Change creates challenges and opportunities for rheumatologists and the American College of Rheumatology.
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Humans↗
Biomedical subjects
A L Weaver
Publications and source records attributed to A L Weaver.
Sensitivity and positive predictive value of Medicare Part B physician claims for rheumatologic diagnoses and procedures.
OBJECTIVE: To examine the sensitivity and positive predictive value of Medicare physician claims for select rheumatic conditions managed in rheumatology specialty practices. METHODS: Eight rheumatologists in 3 states abstracted 378 patient office records to obtain information on diagnosis and office procedures. The Medicare Part B physician claims for these patient visits were obtained from the Health Care Financing Administration. The sensitivity of the claims data for a specific diagnosis was calculated as the proportion of all patients whose office records for a particular visit documented that diagnosis and who also had physician claims for that visit which identified that diagnosis. The positive predictive value was evaluated in a separate sample of 331 patient visits identified in Medicare physician claims. The positive predictive value of the claims data for a specific diagnosis was calculated as the proportion of patients with that diagnosis coded in the claims for a particular visit who also had the diagnosis documented in the medical record for that visit. RESULTS: Ninety percent of abstracted office medical records were matched successfully with Medicare physician claims. The sensitivity of the Medicare physician claims was 0.90 (95% confidence interval [CI] 0.85-0.95) for rheumatoid arthritis (RA), 0.85 (95% CI 0.73-0.97) for systemic lupus erythematosus (SLE), and 0.85 (95% CI 0.78-1.0) for aspiration or injection procedures. The sensitivity for osteoarthritis (OA) of the hip or knee was < or = 0.50 if 5-digit codes specifying anatomic site were required. The sensitivity for fibromyalgia (FM) was 0.48 (95% CI 0.28-0.68). The positive predictive values were at least 0.90 for RA, SLE, and aspiration or injection procedures. Positive predictive values for FM and the 5-digit site-specific codes for OA of the knee were 0.83 (95% CI 0.66-1.0) and 0.88 (95% CI 0.75-1.0), respectively, while the positive predictive value of the 5-digit site-specific codes for OA of the hip was zero (95% CI 0-0.26). The positive predictive value of OA at any site was 0.83 (95% CI 0.76-0.90). CONCLUSION: In specialty practice, Medicare physician claims had high sensitivity and positive predictive value for RA, SLE, OA without specification of anatomic site, and injection or aspiration procedures. The claims had lower sensitivity and predictive value for FM and for OA of the hip. The accuracy of Medicare physician claims for other conditions and in the primary care setting requires further investigation.
Aged↗
Pelvic exenterations: supralevator, infralevator, and with vulvectomy.
The purpose of this study was to determine whether the different types (I, II, and III) of pelvic exenterations have prognostic implications in regard to operative features, postoperative complications, and survival. The records of the 133 patients who underwent pelvic exenteration at the Mayo Clinic from 1977 to 1986 were reviewed. The records were abstracted for duration of hospitalization, febrile morbidity, duration of operation, operative blood loss, number of blood transfusions, performance of a perineal phase, development of an omental carpet, vaginal reconstruction, reoperation, additional tissue resection, complications, and survival. Statistically significant differences were noted univariately between types I, II, and III in regard to the development of an omental carpet, whether or not vaginal reconstruction was done, the performance of a perineal phase, the resection of additional tissues, and the duration of hospitalization. The operative and postoperative morbidity and survival were not influenced significantly by the type of exenteration. The subclassification of the exenteration groups into type I (supralevator), type II (infralevator), and type III (with vulvectomy) is helpful to facilitate understanding of the extent of resection of the pelvic structures and the anatomical changes associated with each operation. Subgrouping facilitates communication, not only between pelvic surgeons but also with third-party payers.
Adolescent↗
Factors that predict malignant thyroid lesions when fine-needle aspiration is "suspicious for follicular neoplasm".
