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[Tetracycline pleurodesis for treatment of malignant pleural effusions. Retrospective study of 91 cases].

BACKGROUND: Malignant pleural effusions (MPE) are a common complication in patients with advanced neoplasms. Even though no large series confirming this exist, tetracycline pleurodesis has become the therapy of choice. The aim of this retrospective study was to evaluate its efficacy, adverse effects and possible factors predicting the success of the method. METHODS: Between 1985 through 1991, 91 patients with cytologically or histologically confirmed MPE were treated with 1,000-1,500 mg tetracycline pleurodesis. There were 49 females and 42 males, with a mean age of 59 years. The most common malignancies were lung, breast and unknown primary carcinomas. 85% patients complained of dyspnea and the volume of the effusion was moderate in half the cases. 12 variables were analyzed in relation with the probability of response through chi 2 test; survival and recurrence times were calculated with Kaplan and Meier's method. RESULTS: 73 patients were evaluable, with a 67% response rate (22 complete, 27 partial). Time to relapse was significantly higher for partial responses (mean 112 days) than for failures (mean 33 days). 37 patients presented mild complications (pain and fever). Karnofsky performance status (70% or greater), size of the effusion (small or moderate), chest radiograph (only effusion) and pleural LDH (600 U/l or less) attained favourable prognostic significance. Median survival was reached at 6 months. CONCLUSIONS: Tetracycline pleurodesis is an effective and well-tolerated paliative treatment for MPE. Along with other known parameters (pleural pH and glucose levels), Karnofsky performance status, size of the effusion, chest radiograph and pleural LDH allow to predict its results and optimize its indications.

Adult↗

Hyperfractionated radiotherapy for clinical stage II non-small cell lung cancer.

BACKGROUND AND PURPOSE: Patients with stage II non-small cell lung cancer who are not suitable for or refuse surgery are treated with radiotherapy, but the results reported so far are not satisfactory. To improve the prognosis of such patients, we have used hyperfractionated radiotherapy. In this paper, we retrospectively analyzed results of the treatment. MATERIALS AND METHODS: Between 1988 and 1993, 67 patients were treated with hyperfractionated radiotherapy with 1.2 Gy twice daily to a total dose of 69.6 Gy. All patients were technically operable, but 43 had medical problems and 24 refused surgery. The median age and Karnofsky performance status score was 60 and 90 years, respectively. No patient received chemotherapy or immunotherapy. The median follow-up period was 61 months. RESULTS: The median survival time and the 5-year survival rate were 27 months and 25% (standard error, SE, 6%), respectively. The 5-year local control rate was 44% (SE,7%). Univariate analysis of prognostic factors revealed that a higher Karnofsky performance status score, weight loss of < or =5% before treatment, and T1 stage were associated with better prognosis, and peripheral location was of borderline significance (P = 0.053). There were two bronchopulmonary and two esophageal acute grade 3 toxicities, and one bronchopulmonary and two esophageal late grade 3 toxicities. No grade 4 or 5 toxicity was observed. CONCLUSION: These results are encouraging and further studies on the use of hyperfractionation seem to be warranted for stage II non-small cell lung cancer.

Aged↗

A double blind randomized study of oral clodronate in the treatment of bone metastases from tumors poorly responsive to chemotherapy.

Bisphosphonates are used in oncology as a means of decreasing complications due to bone metastases, in association with anticancer treatment, especially in patients with breast cancer, prostate cancer and myeloma. Little is known about the effects of bisphosphonates on bone metastases from other tumors and in particular from tumors for which no effective treatment is available. We conducted a randomized, double-blind placebo-controlled trial of oral clodronate in patients with bone metastases from tumors poorly responsive to chemotherapy, with the aims of evaluating the effects of this drug on symptoms control and bone metastases evolution. Sixty-six patients with poorly responsive tumors such as non-small cell lung cancer (NSCLC), bladder cancer, gastrointestinal cancers, kidney cancer, melanoma and metastatic carcinoma of unknown origin entered the study. Patients were randomized to receive either clodronate 1,600 mg/day for one year or identical placebo-containing tablets. Various parameters such as Karnofsky performance status, pain score (measured by a visual-analogue scale) and analgesic requirement were recorded at monthly intervals. Of the 66 patients enrolled, 9 were observed for one month or less; 7 were followed for two months; only 50 patients were followed for more than 2 months and could be adequately evaluated. At 3 months both clodronate and placebo-treated patients had a decrease in Karnofsky performance status, with the decrease being more evident in the placebo group. Mean pain scores showed an increase of pain in patients receiving placebo and a decrease of pain in patients receiving clodronate, although the difference failed to be statistically significant. Analgesics requirement increased in both groups, but significantly more in patients receiving placebo (p = 0.042), in whom increase in opioid requirements was particularly evident. Toxicity was low, with occasional gastroenteric discomfort in both groups. The main problem of this study was the difficulty in recruiting an adequate number of patients and following them for a sufficient period of time: general conditions rapidly deteriorated in many patients, and approximately 25% of the 66 enrolled were not considered evaluable; few patients survived for the length of the study, one year. This might partly account for the lack of significance of some of the parameters under study. With these limits, oral clodronate demonstrated some efficacy in symptom control and in reducing the need for analgesics.

