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At least 217 records · Page 12Linked to original sources
PubMed2004

Evaluating the efficacy and safety of Danning Pian in the short-term treatment of patients with non-alcoholic fatty liver disease: a multicenter clinical trial.

BACKGROUND: Currently, the management of non-alcoholic fatty liver disease (NAFLD) is less than certain. Some choleretic might be of potential benefit and deserve further evaluation. This multicenter clinical trial was designed to evaluate the efficacy and safety of Chinese herbal medicine Danning Pian (composed of rhubarb, grant knotweed, dried green orange peel and dried old orange peel) in the short-term treatment of patients with NAFLD. METHODS: The efficacy and safety of Danning Pian in the short-term treatment of NAFLD were investigated in 232 patients by a multicenter clinical trial during the period of July 1999 to February 2000. The patients consisting of 189 males and 43 females with an average age of 46.1+/-8.7 years were given 3-5 tablets of Danning Pian orally thrice daily for 3 months in addition to the other comprehensive therapy. The effects of Danning Pian on NAFLD were evaluated by the improvement of clinical symptoms, blood lipids, hepatic enzymes and liver ultrasonographic features. The drug safety was monitored by physical examinations, vital signs, and laboratory tests in addition to the assessment of the adverse events. RESULTS: All the enrolled patients completed the study except one whose serum ALT level was moderately increased during the therapy with Danning Pian. The effective rate of Danning Pian for the improvement of clinical symptoms, serum ALT levels, blood lipid and fatty liver was 85.8%, 78.2%, 39.6% and 34.0% respectively after the therapy for 3 months. However, the reduction of excessive body weight and waistline did not reach the significant level on the whole after the therapy. The general mild adverse events included diarrhea, skin rash and mild to moderate elevation of serum ALT level. The incidence of adverse reaction was 15.1%. CONCLUSION: The data of this trial indicate that Danning Pian is effective and safe, generally well-tolerated without severe adverse events, in the treatment of patients with NAFLD over a 3-month period.

Adult↗
PubMed1990

The effect of fresh lymphocytes on increased sensitivity of HIV-1 isolation: a multicenter study.

A multicenter study was undertaken to determine the sensitivity and reproducibility of markers for human immunodeficiency virus type 1 (HIV-1) viral growth and the effect of various preparations of lymphocytes on the sensitivity of standard and routinely used procedures for HIV-1 isolation. In phase 1, cocultivated culture supernatants obtained from 10 HIV-1 cultures were transported to three Multicenter AIDS Cohort Study (MACS) Virology Laboratories. Three commercial HIV-p24 antigen capture (AC) tests and two reverse transcriptase (RT) assays were used to ascertain the replication of HIV-1. The Du Pont and Abbott AC assays were found to be most sensitive (85-100%), and the RT assay with 24-h incubation period had comparable sensitivity (75-100%). In phase II, the sensitivity of standard cocultivation procedure for HIV-1 isolation was compared using freshly phytohemagglutinin-P (PHA-P)-stimulated, stimulated-frozen, and frozen-thawed and then stimulated normal human peripheral blood mononuclear cells (PBMCs) as cocultivating cells. Blood samples from 13 HIV-1 infected individuals with various CD4+ cell counts were cocultivated in each of the three MACS laboratories using one of the aforementioned normal PBMCs. The PHA-P-stimulated fresh normal PBMC showed a maximum isolation rate of 100% (13 of 13) with an average of 8 days to positivity. This rate of isolation was significantly greater than other rates using any one of the other PBMC preparations. These findings demonstrated that the use of freshly PHA-P stimulated PBMCs maximized HIV-1 isolation from blood when a sensitive HIV-1 p24 AC assay or RT assay with overnight incubation is employed for the detection of HIV in culture supernatant.

Blood Preservation↗
PubMed1990

Angiographic assessment of patency and reocclusion: preliminary results of the Dutch APSAC Reocclusion Multicenter Study (ARMS).

