tumoral cells), indicating ESFT. The patient is doing well without further therapy after 1 year of follow-up. To our knowledge, this is the first report of renal ESFT mimicking cystic RCC on diagnostic imaging

男性膀胱癌患者に対する自然排尿型尿路再建術の臨床経験

自然排尿型尿路再建術を施行した23例の男子膀胱癌患者の手術成績を検討した.術式はhemi-Kock法8例, Hautmann法12例, Reddy法3例で, 平均経過観察期間は36ヵ月である.手術関連死はなかった.早期合併症は7例にみられ, パウチからの尿瘻4例, 創感染3例, 腎盂腎炎2例であった.昼間尿禁制は22例で得られたが, 夜間尿失禁は7例にみられ, Reddy法では3例全てにみられた.排尿困難は4例にみられ, うち1例は尿閉となった.晩期合併症としては, 尿道狭窄2例, 創ヘルニア 2例, パウチ内結石1例, 胆石症1例であったBetween 1988 and 1996, 23 male patients with bladder cancer underwent bladder substitution after cystectomy, using either the hemi-Kock, Hautmann, and Reddy procedures. The mean postoperative follow-up period was 36 months, with a range of 3 to 85 months. There were no perioperative deaths, and early postoperative complications occurred in 7 patients (30%); transient urine leak from the pouch in 4, wound infection in 3 and pyelonephritis in 2 patients. Twenty-two of the 23 patients (96%) were continent during the day, while 7 (30%) had nocturnal incontinence. All 3 patients with the Reddy procedure had nocturnal incontinence. Complete continence was preserved in 70% of the patients. Dysuria was seen in 4 patients, including retention in 1 patient. Late complications included urethral stricture in 3, wound hernia in 2, metabolic acidosis in 1, stone in the pouch in 1, and gallbladder stone in 1 patient. However, reoperation was necessary in 1 patient for internal urethrotomy and 1 patient for removal of a stone in the neobladder. Mild degree of hydronephrosis and unilateral reflux were seen in 3 patients each, and followed up conservatively. No urethral recurrence has occurred and only 1 patient died of cancer. The need for reoperation was very low and the high reservoir capacity resulted in continence from the beginning in most patients. We considered the neobladder useful as an alternative form of urinary diversion in selected cases

Efficacy and safety of darolutamide in Japanese patients with nonmetastatic castration-resistant prostate cancer : a sub-group analysis of the phase III ARAMIS trial

Background: Darolutamide, an oral androgen receptor inhibitor, has been approved for treating nonmetastatic castration-resistant prostate cancer (nmCRPC), based on significant improvements in metastasis-free survival (MFS) in the ARAMIS clinical trial. Efficacy and safety of darolutamide in Japanese patients are reported here. Methods: In this randomized, double-blind, placebo-controlled phase III trial, 1509 patients with nmCRPC and prostate-specific antigen (PSA) doubling time ≤ 10 months were randomized 2:1 to darolutamide 600 mg twice daily or matched placebo while continuing androgen deprivation therapy. The primary endpoint was MFS. Results: In Japan, 95 patients were enrolled and randomized to darolutamide (n = 62) or placebo (n = 33). At the primary analysis (cut-off date: September 3, 2018), after 20 primary end-point events had occurred, median MFS was not reached with darolutamide vs. 18.2 months with placebo (HR 0.28, 95% CI 0.11–0.70). Median OS was not reached due to limited numbers of events in both groups but favored darolutamide in the Japanese subgroup. Time to pain progression, time to PSA progression, and PSA response also favored darolutamide. Among Japanese patients randomized to darolutamide vs. placebo, incidences of treatment-emergent adverse events (TEAEs) were 85.5 vs. 63.6%, and incidences of treatment discontinuation due to TEAEs were 8.1 vs. 6.1%. Conclusions: Efficacy outcomes favored darolutamide in Japanese patients with nmCRPC, supporting the clinical benefit of darolutamide in this patient population. Darolutamide was well tolerated; however, due to the small sample size, it is impossible to conclude with certainty whether differences in the safety profile exist between Japanese and overall ARAMIS populations.publishedVersionPeer reviewe