Randomized, surgical adjuvant clinical trial of recombinant interferon alfa-2a in selected patients with malignant melanoma.

1995 ◽  
Vol 13 (11) ◽  
pp. 2776-2783 ◽  
Author(s):  
E T Creagan ◽  
R J Dalton ◽  
D L Ahmann ◽  
S H Jung ◽  
R F Morton ◽  
...  
Keyword(s):  
Treatment Group ◽  
High Risk ◽  
Malignant Melanoma ◽  
Group Versus ◽  
Interferon Alfa ◽  
Stage I ◽  
Stage Ii ◽  
Control Group ◽  
Recombinant Interferon ◽  
Ifn Alpha

PURPOSE We conducted a randomized prospective trial in selected patients with fully resected high-risk stage I and II malignant melanoma. PATIENTS AND METHODS Interferon alfa-2a (IFN-alpha 2a) 20 x 10(6) U/m2 was administered three times each week for 12 weeks by the intramuscular route. Both the treatment group (n = 131) and the control group (n = 131) were evenly balanced with regard to relevant prognostic discriminants. RESULTS The median disease-free survival (DFS) time was 2.4 years for the IFN-alpha 2a group and 2.0 years for the observation group (log-rank P = 0.19). The median survival times were 6.6 years for IFN-alpha 2a and 5.0 years for observation (log-rank P = .40). For stage I patients (n = 102), there was no apparent therapeutic advantage from IFN-alpha 2a therapy. The DFS for stage II patients was a median of 10.8 months in the control group versus 17 months in the treatment group. The overall survival time was 4.1 years for the treatment group versus 2.7 years for the control group. The differences in DFS for stage II patient were significant in a Cox model. These results must be interpreted cautiously because of subset analysis. A severe flu-like toxicity occurred in 44% of patients, 13% lost at least 10% of their baseline weight, and 45% experienced a worsening of Eastern Cooperative Oncology Group (ECOG) performance score. CONCLUSION Our findings indicate trends that suggest a possible benefit for selected patients with high-risk malignant melanoma. The results will require further study in a larger patient population for confirmation.

Regression of cardiac amyloid deposits with novel therapeutics: reaching new frontiers in cardiac ATTR amyloidosis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L Chacko ◽  
A Martinez-Naharro ◽  
T Kotecha ◽  
R Martone ◽  
D Hutt ◽  
...  
Keyword(s):  
Treatment Group ◽  
Cardiac Amyloidosis ◽  
T1 Mapping ◽  
Group Versus ◽  
Control Group ◽  
Cardiac Amyloid ◽  
Attr Amyloidosis ◽  
Amyloid Load ◽  
The Impact

Abstract Background Cardiac involvement is the main driver of outcome in ATTR amyloidosis. Advances in therapeutics hold potential in transforming the course of the disease but the impact on cardiac amyloid load is unknown. The aim of this study was to evaluate the impact of patisiran, a new double stranded RNA based gene silencing therapy and a stabilizer, diflunisal, on cardiac amyloid load as measured by CMR and T1 mapping, in patients with ATTR amyloidosis. Methods and results Thirty-two patients with hereditary cardiac amyloidosis were studied. Sixteen patients received treatment with patisiran, and sixteen control subjects did not receive any disease modifying treatment. Patients were assessed with echocardiogram, CMR, NT-proBNP and six-minute walk time measurements at baseline and at 1 year (Mean interval 11.45±3.08 months in treatment group, mean interval 12.82±5.06 months in the control group). CMR analysis comprised LV volumes, T1 mapping to measure the extracellular volume (ECV) occupied by amyloid, T2 mapping and late gadolinium enhancement imaging. At 1-year follow-up, there was a substantial reduction in cardiac amyloid burden, in keeping with cardiac amyloid regression in 45% of patients on treatment. Overall the treatment group showed a reduction in ECV at 1 year follow up compared to an increase in ECV at 1 year in the control group (−1.37%, 95% CI: −3.43 to 0.68% versus 5.02%, 95% CI: 2.86% to 7.18% respectively, p<0.001). The treatment group also showed an improvement in change in 6MWT at 1 year follow up compared to 6MWT at 1 year in the control group (−8.12 meters, 95% CI: −50.8 to 34.6 meters in the treatment group versus −132.27 meters, 95% CI: −216 to −48.6 meters in the control group, p=0.002). The treatment group showed a reduction in BNP at 1 year follow up compared to an increase in the control group (−567.87, 95% CI: −1288.90 to 153.15 in the treatment group versus 2004, 95% CI: 12.82 to 3995.45 in the control group, p<0.001). There was no significant difference from baseline and 1-year data between the control and treatment groups for the difference in echocardiographic parameters, native T1, T2. There was a significant reduction in the percentage of injected dose by 99Tc-DPD scintigraphy in treated patients at 1 year compared to baseline. Conclusions These findings provide the first compelling evidence of substantial cardiac amyloid regression in ATTR amyloidosis, as well as the potential for CMR to be used to track response in treated patients with ATTR cardiac amyloidosis. Combination therapy with transthyretin knock down and stabilizing agents may well be synergistic given enhanced stoichiometry of stabilizers in the face of much reduced plasma transthyretin concentration. Funding Acknowledgement Type of funding source: None

