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M Hill

Publications and source records attributed to M Hill.

At least 235 records · Page 13Linked to original sources
PubMed1996

African-American mortality at older ages: results of a matching study.

In this paper we investigate the quality of age reporting on death certificates of elderly African-Americans. We link a sample of death certificates of persons age 65+ in 1985 to records for the same individuals in U.S. censuses of 1900, 1910, and 1920 and to records of the Social Security Administration. The ages at death reported on death certificates are too young on average. Errors are greater for women than for men. Despite systematic under-reporting of age at death, too many deaths are registered at ages 95+. This excess reflects an age distribution of deaths that declines steeply with age, so that the base for upward transfers into an age category is much larger than the base for the transfers downward and out. When corrected ages at death are used to estimate age-specific death rates, African-American mortality rates increase substantially above age 85 and the racial "crossover" in mortality disappears. Uncertainty about white rates at ages 95+, however, prevents a decisive racial comparison at the very oldest ages.

Black or African American↗
PubMed1996

[Epitestosterone as an endogenous antiandrogen in men].

The authors assessed in the plasma of 156 boys and men aged 6 - 65 years and in prostatic tissues of 15 men aged 55 - 82 years epitestosterone, C19-steroid with anti-androgenic properties. It was revealed that during the prepubertal period the epitestosterone level is higher than that of testosterone, in adult age the epitestosterone is about ten times lower than the testosterone concentration. In tissue of hyperplastic prostates the epitestosterone level is comparable with the androstendione level; it is about twice as high as the testosterone level and approximately half as high as the dihydrotestosterone level. Thus at least during the prepubertal period in boys and in the androgen-dependent prostate tissue a more significant participation of epitestosterone in the regulation of androgen-dependent processes must be taken into consideration.

Adolescent↗
PubMed1995

Transport of competing Na and K ions by (222) C10-cryptand, an ionizable mobile carrier: effects of pH and temperature.

The kinetics of the electroneutral exchange of competing sodium and potassium with protons across the membrane of large unilamellar vesicles (LUV) were determined at two pH values when transport was induced by the simultaneous presence of (222)C10-cryptand and FCCP (proton carrier) at various temperatures. The aim of the present work was to quantify the pH-dependent enthalpies of an ionizable mobile carrier affinities for competing alkali cations, and to focus on the effects of pH and temperature on the competitive transport selectivity of the carrier for K+ over Na+ ions. At any given temperature and pH, the apparent pH-dependent affinity of (222)C10 was higher for K+ than for Na+. The enthalpy of this affinity for K+ was significantly lower than that for Na+, whereas it varied similarly with the pH (delta H(KpHmK) = 32.8 and 37.0 kJ/mol, and delta H(KpHmNa) = 47.9 and 52.9 kJ/mol at pH 7.8 and 8.8, respectively). When using a kinetic model, the pH effect on these parameters was discriminated (delta H(KmK) = 37.9 kJ/mol and delta H(KmNa) = 53.9 kJ/mol). The pH-dependence of the delta H(KpHm) of the cations could therefore theoretically be shown to arise from the temperature-induced changes in the ionization of the buffer dissolved in the aqueous phases and of the amine groups of the binding cavity of the carrier. The K/Na competitive transport selectivity (Sc(K/Na)) of (222)C10 increased linearly with the K+ concentration. It decreased hyperbolically with increasing concentration of Na+ while being independent of pH at any given temperature. In equimolecular ionic mixtures, Sc(K/Na) varied from 2.2 to 3.0 when temperature rose from 20 degrees C to 35 degrees C (delta H(Sc(K/Na)) = 15.6 +/- 0.5 kJ/mol). The results are discussed in terms of the structural, physico-chemical and electrical characteristics of carriers and complexes.

Bridged Bicyclo Compounds, Heterocyclic↗
PubMed1995

Na/K competitive transport selectivity of (221)C10-cryptand: effects of pH and carrier concentration.

