Significant Difference In Median Time Research Articles

Oncological control associated with surgical resection of isolated retroperitoneal lymph node recurrence of renal cell carcinoma.

To evaluate the outcome of patients after surgical resection of isolated retroperitoneal lymph node (RPLN) recurrence of renal cell carcinoma (RCC) using a multicentre international cohort. In all, 50 patients were identified who underwent resection of isolated RPLN recurrence of RCC at four institutions after nephrectomy for pTany Nany M0 disease. Progression-free (PFS) and cancer-specific survival (CSS) were estimated using the Kaplan-Meier method. Cox proportional hazards regression models were used to assess the association of clinicopathological characteristics with disease progression. The median (interquartile range, IQR) age at resection was 57.0(50.0-62.5)years. The median (IQR) time to RPLN recurrence after nephrectomy was 12.6(6.9-39.5)months, with no significant difference in median time to RPLN recurrence between patients with N+ disease at nephrectomy (10.7[6.5-24.6]months) and those with Nx/pN0 disease at nephrectomy (13.7[8.7-44.2]months) (P = 0.66). The median (IQR) size of the RPLN recurrence before resection was 2.6(1.9-5)cm. The most common site for RPLN recurrence was within the interaortocaval region (34%). The median (IQR) follow-up after RPLN resection for patients alive at last follow-up was 28.0(13.7-51.2)months. During follow-up, 26 patients developed RCC recurrence, at a median (IQR) of 9.9(4.0-18.5)months after RPLN resection. Of those who developed a secondary recurrence, disease was again isolated to the retroperitoneum in seven patients. In all, 11 patients subsequently died, including 10 who died from disease. The median PFS after RPLN resection was 19.5months, with a 3- and 5-year PFS of 40.5% and 35.4%, respectively. We also found that RPLN recurrence at ≤12months after nephrectomy was associated with a significantly inferior median PFS (12.3months) compared with RPLN recurrence at >12months after nephrectomy (47.6 months; P = 0.003). Moreover, on multivariate analysis, a shorter time to recurrence remained associated with a significantly increased risk for subsequent disease progression (hazard ratio 3.51; P = 0.005). Surgical resection of isolated RPLN recurrence from RCC may result in durable cancer control in appropriately selected patients. Recurrence at ≤12months after nephrectomy was associated with a significantly increased risk of progression after resection, underscoring the importance of this variable for risk stratification. Thus, we recommend that, in the setting of isolated RPLN recurrence of RCC (in patients without precluding comorbidities), careful consideration with the patients and medical oncology colleagues be undertaken about the relative and individualised benefits of surgical resection, systemic therapy, and surveillance.

Retrospective cohort study comparing activated partial thromboplastin time versus anti‐factor Xa activity nomograms for therapeutic unfractionated heparin monitoring in pediatrics

Unfractionated heparin (UFH) is widely used to treat thromboembolic disease, but monitoring in children is challenging. Both activated partial thromboplastin time (aPTT) and anti-factor Xa activity (anti-Xa) are utilized, but a comparison of dosing nomograms has not been reported in pediatrics. To compare the performance of aPTT and anti-Xa for UFH monitoring in pediatric patients. A retrospective cohort study was conducted in patients ≤21years old treated with UFH at Johns Hopkins Hospital from January 2009 to May 2011. For monitoring, an aPTT nomogram was used for the initial 15months, and an anti-Xa nomogram was used for the subsequent 12months. Clinical characteristics, laboratory data and outcomes were analyzed. Thirty-four patients were monitored with aPTT and 26 patients with anti-Xa. There was no significant difference in median time to therapeutic range (11.6h aPTT, 95%CI=6.0-17.0; 9.9h anti-Xa, 95%CI=7.3-20.7) or per cent of patients achieving therapeutic measurements at 24 (79% aPTT, 95%CI=62-91; 73% anti-Xa, 95%CI=52-88) and 48h (88% aPTT, 95%CI=73-97; 96% anti-Xa, 95%CI=80-100). However, anti-Xa measurements were more frequently therapeutic than aPTT (74% [95%CI=69-78] vs. 54% [95%CI=50-59]). Variance between anti-Xa and aPTT measurements was high (R(2) =0.236). No significant difference was seen in bleeding incidence (9% aPTT, 95%CI=2-24; 15% anti-Xa, 95%CI=4-35). The time to achieve therapeutic measures and bleeding outcomes were not significantly different between anti-Xa and aPTT nomograms. However, a small study size limits the power to detect clinically relevant differences. The results warrant larger prospective studies of UFH monitoring in children with thromboembolic disease.