OBJECTIVE: To assess clinical factors that may improve the ability to predict the presence of a malignant lesion in thyroid nodules that are found to be "suspicious for follicular neoplasm" by fine-needle aspiration (FNA) cytology. MATERIAL AND METHODS: We undertook a retrospective review of the medical records of all patients at the three Mayo Clinic facilities who underwent a thyroid surgical procedure between January 1992 and December 1994 and had a preoperative FNA report of "suspicious for follicular neoplasm." Patient and nodule characteristics were analyzed statistically for associations with the presence of cancer. RESULTS: The study cohort consisted of 219 patients with a mean age of 54.3 years. Eighty-four percent of resections were done for benign disease. Of the 35 malignant lesions, 9 were incidental papillary cancers separate from the primary nodule; thus, only 26 cancers were found in the index nodule, and only 19 (9% of the total group) were follicular carcinomas. Clinical findings associated with a malignant index nodule were larger diameter, fixation of the mass, and younger age of the patient. CONCLUSION: Clinical characteristics may be used for more accurate assessment of the risk of the presence of a malignant lesion when FNA cytology of a thyroid nodule is reported as "suspicious for follicular neoplasm."
Adenocarcinoma, Follicular↗
Analysis of 281,797 consecutive blood cultures performed over an eight-year period: trends in microorganisms isolated and the value of anaerobic culture of blood.
The results for 281,797 blood culture sets of specimens collected from adult patients at the Mayo Clinic over an approximately 8-year period (1 November 1984 through 30 November 1992) were analyzed in order to determine whether there were differences in the types of microorganisms isolated over this time and to assess the usefulness of anaerobic culturing of blood. Each blood culture set consisted of two aerobic blood cultures (Septi-Chek [Becton Dickinson, Sparks, MD] and Isolator [Wampole Laboratories, Cranbury, NJ]) and one anaerobic culture (nonvented tryptic or trypticase soy broth [NVTSB; Difco Laboratories, Detroit, or Becton Dickinson]). The relative frequency of isolation of aerobic and facultatively anaerobic gram-positive bacteria and obligately anaerobic bacteria increased over the second half of the 1984-1992 surveillance period. The value of the NVTSB anaerobic blood culture was demonstrated for diagnosing bloodstream infections caused by certain facultatively anaerobic bacteria in addition to obligately anaerobic bacteria and supported the inclusion of the NVTSB anaerobic blood culture as a standard part of the three-component blood culture set used at this institution.
Adult↗
Reduction mammaplasty: an outcome study.
Outcome studies of the value of reduction mammaplasties have only recently appeared in the literature. Medical directors of insurance companies and managed care plans have been reluctant to pay for reduction mammaplasties, citing the uncertainty of the medical necessity of the procedure. They have defended their position by stating that the medical literature is devoid of studies documenting that reduction mammaplasty is medically beneficial to the patient. For this reason, reduction mammaplasty is often excluded from health care benefit plans. Because of the need for outcome studies for this procedure, the charts of 363 consecutive patients who had reduction mammaplasty at the Mayo Clinic from January of 1986 to December of 1993 were reviewed. Questionnaires were sent to all these patients asking them to evaluate their outcome, and 328 responded (90.4 percent response rate). Of the respondents, 94.2 percent believed that the procedure was completely or very successful, and only 1.5 percent believed that it was not very successful or completely unsuccessful. The symptoms most frequently reported by patients preoperatively were as follows: uncomfortable feeling about their body, 97.0 percent: inability to find clothes that fit, 95.7 percent; pain in bra-strap groove, 92.4 percent; shoulder pain, 86.0 percent; inability to run, 79.3 percent; upper back pain, 79.0 percent; inability to participate in sports, 77.4 percent; neck pain, 70.7 percent; lower back pain, 64.0 percent; and intertrigo, 61.0 percent. The symptoms least frequently reported by patients preoperatively were as follows: pain or numbness in the hands, 22.6 percent; headaches, 30.2 percent; arm pain, 35.4 percent; and breast pain, 58.2 percent. These symptoms were either relieved or partially relieved in 88 percent or more of the patients. Of the 328 patients, 97.3 percent responded that they definitely or probably would have the procedure again, and only 1.2 percent definitely or probably would not have the operation again. Evaluation of medical treatment used to relieve symptoms showed a marked decrease in the need for such measures after reduction mammaplasty. Study of the charges for the procedure revealed that the setting of practice parameters for the procedure and the use of an ambulatory surgery center significantly decreased the charges for the procedure. This outcome study supports the hypothesis that reduction mammaplasty is an effective procedure and the treatment of choice for symptomatic mammary hyperplasia.
