Sentinel Lymph Node Biopsy Versus Axillary Dissection in Node-Negative Early-Stage Breast Cancer: 15-Year Follow-Up Update of a Randomized Clinical Trial

Background

Sentinel lymph node biopsy (SLNB) allows for staging of the axillary node status in early-stage breast cancer (BC) patients and avoiding complete axillary lymph node dissection (ALND) when the sentinel lymph node (SLN) is proven to be free of disease. In a previous randomized trial we compared SLNB followed by ALND (ALND arm) with SLNB followed by ALND only if the SLN presented metastasis (SLNB arm). At a mid-term of ≈ 6 years median follow-up, the two strategies appeared to ensure similar survival and locoregional control. We have revised these previous findings and update the results following a 15-year observation period.

Methods

Patients were randomly assigned to either the ALND or SLNB arm. The main endpoints were event-free survival (EFS), overall survival (OS), and axillary disease recurrence. EFS and OS were assessed using Kaplan–Meier analysis and the log-rank test.

Results

The ALND and SLNB arms included 115 and 110 patients, respectively. At 14.3 years median follow-up, 39 primary BC-related recurrences occurred, 22 (19 %) of which occurred in the ALND arm and 17 (16 %) occurred in the SLNB arm (p = 0.519). No axillary relapse developed in the SLNB arm, while two were observed in the ALND arm. OS (82.0 vs. 78.8 %) and EFS (72.8 vs. 72.9 %) were not statistically different between the ALND and SLNB arms (p = 0.502 and 0.953, respectively).

Conclusions

SLNB is a safe and efficacious component of the surgical treatment of early-stage BC patients. In the long-term, SLNB is equivalent to ALND in terms of locoregional nodal disease control and survival in this subset of patients.

     

Prediction of improvement in global left ventricular function in patients with chronic coronary artery disease and impaired left ventricular function: rest thallium-201 SPET versus low-dose dobutamine echocardiography

Accurate assessment of myocardial viability permits selection of patients who would benefit from myocardial revascularization. Currently, rest-redistribution thallium-201 scintigraphy and low-dose dobutamine echocardiography are among the most used techniques for the identification of viable myocardium. Thirty-one consecutive patients (all men, mean age 60NJ years) with chronic coronary artery disease and reduced left ventricular ejection fraction (31%lj%) were studied. Rest ²⁰¹Tl single-photon emission tomography (SPET), low-dose dobutamine echocardiography and radionuclide angiography were performed before revascularization. Radionuclide angiography and echocardiography were repeated after revascularization. An a/dyskinetic segment was considered viable on ²⁰¹Tl SPET when tracer uptake was >65%, while improvement on low-dose dobutamine echocardiography was considered a marker of viability. Increase in global ejection fraction was considered significant at ̓%. In identifying viable segments, rest ²⁰¹Tl SPET showed higher sensitivity than low-dose dobutamine echocardiography (72% vs 53%, P<0.05), while specificity was not significantly different (86% vs 88%). In 17 patients, global ejection fraction increased ̓% (group 1) while in 14 it did not (group 2). A higher number of a/dyskinetic segments were viable on ²⁰¹Tl SPET in group 1 than in group 2 (2.6ǃ.9 vs 0.6ǃ.2, P<0.005), while no significant differences were observed on low-dose dobutamine echocardiography (1.7ǃ.6 vs 1.1ǃ.6). A significant correlation was found between the number of a/dyskinetic segments viable on ²⁰¹Tl SPET and post-revascularization changes in ejection fraction (r=0.52, P<0.05), but such a correlation was not observed for low-dose dobutamine echocardiography. Using as the cut-off the presence of at least one viable a/dyskinetic segment, rest ²⁰¹Tl SPET had a higher sensitivity (82% vs 53%, P=0.07) and showed a trend towards higher accuracy and specificity (77% vs 58%, and 71% vs 64%, respectively) as compared with low-dose dobutamine echocardiography. In conclusion, these findings suggest that when severely reduced global function is present, rest ²⁰¹Tl SPET evaluation of viability is more accurate than low-dose dobutamine echocardiography for the identification of patients who will benefit most from revascularization.     

Hypercytokinemia-induced metabolic encephalopathy in a multiple myeloma patient on hemodialysis undergoing autologous stem cell transplantation: Clinical response after plasma exchange

We report here a 50-years old female with multiple myeloma-associated chronic renal failure who underwent high-dose chemotherapy supported by autologous hematopoietic stem cell transplantation. She developed progressive encephalopathy on day 5 progressing to coma despite hemodialysis and no obvious organ failure. She finally recovered after a single 1-liter plasma exchange. The final diagnosis was metabolic encephalopathy due to hypercytokinemia, particularly high serum TNF levels. We discuss here the pathogenesis and raise an alert for monitoring cytokine levels in patients with renal failure undergoing high-dose chemotherapy.     

