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PubMedDate not supplied

Single-dose brachytherapy versus metal stent placement for the palliation of dysphagia from oesophageal cancer: multicentre randomised trial.

BACKGROUND: Both single-dose brachytherapy and self-expanding metal stent placement are commonly used for palliation of oesophageal obstruction due to inoperable cancer, but their relative merits are unknown. We undertook a randomised trial to compare the outcomes of brachytherapy and stent placement in patients with oesophageal cancer. METHODS: Nine hospitals in the Netherlands participated in our study. Between December, 1999, and June, 2002, 209 patients with dysphagia from inoperable carcinoma of the oesophagus or oesophagogastric junction were randomly assigned to stent placement (n=108) or single-dose (12 Gy) brachytherapy (n=101), and were followed up after treatment. Primary outcome was relief of dysphagia during follow-up, and secondary outcomes were complications, treatment for persistent or recurrent dysphagia, health-related quality of life, and costs. Analysis was by intention to treat. FINDINGS: Nine patients (six [brachytherapy] vs three [stent placement]) did not receive their allocated treatments. None was lost to follow-up. Dysphagia improved more rapidly after stent placement than after brachytherapy, but long-term relief of dysphagia was better after brachytherapy. Stent placement had more complications than brachytherapy (36 [33%] of 108 vs 21 [21%] of 101; p=0.02), which was mainly due to an increased incidence of late haemorrhage (14 [13%] of 108 vs five [5%] of 101; p=0.05). Groups did not differ for persistent or recurrent dysphagia (p=0.81), or for median survival (p=0.23). Quality-of-life scores were in favour of brachytherapy compared with stent placement. Total medical costs were also much the same for stent placement (8215) and brachytherapy (8135). INTERPRETATION: Despite slow improvement, single-dose brachytherapy gave better long-term relief of dysphagia than metal stent placement. Since brachytherapy was also associated with fewer complications than stent placement, we recommend it as the primary treatment for palliation of dysphagia from oesophageal cancer.

Aged↗
PubMed2003

[Treatment of anterior glenohumeral instability: personal experience with an arthroscopic stabilization technique, its indications and results].

PURPOSE OF THE STUDY: Arthroscopic treatment of anterior post-traumatic instability of the glenohumeral joint is a recent surgical procedure. The aim of this study was to evaluate the outcomes of the method and define criteria on which indications for this treatment are based. MATERIAL: Fifty-six active, young patients less than 30 years of age were distributed into three groups according to the method of treatment. Twenty patients were treated conservatively (group A), 12 patients had open surgery (B) and 23 patients underwent arthroscopic stabilization of the glenohumeral joint (C). The average follow-up periods in groups A, B and C were 26, 38 and 18 months, respectively. The treatment of all patients in groups B and C was preceded by physical therapy lasting at least 3 months. Contraindications to arthroscopic treatment included Hill-Sachs bony defects, instability involving a fracture of the glenoid cavity, conditions after previous surgery, posterior or multidirectional instability and anterior instability due to a full rupture of the rotator cuff. METHODS: Conservative treatment consisted of early closed reduction, 3 to 4 weeks of immobilization and subsequent physical therapy. Open procedures for Bankart lesions were carried out according to either Cave and Rowe or Bristow, with post-operative immobilization for 4 weeks. Arthroscopic stabilization was performed by the Wolf method. After the size of the defect had been identified, the glenoid rim was scratched to bleed, the detached labrum, including the inferior glenohumeral ligament, was mobilized and, after drilling holes in the glenoid rim, the capsulolabral complex was fixed by means of a Mitek GII anchor with a 1-0 PDS fibre. Three anchors were inserted as a rule. In each group, the number of recurrent dislocations was recorded. In the patients undergoing surgery, the loss of passive external rotation in 90 degrees abduction was assessed and the outcome was evaluated according to the Rowe rating system. RESULTS: Recurrent dislocations were experienced by 13 patients (65%) in group A and two patients (8.7%) in group C; no recurrent dislocation occurred in group B patients. The average loss of external rotation in 90 degrees abduction was 11.3 degrees and 6.7 degrees in groups B and C, respectively. The Rowe scores showed an excellent outcome in 80%, good in 8%, satisfactory in 2% and poor outcomes in 10% of the group B patients; in group C 78% had excellent, 7% had good, 8% had satisfactory, and 7% had poor outcomes. DISCUSSION: The number of recurrent dislocations (8.7%) in our patients treated by arthroscopy was in agreement with the literature data (1 to 40%); both figures refer to recurrent dislocations in subjects involved in body-contact sports. In our patients treated by arthroscopy, the average post-operative loss of external rotation in 90 degrees abduction was lower than in the open surgery group. There were no differences in the Rowe scores between the two surgically treated groups. The patients treated conservatively showed a high number of recurrent dislocations (65%), thus confirming reports by other authors on the failure of this method. CONCLUSIONS: The arthroscopic treatment of anterior post-traumatic glenohumeral instability, using the Wolf method, resulted in a reduction of recurrent dislocations, supposing indication criteria were observed. Its outcomes were comparable with the results of conventional open surgery.

