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At least 37 records · Page 2Linked to original sources
PubMed2000

Submacular surgery trials randomized pilot trial of laser photocoagulation versus surgery for recurrent choroidal neovascularization secondary to age-related macular degeneration: I. Ophthalmic outcomes submacular surgery trials pilot study report number 1.

PURPOSE: To report complications and changes in vision during 2 years of follow-up of patients with age-related macular degeneration assigned randomly to surgical removal or to laser photocoagulation of subfoveal recurrent neovascular lesions in a pilot trial designed to test methods, to refine estimates of outcome rates, and to project patient accrual rates for a larger multicenter randomized trial to evaluate submacular surgery. PATIENTS AND METHODS: Eligible patients with previous laser photocoagulation of extrafoveal or juxtafoveal choroidal neovascularization secondary to age-related macular degeneration were enrolled at 15 collaborating clinical centers. Assignments to treatment arm were made by personnel at a central coordinating center. Adherence to eligibility criteria and treatment assignment was assessed centrally at a photograph reading center. Patients were examined at 3, 6, 12, and 24 months after treatment for data collection purposes. Outcome measures reported include treatment complications, adverse events, requirements for additional treatment, and 2-year changes in visual acuity from baseline. RESULTS: Of 70 patients enrolled, 36 were assigned to laser photocoagulation and 34 to submacular surgery; all were treated as assigned. One patient in each group died before the 2-year examination. Visual acuity was measured at the 2-year examination for 31 of the surviving patients (89%) in the laser arm and for 28 of the surviving patients (85%) in the surgery arm. The 2-year measurements for 36 of the 59 patients (61%) were made by an examiner masked to treatment assignment and to the identity of the study eye. Improvements and losses of visual acuity were observed in both treatment arms; 20 of 31 study eyes (65%) in the laser arm and 14 of 28 study eyes (50%) in the surgery arm had visual acuity 2 years after enrollment that was better than or no more than 1 line worse than the baseline level. Changes in visual acuity and the size of the central macular lesions from baseline to the 2-year examination were similar in the treatment arms. Few serious complications were observed in either arm at the time of initial treatment; serious adverse events were rare. During follow-up, 11 laser-treated eyes and 18 surgically treated eyes had additional intraocular procedures. CONCLUSIONS: The data from this pilot trial suggest no reason to prefer submacular surgery over laser photocoagulation for treatment of patients with age-related macular degeneration who have lesions similar to those studied in this pilot trial. Any clinical trial designed to compare submacular surgery with laser photocoagulation in eyes with age-related macular degeneration and subfoveal recurrent neovascular lesions must enroll several hundred patients in order to reach a statistically valid conclusion regarding differences between these two methods of treatment with respect to either changes in visual acuity or complication rates.

Aged↗
PubMed1989

Estimation of trial-to-trial variation in evoked potential signals by smoothing across trials.

Averaging single trial evoked potential data to produce an estimate of the underlying signal obscures trial-to-trial variation in the response. We describe a method for estimating slow changes in the evoked potential signal by smoothing the data over trials. We discuss the crucial issue of deciding how much to smooth and suggest that an appropriate smoothing parameter is one that minimizes the estimated mean average square error of the smoothed data. Equations to estimate the mean average square error for a one-dimensional local linear regression smoother are presented. Performance of the method is assessed using simulated evoked potential data with several different models of a changing signal and different values of the signal-to-noise ratio. We find that the method rarely imputes trial-to-trial variation to data sets that have an unchanging signal, while it almost always produces less error than averaging when estimating a varying signal. The ability of the method to reveal signal heterogeneity is hampered by very low signal-to-noise ratios. When applied to real auditory evoked potential data from a sample of elderly subjects, the method indicated a changing signal in 35% of all subjects and in 56% of subjects with signal-to-noise ratios above 0.6. Consistent patterns of variation in the auditory evoked potential were present in this sample.

Aged↗
PubMed1995

Design of a multicenter trial to evaluate long-term life-style intervention in adults with high-normal blood pressure levels. Trials of Hypertension Prevention (phase II). Trials of Hypertension Prevention (TOHP) Collaborative Research Group.