Droperidolv. haloperidol for sedation of aggressive behaviour in acute mental health: Randomised controlled trial

Agitation and aggression are significant problems in acute psychiatric units. There is little consensus on which drug is most effective and safest for sedation of these patients. To compare the effectiveness and safety of haloperidol v. droperidol for patients with agitation and aggression. In a masked, randomised controlled trial (ACTRN12611000565943) intramuscular droperidol (10 mg) was compared with intramuscular haloperidol (10 mg) for adult patients with acute behavioural disturbance in a psychiatric intensive care unit. The primary outcome was time to sedation within 120 min. Secondary outcomes were use of additional sedation, adverse events and staff injuries. From 584 patients, 110 were randomised to haloperidol and 118 to droperidol. Effective sedation occurred in 210 (92%) patients within 120 min. There was no significant difference in median time to sedation: 20 min (interquartile range 15-30, range 10-75) for haloperidol v. 25 min (IQR 15-30, range 10-115) for droperidol (P = 0.89). Additional sedation was used more often with haloperidol (13% v. 5%, P = 0.06), but adverse effects were less common with haloperidol (1% v. 5%, P = 0.12). There were 8 staff injuries. Both haloperidol and droperidol were effective for sedation of patients with acute behavioural disturbance.

Intrathecal ropivacaine with fentanyl for LSCS Comparison of hyperbaric and isobaric solution

We compared the characteristics of spinal anesthesia with plain and hyperbaric ropivacaine for LSCS. Method:-In this prospective randomized double blind study 60 pregnant patient of ASA physical status1&2 were given 15mg of either isobaric ropivacaine(n=30) or hyperbaric ropivacaine(n=30) in glucose 8% along with fentanyl 25mcg intrathecally for LSCS. The characteristics of spinal anesthesia, hemodynamic parameters, quality of anesthesia and muscle relaxation as well as duration of post-operative analgesia were compared. RESULT: -There were no significant difference in median time to onset of sensory block at T6 (plain6.33±4.62 vs. hyperbaric 4.52±2.84 minutes; p>0.05), maximum sensory level achieved (plain 8.10±3.92 vs. Hyperbaric 6.63±2.47 min, p>0.05) and onset of grade 3 motor block (plain 8.20±5.38 vs. hyperbaric 6.10±2.38 minutes; p>0.05). Median maximum extent achieved was also comparable, but in group H duration of sensory (plain 206.23±24.42 vs. hyperbaric164.50±30.29 min., p<0.001) and motor blockade (plain170.50±39.19vs hyperbaric 133.33±30.17min; p<0.001) and duration of post-operative analgesia were significantly shorter. Incidences of hypotension were more in the group H (43.33%) compared with group I (23.33%). Quality of anesthesia and muscle relaxation was satisfactory in most patients in either group. Total duration of analgesia was 218.37±28.74min in group H and 239.30±28.28min. In group I(p<0.05). CONCLUSION: 15mg of (0.75%) hyperbaric ropivacaine provides similar, reliable and effective quality of spinal anesthesia with shorter duration of sensory and motor block, when compared with 15mg of (0.75%) isobaric ropivacaine.

Abstract 17595: The Value of Continuous ST-Segment Monitoring in the Emergency Department: a Quasi-Experimental Pre-Post Study

Purpose: The AHA Practice Standards for ECG Monitoring recommend continuous ST-segment monitoring (C-STM) in patients presenting to the emergency department (ED) with signs and/or symptoms suggestive of acute coronary syndrome (ACS), but few studies have evaluated its use in the ED. Our aims were to compare the time to diagnosis and 30-day adverse events (return to the ED with signs and/or symptoms of ACS, hospital admission, acute myocardial infarction, use of reperfusion therapy, or mortality) before and after implementation of C-STM. We also evaluated the diagnostic accuracy of C-STM in detecting ischemia or infarction, using stress test and troponin I results as reference standards. Methods: We prospectively studied 163 adults (pre-intervention phase: n=78; intervention phase: n=85) in the ED at a single hospital. We stratified patients into low (n=51), intermediate (n=100), or high (n=12) risk using HEART scores. The principal investigator monitored participants, activating C-STM on bedside monitors in the intervention phase. We used likelihood ratios (LRs) as the measure of diagnostic accuracy. By convention, a positive (+) LR is diagnostic at &gt;10 and a negative (-) LR at &lt;0.1. Results: Overall, 9% of patients were diagnosed with ACS. There was no significant difference in median time to ACS diagnosis before and after implementation of C-STM (5.55 vs. 5.98 hours; p=0.43 for Mann-Whitney U test). In risk-stratified analyses, no significant pre-post difference in time to ACS diagnosis was found in low-, intermediate-, or high-risk patients. There was no difference in the rate of any 30-day adverse event before vs. after C-STM implementation (11.5% vs. 10.6%; p=0.85 Chi-squared test). None of 3 episodes of ST-segment changes on C-STM represented ACS. The +LR and -LR of C-STM for ischemia were 24.0 (95% CI 1.4 - 412.0) and 0.3 (95% CI 0.02 - 2.9), respectively; and for infarction were 13.7 (95% CI 1.7 - 112.3) and 0.7 (95% CI 0.3 - 1.5), respectively. Conclusion: In this sample of mainly low- to intermediate-risk patients, use of C-STM did not improve time to diagnosis or 30-day adverse outcomes, nor provide much benefit in detecting myocardial ischemia or infarction. Use of C-STM may need to be re-evaluated for patients with low to intermediate risk for ACS in the ED.