The main objective of the ARMS (APSAC Reocclusion Multicenter Study) trial was to obtain patency and reocclusion data. In an open multicenter study, a total of 156 patients were treated with 30 U of anistreplase or anisoylated plasminogen streptokinase activator complex (APSAC) within 4 h after onset of pain. Patency of the infarct-related vessel was assessed by coronary angiography performed 90 minutes after anistreplase administration. In those patients with a patent infarct-related vessel at 90 min, repeat coronary angiography was performed at 24 h to assess the reocclusion rate. Two independent cardiologists evaluated the angiograms and scored the coronary artery perfusion of the infarct-related vessel. The preliminary data of the first 148 patients indicate that the patency rate at 90 min was 73-75% and the reocclusion rate at 24 h was 4%. This patency rate corresponds with previous studies. The low reocclusion rate is noteworthy and probably reflects the prolonged action of anistreplase.

Acute Disease↗
PubMed1990

Quantitative analysis of tomographic stress thallium-201 myocardial scintigrams: a multicenter trial.

The accuracy of the previously developed and validated Cedars-Sinai Medical Center (CSMC) computer program for quantitative analysis of thallium-201 (201TI) stress myocardial tomograms was assessed in a multicenter trial consisting of 242 patients with coronary angiography and 76 with a low likelihood (LL) of coronary artery disease (CAD) involving various cameras, computers, and operators. The program utilized gender-matched normal limits developed from 35 LL patients at CSMC. The multicenter results as compared to those of 168 patients from CSMC were not significantly different with respect to the overall sensitivities (94% versus 95%) and specificities (44% versus 56%) for identification of CAD and normalcy rates which were determined in LL patients (82% for both) and with respect to identification of individual diseased arteries. The results indicate that our method for quantifying tomographic 201TI stress scintigrams utilizing standard normal limits can be applied at other institutions by different operators, using a variety of cameras and computers, with similar accuracy to that currently obtained at our institution.

Coronary Disease↗
PubMed1989

ARIC hemostasis study--I. Development of a blood collection and processing system suitable for multicenter hemostatic studies.

In order to carry out a multicenter study aimed at understanding the association of hemostatic factors with atherosclerotic vascular disorders for the Atherosclerosis Risk In Communities (ARIC) Study, we compared a blood collection and processing system developed in our laboratory with the state-of-the-art-procedures. The salient features of our system included the use of a new phlebotomy set for venipuncture, the use of Millipore filters for removing platelet residues in the plasma and the use of a mixture of anticoagulants and antiplatelet agents for inhibiting the in vitro activation of platelets, coagulation and fibrinolytic system. The results derived from systematic evaluations indicate that this newly developed system yields the lowest values of plasma beta TG, PF 4 and FPA when compared with the reported values. The technique also gave reliable values of representative hemostatic measurements such as fibrinogen, factor VII, factor VIII, von Willebrand factor, antithrombin-III, protein C, tissue-type plasminogen activator, and serum thromboxane B2. Further experiments revealed that the samples withstood temporary storage at -70 degrees C and overnight "shipping" manipulations without significant changes in the hemostatic values. We conclude that the described blood collection and processing system may be a valuable asset for conducting multicenter cooperative clinical trials and epidemiologic studies involving blood collection by multiple field centers or clinics.

Adult↗
PubMed1989

[Direct transfer of obstetrical data by magnetic means in a randomized multicenter trial of the subjective count of fetal movements by the mother-to-be].

Ten Belgian maternity hospitals have collaborated in an international clinical multicenter trial: Multicenter Fetal Movement Trial. Nine maternity hospitals were already managing a computerized data bank before their participation in the trial. In seven of these centers the local team was able to write a program for direct transmission of data, using standard sequential ASCII files. This procedure presents many advantages: there is a gain in time and money, since it is no longer necessary to fill out data collecting forms, or coding at a central level. Transcription errors are avoided, adhesion to strict and standard definitions is guaranteed, the micro-systems are performing in a suitable fashion in each center, modifications of parameters (and corrections) are done very quickly and, automatically carried out, on the basis of clinical data as well as "research" data, transmission by telecommunication is immediately and easily feasible.

Belgium↗
PubMed1988

Famotidine in the management of duodenal ulcer: an analysis of multicenter findings worldwide.