The kinetics of the competitive transport of Na+ and K+ ions across the membrane of large unilamellar vesicles (LUV) were determined when transport was induced by (221)C10-cryptand, an ionizable mobile carrier. The experiments were performed at various pH values (7.7 and 8.7) and carrier concentrations (0.1, 0.5 and 1.0 microM) in order to quantify the effects of these parameters on the Na/K competitive transport selectivity of this mobile carrier. At any given pH and carrier concentration, the apparent affinity of (221)C10 for Na+ was higher and less dependent on the concentration of the other competing ion than that for K+. The Na/K competitive transport selectivity (SC(Na/K)) of (221)C10 increased linearly with the Na+ concentrations, decreased hyperbolically with increasing those of K+ and was independent of the pH and of the carrier concentration. In equimolecular ionic mixtures, this competitive selectivity amounted to about 1.5 and when the pH rose, the carrier selectivity for Na+ over K+ ions was enhanced by cation competition compared to transport of cations as unique substrates. Equations were established to describe the variations of the competitive transport selectivity (SC) of cryptands, and for comparison of their noncompetitive selectivity (SNC), with the ionic concentrations, the Michaelis parameters of the cations and the pH. The reaction order in Na+ (n(Na)) increased significantly with decreasing the pH and the K+ concentration. The results are discussed in terms of the structural, physico-chemical and electrical characteristics of carriers and complexes.

Binding, Competitive↗
PubMed1995

Heuristically derived tumor burden score as a prognostic factor for stage IIIB carcinoma of the cervix.

PURPOSE: A retrospective analysis of radiotherapeutic management of locally advanced carcinoma of the uterine cervix was performed to evaluate the effect of various treatment parameters and disease extent upon treat outcome. METHODS AND MATERIALS: Between 1976 and 1989, 89 patients with Stage IIIB disease were treated with external beam radiotherapy and brachytherapy. Treatment outcomes were evaluated by dose to Point A, the proportion of Point A dose delivered by brachytherapy, clinical response at 3 months, and a newly developed tumor burden scoring system that quantifies the anatomical extent of disease. Kaplan-Meier estimates of tumor control and survival parameters were determined. RESULTS: Loco-regional control (LRC), disease-free survival (DFS), and overall survival (OVS) at 5 years were 52.9%, 45.5%, and 50.3%, respectively. Clinical response at 3 months was highly predictive of local and distant tumor control. There was no correlation between proportion of brachytherapy dose and treatment outcome. The tumor burden scoring system demonstrates that FIGO Stage IIIB disease can be clinically divided into two prognostic groups of low and high tumor burden. Five year LRC was 62.9% and 40.2% for the low and high tumor burden groups, respectively (p = 0.024). Within the high tumor burden group the LRC was 53.0% and 22.5% when the point A dose given was > 78 Gy and < or = 78 Gy, respectively (p = 0.047). This correlated with improved DFS and OVS. CONCLUSION: The tumor burden scoring system subdivides FIGO Stage IIIB cervical carcinoma into two prognostic groups, predicting for overall survival and demonstrating a dose response in the high tumor burden group. This system may serve to improve future comparison of treatment outcome and to guide selection of patients who may benefit from a more aggressive treatment approach.

Adult↗
PubMed1995

Probucol protects against adriamycin cardiomyopathy without interfering with its antitumor effect.

BACKGROUND: The usefulness of adriamycin (ADR), a potent antitumor antibiotic, is limited by the development of life-threatening cardiomyopathy and congestive heart failure. Subcellular changes leading to heart failure are suggested to be mediated by a drug-induced increase in free radicals and lipid peroxidation. In an earlier study, concurrent treatment with probucol (PROB), a lipid-lowering drug with strong antioxidant properties, was shown to offer only partial protection against ADR cardiomyopathy. The present study had two aims: to determine whether this protective effect can be improved further by extended treatment with PROB, and to determine whether PROB affects the antitumor properties of ADR. METHODS AND RESULTS: ADR (cumulative dose, 15 mg/kg body wt) was administered in rats in six equal injections (IP) over a period of 2 weeks. Three weeks after the end treatment, cardiomyopathy and congestive heart failure were characterized by ascites, congested liver, depressed cardiac function, elevated left ventricular end-diastolic pressure, and myocardial cell damage. Myocardial glutathione peroxidase (GSHPx) activity was decreased and lipid peroxidation was increased. Administration of PROB (cumulative dose, 120 mg/kg body wt) in 12 equal injections (IP), before and concurrent with ADR, completely prevented these cardiomyopathic changes, normalized left ventricular function, lowered mortality, and eliminated ascites. Treatment with PROB was also accompanied by an increase in myocardial GSHPx and superoxide dismutase activities with a concomitant decrease in lipid peroxidation. Tumor regression in syngeneic DBA/2 mice inoculated with L5178Y-F9 lymphoma cells in the ADR+PROB group was significant and comparable to the ADR group. CONCLUSIONS: These data show for the first time that PROB can provide complete protection against ADR cardiomyopathy without interfering with antitumor properties of the drug. This protective effect of PROB may be related to the maintenance of the antioxidant status of the heart.