Phase II of the Trials of Hypertension Prevention (TOHP) is a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute designed to test whether weight loss alone, sodium reduction alone, or the combination of weight loss and sodium reduction will decrease diastolic (DBP) and systolic blood pressure (SBP) as well as the incidence of hypertension (DBP > or = 90 mm Hg, SBP > or = 140 mm Hg, and/or use of antihypertensive medications) in subjects with high-normal DBP (83 to 89 mm Hg) and SBP less than 140 mm Hg at entry. These interventions were chosen for longer-term testing with end points including hypertension prevention as well as blood pressure (BP) change based on their demonstrated short-term efficacy in reducing BP in phase I of TOHP. The phase II study population is comprised of 2382 participants (1566 men and 816 women) who are 110 to 165% of desirable body weight, allocated at random to the four treatment arms using a 2 x 2 factorial design. The trial has 80% power to detect an overall treatment effect on DBP of 1.2 mm Hg for weight loss or sodium reduction and a difference of 1.6 mm Hg between the combined intervention and placebo groups. BP observers are blinded to participant treatment assignments. Participants will be followed for 3 to 4 years. This trial may have important public policy implications concerning the ability of life-style modifications to reduce BP and prevent the development of hypertension over the long term, thereby avoiding the need for drug therapy which while effective is costly and may have side effects.

Adult↗
PubMed1984

Trials on trial. A review of trials of antibiotic prophylaxis.

The ability of a small-scale random-control clinical trial comprising less than 500 patients to disclose clinically important differences between treatment groups depends on the event rate in the control group. The high rate of wound infection after abdominal operations has attracted many trials of methods of antibiotic prophylaxis. We reviewed all of the pertinent English literature recorded in Index Medicus in 1980 and 1981. We examined 45 articles for defects in design, analysis, and presentation. Of the 45 articles, 25 reported statistically significant differences between treatment groups and 20, no significant differences. Unsatisfactory methods of randomization were used in four trials, ethics were questionable in 22, statistical methods were incorrect in 31, and presentation was inadequate in 40. We concluded that there is room for improvement in the conduct of clinical trials.

Anti-Bacterial Agents↗
PubMed1983

[Clinical trial under trial. 'Trial and error'].

Randomized controlled clinical trials are being exposed to severe criticism in recent years. It is questioned if the use of placebos in such trials is ethically justified. This and other ethical problems will be discussed in this paper. Ethical problems include, besides the use of placebos, obtainment of informed consent and the belief in 'treatment indifference'. Beforehand a historical overview is presented and the design of the randomized controlled clinical trial is explained. Some other types of clinical trials will also be touched upon.

Clinical Trials as Topic↗
PubMedDate not supplied

Role of antiarrhythmic agents after myocardial infarction with special reference to the EMIAT and CAMIAT trials of amiodarone. European Myocardial Infarct Amiodarone Trial. Canadian Amiodarone Myocardial Infarction Trial.

The role of antiarrhythmic agents in the post-MI patients has been investigated for several years. Recently, clinical trials have assessed the effects of amiodarone in the post-MI population. The Basel Antiarrhythmic Study of Infarct Survival (BASIS) trial showed a reduction in total mortality, sudden death, and life-threatening ventricular arrhythmias with amiodarone therapy. The European Myocardial Infarct Amiodarone Trial (EMIAT) did not show a mortality benefit, but amiodarone was associated with fewer antiarrhythmic deaths. The Canadian Amiodarone Myocardial Infarction Trial (CAMIAT) showed no significant impact on mortality, but arrhythmia deaths and resuscitated cardiac deaths were reduced. Amiodarone therapy after MI should be reserved for the treatment of symptomatic or sustained ventricular arrhythmias. The current data do not support routine use of amiodarone in all patients after MI.

Amiodarone↗
PubMed2003

Do arrhythmia patients improve survival by participating in randomized clinical trials? Observations from the Cardiac Arrhythmia Suppression Trial (CAST)and the Antiarrhythmics Versus Implantable Defibrillators Trial (AVID).

