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OBJECTIVE: This study was done to determine the long-term outcome of breast conservation therapy (BCT) for patients with early-stage breast cancer during a period of treatment evolution at a single institution. SUMMARY BACKGROUND DATA: Breast cancer treatment has evolved from extensive surgical extirpation of the breast to treatment options that conserve the breast. Prospective and retrospective studies have confirmed the efficacy of BCT and justify its use for many patients with early breast cancer, but there is no universally accepted consensus as to who benefits from more aggressive application of surgery or radiotherapy in BCT. Prognostic variables for breast cancer and information on factors that contribute to local recurrence help predict BCT results. Continued analysis of BCT still is necessary to improve patient outcome. METHODS: Eighty-five patients treated with BCT (lumpectomy with adjuvant radiation therapy) at the Medical College of Virginia from 1980 to 1990 were identified. Clinicopathologic parameters and treatment details were analyzed for relationship to development of local recurrence, distant metastasis, and survival. Fisher's exact test was used for comparisons. Actuarial survival curves were plotted. The earlier treatment period (1980-1985) was compared with the later treatment period (1985-1990). RESULTS: Median follow-up was 5 years. Actuarial overall survival was 83% at 5 years (69% at 10 years), and 5-year distant metastasis-free survival was 79%. The 5-year actuarial local recurrence rate was 6.6% (crude rate 10.6%, 9/85). Young patients (age < 40 years) were found to be at increased risk for local recurrence (24% < 40 years vs. 6% > or = 40 years, p < 0.05). Tumor margins < or = 3 mm were more frequently found, and lumpectomy site radiation boost was used increasingly from 1986 to 1990. Almost half of all local recurrences occurred after 5 years. CONCLUSIONS: Survival and local recurrence rates were comparable to other series. Young patients were found to be at increased risk for local recurrence. Negative microscopic margins, even when close, can provide low local recurrence rates when adjuvant radiation therapy is administered.

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BACKGROUND: Wound complication rates after mastectomy are associated with several factors, but little information is available correlating biopsy technique with the development of postmastectomy wound complications. Fine-needle aspiration (FNA) biopsy is an accurate method to establish a diagnosis, but it is unknown whether this approach has an impact on complications after mastectomy. METHODS: Charts of 283 patients undergoing 289 mastectomies were reviewed to investigate any association between biopsy technique and postmastectomy complications. RESULTS: The diagnosis of breast cancer was made by FNA biopsy in 50%, open biopsy in 49.7%, and core needle biopsy in 0.3%. The overall wound infection rate was 5.3% (14 of 266), but only 1.6% when FNA biopsy was used compared with 6.9% with open biopsy (p = 0.06). Among 43 patients undergoing breast reconstruction concomitantly with mastectomy, the infection rate was 7.1% (0% after FNA, 12% after open biopsy). Neither the development of a postoperative seroma (9.8%) nor skin flap necrosis (5.6%) was influenced by the biopsy technique used. CONCLUSIONS: These data suggest that wound infections after mastectomy may be reduced when the diagnosis of breast cancer is established by FNA biopsy.

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Fifty consecutive patients who underwent 52 formal hepatic resections (excluding isolated wedge resections) for metastatic colorectal cancer were analyzed to determine whether DNA content was of prognostic significance. The Dukes' stages of the colorectal primaries were: A (10%), B (20%), C (40%), D (28%), and unknown in 2%. Four patients whose liver metastases were discovered at the time of resection of the primary bowel cancer underwent concomitant liver resection, and the remaining patients underwent delayed resections. The hepatic resections performed were right lobectomy (50%), extended right lobectomy (19%), left lobectomy (13%), left lateral segmentectomy (6%), left lobectomy and right wedge (6%), extended left lobectomy (4%), and right lobectomy and left wedge (2%). The overall morbidity rate was 29%. The in-hospital mortality rate was 9%. As of November 1991, 36 patients have recurred. The 5-year actuarial survival was 28%. Flow cytometry could be performed on 37 archival specimens, 15 of which were found to be diploid whereas 22 were aneuploid. All metastases from Dukes A colorectal primaries demonstrated a diploid DNA content. In addition, there was no difference in actuarial survival between diploid and aneuploid tumors. These data suggest that in selected patients, formal hepatic resection of colorectal liver metastases can be performed with an acceptable morbidity rate, mortality rate, and survival, but ploidy of the resected tumor is not of prognostic significance.