Adult↗
Risk of recurrent biliary tract disease after cholecystectomy in patients with duodenal diverticula.
OBJECTIVE: To determine if the presence of duodenal diverticula predisposes to the development of common bile duct stones. DESIGN: Cohort study; median follow-up, 10.0 years (25th and 75th percentiles, 5.2 and 16.1 years, respectively). SETTING: Tertiary care center. PATIENTS: One hundred fifty-seven patients with radiologically diagnosed duodenal diverticula who had undergone cholecystectomy from 1950 through 1987 and were asymptomatic at the initiation of follow-up. MAIN OUTCOME MEASURES: All patients were followed up for evidence of recurrent biliary tract disease to the following end points: (1) evidence of choledocholithiasis demonstrated by radiologic surgical, or biochemical means and (2) clinical or biochemical evidence of biliary pancreatitis. RESULTS: Of the 157 patients in the study cohort, 13 patients were categorized as having had recurrent biliary tract disease. Using the Kaplan-Meier survivorship method, the cumulative probabilities of recurrent biliary tract disease in patients with radiologically diagnosed duodenal diverticula were 3.6% at 5 years (95% confidence interval, 0.5-6.9), 5.5% at 10 years (95% confidence interval, 1.5-9.4), and 10.2% at 15 years (95% confidence interval, 3.8-16.7). Age, common bile duct exploration and choledochotomy, and the presence of common bile duct dilatation were not found to be significantly associated with recurrence based on a univariate analysis of risk factors by means of the log-rank statistic. CONCLUSIONS: For patients with radiologically diagnosed, second-portion duodenal diverticula, the risk of developing recurrent bile duct stones after cholecystectomy is lower than has been suggested in previous studies. In the absence of concurrent choledocholithiasis, sphincterotomy or biliary bypass at the time of cholecystectomy seems unwarranted.
Adult↗
A prospective psychological evaluation of patients with dysphagia of various etiologies.
We hypothesized that patients who complain of dysphagia without demonstrable organic abnormality may have an underlying psychological dysfunction. We thus conducted a comprehensive assessment in three groups of patients with dysphagia. Dysphagia was classified as obstructive (Obst) when an obstructive lesion was present on esophagoscopy or barium swallow, motility-related (Mot) when abnormal motility was shown on esophageal manometry in the presence of normal esophagoscopy or barium swallow, or nonobstructive, nonmotility-related (NONM) when manometry and esophagoscopy or barium swallow were both normal. We prospectively evaluated 71 patients with Obst-dysphagia, 15 patients with Mot-dysphagia and 10 patients with NONM-dysphagia with a battery of standardized psychological tests including the Minnesota Multiphasic Personality Inventory (MMPI), the Symptom Checklist-90-Revised (SCL-90-R), and the Millon Behavioral Health Inventory (MBHI). The results indicate that patients with NONM-dysphagia have psychological attributes similar to those found in patients with Obst-dysphagia or Mot-dysphagia. Combination of scores for parameters such as somatization, depression, and anxiety could not distinguish among the three groups of dysphagia patients. We thus conclude that patients with NONM-dysphagia, as a group, have similar psychological profiles compared to patients with dysphagia due to organic causes.
Adult↗
Curative reoperations for locally recurrent rectal cancer.