Administration, Oral↗

Performance status and outcome after coronary artery bypass grafting in persons aged 80 to 93 years.

Although coronary artery bypass grafting (CABG) effectively eliminates or diminishes symptoms of myocardial ischemia, the overall performance status and functional outcome in elderly patients undergoing CABG is poorly documented. Therefore, 86 consecutive patients aged 80 to 93 years undergoing isolated CABG were reviewed. Preoperative, intraoperative, and postoperative characteristics and pre- and postoperative performance status (Karnofsky score) were examined. Forty patients (47%) were women, and most patients had highly symptomatic coronary artery disease with class III or IV angina in 94% and unstable angina in 90%. Significant co-morbid disease was present in 49% of patients, and cardiac catheterization revealed left main or 3-vessel disease in 74% of patients. The rate of significant in-hospital complications was 29%, with infection in 14%, stroke in 9%, and respiratory failure in 8% being most frequent. Median performance status (Karnofsky score) improved from 20 to 70% (p = 0.0001) with 89% of hospital survivors being discharged home. Factors associated with failure to achieve a successful functional outcome at discharge were presence of 1 or more preoperative co-morbid conditions (p = 0.048), preoperative myocardial infarction within 7 days of operation (p less than 0.01), and postoperative low cardiac output (p less than 0.01). Survival at 30 days, 6 months, and 3 years were 90, 78, and 64%, respectively. These data demonstrate that CABG can be offered to selected elderly patients with acceptable morbidity and mortality, marked improvement in performance status, and an acceptable quality of life.

Activities of Daily Living↗

Weekly doxorubicin in endocrine-refractory carcinoma of the prostate.

Twenty-five patients with endocrine-refractory prostatic carcinoma were treated with doxorubicin, 20 mg/m2 given weekly. All patients had prior hormonal therapy (68% had two or more prior hormonal maneuvers), and 21 (84%) had prior therapeutic or palliative irradiation. Median Karnofsky performance status at the time of entry was 70. Hemoglobin was less than 12.0 g/dL in 15 patients. Bidimensional tumors were present in 12 patients in 19 disease sites; four of the 12 patients (33%) responded in eight of the 19 sites (42%); and three of eight patients had a 75% decrease in prostatic nodule size. Ten of 20 evaluable patients had an improvement of 20% or greater in Karnofsky performance status and 67% (14 of 21) had marked improvement in pain. A greater than 50% reduction or normalization of acid phosphatase occurred in 19% and of alkaline phosphatase in 53%. The overall response rate by National Prostatic Cancer Project criteria was 84%. Gastrointestinal toxicity and alopecia were minimal and myelosuppression was not life threatening in any patient.

Aged↗

[Do psychological factors modify survival of cancer patients? II: Results of an empirical study with bronchial carcinoma patients].

The present prospective test study of hypotheses addressed the question whether psychological factors are predictive of survival time in lung cancer patients. The hypotheses were: Emotional distress, depression and depressive coping are associated with shorter survival; hope and active coping with longer survival. The study was based on a sample of n = 103 patients who were investigated post-diagnosis and before the beginning of primary treatment. Emotional distress and hope were assessed by clinical scales (self-reports and interviewer ratings), depression by the Depression Scale of von Zerssen, depressive coping and active coping by the Freiburg Questionnaire on Coping with illness by Muthny. At follow-up, which took place three to five years later, n = 74 patients had died, for n = 29 patients the survival data are censored. The prediction of the survival time was performed applying multivariate analyses (Kaplan-Meier-method, Cox-Regression), adjusting for biological risk factors (histological classification, stage of the disease, type and amount of treatment, Karnofsky performance status, age). Results were as follows: Active coping and hope were associated with longer survival, emotional distress, depression and depressive coping with shorter survival, respectively. These associations were found consistently across assessment methods. The predictive effects of coping and distress were statistically independent of the influence of the somatic risk factors. The best psychological predictor was the interviewer rating of active coping. Its predictive power equalled that of the Karnofsky performance status. However, there was evidence that the effects of the psychological factors varied somewhat in interaction with treatment modalities. The findings are discussed from a methodological perspective. Possible causal models and mechanisms are presented which could account for interactions of psychological measures and the course of the disease: Thus, it can be conceived that psychological effects were mediated by patients' compliance with medical treatment. In addition, it cannot be ruled out that psychological factors themselves were influenced by the physical status of the patients at the time of entry to the study.

Adaptation, Psychological↗

Palliative treatment by high-dose-rate intraluminal brachytherapy in patients with advanced esophageal cancer.