Adolescent↗
PubMed1997

[Constant point evaluation for reconstruction of the rotator cuff].

Thirteen patients aged 36-63 years underwent surgery for full thickness rotator cuff rupture. The average follow-up was 21.1 months (range 12-36 months). Supraspinatus tendon was torn in 7 cases, supraspinatus and infraspinatus in 4, subscapularis in 1 and all three tendons were ruptured in 1 patient. Subacromial decompression and cuff reconstruction was done in 11 cases, decompression combined with cuff debridement and partial subscapularis tendon reconstruction in 1 case and subscapularis reconstruction in 1 patient. Constant Score (version corrected for age and sex) was used for shoulder function evaluation. There were 6 very good, 4 good, 1 fair and 2 bad results. Recurrence of cuff tear was diagnosed sonographically in 2 cases of both supra- and infraspinatus rupture. Statistical analysis disclosed significant correlation between extent of the tear and final functional result. Constant Score can be recommended as an objective and useful method for shoulder function assessment.

Adult↗
PubMed2004

Stereotactic radiosurgery for multiple brain metastases from breast carcinoma.

BACKGROUND: The current study analyzed the feasibility and outcome of stereotactic radiosurgery (SRS) for treatment of brain metastases from breast carcinoma. METHODS: During an 8-year period, 151 patients with a combined total of 620 brain metastases from breast carcinoma underwent 197 outpatient SRS procedures. Sixty-three percent of all patients had multiple brain metastases. The median tumor volume was 2.2 cm(3) (range, 0.1-20.9 cm(3)). The mean prescribed tumor dose was 19 +/- 4 grays. Local/distant tumor recurrences were treated with additional radiosurgical therapy for patients with stable systemic disease. All patients were categorized according to the Radiation Therapy Oncology Group classification. Survival time and freedom from local tumor recurrence were analyzed using the Kaplan-Meier method. Prognostic factors were identified using the Cox proportional hazards model. RESULTS: The overall median survival duration was 10 months after SRS. Ninety-four percent of patients did not experience local brain tumor recurrence after radiosurgery. In addition, 70.2% of patients did not have disease recurrence in the brain. Most patients died of systemically progressing malignancy. A Karnofsky performance score > 70 and recursive partitioning analysis Class I were related to prolonged survival in the univariate and multivariate analyses. Age, whole-brain radiotherapy, surgery, number of metastases, chemotherapy, and latency period from diagnosis of the primary tumor to the development of brain metastases did not reach prognostic relevance in the multivariate model. Patients with RPA I, II, and III survived 34.9, 9.1, and 7.9 months, respectively. There was no treatment related permanent morbidity and mortality. The transient morbidity rate was 17%. Sixteen patients exhibited symptomatic transient complications related to treatment. CONCLUSIONS: The results of the current study indicate that SRS is a feasible treatment concept for selected patients with multiple brain metastases from breast carcinoma.

Adult↗
PubMed2003

Empirical prescribing for dyspepsia: randomised controlled trial of test and treat versus omeprazole treatment.