Abstract 339: Insights into Readmission Rates of Atrial Fibrillation Patients

Purpose and Background: Bridging the Discharge Gap Effectively (BRIDGE) is an NP-driven transitional care program for cardiovascular patients. It has demonstrated lower rates of readmission for patients with acute coronary syndrome who participated, but a similar benefit was not seen for atrial fibrillation (AF) patients. We sought to assess differences between AF patients who participated in the BRIDGE program and those who did not. Methods: Retrospective review of all patients referred to BRIDGE with a primary discharge diagnosis of AF was conducted (n=148). An equal number of BRIDGE attendees was randomly matched to non-attendees (n=36). Univariate techniques were used to compare groups. Results: Of 148 AF patients referred to BRIDGE, 84 (56.8%) attended BRIDGE, 36 (24.3%) saw cardiologists or PCPs for their first post-discharge follow-up, and 28 (18.9%) saw other providers or had unknown follow up. There was no significant difference in median time to follow up (12.5 days for attendees vs 9.0 days for non-attendees, p=0.503). Of the 72 patients reviewed, 17 (23.6%) were readmitted within 30 days (Table 1). Non-attendees were more likely (85.7% vs 40% p=0.134) to be readmitted with AF/related diagnoses as compared to attendees. More than half of 30-day readmissions for BRIDGE attendees were unrelated to AF (n=6, 60.0%). There was a trend toward greater incidence of comorbid CAD, HTN, CHF, or vascular disease among BRIDGE attendees, compared to non-attendees. Conclusion: Readmission patterns vary in AF patients; comorbid conditions play a role in early 30-day readmissions for AF patients despite adequate transitional care. NP-driven transitional care models, compared to traditional follow-up with a physician provider, may help identify additional issues related to comorbidities, leading to readmission. A larger sample is needed to better understand this dichotomy and to determine what measures can be taken to enhance the BRIDGE program for AF patients.

The impact of KRAS mutation on radioembolization in the treatment of unresectable liver predominant metastatic colorectal cancer.

664 Background: Radioembolization with either Yttrium-90 labeled resin or glass microspheres is an FDA approved treatment for hepatic metastases from primary colorectal cancer. Y-90 therapy is used almost exclusively in unresectable liver metastases. However, radioembolization is only an optional part of the treatment process along with first-line, second-line, and salvage chemotherapy. KRAS is a known proto-onco gene that has typically been studied as a negative prognostic factor in the chemotherapeutic treatment of metastatic colorectal cancer (mCRC). KRAS is a known marker for resistance to anti-EGFR antibodies and generally have a poorer prognosis. The aim of this study is to begin to shed light on the impact of KRAS status on the outcome of patients undergoing radioembolization for the treatment of unresectable liver predominant metastatic CRC, regardless of their chemotherapy regimens. Methods: This is a retrospective analysis of 18 subjects treated with radioembolization for liver predominant metastatic CRC. KRAS status and treatment outcomes were followed for each patient up to the study close date of 9/15/13. Statistical analysis was performed using the Mann-Whitney U test. Results: Of the 18 subjects included in the study, 5 were found to have KRAS mutant oncogene. The remaining 13 were found to have the KRAS wildtype. Overall, those subjects with KRAS mutant were found to have a statistically significant difference in median time to progression of intrahepatic metastatic disease burden when compared to KRAS wildtype even when liver-directed therapy was utilized (2.0 vs. 6.4 months). Differences in median time to progression of extrahepatic metastatic disease burden and overall survival were not found to be statistically significant at this time. Conclusions: KRAS mutant patients are exceedingly difficult to treat due to both intrahepatic and extrahepatic disease recurrence/progression.

Low-dose versus standard-dose gemcitabine infusion and cisplatin for patients with advanced bladder cancer: a randomized phase II trial—an update

Prolonged infusion of low-dose gemcitabine and cisplatin (GC) proved to be an effective treatment for patients with advanced bladder cancer. One hundred and twenty untreated patients with stage III/IV bladder cancer were randomized to receive either gemcitabine (250 mg/m(2)) 6-h infusion on days 1 and 8, and cisplatin (70 mg/m(2)) on day 2 every 21-day cycle (arm 1) or gemcitabine (1,250 mg/m(2)) 30-min infusion on days 1 and 8, with the same dose of cisplatin (arm 2). The 92 males and 28 females included in the study had a median age of 62 years (range 40-85 years). Among the 120 patient, complete response was achieved in 11.7 % (7/60 patients of arm 1) and 5 % (3/60 patients of arm 2). Eighteen patients in arm 1 (30 %) and 17 patients (28.3 %) in arm 2 had partial response on therapy. Thus, the overall response rate of patients in arm 1 and arm 2 was 41.7 % (25/60 patients) and 33.3 % (20/60 patients), respectively (p = 0.37). No significant difference in median time to disease progression (26 vs. 24 months, p = 0.4), median survival (12 vs. 16 months, p = 0.8), and 1-year survival (49.9 vs. 54.7 %, p = 0.8) was detected between arms 1 and 2, respectively. Main toxicities were similar in both arms with no statistically significant differences. Low-dose, prolonged infusion gemcitabine in combination with cisplatin is not inferior to the standard GC regimen with favorable toxicity profile and less financial costs.