High Risk Status for Stage I Palliation Increases Mortality Following Stage II But Not Stage III

2021 ◽  
Author(s):  
Garrett N. Coyan ◽  
Carlos Diaz-Castrillon ◽  
Mario Castro-Medina ◽  
Luciana Da Fonseca Da Silva ◽  
Melita Viegas ◽  
...  
Keyword(s):  
High Risk ◽  
Stage I ◽  
Stage Ii ◽  
Stage Iii ◽  
Risk Status

Effects of Early Intervention and Stimulation on the Preterm Infant

PEDIATRICS ◽  
1980 ◽  
Vol 66 (1) ◽  
pp. 83-90
Author(s):  
Susan A. Leib ◽  
D. Gary Benfield ◽  
John Guidubaldi
Keyword(s):  
Weight Gain ◽  
Early Intervention ◽  
Treatment Group ◽  
High Risk ◽  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Infant Development ◽  
Intervention Program ◽  
Control Group ◽  
Enrichment Program

To test the hypothesis that early intervention can enhance the development of high-risk preterm infants, a prescribed multimodal sensory enrichment program, within a regional neonatal intensive care unit, was designed and implemented. Twenty-eight appropriate-for-gestational age infants with birth weights between 1,200 and 1,800 gm were selected for study. To prevent control group contamination by the enrichment procedure, the first 14 infants were designated as the control group, and the next 14 as the treatment group. Treated infants had significantly higher developmental status than control infants, as measured by the Bayley Scales of Infant Development, at six months past the maternal expected date of confinement (F = 14.98, P < .001, and F = 16.46, P < .001 for the mental and motor scales, respectively). Mean infant weight gain per day and mean total weight gain during the hospitalization were not significantly different for the two groups although the treatment group received significantly less calories per kilogram per day than the control group (F = 9.02 P < .006). Our data suggest that a prescribed intervention program for high-risk preterm infants appears to enhance the quality of development as measured at six months past the expected date of confinement. Further studies are necessary to determine the long-term value of early intervention and the apparent ability of infants receiving an enrichment program to utilize calories more efficiently than control infants.

The Effect of Lullaby Intervention on Anxiety and Prenatal Attachment in Women with High-Risk Pregnancy: A Randomized Controlled Study

2021 ◽  
pp. 1-9
Author(s):  
Nazlı Baltacı ◽  
Mürüvvet Başer
Keyword(s):  
High Risk ◽  
Intervention Group ◽  
Group Versus ◽  
Mean Difference ◽  
High Risk Pregnancy ◽  
Controlled Study ◽  
Control Group ◽  
Prenatal Attachment ◽  
Randomized Controlled ◽  
Risk Pregnancy

