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Biomedical subjects

B Lund

Publications and source records attributed to B Lund.

At least 91 records · Page 5Linked to original sources
PubMed1994

The outcome of nonoperated patients with chronic lateral instability of the ankle: a 20-year follow-up study.

Thirty-seven patients conservatively treated because of chronic lateral instability of the ankle were studied 18 to 23 years after their index visit. Twenty-two patients, 12 with unilateral and 10 with bilateral symptoms (32 of 49 ankles), still suffered from instability, but only three considered further treatment. Degenerative changes were observed in six of 46 radiographically examined ankles, with no correlation to age or persistent instability.

Adolescent↗
PubMed1994

Single-agent activity of weekly gemcitabine in advanced non-small-cell lung cancer: a phase II study.

PURPOSE: To evaluate the efficacy and safety of gemcitabine, a pyrimidine antimetabolite with activity against solid tumours. PATIENTS AND METHODS: Eighty-two patients with unresectable stage IIIa to IV non-small-cell lung cancer (NSCLC) were entered. The first 54 patients received gemcitabine 800 mg/m2, and subsequent patients 1,000 mg/m2, as a 30-minute intravenous infusion on days 0, 7, and 14. Courses of therapy were repeated every 28 days. Twenty percent dosage escalation was permitted after course no.1 if World Health Organization (WHO) toxicity was < or = 1. RESULTS: Sixteen (20%; 95% confidence interval [CI], 12% to 31%) of 79 patients assessable for response had independently validated partial responses, with a median duration of 7 months. The overall median survival duration was 7 months. Gemcitabine improved disease-related symptoms (70% patients) and increased WHO performance status (44%). Toxicity was generally mild and reversible. Patients experienced little WHO grade 3 and 4 toxicity, with anemia in four (5%), thrombocytopenia in one (1%), leukopenia in six (7%), and neutropenia in 18 (22%). Infection occurred in nine patients (12%) during the study (four were neutropenic), but there were no episodes of WHO grade 3 or 4 infection. WHO grade 3 and 4 biochemical toxicity occurred with transient elevations of transaminases in 10 patients (12%). Two patients had transient WHO grade 3 elevation of serum creatinine levels, and two developed acute renal failure 4 and 6 weeks after the last dose of gemcitabine. There was no WHO grade 4 symptomatic toxicity. WHO grade 3 vomiting occurred in 31 patients (38%) and grade 3 alopecia in one (1%). Flu-like symptoms were associated with gemcitabine administration in 36 patients (44%). Twenty-six patients (32%) experienced fever (1% WHO grade 3), 33 (40%) ankle edema not associated with cardiac failure, 31 (38%) lethargy, and 11 (13%) dyspnea. CONCLUSION: Gemcitabine is an active new agent in the treatment of NSCLC. This schedule was associated with little alopecia or myelosuppression. Gemcitabine warrants further investigation in other malignancies and in combination with other agents.

Adult↗
PubMed1994

Clinical studies with EO9, a new indoloquinone bioreductive alkylating cytotoxic agent. EORTC Early Clinical Trials Group.

EO9 [3-hydroxy-5-aziridinyl-1-methyl-2-(1H-indole-4,7-indione)-prop-be ta- en-alpha-ol] is a new bioreductive alkylating indoloquinone with a distinct antitumor activity against solid tumors, excellent activity under hypoxic conditions, and lack of bone marrow toxicity in preclinical models. Clinical phase I studies were performed to determine the toxicities, maximally tolerated dose, and pharmacology of EO9. The drug was administered as a 5-min IV infusion at intervals of 3 weeks or weekly to 59 patients with solid tumors. The starting dose of 2.7 mg/m2 was one-tenth of the mouse-equivalent dose lethal to 10% of mice. Doses were escalated according to a Fibonacci-like schedule. The pharmacokinetics of EO9 and its aziridine ring-opened metabolite EO5A were determined using a new high performance liquid chromatography method and noncompartmental calculation of kinetic parameters. The sigmoid maximal effects (Emax) model was used to fit pharmacokinetic parameters to toxicities. The 59 patients received in total 150 evaluable courses of EO9. The dose-limiting toxicity was proteinuria, which was accompanied by sodium and water retention. With the 3-weekly schedule, all symptoms were reversible on day 15 except in 2 patients, who developed acute renal failure. The renal function and proteinuria were quantitated and further evaluated by determining renal clearance ratios of immunoglobulin G/albumin and pancreatic/salivary amylase. The immunogobuline G/albumin and pancreatic/salivary amylase ratios pointed to a loss of glomerular negative charge consistent with a minimal change glomerulopathy. The maximum tolerated dose was 27 mg/m2, the recommended dose 22 mg/m2. The pharmacokinetics showed rapid elimination from the central compartment and wide interpatient variation in disposition.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1994

The value of CA 125 measurement before second-look laparotomy in patients with ovarian carcinoma.