Medium-Term Anatomic and Functional Results of Laparoscopic Sacrocolpopexy Beyond the Learning Curve

Background

Limited prospective data on the anatomic and functional outcome after laparoscopic sacrocolpopexy (LSC) are available in the literature.

Objective

To describe the medium-term anatomic and functional outcome of LSC.

Design, setting, and participants

Prospective consecutive series of 132 women with vaginal vault prolapse undergoing LSC between 2001 and 2006, which was after our learning curve. Patients with urodynamically proven stress incontinence (SI) underwent a concomitant tension-free vaginal tape (TVT) procedure.

Intervention

Patients underwent LSC with a polypropylene implant.

Measurements

Principal outcome measures were anatomic cure (stage 1 or lower) assessed by the Pelvic Organ Prolapse Quantification (POPQ) system and subjective cure and impact on quality of life measured by a standardised interview and, since its introduction in 2004, by a prolapse-specific quality-of-life questionnaire (P-QOL).

Results and limitations

At a mean follow-up of 12.5 mo, the anatomic cure rate for the apex was 98%. Anatomic failures elsewhere were mainly at the posterior compartment (18%). Subjective prolapse cure rate was 91.7%, and no patients required reoperation for recurrent prolapse. Symptoms of preoperative SI, urge incontinence, or constipation were cured in 43%, 46%, and 42% of patients, respectively. The rate of de novo SI was 7.3%. De novo constipation developed in 5% and de novo dyspareunia developed in 19%. Patients’ quality of life improved significantly. Erosions occurred in 4.5%, all within 1 yr. A limitation of the study is that the quality-of-life assessment score became available halfway through the study, limiting the number of preoperative observations (n = 36).

Conclusions

We demonstrated that LSC results in good anatomic outcome and subjective cure of prolapse symptoms at medium term. The posterior compartment was most vulnerable for recurrence.     

Comparison of cyclosporine microemulsion and tacrolimus in 39 recipients of living donor liver transplantation.

New immunosuppressive agents and regimens should be evaluated specifically in living donor liver transplant patients due to potential clinical and pharmacokinetic differences between deceased donor and living donor transplant recipients. The analysis presented here is the first direct comparison of clinical outcomes using cyclosporine microemulsion (CsA-ME) with monitoring of blood concentration at 2 hours postdose (C2) and tacrolimus-based immunosuppression in living donor liver transplantation. The analysis was conducted on the data provided by the 39 recipients of a living donor transplant out of the 495 patients enrolled in a 6-month, randomized, prospective, multicenter, open-label study (LIS2T). Patients were randomized to CsA-ME (C2 monitoring) or tacrolimus (monitoring of predose trough drug blood level [C0)]) and were administered corticosteroids with or without azathioprine. Twenty-three living-donor patients received CsA-ME and 16 received tacrolimus. By month 6, 9% of patients receiving CsA-ME and 19% of those receiving tacrolimus had lost their graft or died (not significant [NS]). Nine episodes of biopsy-proven acute rejection were reported: 4 in the CsA-ME group (17%) and 5 in the tacrolimus cohort (31%, NS). There were no significant differences in any safety parameter between groups. The most frequently reported serious adverse events were infections, which occurred in 14 patients in the CsA-ME group (61%) and 13 patients in the tacrolimus arm (81%, NS). Twelve patients in the CsA-ME arm (52%) and 5 in the tacrolimus arm (31%, NS) discontinued the study prematurely. In conclusion, CsA-ME C2 monitoring or tacrolimus both offer effective protection against rejection in living donor liver transplants while maintaining a good safety profile.     

Improving the preservation of the urethral sphincter and neurovascular bundles during open radical retropubic prostatectomy