<b><i>Background:</i></b> Women with high-risk pregnancy experience anxiety and low mother-fetal attachment when faced with signs of danger and health problems. This study aimed to investigate the effects of lullaby intervention on anxiety and prenatal attachment in women with high-risk pregnancy. <b><i>Materials and Methods:</i></b> This randomized controlled trial was conducted in the perinatology clinic of a state maternity hospital in Turkey. Seventy-six women with high-risk pregnancy were included. The intervention group listened to lullabies for 20 min once a day, and accompanied by lullabies touched their abdomen and thought about their babies, but the control group did not. Data were collected using the Pregnant Information Form, the State Anxiety Inventory, and the Prenatal Attachment Inventory. <b><i>Results:</i></b> Baseline anxiety did not differ in the intervention versus control group (47.83 ± 10.74 vs. 44.10 ± 8.08, mean difference 3.73 [95% Cl –1.18 to 8.64], <i>p</i> = 0.13), but after the 2nd day lullaby intervention anxiety was lower in the intervention group versus control group (33.66 ± 9.32 vs. 43.06 ± 8.10, mean difference –9.40 [95% Cl –13.91 to –4.88], <i>p</i> &#x3c; 0.01). Baseline prenatal attachment did not differ in the intervention versus control group (56.03 ± 10.71 vs. 53.86 ± 9.98, mean difference 2.16 [95% Cl –3.18 to 7.51], <i>p</i> = 0.42), but after the 2nd day lullaby intervention prenatal attachment was higher in the intervention group versus control group (66.70 ± 7.60 vs. 54.36 ± 9.52, mean difference 12.33 [95% Cl 7.87 to 16.78], <i>p</i> &#x3c; 0.01). In the within-group analysis the intervention group had lower anxiety and better prenatal attachment (<i>p</i> &#x3c; 0.01), but not in the control group (<i>p</i> &#x3e; 0.05). <b><i>Conclusion:</i></b> Lullaby intervention can play an effective role in reducing anxiety and improving prenatal attachment. The use of this integrative, noninvasive, non-pharmacologic, time-efficient, and natural intervention is suggested in the care of pregnant women.

Local Excision and Regional Perfusion in High-Risk Stage-I Malignant Melanoma of the Extremities

1984 ◽  
pp. 181-189
Author(s):  
H. Schraffordt Koops ◽  
J. Oldhoff ◽  
M. Nap ◽  
J. W. Oosterhuis ◽  
H. Beekhuis
Keyword(s):  
High Risk ◽  
Malignant Melanoma ◽  
Local Excision ◽  
Regional Perfusion ◽  
Stage I

scholarly journals Clinical Outcome of Patients With High-Risk Endometrial Carcinoma After Treatment With Chemotherapy Only

2018 ◽  
Vol 28 (9) ◽  
pp. 1789-1795 ◽  
Author(s):  
Elisabeth Smogeli ◽  
Milada Cvancarova ◽  
Yun Wang ◽  
Ben Davidson ◽  
Gunnar Kristensen ◽  
...  
Keyword(s):  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Recurrence Rate ◽  
Total Population ◽  
Standard Treatment ◽  
International Federation ◽  
Stage I ◽  
Stage Ii ◽  
Stage Iiic ◽  
Gynecology And Obstetrics

ObjectivesAdjuvant treatment of high-risk endometrial cancer (EC) is still controversial. Several studies have tried to clarify the best treatment strategy, and guidelines have been made, but no study to date has shown a survival benefit for radiation over chemotherapy. We aimed to evaluate the outcome of high-risk EC patients treated with adjuvant chemotherapy only in a population where the routine administration of adjuvant radiotherapy was omitted.MethodsThis is a retrospective study including 230 EC patients with International Federation of Gynecology and Obstetrics stage I type II, stage Ib type I/G3, stage II, and IIIc treated at Oslo University Hospital between 2005 and 2012. Standard treatment was hysterectomy, bilateral salpingo-oophorectomy and at least pelvic lymphadenectomy followed by adjuvant chemotherapy.ResultsOf the 230 high-risk patients, standard treatment was given to 146 patients (63.5%): 60 patients in stage I, 10 patients in stage II, and 76 patients in stage IIIc. Only 10% of patients with stage I disease relapsed, with 3.3% locoregional relapses and 6.7% distant relapses. Recurrence rate in stage IIIc was 39.5%, with 7.9% isolated vaginal and 31.6% distant relapses. The 3-year disease-free survival was 92% for stage I, 80% for stage II, and 60% for stage IIIc disease. In the total population, 55 patients had International Federation of Gynecology and Obstetrics stage Ia, 43 Ib, 42 stage II, and 90 stage IIIc disease. Recurrence rate in the total population was 29.6%, with 9.6% isolated vaginal recurrences, 1.7% recurrences located in the pelvis, and 18.3% distant recurrences.ConclusionsPatients with high-risk EC have acceptable vaginal/pelvic control rates after adjuvant chemotherapy. However, prognosis remains poor for patients with stage IIIc disease, also after chemotherapy.