An integrated analysis of the fifteen published prospective multicenter studies that have examined the safety and efficacy of famotidine for the short-term (13) and maintenance (2) therapy of duodenal ulcer included over 2,600 patients. The thirteen studies of endoscopically proved acute duodenal ulcer that were published in English or were available in a complete English translation were reviewed. Six of these studies compared famotidine with ranitidine, one with cimetidine, one with gefarnate, and one with placebo, and four were uncontrolled. In controlled studies of the short-term therapy of symptomatic duodenal ulcer, famotidine was equal in efficacy to ranitidine or cimetidine and superior to placebo and gefarnate at all times examined. The efficacy of famotidine was examined in three oral dosing regimens--20 mg BID, 40 mg HS, and 40 mg BID. There were no significant differences in efficacy or side effects associated with these three regimens. Overall, the cumulative healing rate with famotidine was 46% at two weeks, 77% at four weeks, and 91% at eight weeks. In studies involving 50 patients or more, famotidine 40 mg orally HS resulted in healing rates for active duodenal ulcer of 82% to 100% after four weeks. Adverse effects were uncommon with all dosages examined. Adverse effects led to the discontinuation of therapy in three patients--two owing to the development of rash and one because of dizziness. Headache and constipation were the most common adverse experiences, but in no study were the adverse experiences that were seen with famotidine significantly more frequent than those seen with ranitidine or placebo. No patient undergoing therapy for active duodenal ulcer had a biochemical abnormality that required a change in therapy or that was drug related in the opinion of the investigator. Multicenter studies examining the efficacy of famotidine in reducing the incidence of duodenal ulcer recurrence showed that famotidine was superior to placebo at all intervals examined. In conclusion, the data from the studies included in this review show that famotidine is highly effective and generally well tolerated both in the short-term treatment of active duodenal ulcer and in the maintenance therapy of duodenal ulcer.

Drug Administration Schedule↗
PubMed2003

Risk factors for postoperative infectious complications in noncolorectal abdominal surgery: a multivariate analysis based on a prospective multicenter study of 4718 patients.

HYPOTHESIS: Infectious complications are the main causes of postoperative morbidity in abdominal surgery. Identification of risk factors, which could be avoided in the perioperative period, may reduce the rate of postoperative infectious complications. DESIGN: A database was established from 3 prospective, randomized, multicenter studies. Multivariate analysis was performed using nonconditional logistic regression expressed as an odds ratio (OR). SETTING: Multicenter studies (ie, private medical centers, institutional hospitals, and university hospitals). PATIENTS: From June 1982 to September 1996, a database was established containing the information of 4718 patients who underwent noncolorectal abdominal surgery. MAIN OUTCOME MEASURES: The dependent variables studied included surgical site infection (SSI) (divided into parietal and deep infectious complications with or without fistulas) and global infectious complications (SSI and extraparietal and abdominal infectious complications). RESULTS: The rate of global infectious complications was 13.3%; SSI, 4.05%; parietal infectious complications, 2.2%; deep infectious complications with fistulas, 2.18%; and deep infectious complications without fistulas, 1.38%. In multivariate analysis, the following 7 independent risk factors for global infectious complications have been identified: age (60-74 years, OR, 1.64; >or=75 years, OR, 1.45); being underweight (OR, 1.51); having cirrhosis (OR, 2.45), having a vertical abdominal incision (OR, 1.66); having a suture placed or an anastomis of the bowel (OR, 1.48) in the digestive tract; having a prolonged operative time (61-120 minutes, OR, 1.66; 121 minutes, OR, 2.72); and being categorized as having a class 4 surgical site (ie, obese patients or having a risk factor of a healing defect) (OR, 1.66). Ceftriaxone sodium therapy was identified as a protective factor (OR, 0.43). In multivariate analysis, the following 5 independent risk factors for SSI have been identified: the existence of a preoperative cutaneous abscess or cutaneous necrosis (OR, 4.75), having a suture placed or an anastomosis of the bowel (OR, 1.82) in the digestive tract, having postoperative abdominal drainage (OR, 2.15), undergoing a surgical procedure for the treatment of cancer (OR, 1.74), and receiving curative anticoagulant therapy (OR, 3.33) postoperatively. CONCLUSIONS: Our data show that risk factors for SSI and for global infectious complications are disparate. Indeed, only the placement of a suture or having an anastomosis of the bowel in the digestive tract is a risk factor for both SSI and global infections. Some of these factors may be modifiable before or during the surgical procedure to reduce the infection rate or to prevent postoperative complications.