It is debatable whether patients benefit directly from participation in a randomized clinical trial. We attempt to address this question for participants in the Cardiac Arrhythmia Suppression Trial (CAST) and the Antiarrhythmics Versus Implantable Defibrillators (AVID) studies. Survival rates were compared between eligible patients who enrolled in the trials and eligible patients who did not enroll, adjusting for baseline covariates. In CAST, despite that the active therapy was found to confer an almost threefold increased risk of death, survival was similar between the 3163 enrolled and the 1363 nonenrolled eligible patients. However, when patients were under study management, their risk of death was approximately 20% lower than when they left study management. In AVID, overall survival was similar between the 1016 enrolled and the 1246 nonenrolled eligible patients. However, mortality was substantially higher among patients not enrolled because the referring physician mandated the type of therapy. Overall these observational analyses suggest a net improvement in survival for the participants in these two trials.

Arrhythmias, Cardiac↗
PubMed1999

Rationale and design of The National Emphysema Treatment Trial: a prospective randomized trial of lung volume reduction surgery. The National Emphysema Treatment Trial Research Group.

The National Emphysema Treatment Trial is a multicenter, randomized clinical trial of medical therapy vs medical therapy plus lung volume reduction surgery (LVRS) for the treatment of patients with severe bilateral emphysema. LVRS will be accomplished by bilateral stapled excision via median sternotomy or video-assisted thoracoscopic surgery. Every patient will complete 6 to 10 weeks of pulmonary rehabilitation prior to randomization and will participate in a maintenance program of pulmonary rehabilitation after randomization. The primary outcome to be assessed by the trial is survival. Additional outcomes to be assessed are maximum exercise capacity, pulmonary function, oxygen requirement, distance walked in 6 min, quality of life, respiratory symptoms, and health-care utilization and costs. In addition, selected clinics will evaluate lung mechanics and respiratory muscle function, partial and maximal flow-volume curves, gas exchange during maximal exercise, and right heart function. The trial is targeted to enroll patients with severe emphysema who have no significant comorbid conditions; each patient will be randomized to one of the two treatment groups. The study duration is 4.5 years with a close-out period of 6 months.

Humans↗
PubMed1982

Progress report on two clinical trials in women with advanced breast cancer. Trial I: tamoxifen versus tamoxifen plus aminoglutethimide. Trial II: aminoglutethimide in patients with prior tamoxifen exposure.

A progress report is presented on two on-going clinical trials in women with advanced breast cancer. In Trial I to date, 56 patients have been randomized to tamoxifen (TAM) alone or TAM plus aminoglutethimide (AG) (plus hydrocortisone). Patients failing TAM can then receive AG. The two groups are reasonably well balanced with respect to prior hormonal therapy exposure (TAM, 19%; TAM plus AG, 17%), age, disease-free interval, performance score, and estrogen receptor status. The TAM plus AG group has a higher incidence of visceral dominant disease (41 versus 26%) and prior chemotherapy exposure (41 versus 33%). Responses have been observed in 7 of 27 (26%) patients on TAM and 11 of 28 (39%) on TAM plus AG. Median times to treatment failure (defined as disease progression, unacceptable toxicity, or patient refusal) are 211 and 123 days, respectively (log-rank on time to treatment failure, p = 0.87). Toxicity is greater for TAM plus AG with a higher incidence of skin rash, lethargy, and dizziness. Thrombotic events were seen in one patient on TAM and two patients on TAM plus AG. One patient on TAM plus AG developed leukopenia and sepsis. The data are too preliminary for one to draw firm conclusions regarding relative efficacy. In TRial II to date, 35 patients with prior tamoxifen exposure have received AG. The mean number of prior systemic therapies is 3.2 (range, 1 to 7). The response rate is 20% and similar with (21%) or without (19%) prior chemotherapy exposure. The median time to treatment failure is 92 days. One patient developed leukopenia and sepsis. Additional patient accrual is necessary to allow characterization of potential efficacy within prognostically important subsets.

Adult↗
PubMed2000

Rationale and design of the national emphysema treatment trial. A prospective randomized trial of lung volume reduction surgery. The national emphysema treatment trial research group

The National Emphysema Treatment Trial is a multicenter, randomized clinical trial of medical therapy vs medical therapy plus lung volume reduction surgery (LVRS) for the treatment of patients with severe bilateral emphysema. LVRS will be accomplished by bilateral stapled excision via median sternotomy or video-assisted thoracoscopic surgery. Every patient will complete 6 to 10 weeks of pulmonary rehabilitation prior to randomization and will participate in a maintenance program of pulmonary rehabilitation after randomization. The primary outcome to be assessed by the trial is survival. Additional outcomes to be assessed are maximum exercise capacity, pulmonary function, oxygen requirement, distance walked in 6 min, quality of life, respiratory symptoms, and health-care utilization and costs. In addition, selected clinics will evaluate lung mechanics and respiratory muscle function, partial and maximal flow-volume curves, gas exchange during maximal exercise, and right heart function. The trial is targeted to enroll patients with severe emphysema who have no significant comorbid conditions; each patient will be randomized to one of the two treatment groups. The study duration is 4.5 years with a close-out period of 6 months.

