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Biomedical subjects

L E James

Publications and source records attributed to L E James.

11 recordsLinked to original sources
PubMed1997

Five-day oral etoposide treatment for advanced small-cell lung cancer: randomized comparison with intravenous chemotherapy.

BACKGROUND: Oral etoposide is an active single agent in small-cell lung cancer (SCLC) and is widely prescribed as first-line treatment as an alternative to intravenous combination chemotherapy in patients with extensive disease. PURPOSE: The intention of this study was to determine if the effects of oral etoposide therapy on survival and quality of life are equivalent to those of intravenous chemotherapy. METHODS: In a randomized trial of palliative treatment in advanced SCLC, oral etoposide (100 mg given twice daily for 5 days) was compared with intravenous chemotherapy consisting of alternating cycles of cisplatin and etoposide (PE) and cyclophosphamide, doxorubicin, and vincristine (CAV). Six cycles of chemotherapy were administered every 21 days in both regimens. Symptom control and quality of life were measured with the Rotterdam Symptom Checklist and a daily diary card. In January 1996, after 155 patients had been randomly assigned from a projected intake of 365 patients, an independent Data Monitoring Committee examined the interim results. Survival was determined by the Kaplan-Meier method, and the logrank test was used to compare treatments. For quality-of-life comparisons, average scores were calculated for each time point. The Mann-Whitney U test was used to determine any significant overall differences between treatments. For the Rotterdam Symptom Checklist, separate analyses were done for each subset (psychological well-being, physical symptoms, lung cancer symptoms, treatment symptoms, activity, and quality of life). Response rates and toxicity scores were compared by using chi2. All statistical tests were two-sided. RESULTS: Survival was inferior at 1 year in the oral etoposide group compared with intravenous therapy (9.8% for oral versus 19.3% for intravenous; difference = 9.5%; 95% confidence interval of difference = 0.3%-18.7%; P<.05), and there was a trend toward inferior overall survival. Median survival was 4.8 months for oral treatment and 5.9 months for intravenous therapy. Progression-free survival was worse in the oral etoposide arm (median = 3.6 months versus 5.6 months; P<.001), as well as overall response rate (32.9% versus 46.3%; P<.01). With the exception of acute nausea and vomiting associated with intravenous chemotherapy, all aspects of symptom control and quality of life were either the same or worse in the oral etoposide group. Study closure was recommended. CONCLUSIONS: These interim results show that this schedule of oral etoposide is inferior to intravenous chemotherapy in the treatment of advanced SCLC and should not be used as first-line treatment of this disease.

Administration, Oral↗
PubMed1996

A randomised trial of low-dose/high-frequency chemotherapy as palliative treatment of poor-prognosis small-cell lung cancer: a Cancer research Campaign trial.

We report the results of a randomised trial in extensive small-cell lung cancer (SCLC) of a novel approach to palliative chemotherapy. A widely used 3 weekly regimen was compared with the same drugs given at half the dose but twice the frequency with the same intended overall dose intensity (DI). A total of 167 patients defined as having extensive SCLC with adverse prognostic features were randomised to receive either a 3 weekly regimen of cisplatin 60 mg m-2 i.v. on day 1 and etoposide 120 mg m-2 i.v. on day 1 and 100 mg b.d. orally on days 2 and 3 alternating with cyclophosphamide 600 mg m-2 i.v., doxorubicin 50 mg m-2 i.v. and vincristine 2 mg i.v. all on day 1 for a maximum of six courses (3 weekly); or treatment with the same drugs but with each course consisting of half the 3 weekly dose given every 10 or 11 days for a maximum of 12 courses. In the 10/11 day regimen overall response rate was 58.9% (95% CI, 47.9-69.2%) with 12.8% complete responses (CR). For the 3 weekly treatment the overall response rate was 44.9% (95% CI, 35.0-55.5%) with 10.1% CR. Median survival was similar in the two arms at 6.4 months (95% CI, 4.9-7.3 months) and 5.8 months (95% CI, 4.0-6.6 months) respectively. Survival at 1 year was 9.9% (95% CI, 5.0-18.5%) and 8.9% (95% CI, 4.6-16.6%). The 95% CI for the difference in survival at 1 year is -7.09% to +9.09%. Haematological toxicity and treatment delays owing to infection were more frequent with the 10/11 day regimen but other toxicities were equal in both arms. Other aspects of quality of life were measured in a small representative cohort of patients using a daily diary card (DDC). There was a trend of improved quality of life on the 10/11 day arm, but there was little difference between the two treatments. The trial shows that a low-dose/high-frequency regimen with the same DI as conventionally scheduled chemotherapy gives similar response rates and survival. This and other modifications of the schedule may offer new approaches to palliative treatment of advanced cancer. However, in this trial there was no significant benefit in toxicity or other aspects of quality of life.