OBJECTIVES: To describe a technique for open nerve-sparing radical retropubic prostatectomy. METHODS: The technique basically implies incising the levator and prostatic fasciae high anteriorly (1 and 11 o'clock positions) over the prostate, developing the plane between the prostatic capsule and prostatic fascia, and displacing the neurovascular network localized between the two fasciae laterally. This allows for a minimal-touch dissection of the external urethral sphincter and a very efficient dissection of the neurovascular bundles at the level of membranous urethra and prostatic apex. RESULTS: Forty-two patients underwent a bilateral nerve-sparing operation and were followed- up for 6 months. Six patients (14.3%) had positive margins: 4 patients had pT2 disease (in all, the positive margin was monofocal) and 2 patients had pT3 disease (both had multifocal positive margins). Continence (defined as being dry or having one pad remain dry for 24 hours) was achieved in 44% of patients at catheter removal, and in 60%, 72%, and 90% of patients at the 1-, 3-, and 6-month follow-up visits. Potency (defined as an erectile function domain score > or =26) was obtained in 15%, 40%, and 52% of patients at the 1-, 3-, and 6-month follow-up visits. All patients used a PDE5-inhibitor during the investigation period. CONCLUSIONS: These preliminary results suggest that the high incision of the levator and prostatic fasciae may facilitate efficient preservation of the external urethral sphincter and the neurovascular bundles innervating the corpora cavernosa and the sphincter.     

Robotic-assisted heller myotomy versus laparoscopic heller myotomy for the treatment of esophageal achalasia: multicenter study

Laparoscopic Heller myotomy (LHM) has become the standard treatment option for achalasia. The incidence of esophageal perforation reported is about 5%–10%. Robotically assisted Heller myotomy (RAHM) is emerging as a safe alternative to LHM. Data comparing the two approaches are scant. The aim of this study was to compare RAHM with LHM in terms of efficacy and safety for treatment of achalasia. A total of 121 patients underwent surgical treatment of achalasia at three institutions. A retrospective review of prospectively collected perioperative data was performed. Patients were divided into two groups: group A (RAHM), 59 patients, and group B (LHM), 62 patients. All the operations were completed using minimally invasive techniques. There were 63 women and 58 men, with a mean age of 45 ±19 years (14–82 years). Fifty-one percent of patients in group A and 95% of patients in group B reported weight loss. Duration of symptoms was equal for both groups. Dysphagia was the main complaint in both groups (P = NS). There was no difference in preoperative endoscopic treatment in both groups (44% versus 27%, P = NS). Operative time was significantly shorter for LHM in the first half of the experience (141 ± 49 versus 122 ± 44 minutes, P < .05). However, in the last 30 cases there was no difference in operative time between the groups (P = NS). Intraoperative complications (esophageal perforation) were more frequent in group B (16% versus 0%). The incidence of postoperative heartburn did not differ by group. There were no deaths. At 18 and 22 months, 92% and 90% of patients had relief of their dysphagia. This study suggests that RAHM is safer than LHM, because it decreases the incidence of esophageal perforation to 0%, even in patients who had previous treatment. At short-term follow-up, relief of dysphagia was equally achieved in both groups. Presented at the Forty-Sixth Annual Meeting of The Society for Surgery of the Alimentary Tract, Chicago, Illinois, May 14–18, 2005 (oral presentation). This study was supported in part by a grant provided by Intuitive Surgical, Inc. and Ethicon Endo-Surgery, Inc.     

A new mutation in two siblings with cystinosis presenting with Bartter syndrome

Nephropathic cystinosis is a severe autosomal recessive inherited metabolic disease characterized by accumulation of free cystine in lysosomes. Cystinosis can lead to renal failure and multiorgan impairment. Only five cases of cystinosis with associated Bartter syndrome are reported in the literature, and no genetic evaluation has been reported. We describe two siblings with nephropathic cystinosis presenting with features of Bartter syndrome and their genetic pattern.     

Comparison of computed tomographic angiography with digital subtraction angiography in the diagnosis of cerebral aneurysms: a meta-analysis

OBJECTIVE: To compare a novel diagnostic radiological technique, computed tomographic angiography (CTA), with the standard method, namely digital subtraction angiography (DSA), in the diagnosis of cerebral aneurysms. METHODS: A comprehensive search of the world literature on CTA was performed. Articles that reported on prospective comparisons of CTA and DSA in the evaluation of patients suspected of harboring cerebral aneurysms were selected for data extraction. Suitable statistical methods were applied to the extracted data for meta-analysis. RESULTS: Twenty-one references met the criteria for use in the meta-analysis. Unweighted calculations based on data for 1251 patients resulted in a sensitivity of 0.933 (93.3%; range, 75.4-100%) and a specificity of 0.878 (87.8%; range, 0-100%). When the studies were weighted for the number of patients in each study, the sensitivity decreased slightly, to 0.927 (92.7%), and the specificity decreased more substantially, to 0.772 (77.2%). CONCLUSION: On the basis of this meta-analysis, DSA remains the standard method. However, many who use CTA have reported it to be as good as or better than DSA in the diagnosis and treatment of cerebral aneurysms, as well as being of less risk and discomfort to their patients and easier and less expensive to perform.