Journal Article↗
PubMed2000

Submacular surgery trials randomized pilot trial of laser photocoagulation versus surgery for recurrent choroidal neovascularization secondary to age-related macular degeneration: II. Quality of life outcomes submacular surgery trials pilot study report number 2.

PURPOSE: To summarize findings from health-related quality-of-life interviews with patients who had recurrent subfoveal choroidal neovascularization secondary to age-related macular degeneration and participated in a randomized pilot trial (focal confluent laser photocoagulation versus submacular surgery) that may assist in planning future assessments of health-related quality of life in patients with age-related macular degeneration. PATIENTS AND METHODS: Of 70 patients enrolled in the pilot trial, 54 were interviewed before random assignment to treatment and provided the data analyzed for this report. Patients were scheduled for follow-up interviews at 6, 12, and 24 months after enrollment. The 36-Item Short-Form Health Survey was used in all cases and was administered by an interviewer. The summary scales, Physical Component Summary and Mental Component Summary, were the focus of this analysis. RESULTS: Median Physical Component Summary and Mental Component Summary score at baseline were 47 and 53, respectively. Distributions of scores at baseline and throughout the 2-year follow-up period were similar in the two treatment arms and consistent with those of a sample of the general US population of similar age. Distributions of both Physical Component Summary scores and Mental Component Summary scores for individual patient subgroups at baseline suggested sensitivity to some measures of baseline vision. During 2 years of follow-up interviews, median changes in Physical Component Summary scores were decreases of six points in the laser arm and three points in the surgery arm; in both treatment arms, median change in Mental Component Summary scores was an increase of 2 points. Two-year changes in visual acuity had no discernible effect on Physical Component Summary scores or Mental Component Summary scores; baseline scores were the strongest predictors of 2-year changes in Physical Component Summary and Mental Component Summary scores. CONCLUSIONS: Overall, summary scores from the 36-Item Short-Form Health Survey and changes in scores over 2 years in this pilot trial were consistent with the ophthalmic outcome measures (reported elsewhere) that showed no important differences between the treatment arms. These health-related quality-of-life findings provided assurance that the similarity of ophthalmic outcomes in the two treatment arms did not mask changes potentially important to patients that were not captured as part of the clinical outcome data.

Aged↗
PubMed1996

Preliminary results from the cancer research campaign trial evaluating tamoxifen duration in women aged fifty years or older with breast cancer. Current Trials working Party of the Cancer Research Campaign Breast Cancer Trials Group.

BACKGROUND: Although trials of post-surgical tamoxifen therapy for patients with breast cancer have convincingly demonstrated reductions in relapse rates and improvements in survival, the optimal duration of therapy is as yet unclear. PURPOSE: Our objective is to determine whether 2 or 5 years of tamoxifen therapy (20 mg/day orally) is preferable in the treatment of patients with early breast cancer. METHODS: A randomized trial that was pragmatic in policy, allowing flexibility in primary treatment (i.e., type of surgery) and adjuvant therapy other than tamoxifen (i.e., radiotherapy or chemotherapy), was used to encourage maximum participation of clinicians and patients. This design allowed comparison of the two durations of tamoxifen therapy under conditions in which they would subsequently be applied in clinical practice. The patients were recruited from the oncology departments of participating hospitals in the U.K., Belgium, Poland, and Hong Kong. Those women who had completed an initial 2-year course of tamoxifen therapy after primary surgery and had not experienced a recurrence of breast cancer were asked to consider random assignment either to no further therapy or to an additional 3 years of tamoxifen. Follow-up reports (every 6 months for 3 years after random assignment and then annually) were required for all surviving study subjects. These reports recorded all breast cancer-related events (i.e., locoregional relapse and distant metastasis) or the development of new primary tumors (in the opposite breast or at any other site). For patients who died, the date and cause of death were recorded. Event-free survival; overall survival; and time to locoregional relapse, distant metastasis, or the development of new primary cancers were end points for the analysis. Survival comparisons were made by use of life tables and the logrank test. Reported P values are two-sided. RESULTS: By December 31, 1994, 2937 patients had accepted random assignment to treatment; 1470 were assigned to stop tamoxifen therapy after having received it for 2 years and 1467 were assigned to continue therapy for an additional 3 years (total, 5 years). An analysis was performed when the target for patient accrual had been reached, although the trial remains open. At a median follow-up of 2 years since the randomization, no difference in survival between the two treatment groups was detected (relative risk = 0.89; 95% confidence interval = 0.69-1.15), but a statistically significant delay in the time to relapse for patients receiving the longer treatment was demonstrated (relative risk = 0.81; 95% confidence interval = 0.69-0.98). CONCLUSIONS AND IMPLICATIONS: Our results suggest that 5 years may be better than 2 years of tamoxifen therapy, but more evidence regarding the optimal duration of tamoxifen therapy must be obtained.