OBJECTIVE: To compare the efficacy of a "Helicobacter pylori test and treat" strategy with that of an empirical trial of omeprazole in the non-endoscopic management by empirical prescribing of young patients with dyspepsia. DESIGN: Randomised controlled trial. SETTING: Hospital gastroenterology unit. PARTICIPANTS: 219 patients under 45 years old presenting with dyspepsia without alarm symptoms. INTERVENTION: Patients received treatment with omeprazole 20 mg (group A) or with a urea breath test followed by an eradication treatment in case of H pylori infection or omeprazole alone in non-infected patients (group B). Lack of improvement or recurrence of symptoms prompted endoscopy. MAIN OUTCOME MEASURES: Improvement in symptoms assessed by a dyspepsia severity score every two months; use of medical resources (endoscopic workload and medical consultation); clinical outcome. RESULTS: 96/109 (88%) patients in group A and 61/110 (55%) in group B (P < 0.0001) had endoscopy: in 19 patients in group A and 32 in group B (20/67 infected and 12/43 non-infected) because of no improvement; in 77 further patients in group A and 29 in group B (7 infected and 22 non-infected) because of recurrence of symptoms during follow up. Endoscopy showed peptic ulcers only in group A; oesophagitis occurred significantly more often in group B than in group A. About 80% of examinations were normal in both groups, but nine duodenal scars occurred in group A. CONCLUSIONS: Eradication treatment allows resolution of symptoms in a large number of patients with dyspepsia and reduces the endoscopic workload. After a trial of omeprazole, symptoms recur in nearly every patient. Such treatment is also likely to mask an appreciable number of peptic ulcers and cases of oesophagitis.

Adult↗
PubMed1993

Factors affecting short- and long-term outcome of a short therapeutic trial with cisapride in dyspeptic patients.

In a Dutch general practice trial conducted in 599 patients with symptoms of dyspepsia, the response to 5 mg cisapride three times daily was rated excellent or good in 61% of patients at week 2. On increasing the dose to 10 mg three times daily in 132 patients with poor to moderate response, the result at the end of treatment was rated as good or excellent in 45% of these patients, and the mean symptom score further decreased significantly (p < 0.05). The longer the pretreatment duration of dyspeptic symptoms, the lower was the overall response rate to cisapride short-term therapy (80% in patients with complaints < 3 months versus 50% in those with complaints > 4 years). Cisapride also proved effective in patients previously treated with prokinetic agents (72% response rate), antacids (66%) and H2-receptor antagonists (48%). On long-term follow-up, dyspepsia relapse rates among the total patient population (n = 357) and the patient sample fully 'cured' after 4 weeks of cisapride (n = 226) were respectively 30% and 27% after 6 months. Factors affecting recurrence of dyspeptic symptoms included age, duration of symptoms prior to trial entry and mean symptom score at end of the treatment study, but not the symptom severity prior to treatment. Relapsing patients presented mainly with the same symptom profile as at the first study, and the majority (88%) responded well to repeated treatment with cisapride. In conclusion, most patients responded well to a short therapeutic trial with cisapride and remained free from relapse in the subsequent 6 months. Repeated treatment in patients with recurrent symptoms appeared to be successful.

Adult↗
PubMed2000

[Clinical analysis of 13 infected total knee replacements].

OBJECTIVE: To investigate the cause, treatment and its result of infected total knee replacements (TKRs). METHODS: Between 1987 and 1999, 13 infected TKRs in 13 patients were treated with surgical debridement and one-stage or two-stage reimplantation. The preoperative average ROM of knees was 55 degrees and the average Hospital for Special Surgery (HSS) knee score was 36.5 points. Clinical results were evaluated after average follow-up for 3 years and 5 months. We analyzed the factors for TKR infection. RESULTS: No recurrent infection was noted, and pain was significantly alleviated in all patients. The average ROM of knees was 85 degrees and the average HSS knee score was 73.5 points. CONCLUSIONS: The high risk factors for TKR infection are rheumatoid arthritis, steroid administration, associated diabetes mellitus, hinged prosthesis and previous knee surgery. Early surgical debridement with intravenous antibiotics is necessary as soon as deep infection is detected. Two-stage reimplantation is more effective in eradicating deep infection than single debridement or one-stage reimplantation.