Low-dose versus standard-dose gemcitabine infusion and cisplatin for patients with advanced bladder cancer: A randomized phase II trial: An update.

4537 Background: Bladder carcinoma is still one of the foremost oncologic problems in Egypt. In previous single-arm and double-arm phase II studies, prolonged infusion of low dose gemcitabine and cisplatin proved to be an effective treatment for such patients with advanced disease. Methods: To compare efficacy and safety of both prolonged infusion and standard gemcitabine-cisplatin combination, we updated the data and duplicated the number of patients of our previously published phase II randomized study to 120 untreated patients with stage III/IV bladder cancer. Patients were randomized to receive either gemcitabine (250 mg/m2) 6-hour infusion on days 1 and 8, and cisplatin (70 mg/ m2) on day 2 every 21-day cycle (Arm1) or gemcitabine (1,250 mg/ m2) 30-min infusion on days 1 and 8, and cisplatin (70 mg/ m2) on day 2 every 21-day cycle (Arm 2). Results: The 92 males and 28 females had a median age of 62 years (range 40-85 years). A total of 87 patients had transitional cell, 28 had squamous cell, and 5 had undifferentiated cell carcinoma. Among the 105 evaluable patients (52patients in arm1 and 53patients in arm 2), complete response rate was achieved in 13.5% (7/52 patients of arm 1) and 5.7% (3/53 patients of arm 2). Eighteen patients in arm 1 (34.6%) and 17 patients (32.1%) in arm 2 had partial response on therapy. Thus the overall response rate of patients in arm1 and arm 2 was 48% (25/52 patients) and 37.7% (20/53patients), respectively (p = 0.26). No significant difference in median time to disease progression (26 months versus 24 months, p =0.4), median survival (12 months versus 16 months, p =0.8), and 1-year survival (49.9 % versus 54.7%, p = 0.8) was detected between arms 1 and 2, respectively. No treatment- related deaths occurred. Main hematologic and nonhematologic toxicities were similar in both arms with no statistically significant differences. Conclusions: In the treatment of advanced bladder cancer, gemcitabine in low dose and prolonged infusion in combination with cisplatin is not inferior to high-dose short infusion gemcitabine and cisplatin in terms of overall survival, time to disease progression, and response rates with favorable toxicity profile and less financial costs.

A Risk-Adapted Protocol for Delayed Administration of Filgrastim After High-Dose Chemotherapy and Autologous Stem Cell Transplantation

The routine use of recombinant human granulocyte-colony stimulating factor (rhG-CSF) after high-dose chemotherapy and autologous stem cell transplantation (auto-SCT) is associated with increased costs. We prospectively explored a strategy that used prophylactic delayed filgrastim only in patients with risk factors. This sequential cohort analysis compared the outcomes of consecutive patients, treated on the risk-adapted protocol (RAP) (risk factors: prior febrile neutropenia; age >60 years; and CD34+ cell infused dose of <2 × 10(6/)/kg), who received filgrastim from day +6 after auto-SCT with a historical cohort (historical day-1 cohort [HD1]), who received filgrastim from day +1. Eighty-two patients were treated in the RAP cohort and compared with 115 patients in the HD1 cohort. There were no differences in median age (55 years) or median CD34+ cell dose (5.21 × 10(6)/kg [range, 2-62.2 × 10(6)/kg] vs. 5.24 × 10(6)/kg [range, 2.4-29.8 × 10(6)/kg]). Filgrastim was used for 6 fewer days in the RAP cohort (median 5 days [range, 0-11 days] vs. 11 days [range, 9-47 days]). There was a small absolute but significant difference in median time to neutrophil recovery in the HD1 cohort for the whole group, 10 days (range, 8-46 days) vs. 11 days (range, 9-22 days) (P = .03) and in patients with myeloma; 10 days (range, 9-14 days) vs. 11 days (range, 9-18 days) (P < .0001) as compared to the RAP cohort. There was no difference in median inpatient duration, 13 days (range, 10-26 days) vs. 12 days (range, 1-38 days) (P = .22) and 3-year survival (79% vs. 83% [P = .43]) between HD1 and RAP cohorts respectively. The use of a RAP to identify patients likely to benefit from prophylactic filgrastim is safe and results in cost savings. Patients with myeloma benefit from earlier introduction of filgrastim in terms of neutrophil recovery; this disease-specific observation is an important consideration for future studies.