Administration, Oral↗
PubMed1998

Phase III, large-scale chemoprevention trials. Approach to chemoprevention clinical trials and phase III clinical trial of tamoxifen as a chemopreventive for breast cancer--the US National Cancer Institute experience.

Clinical trials to evaluate interventions for cancer prevention are designed as early (phase I, IIa, and IIb) or late-phase studies. Whereas the former are small and generally rely on intermediate endpoint biomarkers of carcinogenesis, the latter are large-scale, long-term, randomized, phase III studies that address endpoints such as cancer incidence. The Breast Cancer Prevention Trial, P-1, conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP), is discussed as an example of a large, extended, phase III trial designed to answer the question of whether tamoxifen reduces the incidence of breast cancer in women who are at increased risk for the disease.

Breast Neoplasms↗
PubMed1990

Mortality rates after 10.5 years for participants in the Multiple Risk Factor Intervention Trial. Findings related to a priori hypotheses of the trial. The Multiple Risk Factor Intervention Trial Research Group.

The Multiple Risk Factor Intervention Trial was a primary prevention trial to test the effect of multifactor intervention on coronary heart disease mortality in high-risk men who were randomly assigned to special intervention (n = 6428) or to their usual sources of health care (n = 6438). As previously reported, after 6 to 8 years of intervention, mortality from coronary heart disease and from all causes did not differ significantly between men assigned to special intervention and men assigned to their usual sources of health care. This report describes the mortality findings after 10.5 years (an average of 3.8 years after the end of intervention). Mortality rates were lower for men who received special intervention than for men who received their usual care by 10.6% for coronary heart disease and by 7.7% for all causes. Differences in mortality rates were substantially larger after the end of intervention than observed to that point. Differences in mortality rates after 10.5 years were primarily due to a 24% reduction in the death rate from acute myocardial infarction in men receiving special intervention compared with men receiving their usual care. As before, mortality differences between special intervention and usual care varied according to the presence of resting electrocardiographic abnormalities. These data suggest that multiple risk factor intervention confers a mortality benefit in middle-aged men over a period of about 10 years.

Adult↗
PubMed2005

Randomized trial comparing cyclophosphamide, epirubicin, and fluorouracil with cyclophosphamide, methotrexate, and fluorouracil in premenopausal women with node-positive breast cancer: update of National Cancer Institute of Canada Clinical Trials Group Trial MA5.