Animals↗
PubMed1995

Detection of a recessive major gene for high IgE levels acting independently of specific response to allergens.

The genetic control of the total IgE, the immunoglobulins E involved in allergy, remains still unclear. Although high IgE levels were found to be determined by a recessive major gene in several studies, other modes of inheritance were also reported. Moreover, at least two different genetic mechanisms controlling the IgE regulation have been suggested: one involved in the specific IgE response and the other one in the nonspecific response. To better understand the genetic mechanisms controlling IgE variation, we performed segregation analysis of IgE levels by ignoring or taking into account the specific response to allergens (SRA). Analyses were conducted using the class D regressive model, in a sample of 234 Australian nuclear families randomly selected during the winter months, when IgE levels are the lowest (basal). SRA, when included as a covariate in the model, was defined by one of the three following criteria: (1) raised specific IgE level for one or more allergens, (2) positive skin test for one or more allergens, and (3) at least one of the (1) or (2) criteria. When the presence of SRA is ignored, the familial transmission of total IgE level is compatible with the segregation of a recessive major gene and residual familial correlations. When the presence of SRA is accounted for in the analysis, whether defined by criteria (1), (2), or (3), there is still evidence for a recessive major gene controlling IgE levels but residual familial correlations are no longer significant. In addition, no interaction between this major gene and SRA is shown here. Our results suggest that this gene, which accounts for 28% of the variation of the trait, may be involved in the control of basal IgE production, independently of specific response to allergens.

Adolescent↗
PubMed1995

Combination therapy with probucol prevents adriamycin-induced cardiomyopathy.

Adriamycin (doxorubicin) is a broad spectrum anti-tumor antibiotic used to treat cancer patients. However, the potential usefulness of this drug is currently limited by the development of a dose-dependent cardiomyopathic process terminating in severe heart failure. Although several mechanisms have been suggested to explain the pathogenesis of adriamycin-induced cardiomyopathy, free-radical induced oxidative stress appears to play an important role. A concise description of adriamycin-induced cardiomyopathy is provided. Various combination therapies which have been attempted in the past to modulate the adriamycin-induced cardiomyopathy are also discussed. Recently, it has been discovered that probucol, a lipid lowering agent and potent antioxidant, provides complete protection against adriamycin-induced cardiomyopathy in rats without interfering with the anti-tumor properties of this antibiotic. Clinical trials employing adriamycin therapy in combination with probucol are needed to determine the applied value of these laboratory findings.

Animals↗
PubMed1995

Radioimmunoassay of three deoxycorticoids in human plasma following HPLC separation.

A radioimmunoassay of three deoxycorticoids, namely 11 beta,17 alpha-dihydroxy-4-pregnene-3,20-dione (21-deoxycortisol), 17 alpha,21-dihydroxy-4-pregnene-3,20-dione (11-deoxycortisol), and 21-hydroxy-4-pregnene-3,20-dione (11-deoxycorticosterone) which are important for differential diagnosis of congenital adrenal disorders, is described and evaluated. Antisera against 3-(O-carboxymethyl)oximes conjugated to bovine serum albumin were raised in rabbits. The radioligands were prepared by radioiodination of previously synthesized homologous tyrosine methyl ester derivatives. Following diethyl ether extraction, the steroids were separated from each other and from cross-reactants by HPLC using a Nucleosil C8 reverse-phase column and a methanol-water mixture (7:5, v/v) as an eluent. Normal levels of analyzed steroids ranged from 0.02 to 0.348, 0.185 to 3.80, and 0.013 to 0.299 nmol/l, for 21-deoxycortisol, 11-deoxycortisol and 11-deoxycorticosterone, respectively. The levels of both deoxycortisols rose significantly after ACTH treatment. Data are given with respect to the concentrations of these steroids in some pathological situations such as 21-hydroxylase and 11 beta-hydroxylase block, hyperaldosteronism, and polycystic ovary syndrome.

Adolescent↗
PubMed1995

Plasma levels of epitestosterone from prepuberty to adult life.