Adult↗
PubMed1998

Rate of insufficient samples for fine-needle aspiration for nonpalpable breast lesions in a multicenter clinical trial: The Radiologic Diagnostic Oncology Group 5 Study. The RDOG5 investigators.

BACKGROUND: Radiologic Diagnostic Oncology Group 5 is a multicenter clinical trial designed to evaluate fine-needle aspiration (FNA) of nonpalpable breast lesions performed by multiple operators using the same protocol. METHODS: Four hundred and nineteen women with mammographically detected nonpalpable breast lesions were enrolled on the trial at 18 institutions. Group A institutions randomized women to stereotactically guided FNA (SFNA) followed by stereotactically guided core needle biopsy (SCNB), or SCNB only. Group B institutions randomized women to SFNA and SCNB, SCNB, or ultrasonographically guided FNA followed by ultrasonographically guided core needle biopsy (USCNB), or USCNB only. A total of 377 women were eligible for analysis. RESULTS: FNA yielded 128 insufficient samples for the 377 patients (33.95%; 95% confidence interval, 29.2-38.7%). The rate of insufficient samples varied by type of lesion with calcified lesions associated with a significantly higher rate of insufficient sampling than masses (P < 0.001). The radiologist's level of suspicion of the lesion was not a statistically significant predictor of insufficient samples for mass lesions, but was a predictor for calcified lesions. For the 336 lesions for which histologic information was available, insufficient samples occurred in significantly more benign than malignant lesions. CONCLUSIONS: The high rate of insufficient samples for FNA of nonpalpable breast lesions in this multicenter trial makes its use impractical in this setting. Because of this factor, the study was terminated early.

Adult↗
PubMed1999

Identification of sentinel lymph nodes in vulvar carcinoma patients with the aid of a patent blue V injection: a multicenter study.

BACKGROUND: The aim of this multicenter study was to investigate the feasibility and negative predictive value of sentinel lymph node detection with blue dye in vulvar carcinoma patients. METHODS: In patients with squamous cell carcinoma of the vulva without suspicious groin lymph nodes, patent blue V was injected intradermally shortly before surgery. Routine groin lymph node dissection and radical vulvectomy were performed. During the surgery, blue lymph vessels and lymph nodes were identified, and the blue lymph nodes were sent separately for histologic examination. The negative predictive value of the blue lymph nodes for the absence of metastases was assessed by histologic examination of the groin lymph node specimens. RESULTS: Fifty-one patients in whom 93 groin lymph node dissections were performed were entered. One or more blue lymph nodes were detected in only 52 groins (56%). Nine (17%) of these were tumor positive, and 6 blue lymph nodes were the only tumor positive lymph nodes in the specimen in which they were found. There were two false-negative blue lymph nodes. The negative predictive value was 0.953. CONCLUSIONS: It was shown in this multicenter study that sentinel lymph node detection in vulvar carcinoma patients with blue dye only is not feasible because its negative predictive value is too low. Further studies involving the use of a combination of radioactive labeled technetium and blue dye are warranted.

Adult↗
PubMed1997

Reliability of maximal voluntary isometric contraction testing in a multicenter study of patients with amyotrophic lateral sclerosis. Syntex/Synergen Neuroscience Joint Venture rhCNTF ALS Study Group.

Maximal voluntary isometric contraction (MVIC) is becoming widely used for monitoring disease progression in amyotrophic lateral sclerosis (ALS). We evaluated the variability of MVIC in a large multicenter (29 sites) drug trial in ALS. Intra- and interrater variability were assessed twice during the 19-month study. Intrarater reliability increased from the first to the second test, approaching the reliability reported for a single experienced clinical evaluator, but interrater reliability did not. Multiple clinical evaluators in a single site increased the variability of MVIC measurements. Rigorous quality assurance standards and monitoring of clinical evaluators should be incorporated into the design of multicenter studies using MVIC, since low variability is necessary to detect a modest treatment effect.

Adult↗
PubMed1998

Sentinel lymph node biopsy and axillary staging of T1-T2 N0 breast cancer: a multicenter study.