PURPOSE: Certain anthracycline-containing adjuvant chemotherapy regimens are associated with improved relapse-free survival (RFS) and overall survival (OS) compared with the classic regimen of cyclophosphamide, methotrexate, and fluorouracil in women with early-stage breast cancer. PATIENTS AND METHODS: Between 1989 and 1993, 710 pre- and perimenopausal women with axillary node-positive breast cancer were randomly assigned to either cyclophosphamide 75 mg/m(2) orally days 1 through 14, epirubicin 60 mg/m(2) intravenously days 1 and 8, and fluorouracil 500 mg/m(2) intravenously days 1 and 8 (CEF) or CMF (cyclophosphamide 100 mg/m(2) orally days 1 through 14, methotrexate 40 mg/m(2) intravenously days 1 and 8, and fluorouracil 600 mg/m(2) intravenously days 1 and 8). On the basis of follow-up to May 1997 (median follow-up time, 59 months), there was a statistically significant improvement in RFS and OS for CEF compared with CMF. RESULTS: The trial results are now updated, with a median follow-up of 10 years for live patients. The 10-year RFS is 52% for patients who received CEF compared with 45% for CMF patients (hazard ratio [HR] for CMF v CEF = 1.31; stratified log-rank, P = .007). The 10-year OS for patients who received CEF and CMF are 62% and 58%, respectively (HR for CMF v CEF = 1.18; stratified log-rank, P = .085). The rates of acute leukemia have not changed since the original report, whereas the rates of congestive heart failure are slightly higher but acceptable (four patients [1.1%] in the CEF group v one patient [0.3%] in the CMF group). CONCLUSION: The previously demonstrated benefit of CEF compared with CMF adjuvant chemotherapy is maintained with longer follow-up in the MA5 trial.

Administration, Oral↗
PubMed2003

International Collaborative Ovarian Neoplasm trial 1 and Adjuvant ChemoTherapy In Ovarian Neoplasm trial: two parallel randomized phase III trials of adjuvant chemotherapy in patients with early-stage ovarian carcinoma.

BACKGROUND: Adjuvant chemotherapy has been suggested as a possible strategy to improve survival in women with early-stage ovarian cancer; however, all randomized studies to date have been too small to answer this question reliably. METHODS: We performed a preplanned combined analysis of two parallel randomized clinical trials (International Collaborative Ovarian Neoplasm 1 [ICON1] and Adjuvant ChemoTherapy In Ovarian Neoplasm [ACTION]) in early-stage ovarian cancer that compared platinum-based adjuvant chemotherapy with observation following surgery. Between November 1990 and January 2000, 925 patients (477 in ICON1 and 448 in ACTION) who had surgery for early-stage ovarian cancer were randomly assigned to receive platinum-based adjuvant chemotherapy (n = 465) or observation (n = 460) until chemotherapy was indicated. Kaplan-Meier analysis was used to compare overall and recurrence-free survival by treatment allocation. In subgroup analyses of pretreatment age, tumor stage, histologic cell type, and differentiation grade, the differences in relative size of effect were tested using a chi-square test for interaction or a chi-square test for trend. All tests of statistical significance were two-sided. RESULTS: After a median follow-up of over 4 years, 245 patients had died or had a recurrence (ICON1: 133, ACTION: 112). Overall survival at 5 years was 82% in the chemotherapy arm and 74% in the observation arm (difference = 8% [95% confidence interval (CI) = 2% to 12%]; hazard ratio [HR] = 0.67, 95% CI = 0.50 to 0.90; P =.008). Recurrence-free survival at 5 years was also better in the adjuvant chemotherapy arm than it was in the observation arm (76% versus 65%, difference = 11% [95% CI = 5% to 16%]; HR = 0.64, 95% CI = 0.50 to 0.82; P =.001). Subgroup analyses provided no evidence of a difference in the size of effect of chemotherapy on survival in any pretreatment subcategory. CONCLUSIONS: Platinum-based adjuvant chemotherapy improved overall survival and recurrence-free survival at 5 years in this combined group of patients with early-stage ovarian cancer defined by the inclusion criteria of the ICON1 and ACTION trials.

Aged↗
PubMed1987

Adjuvant tamoxifen in the management of operable breast cancer: the Scottish Trial. Report from the Breast Cancer Trials Committee, Scottish Cancer Trials Office (MRC), Edinburgh.

In a trial that began in 1978, 1312 evaluable patients under 80 years of age who either had negative axillary nodes or were postmenopausal with positive axillary nodes were randomised to receive adjuvant tamoxifen 20 mg daily for 5 years, or tamoxifen for the treatment of first relapse. Estimates of oestrogen receptor (ER) content of primary tumour specimens were made in 57%. There has been a highly significant delay in relapse in the adjuvant arm of the trial. This benefit supersedes that from tamoxifen given as treatment for recurrent disease in control-arm patients (93% received this) so that benefit from adjuvant tamoxifen was maintained in the overall survival comparisons. This improvement seems to be independent of nodal and menopausal status. It does not differ significantly with ER level, although the greatest benefit in disease-free survival is in patients with levels of 100 fmol/mg protein or more.

Adult↗