Serum CA 125 levels were evaluated in 71 patients undergoing second-look laparotomy for primary epithelial ovarian cancer. With a cut-off limit of 35 U/ml, 17 of 45 patients with residual disease (38%) were CA 125-positive. All of 26 patients with pathological complete response were marker-negative. Second-look laparotomy may be avoided in a select group of patients with elevated CA 125 values.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1993

[External hip protectors against hip fractures. A randomized study in a nursing home].

Most hip fractures seem to be related to trauma near the hip, so a controlled trial was conducted to investigate the effect of external hip protectors on the prevention of such fractures in residents of a nursing home. Ten of 28 wards of the nursing home were randomized to receive external hip protectors; thus 167 women and 80 men were given protectors and 277 women and 141 men no protectors. A fall register was set up for two treatment wards (45 residents) and two control wards (76 residents). There were eight hip and 15 non-hip fractures in the hip protector group and 31 hip and 27 non-hip fractures in the control group. The relative risk of hip fractures among women and men in the intervention group was 0.44 (95% CL 0.21-0.94). None of the 8 residents in the intervention group who had a hip fracture was wearing the device at the time of the fracture. 154 falls were registered and 20% of these falls produced a direct impact to the hip. In 25 falls direct impact to the hip was sustained at a time when hip protectors were not being worn, and six fractures were produced. The study indicates that external hip protectors can prevent hip fractures in nursing-home residents.

Accidental Falls↗
PubMed1993

Effect of external hip protectors on hip fractures.

Most hip fractures seem to be related to trauma near the hip, so a controlled trial was conducted to investigate the effect of external hip protectors on the prevention of such fractures in residents of a nursing home. 10 of the 28 wards in the nursing home were randomised to receive external hip protectors; thus 167 women and 80 men were given protectors and 277 and 141 men no protectors. A fall register was set up for 2 treatment wards (45 residents) and 2 control wards (76 residents). There were 8 hip and 15 non-hip fractures in the hip-protector group and 31 hip and 27 non-hip fractures in the control group. The relative risk of hip fractures among women and men in the intervention group was 0.44 (95% CI 0.21-0.94). None of the 8 residents in the intervention group who had a hip fracture was wearing the device at the time of the fracture. 154 falls were registered and 20% of these falls produced a direct impact to the hip. In 25 falls direct impact to the hip was sustained at a time when hip protectors were not being worn, and 6 fractures were produced. The study indicates that external hip protectors can prevent hip fractures in nursing-home residents.

Accidental Falls↗
PubMed1993

Changing incidence and residual lifetime risk of common osteoporosis-related fractures.

Changes in incidence and lifetime risk of fractures are of major importance in the epidemiology of osteoporosis. We focused on hip fractures in women and men and on radial and humeral fractures in women. The study subjects comprised 4500 women and men 20 years old or more with fractures. In women 1735 fractures of the distal radius, 747 fractures of the proximal humerus, 878 cervical and 635 trochanteric hip fractures were included. In men 273 cervical and 232 trochanteric hip fractures were included. The fractures were registered during the period 1976 to 1984 and changes in age-specific incidence were calculated (chi-squared test for linear trend; p-values less than 0.05 were considered significant). On the basis of life tables and population background data, the lifetime risk was estimated. The incidence of cervical hip fractures in women aged 60-89 years decreased significantly (p < 0.05) during the observation period, while no significant decrease was found in the incidence of trochanteric fractures. No significant changes in incidence were observed in women with radial or humeral fractures, or in men with hip fractures. A women 60 years old with a life expectancy of 81 years had an estimated residual lifetime risk of radial, humeral or hip fracture of 17%, 8% and 14% respectively. A man 60 years of age with a life expectancy of 77 years had an estimated risk of hip fracture of 6%.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1993

Radial and humeral fractures as predictors of subsequent hip, radial or humeral fractures in women, and their seasonal variation.

Hip fractures are common in elderly women, and early risk assessment of future hip fractures is relevant in relation to prevention. We studied the predictive value of radial and humeral fractures in women. The influence of weather conditions on the risk was also studied. Women aged 20-99 years with a fracture of the distal radius (n = 1162) or proximal humerus (n = 406) were followed for 0 to 9 years. The relative risk (RR) and 95% confidence limits (CL) of subsequent fracture among women suffering radial or humeral fractures compared with the background population were calculated. Women 60-79 years of age who had suffered a fracture of the distal radius or proximal humerus had relative risks of sustaining a hip fracture of 1.9 (1.3-2.6, 95% CL) and 2.5 (1.3-3.6, 95% CL) respectively. The relative risk of hip fracture was highest within the first years following a fracture of the radius or the humerus. Women suffering an upper extremity fracture (radius or humerus) in snowy or icy weather had a marginally increased risk (RR = 1.3, 0.4-2.3, 95% CL and RR = 1.8, 0.3-3.4, 95% CL) for a later hip fracture. A woman 50 years old with a radial or a humeral fracture had an estimated residual lifetime risk of sustaining a subsequent hip fracture of 17% and 16% respectively compared with 11% for the background population.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1993

Research cost analyses to aid in decision making in the conduct of a large prevention trial, CARET. Carotene and Retinol Efficacy Trial.