PURPOSE: Our aims were to determine the morbidity, survival and its influencing factors, and patterns of failure for patients who underwent further surgery with the hope of cure for locally recurrent rectal cancer. METHODS: Between January 1981 and December 1988, 224 patients with a preoperative diagnosis of recurrent rectal cancer underwent additional surgery at Mayo Medical Center in Rochester, Minnesota. Of these, 65 underwent further surgery with the hope of cure, i.e., no gross/microscopic residual disease at tumor margins after reoperation. Factors assessed included type of original operation, time interval between operation for primary tumor and initial operation for recurrence, symptom status, degree of fixation, types of reoperations for recurrence, and adjuvant therapy. RESULTS: None of the patients died within 30 days of reoperation. Seventeen complications requiring hospitalization and/or surgical procedure were observed in 14 patients. Extended operations (involving partial or complete removal of surrounding organs/structures) required more time to perform, a greater number of transfusions, and a longer hospital stay than more limited operations. Three-year, five-year, and median survival were 57, 34, and 44.7 months, respectively. Survival was greater after curative than after palliative resection (P < 0.001). Survival tended to be greater in females (P < 0.075) and in patients without pain (P < 0.065). Cumulative probability of local failure was 24, 41, and 47 percent at 1, 3, and 5 years, respectively. Cumulative risk of distant metastasis was 30, 51, and 62 percent at 1, 3, and 5 years, respectively. CONCLUSIONS: Our results indicate that complete excision of locally recurrent rectal cancer can provide a significant number of patients with long-term survival and can be accomplished safely in select patients.
Antimetabolites, Antineoplastic↗
Conservative therapy of breast cancer. The Mayo Clinic experience.
PURPOSE: A retrospective analysis of patients with intraductal and early-stage invasive breast cancer treated with breast-conserving surgery and radiation was conducted to determine the local recurrence and survival rates. Between January 1979 and December 1989, 181 patients were treated with breast-conserving surgery and definitive radiation. Nine of these patients also had either synchronous or metachronous bilateral breast cancers also treated with breast conservation. Fourteen cases were intraductal cancer, while the remaining were invasive carcinomas. With a median length of patient follow-up of 4.9 years following initiation of radiation, the overall survival at 5 and 8 years was 93% and 83%, respectively. The local recurrence-free survival at both 5 and 8 years for all patients was 96%. The overall and recurrence-free survival of the intraductal patients alone was 100% at 5 years. Lymph node status and grade were identified as variables associated with time until recurrence based on a stepwise Cox proportional hazards model analysis. Physician assessment of cosmesis was ranked as good to excellent in 82% of patients. This study further substantiates the role of breast-conserving surgery and definitive radiation in the treatment of early-stage breast cancer.
Adult↗
Yield of positive blood cultures in pediatric oncology patients by a new method of blood culture collection.
BACKGROUND: The optimal number of blood cultures and the volume of blood for pediatric blood cultures have not been defined. In 1990 such criteria were established at our institution. We retrospectively reviewed records of all pediatric oncology patients who were admitted for febrile episodes in 1989 and in 1991 and 1992 to determine whether there was an increase in the detection of bacteremia and fungemia. METHODS: Blood was drawn via venipuncture and central intravascular catheters and inoculated into the designated blood culture bottles. Each patient had a minimum of two separate blood draws, i.e. two separate cultures; the volume was determined by the patient's weight. In all cases < 1% of the patient's blood volume was drawn per culture. Patients' records were reviewed regarding type of malignancy, chemotherapy and neutropenia. RESULTS: The rate of bacteremic patients increased from 12% (13 of 113) in 1989 to 22% (27 of 123) in 1991. This increase continued through 1992 with 23% (27 of 118) of patients having positive blood cultures. Gram-positive bacteria predominated throughout the study period. CONCLUSIONS: Although factors such as more aggressive chemotherapy or a different spectrum of malignant diseases may contribute to the statistically significant increase in identification of bacteremic patients, a standardized method of blood culture collection is merited. The consistent volumes of blood per culture and the minimum of two cultures per febrile episode follow the principles of blood culture collection established for adults. The same principles should apply to pediatric patients.
Adolescent↗
Clinical comparison of difco ESP, Wampole isolator, and Becton Dickinson Septi-Chek aerobic blood culturing systems.