Adult↗
PubMed2006

[MELD score in prediction of early mortality in patients suffering refractory ascites treated by TIPS].

UNLABELLED: Transjugular Intrahepatic Portosystemic Shunt (TIPS) is now well established in the treatment of complications of symptomatic portal hypertension such as acute or recurrent variceal bleeding, refractory ascites and Budd-Chiari syndrome. In some patients with refractory ascites who belong to group C according to Child-Pugh classification (score around 12), the indication of the procedure could be very questionable and early mortality is quite high. However, in some cases, the subgroup of such risky patients can profit from TIPS. Child-Pugh classification is used for the stratification of the patients routinely. During the last decade other scoring systems occured to bring a better prognostic value. MELD (Model for End stage Liver Disease) score, based only on laboratory values is one of them. Comparison of these two scoring systems in patients treated by TIPS in previous trials brought certain discrepancy, but MELD score seems to be better in predicting early mortality. The aim of our study was to determine retrospectively the predictive accuracy of MELD score for the early mortality in comparison to Child-Pugh score in patients treated for refractory ascites by TIPS. METHODS: We evaluated 110 patients (mean age 55 years) with liver cirrhosis (61% of patients with alcoholic etiology), who underwent TIPS for refractory ascites in our center from September 1992 to December 2003. MELD and Child-Pugh score was calculated and then compared between groups with early (one month), three month and one year mortality, and those who survived over this period (one, three and twelve months), comparing MELD and Child-Pugh score (ROC analysis and Student's T test were used). RESULTS: Mean follow up was 23 months. Average MELD score in the whole group was (16). In patients, who died within one month the score before TIPS was 21, three months 20 and 18 one year. Comparing MELD score between subgroups and then Child-Pugh score, only for MELD score there was a statistically significant difference (p < 0.05) in one month. Using ROC (AUC) analysis, discriminant power of MELD score was superior to Child-Pugh score for one (0.73 vs 0.63) and three month (0.73 vs 0.67) mortality. The discriminant power for one year mortality was low in both scores. CONCLUSION: MELD scoring system is a better tool to predict the risk of early mortality in patients with refractory ascites treated by TIPS than Child-Pugh classification. The discriminant power was low in both scores in one year horizon.

Ascites↗
PubMed2002

[Outcome quality in visceral surgery interventions for benign illnesses].

Quality assessment of visceral surgery for benign diseases has to differentiate between early and long-term results. In the early postoperative course, general surgery-related problems are important such as postoperative bleeding, hematomas, anastomotic leakage, or lesions of anatomical structures such as the laryngeal recurrent nerve or vagus nerve. Further criteria are blood loss, postoperative pain, quality of incisional scar, and socioeconomic factors such as duration of surgery, hospital stay, inability to work, and costs. The elimination or reduction of symptoms, which were decisive for the indication for operation, can already be assessed in the early postoperative period. However, these symptoms--persistent or recurrent--and possible secondary diseases are the main criteria for the assessment of the long-term course. Important are symptomatic or asymptomatic recurrences, secondary syndromes, and quality of life. For the assessment of symptoms and quality of life, score systems (GLQI score, AFP score) have been developed and evaluated. For the assessment of the surgical results in different diseases, specific criteria have to be taken into account.

Clinical Competence↗
PubMed1982

Oral acyclovir in the treatment of genital herpes. Preliminary report of a multicenter trial.