Because of their larger study populations and longer durations, prevention trials typically are more costly than treatment trials. Thus it is important to analyze costs systematically to aid in making cost-effective decisions during the conduct of prevention trials as well as in the original design. Cost analysis must be tied to sample size estimation because costs depend on such factors as the total number of person-years of follow-up and the number of trial outcomes, which are not basic design parameters but are derived quantities resulting from sample size estimation. We illustrate the use of cost analysis to decide among options for future conduct of an ongoing prevention trial with three issues that have arisen during the Carotene and Retinol Efficacy Trial (CARET): the trade-off between extending the duration of the trial or increasing the number of participants, the effect on costs of delay in accrual, and the cost effectiveness of particular retention activities.

Anticarcinogenic Agents↗
PubMed1993

Advanced ovarian cancer. An overview of multi-variate analyses of prognostic variables with special reference to the role of cytoreductive surgery.

BACKGROUND: Cytoreductive surgery is still widely believed to be a cornerstone in the management of advanced ovarian cancer. In the absence of data from prospective randomized trials, multi-variate analysis can assist in evaluating the role of optimal surgical cytoreduction relative to other possible prognostic variables. MATERIALS AND METHODS: Published analyses of prognostic variables have been reviewed and the consistency and reproducibility of variables have been considered. RESULTS: When reviewing the most recent literature it is obvious that there is a need to develop a consensus as to the most important patient characteristics which should be reported. Furthermore, these characteristics need to be standardized as do definitions such as toxicity, grading, and response criteria and duration. Subjective variables such as performance status, histological grading and typing, present a special problem as these lack reproducibility. The overview of multi-variate analyses for prognostic variables such as residual tumour size, tumour size prior to cytoreductive surgery, cisplatin therapy, grade, stage, histology, and performance status demonstrates that the impact of individual prognosticators depends on the indicators included in the analysis and that the importance of these variables could change as new technologies and treatments are introduced. CONCLUSIONS: The collection of a single data base including all known variables reported for each patient with appropriate attention to the careful evaluation of subjective indicators should be undertaken, with a view to establishing a prognostic index. This would allow the relative risk for individual patients to be assessed.

Clinical Trials as Topic↗
PubMed1993

Long-term follow-up of patients with advanced ovarian carcinoma treated with chemotherapy.

BACKGROUND: The evolution of the management of advanced ovarian carcinoma over the last fifteen years has resulted from a number of well-designed randomized trials involving large numbers of patients. MATERIALS AND METHODS: A critical review of long-term follow-up of patients entered onto eleven major randomized trials of advanced ovarian carcinoma has been performed. RESULTS: In the pre-platinum era no long-term survival benefit was obtained with combination compared with single agent chemotherapy. When adding cisplatin to front-line therapy at least a short-term gain in terms of superior response rate and progression-free intervals is obtained compared with non-cisplatin combination chemotherapy. Survival data are more difficult to assess due to the use of cisplatin-containing salvage therapy. Cisplatin-based combination therapy also offers enhanced patient benefit when compared with cisplatin alone. A slight advantage favouring anthracycline-containing therapy is observed, whereas no advantage is obtained with alternating cisplatin and non-cisplatin regimens or by adding BCG. CONCLUSIONS: Platinum-based combination chemotherapy is clearly associated with improved response rates and progression-free survival and, at least in some studies, better overall survival. At least six cycles of therapy should be given. Such approaches should yield long-term survival rates of 10% or better for patients with large-volume disease and 20% or better for small-volume disease.

Antineoplastic Agents↗
PubMed1993

Second-look laparotomy in the management of patients after radical surgery for ovarian cancer.