The ESP 80A aerobic blood culture of the ESP automated blood culture system (Difco Laboratories. Detroit, Mich.) was compared with two manual aerobic blood culture systems, the Isolator (Wampole Laboratories, Cranbury, N.J.) and the Septi-Chek (Becton Dickinson, Cockeysville, Md.) systems, for the detection of bloodstream microorganisms from 5,845 blood samples for culture collected from adult patients with suspected septicemia. The bottles were incubated for 7 days, and the sediment from the Isolator tube was inoculated onto solid medium and this medium was incubated for 72 h. A total of 609 microorganisms were recovered from 546 blood cultures. There was no statistically significant difference in the total recovery of microorganisms for the ESP 80A system when compared with that for the Septi-Chek system (P = 0.083); however, the Isolator system recovered significantly more microorganisms overall than either the ESP 80A (P < 0.001) or the Septi-Chek (P < 0.001) system. When assessing individual probable pathogens, the Isolator system detected statistically significantly more Staphylococcus aureus and Candida spp. than either the ESP 80A or the Septi-Chek system (P < 0.05). Similarly, the Isolator system detected statistically significantly more bloodstream infections (septic episodes) caused by S. aureus and Candida spp. than either the ESP 80A or the Septi-Chek system (P < 0.05). In blood culture sets which produced growth of the same probable pathogens in the ESP 80A and the Isolator systems, there was no statistically significant difference in the median times to detection for all pathogens combined (P = 0.067). However, a similar comparison showed the Isolator and the ESP 80A systems to have statistically significantly shorter median detection times for all pathogens combined (P < 0.001) when they were independently compared with the Septi-Chek system. The ESP 80A system had 29 (0.5%) false-positive signals. The ESP system required less processing time than the Isolator system and eliminates the hands-on time for the detection of positive cultures required by the manual systems.
Adult↗
Lung nodule enhancement at CT: prospective findings.
PURPOSE: To determine if lung nodule enhancement measured with computed tomography (CT) is directly related to the likelihood of malignancy and to nodule vascularity. MATERIALS AND METHODS: Radiologically indeterminate 7-30-mm pulmonary nodules were studied in 107 patients with malignant neoplasms (n = 52), granulomas (n = 51), and benign neoplasms (n = 4). Attenuation was recorded from serial thin-section CT scans before and after injection of contrast material. Twenty-four histologic specimens were graded after immunoperoxidase vascular staining with antibody to factor VIII-associated antigen. RESULTS: Malignant neoplasms were enhanced (median, 46.5 HU; range, 11-110 HU) statistically significantly more than granulomas and benign neoplasms (median, 8 HU; range, -10 to 94 HU) (P < .001). With 20 HU as the threshold for a positive test result, the sensitivity was 98%, specificity was 73%, and accuracy was 85% (prevalence of malignancy, 49% ¿52 of 107 nodules]). The degree of enhancement was statistically significantly related to the amount of central vascular staining (P < .001). CONCLUSION: Enhancement appears to be an indicator of malignancy and vascularity. These prospective findings corroborate previously reported results.
Adult↗
Systemic gadolinium toxicity in patients with renal insufficiency and renal failure: retrospective analysis of an initial experience.
OBJECTIVE: To study the possible deleterious systemic effects of gadolinium in patients with impaired renal function. DESIGN: We retrospectively analyzed the routine laboratory data and clinical course of patients who had undergone a gadolinium-enhanced magnetic resonance imaging (MRI) examination of the brain and spine and had evidence of impaired glomerular filtration. MATERIAL AND METHODS: Between October 1988 and October 1992, 15,830 patients underwent gadolinium-enhanced MRI at our institution, 151 of whom had a serum creatinine value of more than 2 mg/dL. The clinical records of these 151 patients were thoroughly examined for the period from 3 days before to 30 days after the gadolinium-enhanced MRI examination. All data were analyzed in an attempt to detect any adverse events that could be related to free gadolinium as a result of dissociation from the chelating agent due to prolonged elimination times (that is, increased serum creatinine concentrations). In addition, we calculated the 90-day mortality rate for both the study group and a matched control population of 80 patients who had undergone MRI of the brain and spine before gadolinium was available. RESULTS: The overall incidence of adverse events in the study group was 3.6%. No event was severe or life threatening--nausea and rash occurred in two patients each, and seizure and headache occurred in one patient each. These findings were not significantly different from those in previous studies performed in populations with normal elimination times. Moreover, no significant difference was noted in the 90-day mortality rate (14.6% of the study group) in comparison with that in the control group (13.8%). CONCLUSION: On the basis of this initial retrospective analysis, we were unable to detect any clinical deleterious effects of administration of gadolinium for MRI examination in patients with impaired renal function. Further investigation with prospective studies is needed to confirm these initial retrospective findings.