Effects of Smartphones on Pharmacist-Physician Clinical Communication

Background: Clinical pharmacist interventions are associated with improved patient outcomes and cost savings. Expanded interprofessional communication strategies may improve the efficiency and quality of the communication of these interventions. Objective: To determine the impact of smartphone device use on pharmacists' efficiency when communicating clinical interventions and to determine factors related to smartphone use that improve and impede communication. Methods: A prospective, 2-phase, observational study was completed. In phase 1, work shadowing observations involved general internal medicine (GIM) pharmacists who communicated interventions to a physician's smartphone (BlackBerry device) and multiorgan transplant (MOT) pharmacists who used traditional modes of communication (paging, phone call, face-to-face). On each ward, various aspects of the interventions were documented for a total of 20 hours. In phase 2, 10 interviews were conducted with GIM pharmacists and physicians to gain their perspectives on BlackBerry device communication. Results: In phase 1, no significant difference was found in median time to resolution (order change or drug information response given) between accepted interventions from the smartphone group (15.5 minutes) versus traditional modes of communication in the GIM group (4 minutes) and the MOT group (8.5 minutes) (p = 0.74). In phase 2, themes that emerged across the different clinical groups included perceived improvements in communication processes (efficiency, decreased wait times, and triaging of issues), concerns for potential miscommunication (use of tone in the emails), and recommendations regarding BlackBerry best practices (dealing with urgent/nonurgent issues and establishment of pharmacist-physician interprofessional relationships). Conclusions: Despite no significant difference in median time to resolution of pharmacists' interventions communicated through physician BlackBerry devices compared to traditional modes, the majority of interviewees perceived this device to be a positive communication tool resulting in improved efficiency of team communication.

PD-0032 Preoperative Chemoradiation for Resectable Adenocarcinoma of the Pancreas (ISRCTN 78805636): Pattern of Recurrence.

ABSTRACT Introduction Standard treatment for resectable pancreatic carcinoma is primary surgery, and most patients die of recurrent cancer. Chemoradiation is used to treat locally unresectable pancreatic cancer which is meant to stop local progress at least for a while. Neoadjuvant chemoradiation was introduced prior to surgery in locally resectable cancer in this trial. The local effect of chemoradiation and its influence on resection rates and recurrence patterns after tumor resection is examined now. Methods Patients with histologically proven ductal adenocarcinoma of the pancreatic head encircling peripancreatic vessels for Results Between 01.06.2003 and 31.12.2009, 73 patients were randomised in 8 centres (A n = 37, B n = 36). Due to slow recruitment the trial was closed early (planned n = 254). By 09.03.2012 data of 68 patients (A/B n = 34) could be evaluated, 3 patients withdrew consent (A/B n = 2/1), 1 centre did not sent data (A/B n = 1). Tumor resection was performed in 24 patients (A) and in 20 patients (B) by intention-to-treat-analysis. Explorative laparotomy revealed locally unresectable tumor in 6 patients (A/B n = 4/2) and distant metastasis in 13 patients (A/B n = 5/8). By now 20 patients (A) and 16 patients (B) had recurrence of cancer: 3 patients (A) had residual tumor and/or residual filiae and died within 7 months, 1 patient (B) had residual tumor and died 5 months after randomization. 6 patients (A/B n = 5/1) had local recurrence first, whereas 15 patients (A/B n = 7/8) had distant metastases as primary recurrence localization. 9 patients (A/B n = 4/5) had local recurrence and distant metastases diagnosed simultaneously. The localization of cancer recurrence was not known in 2 patients (A/B n = 1/1). There was no significant difference in median time from randomization until tumor progression with 10 months in group A and 9 months in group B (p = 0.4) after tumor resection. Even though median time to local recurrence was delayed after chemoradiation with 7 months in group A and 10 months in group B. Conclusion In this trial the pattern of local and distant recurrence of pancreatic cancer after tumor resection was not significantly different with and without preoperative chemoradiation treatment. But this might be due to low patient numbers because of early stopping the trial for slow recruitment.

Impact of t (11;14) on the outcome of autologous hematopoietic cell transplantation (Auto-HCT) in multiple myeloma.

