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Enhanced recovery after surgery for radical cystectomy with ileal urinary diversion: a multi-institutional, randomized, controlled trial from the Chinese bladder cancer consortium.
Lin, T, Li, K, Liu, H, Xue, X, Xu, N, Wei, Y, Chen, Z, Zhou, X, Qi, L, He, W, et al
World journal of urology. 2018;(1):41-50
Abstract
PURPOSE Enhanced recovery after surgery (ERAS) has played an important role in recovery management for radical cystectomy with ileal urinary diversion (RC-IUD). This study is to evaluate ERAS compared with the conventional recovery after surgery (CRAS) for RC-IUD. METHODS From October 2014 and July 2016, bladder cancer patients scheduled for curative treatment from 25 centers of Chinese Bladder Cancer Consortium were randomly assigned to either ERAS or CRAS group. Primary endpoint was the 30-day complication rate. Secondary endpoints included recovery of fluid and regular diet, flatus, bowel movement, ambulation, and length of stay (LOS) postoperatively. Follow-up period was 30-day postoperatively. RESULTS There were 144 ERAS and 145 CRAS patients. Postoperative complications occurred in 25.7 and 30.3% of the ERAS and CRAS patients with 55 complications in each group, respectively (p = 0.40). There was no significant difference between groups in major complications (p = 0.82), or type of complications (p = 0.99). The ERAS group had faster recovery of bowel movements (median 88 versus 100 h, p = 0.01), fluid diet tolerance (68 versus 96 h, p < 0.001), regular diet tolerance (125 versus 168 h, p = 0.004), and ambulation (64 versus 72 h, p = 0.047) than the CRAS group, but similar time to flatus and LOS. CONCLUSIONS ERAS did not increase 30-day complications compared with CRAS after RC. ERAS may be better than CRAS in terms of bowel movement, tolerance of fluid and regular diet, and ambulation.
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An open label, single-arm, phase II multicenter study of the safety and efficacy of CG0070 oncolytic vector regimen in patients with BCG-unresponsive non-muscle-invasive bladder cancer: Interim results.
Packiam, VT, Lamm, DL, Barocas, DA, Trainer, A, Fand, B, Davis, RL, Clark, W, Kroeger, M, Dumbadze, I, Chamie, K, et al
Urologic oncology. 2018;(10):440-447
Abstract
OBJECTIVES CG0070 is a replication-competent oncolytic adenovirus that targets bladder tumor cells through their defective retinoblastoma pathway. Prior reports of intravesical CG0070 have shown promising activity in patients with high-grade non-muscle invasive bladder cancer (NMIBC) who previously did not respond to bacillus Calmette-Guérin (BCG). However, limited accrual has hindered analysis of efficacy, particularly for pathologic subsets. We evaluated interim results of a phase II trial for intravesical CG0070 in patients with BCG-unresponsive NMIBC who refused cystectomy. PATIENTS AND METHODS At interim analysis (April 2017), 45 patients with residual high-grade Ta, T1, or carcinoma-in-situ (CIS) ± Ta/T1 had evaluable 6-month follow-up in this phase II single-arm multicenter trial (NCT02365818). All patients received at least 2 prior courses of intravesical therapy for CIS, with at least 1 being a course of BCG. Patients had either failed BCG induction therapy within 6 months or had been successfully treated with BCG with subsequent recurrence. Complete response (CR) at 6 months was defined as absence of disease on cytology, cystoscopy, and random biopsies. RESULTS Of 45 patients, there were 24 pure CIS, 8 CIS + Ta, 4 CIS + T1, 6 Ta, 3 T1. Overall 6-month CR (95% CI) was 47% (32%-62%). Considering 6-month CR for pathologic subsets, pure CIS was 58% (37%-78%), CIS ± Ta/T1 50% (33%-67%), and pure Ta/T1 33% (8%-70%). At 6 months, the single patient that progressed to muscle-invasive disease had Ta and T1 tumors at baseline. No patients with pure T1 had 6-month CR. Treatment-related adverse events (AEs) at 6 months were most commonly urinary bladder spasms (36%), hematuria (28%), dysuria (25%), and urgency (22%). Immunologic treatment-related AEs included flu-like symptoms (12%) and fatigue (6%). Grade III treatment-related AEs included dysuria (3%) and hypotension (1.5%). There were no Grade IV/V treatment-related AEs. CONCLUSIONS This phase II study demonstrates that intravesical CG0070 yielded an overall 47% CR rate at 6 months for all patients and 50% for patients with CIS, with an acceptable level of toxicity for patients with high-risk BCG-unresponsive NMIBC. There is a particularly strong response and limited progression in patients with pure CIS.
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Green-light laser en bloc resection for primary non-muscle-invasive bladder tumor versus transurethral electroresection: A prospective, nonrandomized two-center trial with 36-month follow-up.
