Ninety-day perioperative complications of pediatric robotic urological surgery: A multi-institutional study.

BACKGROUND: Robotic technology is the newest tool in the armamentarium for minimally invasive surgery. Individual centers have reported on both the outcomes and complications associated with this technology, but the numbers in these studies remain small, and it has been difficult to extrapolate meaningful information. OBJECTIVES: The intention was to evaluate a large cohort of pediatric robotic patients through a multi-center database in order to determine the frequency and types of complications associated with robotic surgery for pediatric reconstructive and ablative procedures in the United States. STUDY DESIGN: After institutional review board approvals at the participating centers, data were retrospectively collected (2007-2011) by each institute and entered into a RedCap(®) database. Available demographic and complication data that were assigned Clavien grading scores were analyzed. RESULTS: From a cohort of 858 patients (880 RAL procedures), Grade IIIa and Grade IIIb complications were seen in 41 (4.8%); and one patient (0.1%) had a grade IVa complication. Intraoperative visceral injuries secondary to robotic instrument exchange and traction injury were seen in four (0.5%) patients, with subsequent conversion to an open procedure. Grade I and II complications were seen in 59 (6.9%) and 70 (8.2%) patients, respectively; they were all managed conservatively. A total of 14 (1.6%) were converted to an open or pure laparoscopic procedure, of which, 12 (86%) were secondary to mechanical challenges. DISCUSSION: It is believed that this study represents the largest and most comprehensive description of pediatric RAL urological complications to date. The results demonstrate a 4.7% rate of Clavien Grade IIIa and Grade IIIb complications in a total of 880 cases. While small numbers make it difficult to draw conclusions regarding the most complex reconstructive cases (bladder diverticulectomy, bladder neck revision, etc.), the data on the more commonly performed procedures, such as the RAL pyeloplasty and ureteral reimplantation, are robust and more likely represent the true complication rate for these procedures when performed by highly experienced robotic surgeons. CONCLUSION: Pediatric robotic urologic procedures are technically feasible and safe. The overall 90-day complication rate is similar to reports of laparoscopic and open surgical procedures. COMPLICATIONS: n (%) Life threatening (IVa): 1 (0.1%) Requiring radiologic and or surgical intervention (IIIa and IIIb): 41 (4.8%) Secondary to robotic system: 4 (0.5%) Mechanical failure leading to conversion: 14 (1.6%).

A novel clofarabine bridge strategy facilitates allogeneic transplantation in patients with relapsed/refractory leukemia and high-risk myelodysplastic syndromes.

Patients with relapsed/refractory leukemias or advanced myelodysplastic syndrome (MDS) fare poorly following allogeneic hematopoietic cell transplant (HCT). We report prospective phase II study results of 29 patients given clofarabine 30 mg/m(2)/day i.v. × 5 days followed immediately by HCT conditioning while at the cytopenic nadir. A total of 15/29 patients (52%) were cytoreduced according to pre-defined criteria (cellularity <20% and blasts <10%). Marrow cellularity (P<0.0001) and blast% (P=0.03) were reduced. Toxicities were acceptable, with transient hyperbilirubinemia (48%) and gr3-4 infections (10%). In all, 28/29 proceeded to transplant; 27 received ATG or alemtuzumab. Post HCT, 180 day non-relapse mortality (NRM) was 7% (95% confidence interval (CI): 1-21), relapse was 29% (95% CI: 13-46) and OS was 71% (95% CI: 51-85), comparing favorably to published data for high-risk patients. Two-year graft vs host disease incidence was 40% (95% CI: 21-58) and 2 year OS was 31% (95% CI: 14-48). Disease at the nadir correlated with inferior OS after HCT (HR=1.22 for each 10% marrow blasts, 95% CI: 1.02-1.46). For AML/MDS patients, there was a suggestion that successful cytoreduction increased PFS (330 vs 171 days, P=0.3) and OS (375 vs 195 days, P=0.31). Clofarabine used as a bridge to HCT reduces disease burden, is well tolerated, and permits high-risk patients to undergo HCT with acceptable NRM. Late relapses are common; thus, additional strategies should be pursued. NCT-00724009.

A randomized phase II study of 5-fluorouracil, hydroxyurea, and twice-daily radiotherapy compared with bevacizumab plus 5-fluorouracil, hydroxyurea, and twice-daily radiotherapy for intermediate-stage and T4N0-1 head and neck cancers.

INTRODUCTION: We conducted a randomized phase II study to evaluate the impact of adding bevacizumab (B) to 5-fluorouracil (5-FU), hydroxyurea (HU), and radiotherapy (FHX) for intermediate-stage and select T4 head and neck squamous cell cancers (HNSCC). PATIENTS AND METHODS: Eligible patients had newly diagnosed HNSCC. Randomization was 2:1 in favor of BFHX. All patients received 500 mg HU p.o. b.i.d., 600 mg/m(2)/day continuous infusion 5-FU, and b.i.d. radiotherapy with or without bevacizumab 10 mg/kg administered on day 1 of each 14-day cycle. Patients received five cycles consisting of chemoradiotherapy for 5 days followed by 9 days without therapy. RESULTS: Twenty-six patients were enrolled (19 BFHX and 7 FHX). The study was halted following unexpected locoregional progression. Two-year survival was 68%; 89% treated with FHX and 58% (95% confidence interval 33% to 78%) treated with BFHX. Two-year locoregional control was 80% after chemoradiotherapy and 85% after surgical salvage. All locoregional progression occurred in T4 tumors randomized to BFHX. Two patients receiving BFHX died during therapy, and one died shortly after therapy. No catastrophic bleeding events were seen. CONCLUSIONS: Locoregional progression seen in T4N0-1 tumors treated with BFHX was unexpected and led to study termination. The addition of bevacuzimab to chemoradiotherapy for HNSCC should be limited clinical trials.