8040 Background: Approximately 15-20% of patients with multiple myeloma (MM) present with t(11;14)(q13;q32) involving IgH and CCND1-XT genes. In this study, we report the impact of the t(11;14) on the outcome of patients with MM. Methods: We performed a retrospective chart review on patients with MM who underwent high-dose chemotherapy followed by auto-HCT at the M.D. Anderson Cancer Center between 2/2000 and 8/2010, and had conventional cytogenetic (CC) or fluorescent in situ hybridization (FISH) results available before transplant. The primary objective was to compare the progression free survival (PFS) and overall survival (OS) of patients with t(11;14) to patients without chromosomal abnormalities. Results: CC or FISH studies were available for 1239 patients: 863 normal, 28 with t(11;14), 348 with other abnormalities. Concurrent high-risk abnormalities on CC or FISH were seen in 15/28 patients with t(11;14): del(13q) in 11 , del(17p) in 3, and t(14;16)(q32;q23) in 1. Induction treatment in patients with t(11;14) was: bortezomib + dexamethasone +/- thalidomide/lenalidomide : 15 (53%), thalidomide or lenalidomide + dexamethasone: 11 (39%), others 2 (8%); they received auto-HCT after a median of one line (1-7) of therapy. Median follow up in surviving patients was 39 months. There was no significant difference in median time from diagnosis to auto-HCT from diagnosis (6.9 vs. 7.7 months, p=1.0), disease status at auto HCT (&gt;PR1: 82 vs. 76%, &lt;PR1: 7 vs. 11%, relapsed 10 vs. 13%), complete remission (CR: 21% vs. 32%; p=0.30), very good partial remission (VGPR: 29% vs. 21%; p=0.23) or overall response (75% vs. 85%; p=0.18) between patients with t(11;14) and normal karyotype. Median PFS in patients with t(11;14) and normal karyotype was 15.7 months and 35.9 months, respectively (p=0.017). Median OS in patients with t(11;14) and normal karyotype was 51.4 months and 88.4 months, respectively (p=0.03). There was no difference in PFS (p=0.25) or OS (p=0.71) in patients with t(11;14), with or without other high-risk chromosomal abnormalities. Conclusions: In this large single center study with a long follow up, we demonstrated that t(11;14) in MM is associated with a shorter PFS and OS in the context of auto-HCT.

Patterns of Recurrence Following Complete Response to Regional Chemotherapy for In-Transit Melanoma

Even after complete response (CR) to regional chemotherapy for in-transit melanoma, many patients develop recurrence. Understanding the probability, location, and timing of recurrences can optimize management strategies for this patient population. A prospective database identified patients who underwent 81 first-time hyperthermic isolated limb perfusions (HILPs) and 133 first-time isolated limb infusions (ILIs). Response was defined using the response evaluation criteria in solid tumors; recurrence was defined as development of new disease after in-field CR. HILP exhibited a significantly higher CR rate than ILI (44 vs. 28 %, p = .01). Among 36 HILP-CRs and 37 ILI-CRs, the 3-year recurrence rate was 65 % (95 % confidence interval [95 % CI]: 43-79 %) and 85 % (95 % CI: 63-94%), respectively. Median time to first recurrence was longer for HILP-CR than ILI-CR (23 vs. 8 months, p = .02). There was no statistically significant difference in median time to in-field recurrence between HILP-CR and ILI-CR (46 vs. 25 months, p = .15), but HILP-CR showed a longer median time to out-of-field recurrence (42 vs. 14 months, p = .02). Finally, the overall survival (OS) difference between HILP-CR and ILI-CR (3-year survival: 77 vs. 54 %) did not achieve statistical significance (p = .10). In the largest series comparing patterns of recurrence, we demonstrate that out-of-field recurrence after CR to HILP occurs later than after CR to ILI, though control of in-field disease remains similar. There remains no statistically significant difference in overall survival after CR to the 2 procedures.

669 PROSPECTIVE RANDOMIZED PHASE II TRIAL OF SINGLE EARLY INTRAVESICAL INSTILLATION OF (2′R)-4′-O-TETRAHYDROPYRANYL-DOXORUBICIN (THP) FOR PREVENTION OF BLADDER RECURRENCE AFTER NEPHROURETERECTOMY FOR UPPER URINARY TRACT UROTHELIAL CARCINOMA (UUT-UC)