From December 1996 to May 1998, 84 T1-T2 NO breast cancer patients were recruited for a multicenter study on the lymphoscintigraphic search of the axillary sentinel lymph node (SLN). The SLN was searched intraoperatively with a sodium iodide hand-held gamma-detecting probe (GDP) and excised before the standard axillary dissection was performed. Lymphoscintigraphy was unsuccessful in 8 of 84 cases (9.5%). In 73 of 76 patients with positive lymphoscintigraphy, SLN were found and excised (96%). The SLN proved to be predictive of axillary status in 71 of 73 cases (97.2%). Thirty of 41 patients had axillary metastases: in 16 cases, the SLN was the only site of the metastases (50%). In two cases, the SLN (reactive) did not match with the axillary status (2 of 63 reactive SLN, 4.6% of "skip" metastases). Age, tumor diameter, and histology seem to have little importance in affecting the predictivity of SLN biopsy. These results demonstrate the applicability of the lymphatic mapping techniques to a multicenter setting.

Axilla↗
PubMed1992

Internal radiation therapy for hepatocellular carcinoma. Results of a French multicenter phase II trial of transarterial injection of iodine 131-labeled Lipiodol.

Preliminary Phase I trials have shown iodine 131 (131I)-Lipiodol (ethiodized oil; Laboratoires Guerbet, Aulnaysous-Bois, France) to be well tolerated and most likely effective in the treatment of hepatocellular carcinoma (HCC). In this multicenter Phase II trial, the authors tested the feasibility and reproducibility of this treatment in other medical institutions and evaluated its efficacy in 50 patients with unresectable Stage I or II HCC, by the classification of Okuda et al. The authors studied 47 men and 3 women (63.9 +/- 7.1 years old) with Stage I (n = 18) or II (n = 32) HCC, by the classification of Okuda et al., which was verified by histologic findings (n = 25), cytologic findings (n = 11), or association of a tumor with alpha-fetoprotein serum values greater than 500 micrograms/l (n = 14). This multicenter trial (1) confirmed that the 131I-Lipiodol treatment is well tolerated; (2) showed that there is a high reproducibility of results with respect to other institutions and an objective tumor response in 40% of the cases; and (3) indicated the necessity of performing a randomized controlled study.

Adult↗
PubMed2000

A multicenter validation of an active contour-based left ventricular analysis technique.

Quantitative analysis of functional cardiac magnetic resonance (MR) images has been limited by the lack of well-validated, semiautomatic, methods for rapid analysis. We describe the evaluation of a DICOM-compatible PC-based parallel-processing tool, for cardiac magnetic resonance analysis (CAMRA), which supports semiautomatic image mensuration using an active contour model-based algorithm. The CAMRA software was used to analyze data from 12 patients in a multicenter acquisition and analysis trial to compare semiautomatic contour detection with manual planimetry of the left ventricular endocardium from short-axis, breath-held, cine gradient-echo images. There was excellent agreement between the manual and semiautomatic measurements of global left ventricular function, with no significant (P = 0.32) difference in the determination of ejection fraction (-0.9 +/- 3.1% [mean difference +/- 1 standard deviation]). There was no significant interobserver difference in the semiautomatically measured ejection fraction. Additionally, a single observer completed the analysis on data from 30 patients and found no significant (P = 0.05) difference in the determination of ejection fraction (-1.3 +/- 3.5% [mean difference +/- 1 standard deviation]). The CAMRA software demonstrates the capability for the reproducible evaluation of global left ventricular function in cardiac patients, with adequate interobserver reproducibility for use in multicenter trials.

Adult↗
PubMed2002

A multicenter, randomized, double-blind, placebo-controlled trial of adjuvant methotrexate treatment for giant cell arteritis.