Ninety patients with genital herpes (29 initial and 61 recurrent episodes) were entered into a double-blind randomized trial of oral acyclovir and placebo. Treatment consisted of 200 mg acyclovir five times a day for five days or matching placebo. Therapy was initiated a mean of 2.8 days and 1.0 days after onset of lesions in initial and recurrent infections respectively. The 13 culture-positive patients with initial disease who received acyclovir had a shorter median duration in days of viral shedding (1.0), pain (3.5), combined symptoms (3.5), time to crusting (3.5), and time to complete healing (5.5) than the 11 culture-positive placebo recipients whose scores were 8.0, 4.5, 4.5, 9.0, and 11.0 respectively (p less than 0.05 for all comparisons). Patients with recurrent disease receiving acyclovir also experienced a reduction in the median duration in days of viral shedding (0.5), time to crusting (men only) (3.0), and time to complete healing (5.0), compared with 2.5, 4.0, and 7.0 days, respectively, for control patients (p less than 0.01 for each variable). New lesion formation was effectively prevented by acyclovir in patients with both initial and recurrent infections (p less than 0.05). Oral acyclovir therapy was well-tolerated and shortened the course of both initial and recurrent genital herpes.

Acyclovir↗
PubMedDate not supplied

Predictors of outcome of single-dose brachytherapy for the palliation of dysphagia from esophageal cancer.

BACKGROUND: Single-dose brachytherapy is a commonly used palliative treatment modality for esophageal carcinoma, however, a considerable number of patients need additional treatment for persistent or recurrent dysphagia. Our aim was to establish predictors of an unfavorable outcome after single-dose brachytherapy. METHODS AND MATERIALS: Between December 1999 and July 2002, 95 patients with dysphagia from inoperable esophageal carcinoma were treated with single-dose (12 Gy) brachytherapy. Patients were followed-up prospectively by monthly home visits by a specialized research nurse. We investigated the patient and tumor characteristics that influence the risk of persistent dysphagia (continuing dysphagia within 4 weeks after treatment necessitating a second treatment) or recurrent dysphagia (occurring more than 4 weeks after treatment) after single-dose brachytherapy, using logistic and Cox regressions. RESULTS: At 4 weeks after brachytherapy, the dysphagia score was improved in 62/84 (74%) patients. Major complications occurred in 11/95 (12%) patients. In total, 42/95 (44%) patients were treated for persistent (n = 18) and/or recurrent dysphagia (n = 28). Persistent dysphagia (n = 18) was caused by persisting obstructing tumor confirmed at endoscopy, and these patients were treated with stent placement. Patients needing dilation before treatment had a higher risk of persistent dysphagia (odds ratio = 4.1; 95% CI 1.3-12). There was a trend toward a higher risk of persistent dysphagia for patients previously treated with chemotherapy (odds ratio = 3.2; 95% CI 0.81-12). In total, 34 events of recurrent dysphagia occurred in 28 patients, caused by obstructing tumor regrowth (n = 26), food bolus obstruction (n = 5), or other reasons (n = 3). None of the investigated patient and tumor characteristics had a significant association with the risk of developing recurrent dysphagia. Of all patients needing additional treatment (42/95), those who needed dilation before treatment had a higher risk of persistent and/or recurrent dysphagia (hazard ratio = 2.1; 95% CI 1.1-4.1). CONCLUSIONS: Patients with stenotic esophageal tumors that cannot be bypassed or who previously underwent chemotherapy are poor candidates for single-dose brachytherapy. For these patients, a higher and/or fractionated dose of brachytherapy or alternative palliative treatment modalities should be considered.

Aged↗
PubMed2005

Is a perseveration a perseveration? An evaluation of cognitive error types in patients with subcortical pathology.

This study investigated several constructs of executive functioning in a group of 77 patients with subcortical pathology. Specifically, we examined the validity of categorizing perseverative errors as "recurrent," "stuck-in-set," or "continuous," as proposed by Sandson and Albert (1984). A principal components analysis of 2 measures of recurrent perseveration, 2 measures of stuck-in-set perseveration, and 2 measures of intrusive errors yielded a 2 component solution with stuck-in-set perseverations and intrusive errors loading on Component 1, and recurrent perseverations loading on Component 2. Presence of a continuous perseveration on a graphomotor test was significantly associated with higher factor scores on Component 1, but not Component 2. The stuck-in-set perseveration and intrusion component was associated with the majority of the other neuropsychological tests administered, including tests of executive function and memory. The recurrent perseveration component was not associated with the other measures of cognitive functioning. Presence of a continuous perseveration was associated with executive function but not memory measures. This study provides evidence that recurrent perseverations are distinct from the other types of perseverative and intrusive errors, and that stuck-in-set and intrusive errors are good indicators of general cognitive functioning in patients with subcortical pathology.