Epitestosterone has for a long time been considered as a biologically inactive steroid. However, recently a distinct antiandrogenic activity of this naturally occurring endogenous epimer of testosterone has been demonstrated. Epitestosterone plays a role in the control of doping with testosterone, since an arbitrary ratio of testosterone to epitestosterone in urine has been accepted as a marker for testosterone abuse. For this reason, its urinary excretion has been examined intensively by several authors. On the other hand, its concentration in the blood of men was reported only randomly in a few cases. In the present study the epitestosterone level in human plasma was determined by a specific radioimmunoassay and the concentration of epitestosterone was established in age groups of males of 6 to 65 years of age. There is a clear age dependence of epitestosterone plasma concentration in males. In young boys before puberty, antiandrogenic epitestosterone prevails over testosterone, in adults a striking decline of the ratio epitestosterone:testosterone can be observed.

Adolescent↗
PubMed1995

Endogenous antioxidants in isolated hypertrophied cardiac myocytes and hypoxia-reoxygenation injury.

Effects of hypoxia-reoxygenation (H-R) on myocytes isolated from 10 week hypertrophied and sham control rat hearts were studied. Myocyte hypertrophy was indicated by an increase in cell size. Superoxide dismutase (SOD) and glutathione peroxidase (GSHPx) enzyme activities were significantly higher and lipid peroxidation (TBARS) was lower in hypertrophied myocytes prior to any H-R. Hypertrophied myocyte population showed significantly less damage to cell morphology due to H-R. In sham as well as hypertrophied myocytes, Na+ and Ca2+ contents were increased by H-R, but Ca2+ accumulation was significantly less in the hypertrophied myocytes. Both SOD and GSHPx activities were depressed by the oxidative stress in the sham myocytes whereas these activities were not significantly changed in the hypertrophied myocytes. Catalase activity in the prehypoxic sham and hypertrophied myocytes was comparable and this activity did not change during H-R. There was a significant increase in lipid peroxidation due to H-R but this change was less in hypertrophied myocytes. This study shows less vulnerability of hypertrophied myocytes to oxidative stress and an increase in endogenous antioxidant reserve may have an important role in mediating this protection.

Animals↗
PubMed1995

Delivery of glucocorticoids by jet nebulization: aerosol characteristics and output.

BACKGROUND: Since inflammation has been identified as a critical factor in the pathogenesis of asthma, use of inhaled glucocorticoids has increased. Because young children are often unable to coordinate properly the use of metered-dose inhalers and no glucocorticoids preparations for nebulization have been approved in the United States, parenteral and intranasal glucocorticoids preparations are occasionally administered by nebulization. METHODS: We examined whether a parenteral preparation (triamcinolone acetonide [TAA]; Kenalog) could be delivered by nebulization. TAA, 1000 micrograms (0.1 ml), was placed in the nebulizer bowl (MB5 [MeFar, Brescia, Italy] or Pari-Jet [Dura Pharmaceuticals, San Diego, Calif.]), then diluted with 2.9 ml normal saline solution for a total volume fill of 3 ml. Using a laser particle analyzer, high-performance liquid chromatography, and cascade impactor, we examined the percentage of aerosol volume produced with particles in the respirable range of 1 to 5 microns in diameter, actual TAA output (in micrograms) and concentration of TAA contained in the particles within the respirable range. RESULTS: Laser particle analysis indicated that 34% +/- 3% (mean +/- SEM) (MB5) and 47 +/- 3% (Pari-Jet) of the total aerosol volume produced were within the respirable range of 1 to 5 microns in diameter, and this remained consistent throughout nebulization. The nebulizer was stopped serially for determination of TAA output with high-performance liquid chromatography. TAA output (1000 micrograms less the amount in micrograms remaining after nebulization) was essentially complete after 2 minutes with the Pari-Jet and within 4 minutes with the MB5 and totaled 352 +/- 19 micrograms and 367 +/- 9 micrograms, respectively. Finally, cascade impactor studies confirmed that 33.4% of the TAA aerosol generated by the MB5 nebulizer was contained in particles in the respirable range. CONCLUSION: Approximately 35% (Pari-Jet) and 37% (MB5) of the initial 1000 micrograms of TAA was delivered with the two nebulizers tested. The particles generated within the respirable range were limited to 34% (MB5) and 47% (Pari-Jet) of the amount delivered. TAA was equally distributed in the particles generated. The theoretic amount delivered in the respirable range was approximately 12.5% for the MB5 nebulizer on the basis of the cascade impactor and 16.5% for the Pari-Jet (assuming TAA distribution equivalence) of the TAA placed in each of the nebulizers. Additional clinical studies are needed to define efficacy and safety in view of the excipients used in preparing the parenteral preparation.