OBJECTIVE: To evaluate treatment with methotrexate (MTX) in patients with newly diagnosed giant cell arteritis (GCA) to determine if MTX reduces GCA relapses and cumulative corticosteroid (CS) requirements and diminishes disease- and treatment-related morbidity. METHODS: This was a multicenter, randomized, double-blind study. Over 4 years, 16 centers from the International Network for the Study of Systemic Vasculitides enrolled patients with unequivocal GCA. The initial treatment was 1 mg/kg/day (<or=60 mg every day) prednisone, plus either 0.15 mg/kg/week MTX (increased to 0.25 mg/kg/week, for a maximum weekly dosage of 15 mg) or placebo. Two physicians, both blinded to treatment allocation, evaluated each patient at every trial visit. One physician was responsible for providing global medical care. The other assessed GCA status according to a standard protocol. Treatment failure was defined as 2 distinct relapses or persistence of disease activity after the first relapse, in spite of increased CS therapy. RESULTS: Ninety-eight patients were enrolled. No significant differences between treatment groups were noted with regard to age, frequency of positive findings on temporal artery biopsy (placebo 87%, MTX 79%), or comorbidities at the time of enrollment. The median dosage of MTX was 15 mg/week. The incidence of treatment failure was comparable between groups after 12 months: 57.5% in the MTX group failed treatment (95% confidence interval [95% CI] 41.6-73.4%) compared with 77.3% in the placebo group (95% CI 61.9-92.8%) (P = 0.26). In a Cox regression analysis, MTX was not associated with a reduced risk of treatment failure (relative risk 0.72; 95% CI 0.41-1.28). There were no significant differences between groups with regard to abnormal elevations of the erythrocyte sedimentation rate following initial remissions, serious morbidity due to GCA, cumulative CS dose, or treatment toxicity. In the MTX group, there were fewer cases of GCA relapse heralded by symptoms of isolated polymyalgia rheumatica (1 case versus 5 in the placebo group; P = 0.05). CONCLUSION: The results of this randomized, multicenter trial do not support the adjunctive use of MTX to control disease activity or to decrease the cumulative dose and toxicity of CS in patients with GCA.

Aged↗
PubMed1999

NC100100, a new echo contrast agent for the assessment of myocardial perfusion--safety and comparison with technetium-99m sestamibi single-photon emission computed tomography in a randomized multicenter study.

BACKGROUND AND HYPOTHESIS: Myocardial contrast echocardiography using second-generation agents has been proposed to study myocardial perfusion. A placebo-controlled, multicenter trial was conducted to evaluate the safety, optimal dose, and imaging mode for NC100100, a novel intravenous second-generation echo contrast agent, and to compare this technique with technetium-99m sestamibi (MIBI) single-photon emission computed tomography (SPECT). METHODS: In a placebo-controlled, multicenter trial, 203 patients with myocardial infarction > 5 days and < 1 year previously underwent rest SPECT and MCE. Fundamental and harmonic imaging modes combined with continuous and electrocardiogram-- (ECG) triggered intermittent imaging were used. Six dose groups (0.030, 0.100, and 0.300 microliter particles/kg body weight for fundamental imaging; and 0.006, 0.030, and 0.150 microliter particles/kg body weight for harmonic imaging) were tested. A saline group was also included. Safety was followed for 72 h after contrast injection. Myocardial perfusion by MCE was compared with myocardial rest perfusion imaging using MIBI as a tracer. RESULTS: NC100100 was well tolerated. No serious adverse events or deaths occurred. No clinically relevant changes in vital signs, laboratory parameters, and ECG recordings were noted. There was no significant difference between adverse events in the NC100100 (25.7%) and in the placebo group (17.9%, p = 0.3). Intermittent harmonic imaging using the intermediate dose was superior to all other modalities, allowing the assessment of perfusion in 76% of all segments. Eighty segments (96%) with normal perfusion by SPECT imaging also showed myocardial perfusion with MCE. However, a substantial percentage of segments (61-80%) with perfusion defects by SPECT imaging also showed opacification by MCE. This resulted in an overall agreement of 66-81% and a high specificity (80-96%), but in low sensitivity (20-39%) of MCE for the detection of perfusion defects. CONCLUSION: NC100100 is safe in patients with myocardial infarction. Intermittent harmonic imaging with a dose of 0.03 microliter particles/kg body weight can be proposed as the best imaging protocol. Myocardial contrast echocardiography with NC 100100 provides perfusion information in approximately 76% of segments and results in myocardial opacification in the vast majority of segments with normal perfusion as assessed by SPECT. Although the discrepancies between MCE and SPECT with regard to the definition of perfusion defects requires further investigation, MCE with NC 100100 is a promising technique for the noninvasive assessment of myocardial perfusion.

Aged↗
PubMed2002

The prognostic value of immunohistochemically detected CD44v3 and CD44v6 expression in patients with surgically staged vulvar carcinoma: a multicenter study.

