Paclitaxel, ifosfamide, and nedaplatin as second-line treatment for patients with metastatic urothelial carcinoma: a phase II study of the SUOC group.

There is no standard second-line chemotherapy treatment for recurrent or metastatic urothelial cancer (MUC). The purpose of this phase II study was to evaluate the efficacy and toxicity of the three-drug combination of paclitaxel, ifosfamide, and nedaplatin (TIN). Patients with MUC were eligible after treatment failure with methotrexate, vinblastine, doxorubicin, and cisplatin, or gemcitabine and cisplatin. Doses for TIN therapy were paclitaxel 175 mg/m2 on day 1, ifosfamide 1500 mg/m2 on days 1-3, and nedaplatin 70 mg/m2 on day 1, every 4 weeks. Tumor response, the primary efficacy parameter, was assessed according to unidimensional measurements (Response Evaluation Criteria in Solid Tumors criteria, version 1.0). Secondary efficacy parameters were overall survival (OS) and progression-free survival (PFS). Toxicity was assessed according to the National Cancer Institute Common Toxicity Criteria, version 3.0. A total of 45 patients (13 females and 32 males) with MUC were evaluable for response and toxicity. The overall response rate was 40.0%. Median PFS time was 4.0 months (95% confidence interval [CI], 4.6-11.6). Median OS time was 8.9 months (95% CI, 10.5-18.9). Grade 3 or 4 hematologic adverse events were neutropenia (95.6%), anemia (15.6%), and thrombocytopenia (17.8%). The most common grade 3 or 4 non-hematologic adverse events were anorexia (4.4%) and elevated aspartate transaminase/alanine transaminase (2.2%). No toxic death was observed. The main limitation of this study is that only 10 patients (22.2%) who were previously treated with gemcitabine and cisplatin were included. In conclusion, TIN as second-line treatment for MUC is an active regimen with a manageable toxicity profile.

[Investigation of adverse events and the continuance rate of silodosin in all patients who received silodosin for lower urinary tract symptoms suggestive of benign prostatic hyperplasia].

OBJECTIVES: We retrospectively evaluated patients who received silodosin for lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH/LUTS) in our hospital, to investigate its efficacy, adverse events and continuance rate. METHODS: From the release of silodosin (July 2006) through October 2008, 256 patients received silodosin for BPH/LUTS in our hospital. Of these 256, we evaluated 195, as 61 were excluded due to conditions such as prostate cancer. We evaluated the International Prostate Symptom Score (IPSS), quality of life (QOL) index, uroflowmetry and postvoid residual urine volume before and after medication. We calculated the continuance rate of the drug by the Kaplan-Meier method. RESULTS: The patients' mean age was 68.1 years and the mean medicated period was 3.1 months. Overall severity at baseline estimated by the criteria for severity of BPH was mild in 0%, moderate in 69%, and severe in 31%. Silodosin significantly improved the IPSS, QOL index, maximum urinary flow rate and postvoid residual urine volume in 90 patients whose data were available for analysis of the efficacy. Improvements were observed both in voiding symptoms and in storage symptoms. However, 45.6% of the overall efficacy was insufficient. Adverse events were observed in 56 of the 195 cases (28.7%). The most common adverse event was abnormal ejaculation (10.8%). The patients who reported adverse events were significantly younger in age and had lower IPSS and QOL index values after treatment than those without adverse events (mean age: 65.4 vs. 69.2 years old; mean IPSS: 7.7 vs. 13.1, mean QOL index: 2.9 vs. 3.6). The continuance rate for the drug was 12.0% at 1 year on the Kaplan-Meier curve. The development of adverse events was involved in the low continuance rate of silodosin. CONCLUSIONS: Modification of treatment such as dose reduction is necessary to continue silodosin.

Comparison of 1-day, 2-day, and 3-day administration of antimicrobial prophylaxis in radical prostatectomy.

An adequate protocol for antimicrobial prophylaxis (AMP) in radical prostatectomy has not been established. We retrospectively compared the incidence and severity of infectious complications after radical prostatectomy with three different protocols for AMP. The study cohort consisted of 67 patients with prostate cancer who underwent radical prostatectomy at Hakodate Goryoukaku Hospital between January 2003 and December 2005. As a prophylactic antimicrobial agent, one of the cephalosporins or penicillins was administered intravenously to all patients. The analyzed protocols were for: (1) a 3-day group: administration of AMP until the second postoperative day (POD 2), (2) a 2-day group: administration of AMP until POD 1, and (3) a 1-day group: administration of AMP only on the operative day. The incidence and severity of infectious complications were retrospectively investigated. Three patients in the 3-day group (9.4%), 2 patients in the 2-day group (12.5%), and 2 patients in the 1-day group (10.5%) developed some infectious complications. The incidence of infectious complications was not significantly different among the three groups. No patients developed severe infectious complications such as sepsis. We conclude that single-day AMP is sufficient in patients with radical prostatectomy.

Systemic inflammatory response syndrome in open versus laparoscopic adrenalectomy.

OBJECTIVES: To compare the surgical invasiveness of laparoscopic adrenalectomy with that of open surgery when the invasiveness is evaluated by the incidence of systemic inflammatory response syndrome (SIRS). METHODS: Patients who underwent open adrenalectomy (35 patients) and those who underwent transperitoneal laparoscopic adrenalectomy (35 patients) were included in this study. We retrospectively investigated the incidence and duration of SIRS in the two groups. Of the 70 patients, 39 had primary aldosteronism and 31 had clinically nonfunctioning adrenal tumors. RESULTS: The incidence of SIRS was 51.4% (18 patients) in the open group and 31.4% (11 patients) in the laparoscopic group (P = 0.14, Fisher's exact probability test). The mean duration of SIRS was 1.9 days in the open group and 1.2 days in the laparoscopic group (P = 0.04, unpaired t test). Surgical site infection, which occurred in 2 patients in the open group (5.7%) and 3 patients (8.5%) in the laparoscopic group, was the only infectious complication. No patient had any severe or life-threatening complications. CONCLUSIONS: Laparoscopic adrenalectomy seems less invasive than open surgery, when the magnitude of the invasiveness is evaluated by the incidence of SIRS.

Prophylactic antimicrobial agents in urologic laparoscopic surgery: 1-day versus 3-day treatments.

Although the incidence of surgical site infection (SSI) is generally low in laparoscopic urologic surgery, the standard protocol for prophylactic use of antimicrobial agents remains to be established. We retrospectively compared the incidence and severity of SSI after laparoscopic surgery between two different protocols for prophylactic use of antimicrobial agents. This study included 114 patients who underwent urologic laparoscopic surgery categorized as "clean" or "clean-contaminated" in Sapporo Medical University School Hospital between January 1996 and October 2002. As a prophylactic antimicrobial agent, one of the cephalosporins or penicillins was administered intravenously to all patients. For 46 consecutive patients between January 1996 and July 2000, an antimicrobial agent was given 30 min before operation and thereafter every 12 h on the same day and the next 2 days after operation (the 3-day group). For 68 consecutive patients from August 2000 to October 2002, an antimicrobial agent was given once 30 min before operation and was additionally given only in the evening or night of the day of operation (the 1-day group). The incidence of SSI was retrospectively investigated. There were two patients who developed SSI in each group (4.3% in the 3-day group and 2.9% in the 1-day group). The incidence of SSI was not significantly different between the two groups. The 1-day protocol has efficacy equal to that of the 3-day protocol in prophylaxis of SSI. The 1-day use of a prophylactic antimicrobial agent may be recommended for the clean or clean-contaminated urologic laparoscopic surgery described above.