Aerosols↗
PubMed1995

Adjuvant chemotherapy for oesophagogastric cancer with epirubicin, cisplatin and infusional 5-fluorouracil (ECF): a Royal Marsden pilot study.

Previous trials of adjuvant chemotherapy for oesophagogastric cancer have shown only modest or no improvement in survival. However, the regimens used in these studies produce low response rates in patients with advanced disease. ECF is a new regimen which results in higher response rates and may therefore be more effective in the adjuvant setting. Twenty-nine patients who had undergone a potentially curative resection for oesphagogastric carcinoma were treated with ECF [epirubicin 50 mg m-2 and cisplatin 60 mg m-2 for 18 weeks]. The median age was 52.5 years. Three patients had oesophageal tumours, 14 had tumours of the oesophagogastric junction (OGJ) and 12 had gastric tumours. All were adenocarcinomas apart from one undifferentiated carcinoma. One patient had stage I disease, nine stage II, 17 stage II and two stage IV. The mean number of chemotherapy cycles per patient was 5.2 (range 2-8). The median follow-up was 8.4 months (1.5-36.3 months). Eleven patients relapsed during follow-up (38%). One patient had an anastomotic recurrence and ten patients distant metastases. Overall 3 year survival was 61.5% (95% confidence interval 42-79); 3 year survival in stage II was 50% (21.2-86.3) and in stage III 65.6% (40-86). Chemotherapy was well tolerated, with grade 3/4 toxicity as follows: leucopenia 13.5%, nausea and vomiting 10%, diarrhoea 3.5%, infection 3.5% and thrombocytopenia 3.5%. There were no treatment-related deaths. We conclude that ECF can be administered safely as adjuvant treatment to patients with surgically resected gastro-oesophageal carcinoma. The results, especially in patients with stage III disease, are encouraging and support the investigation of this regimen within a prospective randomised trial.

Adenocarcinoma↗
PubMed1995

Hepatitis C virus in alcoholic patients with and without clinically apparent liver disease.

A high prevalence of antibodies to the hepatitis C virus (anti-HCV) has been demonstrated among patients with alcoholic liver disease, whereas the prevalence of HCV viremia in these patients remains uncertain. The aims of this study were to determine the prevalence of anti-HCV in alcoholic patients both with and without clinically apparent liver disease and to determine the presence of HCV RNA in those patients who tested positive for anti-HCV by RIBA II (Chiron Corporation, Emeryville, CA). One hundred male patients consecutively admitted to an alcoholic rehabilitation program were included. Group 1 was comprised of 40 patients with clinically apparent liver disease. Group 2 was comprised of 60 patients without clinically apparent liver disease. Anti-HCV was performed by a second-generation ELISA assay and confirmed by RIBA II. HCV RNA was performed by Quantiplex assay (Chiron Corporation) and a nested reverse transcriptase-polymerase chain reaction. No significant differences were found between the two groups with regards to age, quantity and duration of alcohol intake, or accepted risk factors for HCV. The overall prevalence of anti-HCV in our patients was 23%, with 43% of these in group 1 and 10% in group 2. HCV RNA tested positive in 94% of the anti-HCV-positive patients in group 1 and in 67% of the anti-HCV-positive patients in group 2. These data suggest that HCV infection is an important cofactor in the pathogenesis of liver disease among alcoholic patients.

Adult↗
PubMed1995

Evaluation of the efficacy of the VEEP regimen in adult Hodgkin's disease with assessment of gonadal and cardiac toxicity.

PURPOSE: The aim of this phase II study was to investigate the potential of the vincristine, epirubicin, etoposide, and prednisolone (VEEP) regimen to reduce the risks of long-term sequelae of chemotherapy such as sterility, cardiopulmonary damage, and second malignancies, while maintaining efficacy in terms of response and survival. PATIENTS AND METHODS: Eighty-five adult patients with newly diagnosed and previously untreated stage II to IV Hodgkin's disease (HD) were entered and monitored for a minimum of 1 year. Patients were treated to maximum response plus two further courses, and if they had not attained a complete response (CR) or CR-unconfirmed/uncertain [CR(u)] were changed to second-line chemotherapy. Adjuvant radiotherapy was administered to patients with bulky disease and those with postchemotherapy residual masses. Measurements of left ventricular ejection fraction (LVEF), gonadotropins in females, and sperm count in males were taken both before and after treatment with VEEP. RESULTS: The maximum rates of response were as follows: CR, 32%; CR(u), 47%; and PR, 21% [CR + CR(u), 79%]. The median follow-up duration is 45 months, with a 5-year overall survival (OS) rate of 89% and failure-free survival (FFS) rate of 62%. Patients in CR at the end of chemotherapy had a higher FFS at 5 years compared with patients in CR(u) (88% v 56%). Acute toxicity was mild, with no pulmonary toxicity or treatment-related deaths. The median LVEF was 62% before VEEP and 57% after VEEP. Gonadal function tests following treatment were normal in 92% of males and 100% of females. No second malignancies have been observed. CONCLUSION: VEEP is an active combination with tolerable acute toxicity that preserves fertility and cardiopulmonary function. The efficacy of VEEP is comparable to that of established regimens, but a definitive evaluation of its potential to reduce second malignancies will require a longer follow-up duration.