You have accessJournal of UrologyUrothelial Cancer: Upper Tract Tumors1 Apr 2011669 PROSPECTIVE RANDOMIZED PHASE II TRIAL OF SINGLE EARLY INTRAVESICAL INSTILLATION OF (2′R)-4′-O-TETRAHYDROPYRANYL-DOXORUBICIN (THP) FOR PREVENTION OF BLADDER RECURRENCE AFTER NEPHROURETERECTOMY FOR UPPER URINARY TRACT UROTHELIAL CARCINOMA (UUT-UC) Akihiro Ito, Makoto Satoh, Ichiro Shintaku, Shigeto Ishidoya, Yoichi Arai, and Tohoku Urological EBM Study Group Akihiro ItoAkihiro Ito Sendai, Japan More articles by this author , Makoto SatohMakoto Satoh Sendai, Japan More articles by this author , Ichiro ShintakuIchiro Shintaku Sendai, Japan More articles by this author , Shigeto IshidoyaShigeto Ishidoya Sendai, Japan More articles by this author , Yoichi AraiYoichi Arai Sendai, Japan More articles by this author , and Tohoku Urological EBM Study Group More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.1599AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Approximately 5% to 50% patients have bladder recurrence after nephroureterectomy for UUT-UC. However standard prophylactic treatment against recurrence has not been established. We evaluated the efficacy of a single early intravesical instillation of THP for prevention of bladder recurrence after nephroureterectomy for UUT-UC. METHODS From December 2005 to November 2008, 77 patients from 11 institutions in the Tohoku Urological EBM Study Group who were clinically diagnosed with UUT-UC were pre-operatively enrolled in this study. Patients were randomly assigned to receive instillation of THP (30mg/30ml) into the bladder within 48 hours after nephroureterectomy or no instillation. The prophylactic and toxic effects of THP instillation were investigated. RESULTS Of the 77 patients, 3 were excluded after surgery because they did not have pathologically confirmed urothelial carcinoma and 2 were excluded for other reasons. The remaining 72 patients were evaluable for this study. Of the 72 patients, 21 (29.2%) had subsequent bladder recurrence; most recurrences were observed at the first cystoscopic examination after nephroureterectomy. Significantly fewer patients who had THP instilled had a recurrence compared with the control group (6/36 [16.7%] vs 15/36 [41.6%]; p = 0.0247). There were no significant differences in median time to first bladder recurrence between groups. No remarkable adverse events were observed in the THP- treated group. CONCLUSIONS The single intravesical instillation of THP immediately after nehproureterectomy was well tolerated and effective for preventing bladder recurrences. A phase III, large-scale, multicenter study is needed to confirm the therapeutic efficacy of THP instillation. © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 4SApril 2011Page: e270-e271 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Akihiro Ito Sendai, Japan More articles by this author Makoto Satoh Sendai, Japan More articles by this author Ichiro Shintaku Sendai, Japan More articles by this author Shigeto Ishidoya Sendai, Japan More articles by this author Yoichi Arai Sendai, Japan More articles by this author Tohoku Urological EBM Study Group More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...

Low-dose versus standard-dose gemcitabine infusion and cisplatin for patients with advanced bladder cancer: A randomized phase II trial.

266 Background: Bladder carcinoma is the foremost oncologic problem in Egypt. Prolonged infusion of gemcitabine and cisplatin is an effective treatment for advanced bilharzial-related bladder cancer based on a previously published phase II trial. Methods: To compare efficacy and safety of both prolonged infusion and standard gemcitabine-cisplatin combination, this phase II randomized study of 60 untreated patients with stage III/IV bladder cancer was conducted. Patients were randomized to receive either gemcitabine (250 mg/m2) 6-hour infusion on days 1 and 8, and cisplatin (70 mg/m2) on day 2 every 21-day cycle (Arm1) or gemcitabine (1,250 mg/m2) 30-min infusion on days 1 and 8, and cisplatin (70 mg/m2) on day 2 every 21-day cycle (Arm 2). Results: The 47 males and 13 females had a median age of 60 years (range 40-73 years). A total of 44 patients had transitional cell, 12 had squamous cell, and 4 had undifferentiated cell carcinoma. Among the 53 evaluable patients (26 patients in arm1 and 27 patients in arm 2), complete response rate was achieved in 19.3% (5/26 patients of arm 1) and 7.4% (2/27 patients of arm 2). Eight patients in arm 1 (30.7%) and 7 patients (25.9%) in arm 2 had partial response on therapy. Thus the overall response rate of patients in arm1 and arm 2 was 50% (13/26 patients) and 33.3% (9/27patients), respectively (p = 0.21). No significant difference in median time to disease progression (6.7 months versus 7.9 months, p = 0.42), median survival (9.7 months versus 8.8 months, p = 0.3), and 1-year survival (27% versus 6%, p = 0.3) was detected between arms 1 and 2, respectively. No treatment- related deaths occurred. Main hematologic and nonhematologic toxicities were similar in both arms with no statistically significant differences. Conclusions: In the treatment of advanced bilharzial bladder cancer, gemcitabine in low dose and prolonged infusion in combination with cisplatin is not inferior to high-dose short infusion gemcitabine and cisplatin in terms of overall survival, time to disease progression, and response rates with favorable toxicity profile and less financial costs. No significant financial relationships to disclose.