Later Stage at Diagnosis and Worse Survival in Cutaneous Malignant Melanoma Among Men Living Alone: A Nationwide Population-Based Study From Sweden

2014 ◽  
Vol 32 (13) ◽  
pp. 1356-1364 ◽  
Author(s):  
Hanna Eriksson ◽  
Johan Lyth ◽  
Eva Månsson-Brahme ◽  
Margareta Frohm-Nilsson ◽  
Christian Ingvar ◽  
...  
Keyword(s):  
Malignant Melanoma ◽  
Clinical Stage ◽  
Age Groups ◽  
Population Based ◽  
Cutaneous Malignant Melanoma ◽  
Stage I ◽  
Stage Ii ◽  
Living Alone ◽  
Stage At Diagnosis ◽  
Population Based Study

Purpose To investigate the association between cohabitation status, clinical stage at diagnosis, and disease-specific survival in cutaneous malignant melanoma (CMM). Methods This nationwide population-based study included 27,235 patients from the Swedish Melanoma Register diagnosed with a primary invasive CMM between 1990 and 2007 and linked data to nationwide, population-based registers followed up through 2012. Results After adjustment for age at diagnosis, level of education, living area, period of diagnosis, and tumor site, the odds ratios (ORs) of higher stage at diagnosis were significantly increased among men living alone versus men living with a partner (stage II v stage I: OR, 1.42; 95% CI, 1.29 to 1.57; stage III or IV v stage I: OR, 1.43; 95% CI, 1.14 to 1.79). The OR for stage II versus stage I disease was also increased among women living alone (OR, 1.15; 95% CI, 1.04 to 1.28). After adjustments for the factors listed earlier, the CMM-specific survival was significantly decreased among men living alone (hazard ratio [HR] for death, 1.48; 95% CI, 1.33 to 1.65; P < .001). After additional adjustments for all potential and established prognostic factors, CMM-specific survival among men living alone versus men living with a partner remained significantly decreased (HR, 1.31; 95% CI, 1.18 to 1.46; P < .001), suggesting a residual adverse effect on survival not accounted for by these parameters. Conclusion In all age groups among men, living alone is significantly associated with reduced CMM-specific survival, partially attributed to a more advanced stage at diagnosis. This emphasizes the need for improved prevention and early detection strategies for this group.

Postoperative chemotherapy or no further treatment for patients with node-negative stage I-II intermediate or high risk endometrial cancer: The ENGOT-EN2/DGCG trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS5613-TPS5613 ◽  
Author(s):  
Mansoor Raza Mirza ◽  
Caroline Lundgren ◽  
Frederic Kridelka ◽  
Annamaria Ferrero ◽  
Stefano Greggi ◽  
...  
Keyword(s):  
Overall Survival ◽  
High Risk ◽  
Combination Chemotherapy ◽  
Primary Objective ◽  
Pelvic Lymphadenectomy ◽  
Stage I ◽  
Stage Ii ◽  
Endometrioid Adenocarcinoma ◽  
Node Negative ◽  
Eortc Qlq

