In the current trial, improvement in 36-month survival was not observed with upfront surgery for stage IV breast cancer patients. However, a longer follow-up study (median, 40 months) showed statistically significant improvement in median survival. When locoregional treatment in de novo stage IV BC is discussed with the patient as an option, practitioners must consider age, performance status, comorbidities, tumor type, and metastatic disease burden.
Introduction: Previous reports of carefully selected patients presenting with stage IV breast cancer (BC) suggest that surgery on the primary tumor may result in improved survival, but this remains unproven. The MF07-01 trial is a phase III randomized controlled trial of BC women with distant metastases at presentation who receive loco-regional (LR) treatment for intact primary tumor compared with those who do not receive such treatment. Aim: The primary objective of the trial is to compare overall survival (OS) in women treated with or without initial LR resection prior to systemic therapy for de novo stage IV BC. Materials and Methods: At the discretion of the surgeon, LR treatments consisted of either mastectomy or breast conserving surgery with level I-II axillary clearance in clinically or sentinel lymph node positive patients. Radiation therapy to whole breast was required following breast conserving surgery. At the discretion of the medical oncologist standard systemic therapy of either endocrine treatment or chemotherapy (plus trastuzumab for HER2 +) was given to all patients either immediately after randomization (no surgery group) or after surgical resection of the intact primary tumor (surgery group). After consideration of previous retrospective studies, the assumed OS difference between the two groups was determined to be 18% (35% in LR treatment group versus 17% in no-LR treatment group). A 10% drop out rate including lost to follow up was assumed. By using a one sided log-rank test with a 95% confidence (α = 0.05) and a 90% power (β = 0.9), sample size calculation revealed that 271 patients were needed to be randomized. Results: There were 140 women in the surgery group and 138 in the no-surgery group. The mean follow up time was 21.1 ± 14.5 months. The mean age was 51.6 ± 13.2 years and the groups were comparable regarding age, BMI, ER/PR, Her 2, Triple negative, tumor type and size between the groups (all p>0.05). Metastatic patterns included bone only in 45.7%, organ except bone in 28.8%, and bone plus organ in 25.5%. There were a total of 86 (31%) deaths. At 54 months the survival rate was 35% in the surgery group and 31% in the no surgery group (p = 0.24). However, OS was statistically higher in bone only, ER/PR positive and patients younger than 50 years but was lower in the triple negative patients (p<0.05). The mean survival was 7.1 months higher in surgery group comparing with no surgery group in bone only metastasis (39.1 ± 1.8 vs 32.0 ± 2.2; p = 0.13). Surgery in the group of patients who had solitary bone only metastasis had statistically significant survival benefit compared with no surgery and with patients who had multiple bone metastasis either with or without surgery (P = 0.03). Conclusion: In early follow-up of this trial comparing surgery of the primary tumor with no surgery in stage IV BC at presentation OS was similar but there were important subgroup differences; in particular those with solitary bone metastasis have a significant survival benefit and patients with bone metastasis only have a trend toward improved survival with initial surgery. Further follow-up will expand on these important findings. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr S2-03.
This is a retrospective study of 44 surgical cases of hepatic hydatid cysts. The most common procedure was omentoplasty in 26 patients (55.3%), 10 with omentoplasty alone and 16 combined with partial cystectomy and tube drainage. The second most common procedure was external tube drainage in 15 (32.0%), where complication rates were higher (73.3%) than omentoplasty (15.4%). The most controversial aspect of hydatid surgery is the management of the cyst cavity. The major advantage of omentoplasty is that it is easy to perform and it is the best way to obliterate the remaining cavity. Hospitalization was shortest for omentoplasty. There was no mortality.
Urinary retention that necessitates catheterization after herniorrhaphy is a well known, but usually ignored, situation. Increased sympathetic activity resulting from surgery may be the contributing factor. Blockade of a receptors in the bladder neck and urethral sphinchter may prevent postoperative urinary retention. In this prospective placebo-controlled study, the efficacy of prazosin in preventing postoperative urinary retention after herniorrhaphy was investigated in 156 patients. Patients were randomized into two groups. Patients in Group I (control) were given placebo orally 12 hours before surgery, just before surgery, and 12 and 24 hours after surgery. In Group II, 1 mg of prazosin was given in the same manner of placebo. Nine of 84 patients (10.8%) in the prazosin group and 18 of 72 patients (25%) in the placebo group developed urinary retention. Catheterization was required in only 3 patients (3.5%) in the prazosin group compared to 10 patients (13.8%) in placebo-treated group (P < 0.05). In conclusion, prophylactic use of prazosin after herniorrhaphy significantly reduced the incidence of urinary retention and catheterization.
Thromboxane A2 is a proaggregative vasoconstrictor that is synthesized and released in reperfusion injury. We aimed to investigate the effects of thromboxane synthase inhibitor, UK 38485, on endothelin-1,2 (ET) response of the renal endothelium and lipid peroxidation and protein oxidation in the early period of kidney transplantation. Four groups (n=8 in group IV and n=10 in the others) [corrected] of Sprague-Dawley rats were designed as Group I (sham nephrectomy), Group II (autotransplantation), Group III (allotransplantation) and Group IV (allotransplantation group in which the allografts were perfused with UK 38485. All subjects underwent right nephrectomy after transplantation. The grafts were flushed with 4 ml of ice-cold Ringer's lactate and in Group IV 10 microg of UK 38485 was added into the solution for each kidney. In allotransplantation groups, the kidneys were harvested from allogeneic white Wistar albino rats. The kidney grafts were allowed 120 min of reperfusion after 40 min of cold ischemic period. ET-1,2 plasma concentrations in the renal vein blood and diene conjugates (DC), hydroxyalkanals (HAA), hydroxyalkenals (HAE) and malondialdehyde (MDA) levels as the products of lipid peroxidation, protein carbonyls and protein sulfhydryls as the indicators of protein oxidation were analyzed in kidney tissue. Plasma ET-1,2 concentrations increased significantly in Group II and Group III (P<0.01) when compared to Group I but decreased in Group IV in comparison with Group III (P<0.05). DC, HAA, HAE and MDA levels increased in Groups II and III (P<0.001). Significant protein oxidation occurred only in Group III (P<0.01). Perfusion of the allografts with UK 38485 prevented lipid peroxidation and protein oxidation in Group IV. Histopathological changes were mild in the last group. We concluded that, in kidney transplantation, local administration of UK 38485 has cytopreservative effects on the allografts and this effect can be related to ET-1,2 concentrations.
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