BACKGROUND: Isoforms of the adhesion molecule CD44 are involved in carcinogenesis and the metastatic cascade of tumor cells by increasing the affinity of malignant cells to their extracellular matrix. Preliminary data with respect to the prognostic value of the CD44 isoforms CD44v3 and CD44v6 in patients with vulvar carcinoma showed promising results. The current multicenter study aimed to determine the prognostic value of CD44v3 and CD44v6 in patients with surgically staged vulvar carcinoma. METHODS: Expression of CD44v3 and CD44v6 in vulvar carcinoma tissue was assessed by immunohistochemistry. Immunohistochemical staining was performed according to established protocols. Results were correlated to clinical data. RESULTS: A positive CD44v3 and CD44v6 staining was detected in 33.3% (33 out of 99) and 39.4% (39 out of 99) of the tumor samples, respectively. Overexpression of CD44v6 was associated with an impaired prognosis with respect to disease-free survival (P = 0.01) and overall survival (P = 0.04). Multivariate analysis showed that CD44v6 provided prognostic information with respect to disease-free survival (P = 0.001) and overall survival (P = 0.005) independently of the two established prognosticators, tumor stage and groin lymph node involvement. Overexpression of CD44v3 had no impact on patient survival. CONCLUSIONS: The current multicenter study, involving a large series of patients with surgically staged vulvar carcinoma, allowed for multivariate survival analysis and showed that CD44v6 confers prognostic information in addition to that provided by the established clinicopathologic parameters of tumor stage and lymph node status.

Adult↗
PubMed2003

High-dose sequential chemotherapy and peripheral blood progenitor cell autografting in patients with refractory and/or recurrent Hodgkin lymphoma: a multicenter study of the intergruppo Italiano Linfomi showing prolonged disease free survival in patients treated at first recurrence.

BACKGROUND: The objective of the current study was to evaluate in a multicenter setting the feasibility and efficacy of a high-dose sequential (HDS) chemotherapy regimen that combined intensive debulking and high-dose therapy (HDT) with peripheral blood progenitor cell (PBPC) autografting in patients with refractory or recurrent Hodgkin lymphoma (HL). METHODS: Data were collected from 102 patients with HL who were treated with the HDS regimen at 14 centers associated with the Intergruppo Italiano Linfomi. Twenty-four patients had primary refractory HL, 59 patients had their first recurrence of HL (within 1 year in 32 patients and > 1 year in 27 patients), and 19 patients had multiple disease recurrences. The HDS regimen included the sequential delivery of high-dose (hd) cyclophosphamide with PBPC harvesting, methotrexate, etoposide, then HDT (usually hd mitoxantrone plus L-phenylalanine mustard) with PBPC autografting. In addition, radiotherapy was delivered to 36 patients at sites of bulky or persistent disease. RESULTS: Ninety-two patients (90%) completed the HDS program. There were five toxic deaths (treatment-related mortality rate, 4.9%) and six secondary malignan cies (five patients developed myelodysplastic syndrome/acute myelogenous leukemia, and one patient developed colorectal carcinoma). At a median follow-up of 5 years, the 5-year overall survival (OS) and event-free survival (EFS) projections were 64% (95% confidence interval [95% CI], 54-74%) and 53% (95% CI, 43-63%), respectively. Patients with their first recurrence had the most favorable outcome, with 5-year OS and EFS projections of 77% (95% CI, 66-88%) and 63% (95% CI, 50-76%), respectively. There were no significant differences between patients with early first recurrence and late first recurrence. The poorest outcome was observed in patients with refractory HL, with 5-year OS and EFS projections of 36% (95% CI, 16-55%) and 33% (95% CI, 14-52%), respectively. Patients who received HDS chemotherapy after multiple recurrences had an intermediate outcome. Multivariate analysis showed that refractory disease and systemic symptoms at the time of initial presentation were associated significantly associated with poor OS and EFS. CONCLUSIONS: The use of HDS chemotherapy for patients with refractory and/or recurrent HL is feasible at the multicenter level. The combination of intensive debulking and HDT with PBPC autografting offers a good chance of prolonged disease free survival for patients with their first recurrence of HL.

Adolescent↗