Chen, J, Zhao, Y, Wang, S, Jin, X, Sun, P, Zhang, L, Wang, M
Lasers in surgery and medicine. 2016;(9):859-865
Abstract
OBJECTIVES To evaluate the safety and efficacy of LBO laser en bloc resection compared with transurethral electroresection (TURBT) for the treatment of primary non-muscle-invasive bladder tumors. METHODS From September 2010 to February 2012, a prospective, nonrandomized two-center trial was performed. A total of 158 patients (83 underwent laser resection and 75 TURBT) were included in the present study. The preoperative, intraoperative, and postoperative clinical characteristics were recorded and compared in the two groups. RESULTS There were no differences with the preoperative characteristics between the patients in the two groups. The mean operative time was 21.46 ± 10.42 minutes for laser resection and 27.47 ± 15.30 minutes for TURBT (P = 0.004). LBO laser group was also associated with less hemoglobin decrease compared with TURBT group (0.87 ± 0.28 g/ml vs. 1.00 ± 0.33 g/ml, P = 0.009). Obturator nerve reflection was absent during laser resection, whereas was observed in nine patients during TURBT (P = 0.001). Two patients in the TURBT group suffered bladder perforation. Three patients in TURBT group and one patient in LBO laser group experienced urethral stricture. The recurrence-free survival rate did not differ significantly between two groups after 36 months follow-up. CONCLUSIONS The results of our trial have shown that LBO laser en bloc resection is feasible, safe, and effective alternative for the treatment of primary non-muscle-invasive bladder tumors. Besides, it can provide intact specimen for the pathologic diagnosis. Lasers Surg. Med. 48:859-865, 2016. © 2016 Wiley Periodicals, Inc.
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A prospective randomized multicenter study of Turkish Society of Urooncology comparing two different mechanical bowel preparation methods for radical cystectomy.
Aslan, G, Baltaci, S, Akdogan, B, Kuyumcuoğlu, U, Kaplan, M, Cal, C, Adsan, O, Turkolmez, K, Ugurlu, O, Ekici, S, et al
Urologic oncology. 2013;(5):664-70
Abstract
OBJECTIVE To investigate the outcomes and complication rates of urinary diversion using mechanical bowel preparation (BP) with 3 day conventional and limited BP method through a standard perioperative care plan. MATERIALS AND METHODS This study was designed as a prospective randomized multicenter trial. All patients were randomized to 2 groups. Patients in standard 3-day BP protocol received diet restriction, oral antibiotics to bowel flora, oral laxatives, and saline enemas over a 3-day period, whereas limited the BP arm received liberal use of liquid diet, sodium phosphate laxative, and self administered enema the day before surgery. All patients received same perioperative treatment protocol. The endpoints for the assessment of outcome were anastomotic leakage, wound infection, wound dehiscence, intraperitoneal abscess, peritonitis, sepsis, ileus, reoperation, and mortality. Bowel function recovery, including time to first bowel movement, time to first oral intake, time to regular oral intake, and length of hospital stay were also assessed. RESULTS Fifty-six patients in 3-day BP and 56 in limited BP arm were evaluable for the study end points. Postoperatively, 1 patient in limited BP and 2 patients in 3-day BP arm died. There was no statistical difference in any of the variables assessed throughout the study, however, a favorable return of bowel function and time to discharge as well as lower complication rate were observed in limited BP group. CONCLUSIONS Regarding all endpoints, including septic and nonseptic complications, current clinical research offers no evidence to show any advantage of 3-day BP over limited BP.
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Rs710521[A] on chromosome 3q28 close to TP63 is associated with increased urinary bladder cancer risk.
Lehmann, ML, Selinski, S, Blaszkewicz, M, Orlich, M, Ovsiannikov, D, Moormann, O, Guballa, C, Kress, A, Truss, MC, Gerullis, H, et al
Archives of toxicology. 2010;(12):967-78
Abstract
Single nucleotide polymorphism (SNP) rs710521[A], located near TP63 on chromosome 3q28, was identified to be significantly associated with increased bladder cancer risk. To investigate the association of rs710521[A] and bladder cancer by new data and by meta-analysis including all published data, rs710521 was studied in 1,425 bladder cancer cases and 1,740 controls that had not been included in previous studies. Blood samples were collected from 1995 to 2010 in Germany (n = 948/1,258), Hungary (n = 262/65), Venezuela (n = 112/190) and Pakistan (n = 103/227) supplemented by a meta-analysis of 5,695 cases and 40,187 controls. Detection of a A/G substitution (rs710521) on chromosome 3q28, position 191128627 was done via fast real-time polymerase chain reaction (rt-PCR). Rs710521[A] is associated with increased risk in the unadjusted analysis (OR = 1.21; 95% Cl = 1.04-1.40; P = 0.011) and in the recessive model adjusted for age, gender, smoking habits and ethnicity (OR = 1.23; 95% Cl = 1.05-1.44; P = 0.010). No difference between individuals occupationally exposed versus not occupationally exposed to urinary bladder carcinogens was observed concerning the relevance of rs710521[A]. Similarly, rs710521[A] did not confer different susceptibility in smokers and non-smokers. Performing a meta-analysis of 5,695 cases and 40,187 controls including all published studies on rs710521, a convincing association with bladder cancer risk was obtained (OR = 1.18; 95% Cl = 1.12-1.25; P < 0.0001). However, the odds ratio is relatively small.