Adult↗
PubMed2001

[Complications with the acetabular cup in the CLS total hip joint endoprosthesis].

PURPOSE OF THE STUDY: The aim of the study is to present complications of acetabular component of CLS total hip replacement and their solution. MATERIAL: In the period of 1986-1999 in total 219 cementless CLS total hip replacements and 2012 CLS cups in hybrid replacements were implanted at 1st Orthopaedic Department in Brno--primary surgeries--2026, revision surgeries--205. Of 2231 CLS cups we encountered 25 complications requiring a revision surgery (1.1% of all cases): 2 cases of the broken metal shell, 3 cases of cup penetration into pelvis, 4 cases of cup migration, 5 cases of aseptic loosening, 5 cases of dislocations and 6 cases of deep infections. METHOD: Broken metal shells were treated by Müller and Eichler ring, cancellous bone grafting with a cemented PE cup. Penetration of cups into pelvis were managed by Girdlestone procedure. Migration of the cup was solved in 1 case by Burch-Schneider ring, other cases with a good function were left in situ. Aseptic loosening with defects of acetabulum was solved by means of metal rings, cancellous bone grafting and cemented PE cup. Dislocation was managed by adjustment of CLS cup in the correct position, longer or closed reduction and orthesis. In infections a two-step procedure was used with a repeated application of CLS cup, Prostalac technique or Girdlestone procedure. RESULTS: The results of cases solved by means of acetabular metal rings, cancellous bone grafting and cemented PE cup are after 2-5 years good. The patients are capable of full weight bearing and have no pains, Harris score is 83-89 points. The radiograph shows in all but one patients a stable implant without radiolucent interface. The function of all patients with dislocations of CLS implant is now very good or good. No recurrence was recorded in patients with infections. The function of the hip with Girdlestone procedure is in 2 patients low--Harris score is 58 and 63 points. Harris score in patients after a two-step revision with a repeated application of CLS cup is 80-89 points. DISCUSSION: In cases of the broken metal shell there occurred a proximolateral defect of the acetabular bone as a result of development dysplasia of the hip. The cup had inadequate circumferential support. The cases of cup penetration into pelvis are connected with a marked primary or subsequent deficiency of the acetabular floor, excessive reaming of subchondral bone and osteoporosis. Revision surgery with a metal ring requires a careful extensive cancellous bone grafting with a complete filling of all defects, support of the ring by the bone and development of a stable bone-ring-cemented PE cup composite. The best results in infections were achieved by a two-step revision with a repeated application of CLS cup. CONCLUSION: Of the total number of 2231 implanted CLS cups in the period of 1986-1999 only 25 complications were recorded requiring a revision surgery, i.e. 1.1% of all cases. Complications relating to the cup were treated in case of acetabular defects by means of metal acetabular rings, cancellous bone grafting and cemented cups. In infections a two-step procedure was used with a repeated application of CLS cup, Prostalac technique or Girdlestone procedure.

Acetabulum↗
PubMedDate not supplied

The effect of treatment for colorectal cancer on long-term health-related quality of life.