Adult↗
PubMed1995

Assessment of 'quality of life' using a daily diary card in a randomised trial of chemotherapy in small-cell lung cancer.

BACKGROUND: Quality of life (QOL) was assessed using a daily diary-card within a multicentre randomised trial of treatment of small-cell lung cancer. The trial compared a weekly dose-intensive regimen with a 3-weekly conventional treatment in good prognosis patients, that is patients with limited disease or extensive disease with a good performance status (ECOG 0or 1) and alkaline phosphatase of less than one and a half times the upper limit of normal. The trial which has been previously reported detected no difference in response or survival. PATIENTS AND METHODS: Daily diary cards (DDCs) were collected for up to eight months from the first day of chemotherapy in a cohort of 75 patients at one centre. Percentages of scores over a specified level were calculated for each of the eight diary card questions and comparisons were made between treatment arms. RESULTS: During the period of chemotherapy compliance in completing DDCs was 72.5% in the weekly arm and 77.2% in the 3 weekly. Significantly worse scores were reported with weekly chemotherapy during this period for six of the eight parameters, namely: ;nausea, vomiting, happiness, appetite, general well-being and sleep. Recognised problems of QOL data collection, in particular, compliance, attrition and generalisability are highlighted by this study and are discussed in the paper. CONCLUSIONS: The QOL measurements indicate that 3 weekly chemotherapy is the preferred treatment. This study demonstrates that QOL measurements may be helpful in choosing between treatment alternatives where no difference in outcome is observed.

Adult↗
PubMed1993

Intracellular glutamine concentration does not decrease in all muscles during sepsis.

The concentrations of glutamine and other amino acids were measured in plasma and intracellular fluid of soleus and extensor digitorum longus (EDL) muscles of rats 4, 8, and 16 hr after induction of sepsis by cecal ligation and puncture or after sham operation. Previous studies have shown that muscle protein breakdown is greatly increased in EDL, but not in soleus muscle, in this sepsis model. Corresponding to previous observations of protein breakdown in sepsis, muscle glutamine was markedly depleted (< 50%) in EDL by sepsis, while no significant fall in glutamine concentration in soleus was observed. Changes in muscle glutamine concentration in sepsis could not be attributed to changes in the precursor of glutamine, glutamic acid. Data were examined for changes consistent with hypothesized alterations in glutamine transport. Correlations among glutamine and other amino acids in muscle, histidine in particular, were consistent with a sepsis-induced alteration in activity of the sarcolemmal glutamine transporter, system Nm. These results thus strengthen the proposed connection between muscle glutamine content and muscle protein metabolism under catabolic conditions.

Amino Acids↗
PubMed1991

A randomised trial of planned versus as required chemotherapy in small cell lung cancer: a Cancer Research Campaign trial.

In a study of chemotherapy as palliative treatment, 300 patients with untreated limited and extensive stage small cell lung cancer (SCLC), who did not have progressive disease after the first cycle of chemotherapy, were randomised to receive either regular 'planned' chemotherapy or chemotherapy given 'as required' (AR). All patients received the same chemotherapy: cyclophosphamide 1 gm m-2 i.v., vincristine 2 mg i.v., and etoposide 120 mg m-2 i.v. on day 1, and etoposide 100 mg b.d. orally on days 2 and 3. Planned chemotherapy was given regularly every 3 weeks. AR chemotherapy was given for tumour-related symptoms, or for radiological progression of disease. Both groups of patients were assessed every 3 weeks and a maximum of eight cycles of chemotherapy was given. A detailed quality of life assessment was made using daily diary cards. The median survival (MS) of patients given AR chemotherapy was not significantly worse than those receiving planned treatment [MS: Planned = 36 weeks (95% C.I. 32-40 weeks), AR = 32 weeks (95% C.I. 28-37 weeks) P = 0.960]. In the AR patients the median interval between treatments was 42 days. On average AR patients received half as much chemotherapy as planned patients. AR patients with a treatment-free interval (TFI) of more than 8 weeks between the first and second cycles of chemotherapy survived longer than those in whom this interval was less than 4 weeks; [MS: TFI greater than 8 = 47 weeks (95% C.I. 32-53 weeks); TFI less than 4 = 24 weeks (95% C.I. 17-34 weeks) P = 0.013]. Contrary to expectation, in the quality of life assessment the AR patients scored themselves as having more severe symptoms than patients receiving planned treatment. AR chemotherapy is a novel method of attempting to use cytotoxic drugs palliatively, which resulted in less drug treatment for approximately equivalent survival. However the palliative effect seen with as required treatment was less satisfactory than with planned chemotherapy.

Aged↗
PubMed1988

Videotaped materials in a school-based smoking prevention program.