BACKGROUND: Radically excised ovarian cancers present an unsolved problem with regard to the value of routine second-look operation. This study presents the outcome of second-look operations in an effort to help elucidate this problem. PATIENTS AND METHODS: Twenty-eight patients who underwent radical surgery for ovarian cancer stage IC-IIIA were given adjuvant chemotherapy with cyclophosphamide 500 mg/m2 i.v., adriamycin 40 mg/m2 i.v. and 5-fluorouracil 500 mg/m2 i.v., all administered on days 1 and 8 every 4 weeks until achievement of a cumulative adriamycin dose of 400 mg/m2. It was planned that second-look laparotomy would be performed 10-12 months after the primary operation. RESULTS: Four of 28 patients (14.3%) had positive findings at second-look laparotomy. Two of these 4 patients had only microscopic disease, and after second-line chemotherapy including cisplatin one of them is clinically free of tumor 50 months after the primary operation. Two of 28 patients had clinical recurrences before the planned second-look operation. Four of the 22 patients (18.2%) with negative second-look operations developed recurrent disease within a median time of 12 months later. The 5-year survival rate for all 28 patients was 67%. CONCLUSION: Although a small group of patients may benefit from a strategy that includes delayed second-look operation, we conclude that this should not be a routine procedure in the management of patients who undergo radical surgery for ovarian cancer.

Adult↗
PubMed1993

Phase I and pharmacokinetics study of topotecan, a new topoisomerase I inhibitor.

PURPOSE: A phase I study with topotecan (SKF 104864-A, NSC 609699), a semisynthetic analog of camptothecin, was performed using a daily-times-5 regimen, given i.v. q 3 weeks, to evaluate the pharmacokinetics and toxicities of the compound. PATIENTS AND METHODS: Patients with a histologically confirmed diagnosis of a solid tumor no longer amenable to established forms of treatment were eligible for the study. Topotecan was given as a 30 min. infusion daily on 5 successive days, repeated every three weeks. In subsequent patient cohorts the dose was escalated from 0.5 to 1.5 mg/m2/day. Weekly evaluations included hematology and biochemistry. Response to treatment was assessed every 2 cycles. Pharmacokinetics were performed using a HPLC method. RESULTS: Forty-eight patients were entered. The maximal tolerated dose was 1.5 mg/m2/day. The dose limiting toxicity was leucocytopenia. Other major toxicities were alopecia and moderate nausea/vomiting. Partial remissions were observed in one patient with pretreated small-cell lung cancer, one with non-small-cell lung cancer and one with no-pretreated pancreatic cancer, lasting 130-240 days. Pharmacokinetics showed a t 1/2 (alpha) of 8.1 +/- 7.6 min., t 1/2 (beta) of 132 +/- 48 min., Vd,ss 72.7 +/- 26.9 L/m2 and Cltot of 0.57 +/- 0.16 L/min/m2. CONCLUSION: Topotecan is an interesting new topoisomerase I inhibitor exerting antitumor activity in this phase I trial. Leucocytopenia is dose-limiting. The recommended dose for phase II studies is 1.5 mg/m2/day for 5 consecutive days every 3 weeks.

Adult↗
PubMed1993

Risk of hip fracture after osteoporosis fractures. 451 women with fracture of lumbar spine, olecranon, knee or ankle.

In a follow-up study during 1976-1984, the risk of a subsequent hip fracture was investigated in women aged 60-99 years, hospitalized for the following fractures: lumbar spine (n 70), olecranon (n 52), knee (n 129) and ankle (n 200). Follow-up ranged from 0 to 9 years. Observation time of the 4 different fractures were 241, 180, 469, and 779, person-years, respectively. In women aged 60-79 years with one of the following fractures the relative risk of a subsequent hip fracture was increased by 4.8 (lumbar spine), 4.1 (olecranon), 3.5 (knee) and 1.5 (ankle). The relative risk of hip fracture showed a tendency to level off 3 years after the primary fracture.

Aged↗
PubMed1993

Risk factors for hip fractures. A review.

Risk factors for hip fracture have been reviewed based on case-control and prospective follow-up studies. Falls with impact to the hip, the capacity of energy absorption in soft tissue, and bone strength are closely linked to the risk of hip fracture. Consistently documented risk factors are age, sex, race, low bone mass, low body weight, estrogen deficiency and earlier fracture. Other risk factors are tendency to fall, disability and immobilisation, low physical activity, use of psychotropic/anxiolytic/hypnotic drugs, use of corticosteroid, low calcium intake in the elderly, osteomalacia, thyreotoxicosis, cigarette smoking, chronic alcoholism, diabetes mellitus, insufficient sunlight exposure and a protective effect from thiazide diuretics. Evidence is lacking for risk factors such as heredity, nutrition and medical conditions. No information is available on the combined effects of the different risk factors. Risk estimation of hip fractures should focus on the risk of falls, the capacity of energy absorption and the bone strength. Recent studies indicate that the prevention of hip fractures is realistic, even in the elderly and definitely osteoporotic population when these fundamental risk factors are modified, which has been shown in controlled trials in nursing homes by vitamin D and calcium supplementation or by wearing external hip protectors.

Aged↗