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New rules for quality assurance provoked a comparison of effects of two approaches used concurrently for 14 years. In an incidental approach, a multidisciplinary conference reviewed all postoperative complications as they occurred and attributed each to one of six causes. Remedies were instituted and data were filed. In a statistical approach, death and complication rates were computed annually and compared with previous years' rates and with rates reported to Congress as national norms. Statistics suggested acceptable quality in each specialty but calculations were tedious and differences achieved significance too rarely or too slowly to identify problems, protect patients, and improve care. The incidental approach was popular and produced immediate improvements in patient care. Conferees attributed one half of complications to errors. Frequent acknowledgment of susceptibility to error may contribute to the safety and quality shown by our statistics.

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The surgeon operating upon patients with primary or metastatic hepatic cancers must determine if resection is feasible and, if it is, the magnitude of required resection. In an attempt to determine which tests best aid the surgeon in these determinations, the authors prospectively compared preoperative computed tomography (CT) of the liver and intraoperative ultrasound (IOU) in 42 patients with liver tumors who underwent 45 exploratory operations. The primary diseases included colorectal cancer metastases in 27 patients, hepatoma in 11 patients, and metastatic cancers of other origins in 4 patients. In the 42 patients there were 89 identified hepatic lesions that were confirmed to be malignant by resection, biopsy, or continued growth on follow-up CT. The sensitivity of either test for detecting these lesions was 69/89 (77%) for CT and 87/89 (98%) for IOU. Resection was not feasible in 13 patients. Five had extrahepatic disease, 4 had more nodules discovered by IOU, 3 were found by IOU to have involvement of all three hepatic veins by tumor and 1 patient had portal-vein invasion. Alternatively, in four patients tumors thought to involve all three hepatic veins by CT were shown to be free of at least one hepatic vein, thereby permitting resection. In one patient who had been previously operated upon, a tumor thought to involve the remaining right hepatic vein was seen to be free of the vein, also permitting resection. Regarding the extent of resection, IOU was also helpful. Lesser procedures than anticipated were proved possible by IOU in seven patients. A more extensive resection was shown to be necessary by IOU in two patients. Thus, IOU affected the operative management in 22 of 45 operative episodes (49%). It was conclude that IOU is superior to both preoperative CT and surgical exploration in assessing both the feasibility and the extent of resection required for primary and secondary hepatic cancers. In the authors' experience, IOU is the most sensitive indicator of number of lesions present in the liver. In addition, the ability of IOU to determine hepatic venous anatomy is a helpful adjunct in determining resectability of liver tumors.

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Because a 1% sterile solution of methylene blue used for occult breast tumor localization has been shown to interfere with the estrogen-receptor protein (ERP) binding-capacity assay, isosulfan blue in a 1% injection was studied as a potential alternate stain. Cytosols derived from ERP-positive lyophilized powders and human breast tissue were evaluated with and without varying levels of treatment with isosulfan blue. No modification of the ERP-specific binding capacity was found with this stain. The use of isosulfan blue for localization of occult breast tumor is suggested when an ERP binding capacity assay is anticipated.

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Methylene blue in a 1% sterile solution for injection to help localize occult breast tumor was shown to interfere with the estrogen-receptor protein (ERP) binding-capacity assay. Cytosols derived from ERP-positive lyophilized powders and human breast tissue were evaluated with and without varying levels of treatment with methylene blue. Cytosols treated with 0.1% methylene blue, a clinically significant level, demonstrated a substantially lower ERP binding capacity compared with control cytosols. This alteration was found to be due to a reduction in specific binding capacity and not to an alteration in apparent cytosol protein concentration. The use of methylene blue for occult breast tumor localization is not recommended when an ERP binding-capacity assay is anticipated.

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Over an 8-year period, among 41 patients with obstructive jaundice caused by metastases to the liver or lymph nodes adjacent to the porta hepatis, palliative biliary decompression was established surgically in 11, by percutaneous transhepatic biliary drainage (PTBD) in 25, and by both methods in 2. Three patients had no drainage procedure performed. Early mortality after drainage occurred in 6 of 38 patients, and the median survivals (actuarial) for the remaining 32 patients were 4.5 months for the surgical group (range 2 to 21 months) and 4 months for the PTBD group (range 2 to 14 months). Although there were trends toward more frequent hospital readmissions and episodes of cholangitis in the PTBD group, the only statistically significant difference was in the number of catheter manipulations required. We concluded that when patients develop obstructive jaundice as a manifestation of metastatic cancer, useful palliation can be achieved by either surgical or percutaneous decompression.