The theory used to frame school-based tobacco use prevention programs is general, and such programs are difficult to replicate. This article seeks to offer a model for prevention videotape production, which other researchers can replicate and improve, and to present an analysis of potential merits and drawbacks of such production. To accomplish these goals, this article presents a detailed description of a school-based prevention program and the videotaped materials used in its curriculum. The theoretical and empirical bases for the project are delineated, and the study design is summarized. A detailed outline of the multi-grade curriculum program is presented, including the rationale behind critical program features, a description of specific curriculum strands, and the way in which videotaped materials fit into each strand. The rationale for using videotaped materials within the theoretical framework is discussed. Each videotape is briefly described. An account of video production, a process extending over 4 years, is set forth, including the student feedback data that helped to shape the production process, formatting, script decisions, casting, location, and the actual filming procedure.

Adolescent↗
PubMed1988

Comparative evaluation of the oxoid signal and Roche Septi-Chek blood culture systems.

The Oxoid Signal blood culture system (Oxoid USA, Inc., Columbia, Md.) was compared with the Roche Septi-Chek system (Roche Diagnostics, Div. Hoffmann-La Roche Inc., Nutley, N.J.), with the latter consisting of a tryptic soy broth (R-TSB) bottle with an attached agar slide unit and a Columbia broth bottle. A total of 5,034 cultures with equal volumes of blood in each bottle were processed. Overall, more organisms were recovered in the R-TSB bottle than in the Signal bottle, with significantly more aerobic organisms (Pseudomonas spp., Acinetobacter spp., and yeasts) recovered in the R-TSB bottles and anaerobes and viridans group streptococci recovered in Signal bottles. Approximately equivalent numbers of organisms were recovered in the Signal and Columbia broth bottles. The times of detection were essentially identical with the three blood culture broth systems. During the study, 30.6% of the Signal bottles had a positive indicator of growth, of which 1,103 (71.7%) were false-positive cultures. Additionally, nonviable organisms resembling streptococci were observed in 13.7% of the Signal bottles that were Gram stained and in unioculated blood culture bottles. With appropriate modifications of the preparation of the media, the latter problem can be eliminated.

Bacteria↗
PubMedDate not supplied

Outcome and socioeconomic aspects of suspected child abuse scald burns.

Fifty-two children suffering from abuse-related scald burns were admitted between January 1, 1986, and June 30, 1991. Their clinical and socioeconomic aspects were compared with those of 50 nonabused scalded children. Patients were matched for age, total body surface area burn, and percentage of full-thickness burn. Patient characteristics and initial nutritional parameters were similar except for race; a higher percentage of black children were in the abused group. A significantly longer length of hospital stay was found in the abused children after using analyses of covariance to control for percentages of total and full-thickness body surface area burn. The number of operations and frequency of complications were increased in the abused group, but not significantly so. Several significant differences were found in the socioeconomic characteristics of the two groups. Children suspected of being scalded intentionally were more likely to be part of a broken home, belong to a single parent, and have a younger mother than were children in the control group. The majority of the parents of abused children were unemployed, and all but two earned less than $20,000/year. All but one of the abused children were discharged with a person other than their parents, and compliance with rehabilitation follow-up was significantly worse than with the control group. The person suspected of performing the abuse was always a family member, except in cases where the baby-sitter was the suspected abuser. Child abuse hurts not only the child but also society by increasing the need for resources to pay for extended hospital admissions.(ABSTRACT TRUNCATED AT 250 WORDS)

Black or African American↗
PubMedDate not supplied

Inhalation injury severity scoring system: a quantitative method.

Inhalation injury, a major contributor to burn-related mortality, has been difficult to quantify. A scoring system paralleling current adult respiratory distress syndrome systems has the potential to distinguish survivors from nonsurvivors. The utility of the PaO2/FiO2 (P/F) ratio in predicting injury severity was first examined. In a review of 120 patients with inhalation injury, those with P/F ratios greater than or equal to 300 after resuscitation were more likely to survive than those with ratios less than 300. The P/F ratio had no value when obtained before resuscitation. Next, a scoring system was developed to assist in comparing the severity of injury in ventilator-dependent patients with burns. Measurements were recorded prospectively in four categories: chest x-ray evaluation, P/F ratio, peak inspiratory pressure, and bronchoscopy. When comparing survivors (20) versus nonsurvivors (6), significant differences were found early (day 0, day 1, and week 1) for P/F ratio and overall severity score. Differences were seen later (week 1 and week 2) for chest x-ray evaluation and peak inspiratory pressure values. Because of low numbers the value of bronchoscopy could not be evaluated. The role of an inhalation injury severity scoring system for predicting survival should be examined in larger prospective trials.

Adult↗