Adult↗
A program to increase breast and cervical cancer screening for Cambodian women in a midwestern community.
OBJECTIVE: To determine local screening rates for breast and cervical cancer screening among Cambodian women older than 50 years of age who had used the health-care system, to compare these rates with those for non-Cambodian women, to identify barriers to screening among Cambodians, and to implement community screening. MATERIAL AND METHODS: From review of medical records, cancer screening rates for 1 year among Cambodians (N = 57) were compared with rates for a matched non-Cambodian sample (N = 57). Southeast Asian focus groups identified barriers to screening as a basis for intervention. The intervention included community informational programs in the Cambodian language, group screening appointments, provision of transportation, use of female physicians and interpreters, and an informal clinic setting. Cancer screening rates were compared before and after the intervention. RESULTS: Initial screening rates for Cambodians were significantly lower than for the non-Cambodians. Expressed barriers included lack of knowledge about cancer, shyness at physical examination, lack of transportation, fear of a large, technical medical center, and individual appointments. After the intervention, community screening rates were almost 5 times higher than at baseline. CONCLUSION: The intervention was successful in overcoming organizational, economic, and cultural barriers to cancer screening among older Cambodian women in this setting.
Aged↗
Constipation in an elderly community: a study of prevalence and potential risk factors.
OBJECTIVE: The epidemiology of chronic constipation in the elderly remains poorly defined. We aimed to study the prevalence of, and potential risk factors for, constipation in a representative elderly community, using symptom-based diagnostic criteria. METHODS: An age and gender-stratified random sample of 1833 eligible residents of Olmsted County, Minnesota, aged 65 yr and over, was mailed a valid self-report questionnaire; 1375 responded (75%). RESULTS: The overall age- and gender-adjusted prevalence (per 100) of any constipation was 40.1 (95% CI 38.9, 44.4); for functional constipation and outlet difficulty or delay, the prevalence rates were 24.4 (95% CI 22.0-26.9) and 20.5 (95% CI 18.2-22.8), respectively. Self-reported constipation did not reliably identify functional constipation or outlet delay. Outlet delay, but not functional constipation, was more frequent in women; functional constipation, but not outlet delay, was associated with advancing age. Nonsteroidal anti-inflammatory drugs and other medications were significant risk factors in subjects with functional constipation and outlet delay combined. CONCLUSIONS: In independently living, elderly persons, constipation is a common complaint; among these subjects, there appear to be symptom subgroups that can be identified.
Age Distribution↗
Misoprostol dosage in the prevention of nonsteroidal anti-inflammatory drug-induced gastric and duodenal ulcers: a comparison of three regimens.
OBJECTIVE: To compare the effectiveness and tolerability of three misoprostol dosing regimens for the prevention of gastric and duodenal ulcers associated with long-term nonsteroidal anti-inflammatory drug (NSAID) therapy. DESIGN: A multicenter, 12-week, randomized, double-blind, placebo-controlled, parallel, four-limb study. PATIENTS: Eligibility criteria included upper gastrointestinal symptoms during NSAID therapy and no endoscopic evidence of gastric or duodenal ulcers. A total of 1623 patients was enrolled; 1197 of these met major accession and regimen-compliance criteria and completed the trial. These 1197 patients composed the evaluable group. INTERVENTIONS: Patients were randomly assigned to one of four regimens: placebo four times daily; 200 micrograms of misoprostol twice daily and placebo twice daily; 200 micrograms of misoprostol three times daily and placebo once daily; and 200 micrograms of misoprostol four times daily. MEASUREMENTS: Upper gastrointestinal endoscopic examinations for ulcers were done after 4, 8, and 12 weeks of therapy. Tolerability and safety of the regimens were assessed by adverse-event monitoring. RESULTS: In the placebo group, the incidence of gastric ulcers was 15.7% and the incidence of duodenal ulcers was 7.5%. The incidence of gastric ulcers was significantly lower in the groups receiving misoprostol twice daily (8.1%; difference, 7.6% [95% CI, 2.7% to 12.5%]; P = 0.002), three times daily (3.9%; difference, 11.8% [CI, 7.4% to 16.3%]; P < 0.001), and four times daily (4%; difference, 11.7% [CI, 6.7% to 16.8%]; P < 0.001) compared with placebo. The gastric ulcer rate was significantly higher in patients receiving misoprostol twice daily compared with those receiving misoprostol three times daily (difference, 4.2% [95% CI, 0.7% to 7.7%]; P = 0.02). A significant (P = 0.02) misoprostol dose-response effect was noted in the prevention of gastric ulcers. The incidence of duodenal ulcers was significantly lower in the groups receiving misoprostol twice daily (2.6%; difference, 4.9% [CI, 1.5% to 8.2%]; P = 0.004), three times daily (3.3%; difference, 4.2% [CI, 0.6% to 7.7%]; P = 0.019), and four times daily (1.4%; difference, 6.1% [CI, 2.6% to 9.6%]; P = 0.007) compared with placebo. No significant difference was detected between patients receiving misoprostol twice daily and those receiving misoprostol three times daily, and no dose-response effect was noted with duodenal ulcers. The incidence of withdrawals for adverse events was significantly lower in the groups receiving misoprostol twice daily (12%) and three times daily (12%) than in the group receiving it four times daily (20%). The incidence of gastrointestinal adverse events was significantly higher in the group receiving misoprostol four times daily (74%) than in the placebo group (62%). CONCLUSION: Misoprostol, 200 micrograms twice or three times daily, offers substantial protection against gastric and duodenal ulcers in patients receiving long-term NSAID therapy. These dosages were better tolerated than the currently approved regimen of 200 micrograms four times daily.
Adult↗
Intraoperative irradiation after palliative surgery for locally recurrent rectal cancer.
BACKGROUND: In patients with locally recurrent rectal cancer, long-term disease control and survival is uncommon with single-modality therapy. This report evaluates results achieved at the Mayo Clinic (Rochester, MN) with single- or combined-modality treatment, including intraoperative irradiation. METHODS: From 1981 to 1988, 106 patients underwent palliative surgical resections at the Mayo Clinic for locally recurrent rectal cancer. None had evidence of extrapelvic disease, and 42 received intraoperative electron beam irradiation (IORT) as a component of treatment. Gross residual disease remained after maximal surgical resection in 34 of the 42 patients and 61 of the patients who did not receive IORT. The IORT dose was 15-20 Gy in 39 patients and 10, 25, and 30 Gy in the other 3. External beam irradiation (EBRT) was administered to 41 of the 42 patients (doses > or = 45 Gy to 38 patients). RESULTS: Kaplan-Meier survival estimates at 3 and 5 years were analyzed for the 106 patients. Palliative surgical resection alone (12 patients) resulted in a 3-year survival of 8% and a 5-year survival of 0%. Statistically significant factors relative to survival based on the univariate analysis of all patients included amount of residual tumor (microscopic vs. gross, P = 0.032) treatment method (P = 0.005), IORT versus no IORT (P = 0.0006), type of symptoms (P = 0.0075), type of fixation (P < 0.0001), and preoperative Eastern Cooperative Oncology Group status (P = 0.03). For patients who received IORT, 3-year survival with gross residual tumor or presentation with pain was 44% and 43%, respectively. Factors not associated with survival (univariate) included extended versus conventional surgical resection, grade, age, and sex. The 3-year cumulative probability of distant metastasis was 60% in the patients who received IORT and 54% in those who did not. The 3-year local relapse rates were 40% versus 93% in patients who received IORT versus those who did not. CONCLUSIONS: Although the addition of IORT to external irradiation and maximal surgical resection appears to improve local tumor control and survival in patients who undergo palliative surgical resection for locally recurrent rectal cancer, further gains in treatment are necessary. Considering the high rates of distant metastasis, more routine systemic therapy with 5-fluorouracil (5-FU) leucovorin, 5-FU levamisole, or all three needs to be incorporated into aggressive treatment approaches. In patients with gross residual tumor after maximum surgical resection, local tumor control is inadequate despite treatment combinations including IORT. The evaluation of radiation sensitizers or biologic modifiers during external irradiation and IORT is indicated.
Adult↗