TPS5613 Background: Patients with medium and high-risk stage I and II endometrial cancers (EC) have, despite radical surgery, a high risk for progression. Adjuvant brachytherapy or EBRT is the traditional therapy for many decades although without impacting on survival. Several studies have failed to demonstrate superiority of adjuvant chemotherapy in unselected population with a high number of low-risk patients. It is of utmost importance to demonstrate efficacy of adjuvant combination chemotherapy in a randomized trial comparing to no further treatment in the medium and high-risk node negative stage I and stage II patients. Methods: The primary objective of this trial is to evaluate the effect on overall survival of carboplatin-paclitaxel combination chemotherapy against no further systemic treatment. Key eligibility criteria include: histologically confirmed EC, stage I grade 3 endometrioid adenocarcinoma or stage II endometrioid adenocarcinoma or stage I and II type 2 histology (clear cell, serous, squamous cell carcinoma, carcinosarcoma or undifferentiated carcinoma); prior surgery with pelvic lymphadenectomy or sentinel lymph node biopsy. Patients may receive vaginal brachytherapy in both arms. 240 patients are randomized to receive six courses of adjuvant carboplatin (AUC5) and paclitaxel (175mg/m2) combination on day one every 21 days or no further treatment (1:1 randomization). Primary endpoint is overall survival of endometrioid subgroup. Secondary endpoints include overall survival of whole study population, disease specific survival, progression-free survival, toxicity, compliance, Quality of Life (assessed via EORTC QLQ-C30 and EORTC QLQ-EN24), rate of isolated pelvic or distant relapses, as well as mixed relapses. Trial is enrolling patients. The following cooperative groups are participating: DGCG (DK), NSGO (DK, FIN, SWE), BGOG (BEL), MaNGO (ITA), MITO (ITA), GEICO (SPA), NOGGO (GER), CEEGOG (Czech), ISGO (ISR) & MDACC (USA). Clinical trial information: NCT01244789.

Serum-based multiplex protein assay for early detection of colorectal cancer and precancerous lesions in a FIT positive population.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16145-e16145
Author(s):  
Herbert A. Fritsche ◽  
Jason Lee Liggett ◽  
Hong Zhang ◽  
Linnea Ferm ◽  
Ib Jarle Christensen ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
High Risk ◽  
Stage Iv ◽  
Stage I ◽  
Stage Ii ◽  
Supervised Machine Learning ◽  
Stage Iii ◽  
Screening Programs ◽  
Medium Risk ◽  
Validation Set

e16145 Background: Colorectal cancer (CRC) is the second leading cancer worldwide in terms of incidence, 5-year prevalence and mortality for both women and men ages 45 years old and up. The current screening method for many countries with organized screening programs is the FIT test for fecal occult blood; however, this test can result in false positive rates as high as 65%. A FIT reflex test could reduce unnecessary colonoscopies while reducing wait times for those patients that need confirmatory colonoscopies the most. Methods: Danish FIT positive colonoscopy confirmed serum samples (n = 1,499) were divided into training and validation sets maintaining approximately equivalent percentages of clean colonoscopy (40%), low risk adenomas (16%), medium risk adenomas (19%), high risk adenomas (13%), stage I CRC (5%), stage II CRC (2%), stage III CRC (4%), and stage IV CRC (0.5%). Proteins were quantified by custom 16-plex immunoassays utilizing the Luminex xMAP platform. A support vector machine supervised machine learning algorithm was trained with the 16 biomarkers plus age and FIT concentration using 1,291 samples for the outcome medium risk adenoma, high risk adenoma, and CRC. Then this algorithm was tested on a blind 208 sample validation set. Results: The training set was 90% sensitive and 27% specific (AUC = 0.68) and the validation set was 93% sensitive and 21% specific (AUC = 0.63). The sensitivities of the validation by risk/stage was as follows: medium risk adenoma 91%, high risk adenomas 92%, stage I CRC 100%, stage II CRC 100%, stage III CRC 100%, stage IV CRC 93%. Conclusions: This study demonstrates feasibility of a novel blood-based multiplex protein immunoassay for use as a reflex to FIT positive results in population wide screening. It detected nearly all adenomas and carcinomas while reducing FIT false positives and thus unnecessary colonoscopies by more than 20%. A FIT reflex test could alleviate endoscopy burden experienced in countries with organized cancer screening programs, while providing better patient outcomes by detecting polyps and early-stage CRC with high sensitivity.

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