BACKGROUND: Little information is available on the impact that therapies used in the treatment of colorectal cancer (CRC) have on long-term, health-related quality of life (HRQL). Knowledge of how HRQL is affected by these therapies is essential in properly selecting patients for treatment. The purpose of this study was to determine the long-term impact that surgical and adjuvant therapy for resectable CRC has on patient-reported HRQL in a male veteran population through a case-control design. METHODS: All participating patients had completed therapy at least 6 months before enrollment. One hundred fifty-eight patients were accrued over a 3-year period (January 1, 1997 to December 31, 1999) at a single institution. The impact of CRC surgery on HRQL was measured by comparing a cohort of 61 patients undergoing surgery alone for the treatment of CRC (CRC-S group) with 44 patients undergoing surgery for benign colonic disease (BCD group). To study the effect of adjuvant therapy for CRC on HRQL, a third cohort of 53 patients undergoing both surgical and adjuvant treatment (CRC-S/A group) was compared with the CRC-S group. For each group, health status was measured by a health survey questionnaire, SHORT FORM 36 (SF36). For patients treated for CRC, an additional disease-specific supplemental questionnaire also was used. RESULTS: Self-reported health status, as measured by mean SF36 score, was significantly reduced for the BCD group compared with CRC-S patients on general health perception (41.9 +/- 3.9 vs. 52.2 +/- 3.0, P = .04) and the standardized physical component score (31.2 +/- 1.7 vs. 37.5 +/- 1.5, P < .005). Despite an increased number of distally located tumors, later stage cancers, and an increased number of recurrences in the CRC-S/A group compared with the CRC-S cohort, no significant differences were identified between these groups on any of the subscales or standardized scores of SF36. Using the supplemental questions, no differences were identified between the CRC groups with respect to appetite, weight, or gastrointestinal or urinary functioning. CONCLUSIONS: Surgical therapy for CRC probably has minimal impact on long-term HRQL when compared with surgery for benign colonic processes. Similarly, there does not appear to be a measurable, lasting impact of CRC adjuvant therapy on HRQL when compared with surgery alone. Although overall impact of therapies for CRC on HRQL appears to be limited, measurement of therapeutic influence on an individual level and identification of selection criteria based on estimated impact on HRQL for these therapies requires prospective validation.

Adult↗
PubMed2004

Intravitreal triamcinolone acetonide for diabetic diffuse macular edema: preliminary results of a prospective controlled trial.

OBJECTIVE: To evaluate prospectively the efficacy and safety of 1 intravitreal injection of 4 mg of triamcinolone acetonide for refractory diffuse diabetic macular edema. DESIGN: Interventional case series. PARTICIPANTS: Fifteen patients with bilateral diabetic macular edema unresponsive to laser photocoagulation. In all patients, one eye received the injection, and the other served as a control. INTERVENTION: Intravitreal injection of 4 mg of triamcinolone acetonide under subconjunctival anesthesia. MAIN OUTCOME MEASURES: The main outcome measure was central macular thickness (CMT) at 1, 3, and 6 months, measured by optical coherence tomography. Secondary outcomes were Early Treatment Diabetic Retinopathy Study (ETDRS) scores, intraocular pressure, and cataract progression. RESULTS: In this preliminary report, we give the results for 12 patients who had a follow-up of at least 3 months. Seven of them were followed up for 6 months. Before injection, CMT was 509.6+/-143.5 microm (mean +/- standard deviation [SD]) in injected eyes, versus 474.4+/-82.6 microm in control eyes. Four weeks after injection, it was 207.3+/-44.2 microm in injected eyes and 506.7+/-122.4 microm in control eyes (P<0.001, bilateral Wilcoxon test for paired samples), and after 12 weeks, 207+/-96.7 microm and 469.3+/-117.6 microm, respectively (P = 0.005). The difference between the CMTs of injected and control eyes was no longer significant at 24 weeks because of the recurrence of macular edema in 5 of 12 injected eyes. Before triamcinolone injection, the ETDRS score was 47.8+/-13 (mean +/- SD; range, 28-66) in injected eyes, versus 51.9+/-14.6 (range, 31-71) in control eyes. Twelve weeks thereafter, the corresponding values were 52.7+/-10.8 (range, 34-70) and 50.8+/-14.3 (range, 29-69), respectively, and at 24 weeks, 54.7+/-7.6 (range, 47-68) and 50.6+/-18.4 (range, 28-71). At no time was the difference between the ETDRS scores for injected and control eyes significant. In 6 of the 12 injected eyes, intraocular pressure exceeded 25 mmHg, and was controlled by topical medication. CONCLUSION: Intravitreal injection of triamcinolone effectively reduces macular thickening due to diffuse diabetic macular edema, at least in the short term. Further studies are required to demonstrate that it provides visual benefit.

Adult↗
PubMed2001

High levels of hepatitis C virus RNA in native livers correlate with the development of cholestatic hepatitis in liver allografts and a poor outcome.