The ‘carry-over’ effects of patient self-testing: Positive effects on usual care management by an anticoagulation management service

Introduction Patient self-testing (PST) of the international normalised ratio (INR) has a positive effect on anticoagulation control. This study investigated whether the benefits of PST (other than increased frequency of testing, e.g. patient education, empowerment, compliance etc.) could be ‘carried-over’ into usual care management after a period of home-testing has ceased. Material and methods Patients that completed a six month period of PST (as part of a randomised controlled trial) but returned to clinic management when the trial ended were included in the study. The primary outcome variable was the difference in anticoagulation control (measured using the time in therapeutic range) between the two periods. A group of patients who were managed solely by the anticoagulation clinic served as the control. Results There was no significant difference in median time in therapeutic range (TTR) between the 52 patients during clinic management post-PST and the six month period of PST (75% vs 75.3%; p = 0.061). Patients tested more frequently while home-testing compared with the subsequent six month period of clinic management (once every 5.6 ± 0.7 days compared with once every 23.2 ± 7.4 days; p = 0.000). Patients with previous experience of PST performed significantly better than the control group of patients (n = 107) that were managed solely by the anticoagulation clinic (75% vs 59.7%; p = 0.009) despite less frequent monitoring of the INR (every 23.2 ± 7.4 days vs. 17.4 ± 6.7 days; p = 0.000). Conclusions The improvements in anticoagulation control observed during a period of PST can be sustained when patients cease home-testing and revert back to usual care management.

Early life exposures and the occurrence and timing of heart disease among the older adult Puerto Rican population

Few studies have examined the effects of early life conditions on the timing of the onset of heart disease. We use the remarkable example of a representative sample of the population of older Puerto Ricans aged 60-74 who lived in the countryside during childhood (n = 1,438) to examine the effects ofseasonal exposures to poor nutrition and infectious diseases during late gestation on the timing of the onset and the probability of ever experiencing adult heart disease. Cox and log logistic hazard models controlling for childhood conditions (self-reported childhood health status and socioeconomic status [SES], rheumatic fever, and knee height) and adult risk factors (adult SES, obesity, smoking, exercise, and self-reported diabetes) showed that the risk of onset of heart disease was 65% higher among those born during high-exposure periods compared with unexposed individuals. However, there were no significant differences in median time of onset for those ever experiencing heart disease. As a comparison, we found that there were no significant seasonality effects for those who lived in urban areas during childhood. We conclude that early exposures in utero have important ramifications for adult heart disease among the older Puerto Rican population. We show, however, that while exposure is associated with the probability of ever experiencing adult heart disease, it is not associated with the timing of onset among those who do experience it.

Posttreatment surveillance after paraaortic radiotherapy for stage I seminoma: a systematic analysis

The extent and duration of routine follow-up after paraaortic (PA) radiotherapy for stage I seminoma remain controversial in terms of efficacy, costs of technical investigations and long-term morbidity. To analyze the current literature assessing routine follow-up after PA radiotherapy for stage I seminoma. We identified all published reports on PA radiotherapy for stage I seminoma (1986-2005). We analyzed time patterns of recurrence, sites and methods of detection of relapse, and follow-up programs used. We identified 11 publications reporting outcome in 2,280 patients. Median time to recurrence in 80 relapsing patients was 15.5 months. Less than 10% of recurrences were diagnosed beyond the third year of follow-up. Isolated locoregional or distant recurrence was observed in 52 and 20 patients, respectively, without significant difference in median time to relapse. 19 out of 43 recurrences with reported method of detection of relapse were diagnosed by routine technical investigations. There was no significant difference in time to relapse between those patients followed with low volume as compared to high-volume imaging protocols. Our data suggest that technical investigations in posttreatment surveillance should be restricted to the first 3 years of follow-up. Furthermore, surveillance programs with a high volume of imaging apparently do not lead to earlier detection or less advanced stage at the time of relapse as compared to protocols with low volume imaging.

Recurrent Glioblastoma Multiforme: ADC Histogram Analysis Predicts Response to Bevacizumab Treatment

To determine if apparent diffusion coefficient (ADC) histogram analysis can stratify progression-free survival in patients with recurrent glioblastoma multiforme (GBM) prior to bevacizumab treatment. The study was approved by the institutional review board and was HIPAA compliant; informed consent was obtained. Bevacizumab-treated and control patients (41 per cohort) diagnosed with recurrent GBM were analyzed by using whole enhancing tumor ADC histograms with a two normal distribution mixture fitting curve on baseline (pretreatment) magnetic resonance (MR) images to generate ADC classifiers, including the overall mean ADC as well as the mean ADC from the lower curve (ADC(L)). Overall and 6-month progression-free survival (as defined by the Macdonald criteria) was determined by using Cox proportional hazard ratios and the Kaplan-Meier method with log-rank test. For bevacizumab-treated patients, the hazard ratio for progression by 6 months in patients with less than versus greater than mean ADC(L) was 4.1 (95% confidence interval: 1.6, 10.4), and there was a 2.75-fold reduction in the median time to progression. For the control patients, there was no significant difference in median time to progression for the patients with low versus high ADC(L) (hazard ratio, 1.8; 95% confidence interval: 0.9, 3.7). For bevacizumab-treated patients, pretreatment ADC more accurately stratified 6-month progression-free survival than did change in enhancing tumor volume at first follow-up (73% vs 58% accuracy, P = .034). Pretreatment ADC histogram analysis can stratify progression-free survival in bevacizumab-treated patients with recurrent GBM.