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Clinical and pathologic data from 73 patients with unresectable carcinoma of the pancreas treated from 1980 to 1987 were reviewed to evaluate the efficacy of biliary enteric bypass and percutaneous transhepatic biliary drainage (PTBD) in the treatment of malignant biliary obstruction. Fifty-two patients underwent biliary enteric bypass with no operative deaths and with a 15% operative morbidity. These patients had a median postoperative hospitalization of 12 days. Four patients (8%) eventually developed recurrent jaundice, and three of these were successfully treated with PTBD. The median survival for these 52 patients was 7 months. Twenty-one patients underwent PTBD with an 81% technical-success rate. These patients had a 33% early complication rate and a 33% in-hospital mortality. The median hospitalization was 13 days postdrainage. Of the 14 patients surviving the initial hospitalization, 86% developed late complications requiring 16 hospital admissions and ten emergency room visits for a total of 155 days of hospitalization. The median survival for those patients undergoing PTBD was 4 months from the time of diagnosis and 2 months from the time of catheter drainage. Surgical bypass offers excellent palliation for malignant biliary obstruction with extremely low morbidity and mortality in properly selected patients; PTBD is useful in the treatment of those patients with extensive disease, who are poor surgical candidates, or who have failed previous surgical drainage. There is a role for both of these palliative procedures in the management of patients with biliary obstruction from pancreatic cancer.

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Clinical and pathologic data from 51 patients with primary sarcomas of the gastrointestinal tract treated from 1951 through 1984 were reviewed to determine clinical presentation, histologic features, treatment, and prognostic factors. The most common signs and symptoms were abdominal pain (62%), gastrointestinal bleeding (40%), and/or abdominal mass (38%). The primary site was stomach in 50%, small bowel in 30%, colorectum in 15%, and esophagus in 5%. Virtually all the sarcomas were leiomyosarcomas. Distribution was uniform among the three histologic grades; although 88% of Grade 1 tumors could be completely excised, only 35% of Grade 3 tumors could be completely resected. The 5-year survival rate was 75% for Grade 1 tumors, 16% for Grade 2 tumors, and 28% for Grade 3 tumors (p = 0.0013, Grade 1 vs. 2 and 3). Thirty of the 51 patients (59%) had curative resection with an operative morbidity rate of 24% and an operative mortality rate of 12%; at 5 years the disease-free survival rate was 58% and the overall survival rate was 63% (48% at 10 years). Eleven patients (42%) had recurrent disease develop at a median interval of 2 years after complete tumor excision. Twenty-one patients (41%) had partial excision or biopsy only of their tumors with an operative morbidity rate of 28%, operative mortality rate of 8%, and median survival of only 9 months. Overall, patients whose tumors were confined to the site of origin had a 58% 5-year survival rate compared with 20% for those whose tumors had invaded adjacent organs (p less than 0.05). If the tumor was less than 10 cm in size, the 5-year survival rate was 78%, significantly better than the 38% for tumors greater than 10 cm (p = 0.03). These data suggest that histologic grade, local invasiveness, size, and extent of resection are the most important prognostic factors for patients with primary gastrointestinal sarcomas. Patients who have resection of all gross tumor, especially if it is well differentiated and localized, have a good prognosis.

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With routine endoscopy, histamine antagonists, proximal gastric vagotomy (PGV) and declining prevalence of duodenal ulcers, morbidity and mortality of ulcer surgery should have declined. Two hundred thirty-four ulcer operations performed since 1976 were compared with 778 between 1961 and 1971. The hospital mortality rate has increased from 2.7 to 14.5%. Increased mortality was related to a doubling of the rate of emergency operations over age 50 and to a 94% decline in elective operations under 50. Mortality was increased by the need for emergency operations and more by concurrent diseases than by old age. Few operations could have been avoided by earlier elective surgery. Most perforations and hemorrhages occurred from previously unsuspected ulcers, many in patients being treated for other advanced or terminal diseases. Although most deaths occurred in this group, 42% survived. Such patients should be expeditiously offered the definitive operations most appropriate to the locations of their ulcers. Since 1976 among 200 survivors, 20 ulcers have recurred. Most recurred after PGV was tried for pyloric and prepyloric ulcers (8 of 16 recurred) and after previously untreated perforated ulcers were simply closed (4 of 11 recurred). The authors so far have one recurrence after 43 PGVs for duodenal ulcers. These recurrences confirm the need for vagotomy in perforated duodenal ulcer and for resection of ulcers proximal to the duodenum.