A subset of hepatitis C virus (HCV)-positive liver transplant recipients develop cholestatic hepatitis (CH). We investigated the role of pretransplantation disease activity (estimated by Knodell score and HCV RNA quantitation) in the native liver explant on the development of CH and graft and patient outcome. Eight patients with CH were identified among HCV-positive liver transplants and were compared with 20 consecutive patients with recurrent HCV hepatitis of noncholestatic type in liver transplants. We evaluated all 28 explanted native livers histologically using the Knodell scoring system. HCV viral load was measured in the native explant and 5 allograft explants from the CH group using Amplicor HCV RNA Monitor test. Six of 8 patients with CH had HCV RNA levels of 5,000 copies/microg of DNA or greater in the native liver explant, whereas only 1 of the control group had viral loads greater than this level. Greater HCV RNA levels correlated with worse graft and patient survival (P <.001). The 3-year survival rate in the CH group was 18% compared with 77% in the control group (P <.001). There was no difference in the primary immunosuppressive regimens used in the 2 groups. We conclude that (1) CH has a uniformly poor prognosis, (2) type of immunosuppressive therapy appears to have little influence on the development of CH, (3) high pretransplantation HCV RNA levels in the native explant may predict the development of CH, and (4) patients with high HCV RNA levels in the explanted native liver may be appropriate candidates for antiviral therapy to prevent the development of CH.

Adult↗
PubMed1999

Response and progression in recurrent malignant glioma.

In this article we report the results of a study of the relationship between response and progression in 375 patients with recurrent glioma enrolled in phase II chemotherapy trials. We reviewed the records of patients from 8 consecutive phase II trials, including 225 patients with recurrent glioblastoma multiforme and 150 with recurrent anaplastic astrocytoma. Median age was 45 years (range, 15-82) and median Karnofsky performance score was 80 (range, 60-100). Forty-one patients (11%) had more than two prior resections and/or more than two prior chemotherapy regimens. Best response was complete (n = 1) or partial (n = 33) in 34 patients (9%). Median time to response was 14 weeks, and median response duration was 44 weeks. Simon-Makuch estimates for 52-week progression-free survival for patients progression-free at 13 weeks were 48% for response and 28% for nonresponse. When response was treated as a time-dependent covariate in a Cox proportional hazards regression analysis, response was associated with significantly lower failure rates (hazard ratio 0.5; 95% confidence interval 0.3-0.8; P = 0.0016). This study showed that response in recurrent glioma is associated with a significant reduction in progression rates.

Actuarial Analysis↗
PubMed2006

Expression of "Spot 14" (THRSP) predicts disease free survival in invasive breast cancer: immunohistochemical analysis of a new molecular marker.

Most breast cancers are "lipogenic", defined by high fatty acid synthase (FAS) content and dependence on fatty acid synthesis for growth and survival. S14 (Spot 14; THRSP) is a nuclear protein that activates genes required for fatty acid synthesis. The S14 gene is amplified in approximately 15% of breast cancers, but clinical correlates of its expression were unknown. We analyzed 131 breast cancers by immunohistochemistry for S14 and FAS. Staining was graded 0, 1, or 2+, and scores were correlated with traditional tumor markers, histological features, and outcome. S14 and FAS staining were related to tumor size (p=0.05 for S14, p=0.038 for FAS), but not to stage. S14 but not FAS scores correlated with tumor grade in both DCIS (p=0.003) and invasive cases (p<0.001). Invasive cases (pooled node - and +) with weak S14 staining (n=21) showed no recurrence over 3000 d follow-up, including 10 cases with lymph node involvement, whereas 32% of 67 strongly-staining tumors recurred (log rank p<0.0001). S14 scores did not cosegregate with sex steroid receptors, Her2/neu, or cyclin D1. Low level S14 expression is associated with prolonged disease-free survival in invasive cases, including those with nodal metastasis. High-level expression of S14 identifies a subset of high-risk breast cancers that is not specified by analysis of sex steroid receptors, Her2/neu, or cyclin D1, and provides a molecular correlate to histologic features that predict recurrence.

Adult↗