Adolescent↗
PubMed1995

Royal Marsden phase III trial of fluorouracil with or without interferon alfa-2b in advanced colorectal cancer.

PURPOSE: Phase II studies have shown that the combination of interferon alfa-2b (IFN) and fluorouracil (5-FU) is active in patients with metastatic colon cancer. This study was designed to investigate whether treatment with the combination of IFN and 5-FU could improve the response rate, duration of response, or survival compared with treatment with 5-FU alone. PATIENTS AND METHODS: Patients with histologically confirmed advanced colorectal cancer were randomized to receive 5-FU 750 mg/m2/d by continuous infusion for 5 consecutive days followed by weekly bolus 5-FU 750 mg/m2 either with or without IFN 10 MU subcutaneously three times weekly. Treatment was continued until disease progression or unacceptable toxicity for up to 12 months. RESULTS: Radiologic response was observed in 26 of 106 assessable patients (25%): 10 of 52 (19%) in the group that received 5-FU plus IFN (all partial responses [PRs]) and 16 of 54 (30%) in the 5-FU-alone group (three complete responses [CRs] and 13 PRs) (P = .21). There was similarly no significant difference between the two groups in progression-free survival (median, 3 months), 1-year survival, or overall survival (median, 8 months). However, patients who received IFN did experience significantly more toxicity in the form of leukopenia (P = .013), lymphopenia (P = .01), depression (P = .014), and alopecia (P = .002), and were significantly more likely to be withdrawn due to adverse events (P = .003). There were four toxic deaths, all of which occurred in patients who had received IFN. CONCLUSION: At the doses and schedules used in this study, IFN affords no benefit to 5-FU in terms of response and survival and significantly increases toxicity for patients with advanced colorectal cancer.

Adult↗
PubMed1995

Impact of protracted venous infusion fluorouracil with or without interferon alfa-2b on tumor response, survival, and quality of life in advanced colorectal cancer.

PURPOSE: The aim of this study was to investigate the effects of adding interferon alfa-2b (IFN) to protracted venous infusion fluorouracil (PVI 5-FU) from the start of treatment in patients with advanced colorectal cancer. PATIENTS AND METHODS: Patients who attended our unit with histologically confirmed advanced colorectal cancer were randomized to receive either PVI 5-FU 300 mg/m2/d via Hickman line, and IFN 5 MU subcutaneously three times weekly, or PVI 5-FU alone. Treatment was given for a maximum of two 10-week blocks, with a 2-week gap for reassessment of all parameters. Quality of life (QL) was measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) pretreatment and every 6 weeks thereafter. RESULTS: A total of 160 patients were randomized, with 155 eligible for assessment. Radiologic response was observed in 43 patients (28%): 17 of 77 (22%) in the 5-FU-plus-IFN arm (all partial responses [PRs]) and 26 of 78 (33%) in the 5-FU-alone group (complete responses [CRs] and 22 PRs) (difference not significant). Symptomatic improvement occurred in the majority of patients, and equally in both arms: 61% to 80% depending on the symptom. There was no significant difference between the two groups in failure-free survival (median, 161 v 193 days) or overall survival (median, 328 v 357 days). However, patients who received IFN did experience significantly more toxicity in the form of leukopenia (P = .001), neutropenia (P = .04), mucositis (P = .008), and alopecia (P = .0002). There were no toxic deaths and few notable differences in QL between the two arms. CONCLUSION: This study confirms that PVI 5-FU is effective in treating the symptoms associated with metastatic colorectal carcinoma, with only mild to moderate toxicity and maintenance of QL. IFN 5 MU three times weekly does not enhance these palliative benefits.

Adolescent↗