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Phase 2 trial of sorafenib in patients with advanced urothelial cancer: a trial of the Eastern Cooperative Oncology Group.
Dreicer, R, Li, H, Stein, M, DiPaola, R, Eleff, M, Roth, BJ, Wilding, G
Cancer. 2009;(18):4090-5
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Abstract
BACKGROUND There is no effective second-line systemic chemotherapy for patients with disease progression after cisplatin-based chemotherapy. A phase 2 trial of sorafenib was performed to determine the activity and toxicity of this agent in a multi-institutional setting in patients previously treated with 1 prior chemotherapy regimen. METHODS Twenty-seven patients with advanced urothelial carcinoma were treated with sorafenib 400 mg orally twice daily continuously until progression or unacceptable toxicity. RESULTS There were no objective responses observed. The 4-month progression-free survival (PFS) rate was 9.5%; median overall survival of the group was 6.8 months. There were no therapy-related deaths, and common grade 3 toxicities included fatigue and hand-foot syndrome. CONCLUSIONS Although sorafenib as a single agent has minimal activity in patients with advanced urothelial cancer in the second-line setting, further investigation of tyrosine kinase inhibitors using different trial designs with PFS endpoints is warranted.
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A phase II study of gemcitabine and docetaxel therapy in patients with advanced urothelial carcinoma.
Gitlitz, BJ, Baker, C, Chapman, Y, Allen, HJ, Bosserman, LD, Patel, R, Sanchez, JD, Shapiro, RM, Figlin, RA
Cancer. 2003;(9):1863-9
Abstract
BACKGROUND The objectives of the current study were to evaluate the safety and efficacy of gemcitabine plus docetaxel in patients with unresectable (Stage T4 or ≥ N1) metastatic or locally advanced transitional cell carcinoma (TCC) of the urothelial tract. METHODS A total of 27 patients were enrolled in the current multisite study, which was performed within the University of California-Los Angeles Community Oncology Research Network. The first 10 patients in the study received 800 mg/m(2) of gemcitabine intravenously on Days 1, 8, and 15 of a 28-day treatment cycle. In addition, on Day 1, the first 10 patients received 80 mg/m(2) of docetaxel intravenously after completion of the gemcitabine infusion. Because of dose-limiting toxicity (neutropenia), the initial dose of docetaxel was reduced to 60 mg/m(2) for the remaining patients who entered the study (n = 17 patients). RESULTS Neutropenia was the most common adverse event that occurred in patients at the Grade 3 level (in 10 of 27 patients; 37.0%) and the Grade 4 level (in 6 of 27 patients; 22.2%). There were no other adverse events at the Grade 4 toxicity level. Twenty-five of 27 patients (92.6%) completed more than 1 cycle of combination therapy and were evaluated for antitumor responses. The frequency of objective clinical responses was 33.3% (9 of 27 patients). Complete responses to therapy were observed in 2 of 27 patients (7.4%), and partial responses were observed in 7 of 27 patients (25.9%). The median duration of response was 20 weeks (range, 12+ weeks to 152 weeks). The median survival duration was 52 weeks (range, 12 weeks to 160+ weeks). Four of 27 patients (14.8%) remained alive at the time of the current data analysis. CONCLUSIONS The results of the current study suggested that combination therapy with gemcitabine and docetaxel was an effective treatment for patients with unresectable (Stage T4 or ≥ N1) metastatic or locally advanced TCC of the urothelial tract. Gemcitabine plus docetaxel appeared to be tolerated well, and treatment-related toxicities were limited to hematologic toxicities. Because cisplatin-containing regimens are contraindicated for patients with impaired renal function, the gemcitabine plus docetaxel combination may prove to be an effective and well tolerated treatment option for these patients.
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[Results of phase II clinical trial of cycloplatam in refractory solid tumors].
Bagrova, SG
Voprosy onkologii. 2001;(6):752-6
Abstract
Cycloplatam, a new platinum derivative, evolved at N.S. Kurnakov Institute of General and Inorganic Chemistry in 1982, has been added to the arsenal of Russian cytostatic drugs. Having passed phase I trials, it was approved for treatment of pleural mesothelioma, ovarian carcinoma and multiple myeloma. Leukothrombocytopenia formation indicates toxicity-related limit of dosage. Phase II clinical trials are under way at the Center. They include treatment of solid tumors with cycloplatam alone in urinary bladder tumors, cervical carcinoma and malignant pleurites of various etiology as well as in combination with other cytostatics (carcinoma of the prostate, pleural mesothelioma and urinary bladder tumors). The drug may be recommended both for oral and intracavitary administration; side-effects may include moderate toxicity, chiefly, hematological one.