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Four hundred patients with resectable colon and rectal cancers were operated on by 37 surgeons at 31 institutions. Patients were monitored with carcinoembryonic antigen (CEA) level determinations and clinical examinations. One hundred thirty patients had recurrences, and 75 were reoperated on, with 43 reoperations CEA-directed and 32 clinically directed. Two of 75 died within 1 month after the second operation. Twenty-two second-look patients remain free of disease 5 years after their second operation. The highest resectability of recurrent cancer occurred in patients with a CEA level below 11 ng/ml in whom the CEA level was determined at intervals of 1 to 2 months.

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Charts and slides of 47 patients with primary retroperitoneal sarcomas (excluding pediatric rhabdomyosarcoma) were reviewed to determine clinical presentation, histologic features, extent of surgical resection, operative morbidity and mortality, use of radiation and/or chemotherapy, and survival data. Most patients presented with pain and a palpable mass. Leiomyosarcomas and liposarcomas were the most common tumors. Eighteen of the 47 patients (38%) had complete tumor excision; 68% required resection of adjacent organs. Operative morbidity was 33% with no mortality. After complete resection, the disease-free 5-year survival was 50% and the overall survival was 70% at 5 years; 10-year disease-free survival was 25% with an overall 58% survival at 10 years. Eleven patients (61%) developed recurrent disease with a median interval of 5 years following complete excision. Six patients received adjuvant radiation and/or chemotherapy with four remaining disease-free from 46 to 61 months. Eighteen patients underwent partial excision of tumor and 11 patients underwent biopsy only; these groups had similar survival curves with only 4% alive at 5 years. Their operative morbidity was 18% and mortality was 7%; median time to clinical evidence of tumor progression was 12 months. Sixty per cent of these patients received therapeutic radiation and/or chemotherapy, but their survival was the same as those undergoing surgery alone. These data emphasize the importance of an aggressive surgical approach in the treatment of retroperitoneal sarcomas. Complete tumor resection and total excision of recurrences will allow many patients long-term survival.

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The clinicopathologic features of a malignant fibrous histiocytoma arising in a female breast are presented. Seven cases have been previously reported. These may be divided into three subgroups based on history and pathologic findings. Three of the seven occurred in women without a history of other tumors or previous irradiation. One appeared with a cystosarcoma phyllodes, and three arose following radiation for carcinoma of the breast. The patient in this study had received no radiation. Treatment has been based on surgical resection; the roles of chemotherapy and radiation are uncertain. Although resection alone in the first subgroup has lead to no reported mortality, the small number of cases and the relatively short follow-up does not allow a meaningful assessment of the prognosis in this disease.

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p6 participants in the Veterans Administration Cooperative Studies Program investigating antibiotic prophylaxis in colorectal operations, 693 consecutive patients (1978-1981) from three hospitals were studied. This report concerns 20% of these patients who presented with either perforation, obstruction, or hemorrhage necessitating emergent surgical intervention on unprepared bowel. The 30-day, in-hospital mortality of the 138 patients undergoing emergency operations was 28%. Elective colorectal procedures during the same period had a six per cent mortality rate. There is a striking difference in the cause of death in prepared patients and those needing emergent surgery. Death in prepared patients was usually of a vascular etiology, while septic-related mortality was present in only one per cent. On the other hand, despite massive doses of antibiotics, fecal diversion, surgical drainage and lavage, abdominal sepsis was documented in 20% and septic related mortality was present in 17% of patients undergoing emergency operations. Early, elective treatment and prevention of obstruction and perforation will improve our results in colorectal disease.

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A cooperative Veterans Administration study of the septic complication rate during large-bowel surgery was undertaken in two groups of patients. The first group received oral neomycin and erythromycin base plus parenteral placebo; the second, the oral antibiotics plus parenteral cephalothin sodium. During a five-year period, 1,128 patients were studied. The overall septic complication rate was 7.8% in patients receiving only oral antibiotics, and 5.7% in patients receiving both oral and parenteral antibiotics. This difference was not significant. The only significant finding was a greater incidence of fever of unknown origin in patients receiving only oral antibiotics. None of those patients were treated with additional antibiotics, and all fevers cleared spontaneously. There seems to be no discernible benefit from adding parenteral antibiotic prophylaxis when performing elective colon surgery if appropriate mechanical cleansing and oral neomycin and erythromycin therapy are employed.

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