PURPOSE: The aim of this work was to analyze the results of palliative HDR brachytherapy in patients with advanced esophageal cancer. METHODS AND MATERIALS: Ninety-one patients with unresectable, advanced esophageal cancer were treated palliatively by HDR brachytherapy. All patients received a total dose of 22.5 Gy in three fractions per week. Remissions of dysphagia and other clinical and radiological factors were assessed in the first month posttreatment, and then in the third, sixth, and twelfth months. The survival rate was compared with some chosen clinical factors using a log-rank test and the Kaplan-Meier method. RESULTS: The median survival time among all patients was 8.2 months. The median survival time according to the obtained remission was 14.6, 7.2, and 3.8 months (log-rank p = 00001, F Cox p = 0.00001) for complete remission (CR), partial remission (PR), and lack of remission (NR), respectively. A longer median survival time was observed when tumor size was less then 5 cm (12.1 months), than between 5 and 10 cm (7.8 months), or longer than 10 cm (6.4 months) (log-rank p = 0.002). Longer median survival times were observed in clinical stage II (14.1 months), compared with clinical stage III (7.7 months) and IV (7.2 months) (log-rank p = 0.01). Significant correlations were found between survival and the Karnofsky Performance Status, grade of dysphagia, and age. CONCLUSIONS: HDR brachytherapy for advanced esophageal cancer allowed for improvement of dysphagia in most patients. The complete or partial remission, the older age of patients, and the lower grade of dysphagia observed in first month posttreatment were the most important prognostic factors allowing for prolonged survival (confirmed by a multivariate analysis). In the univariate analysis, important prognostic factors for prolonged survival were: a higher Karnofsky Performance Status, a lower clinical stage and a small tumor size.

Adult↗

Primary lymphoma of brain: results of management of a modern cohort with radiation therapy.

PURPOSE: To assess the outcome and prognostic factors for patients with primary lymphoma of brain managed with radiation therapy between 1979 and 1988. METHODS AND MATERIALS: A retrospective review was undertaken of 49 patients referred to Princess Margaret Hospital. There were 25 males and 24 females. Median age was 60 years, with a range of 17-80 years. Tumors were located supratentorially in 35, infratentorially in 10, and both in 4 patients. Single masses were demonstrated on CT brain in 36, and multiple lesions in 13 patients. Cranial irradiation was given in 48, and 11 patients received chemotherapy. All patients in this series were immunocompetent. RESULTS: Over a follow-up range of 3-11 years of surviving patients, with a median of 6 years, 40/49 patients have died. Overall median survival was 1.4 years (17 months) and 5-year actuarial survival was 26%. Statistical analysis revealed the following significant factors: Karnofsky performance status (KPS), age, and distribution pattern of disease on presenting CT brain. Five-year actuarial survival for patients with a KPS > 60 or <60 was 56% and 10%, respectively (P = 0.01); for patients with age < 60 or >60, 5-year actuarial survival was 42% and 9%, respectively (P = 0.03); for patients with solitary or multiple lesions, 5-year actuarial survival was 30% and 15%, respectively (P = 0.04). CONCLUSIONS: We conclude that Karnofsky performance status, age, and distribution pattern on pretreatment CT of brain are significant prognostic factors in primary lymphoma of brain, and that new approaches need to be developed for these patients.

Adolescent↗

Linac stereotactic radiosurgery: an effective and safe treatment for elderly patients with brain metastases.

PURPOSE: To evaluate the outcomes of radiosurgery for brain metastases in patients 65 years or older. PATIENTS AND METHODS: Between January 1994 and January 2003, 117 patients (47 women, 70 men), median age 71 years (range, 65-86 years), received radiosurgery for 227 metastases. Sixty-one patients (55%) presented symptoms in relation to the brain metastases. Thirty-eight patients (32%) received whole-brain radiotherapy. Median metastasis diameter and volume were 21 mm (range, 0.5-75 mm) and 1.7 cc (range, 0.02-71 cc), respectively. RESULTS: Median follow-up was 7 months (range, 1-45 months), 9.5 months for alive patients (range, 1-45 months). Median minimum and maximum doses were 14.5 Gy (6.5 Gy, 19.5 Gy), and 20.4 Gy (13.2 Gy, 41.9 Gy), respectively. Median survival was 8 months from the date of radiosurgery. Overall survival rates at 6 and 24 months were 58% +/- 5% and 13% +/- 4%, respectively. According to multivariate analysis, a low Karnofsky performance status was an independent unfavorable prognostic factor for overall survival (p = 0.003; odds ratio [OR] = 0.28; 95% confidence interval [CI], 0.14-0.56). Median brain disease-free survival was 10 months. Brain disease-free survival rates at 6 and 24 months were 67% +/- 6% and 40% +/- 7%, respectively. According to multivariate analysis, a radiosensitive lesion was an independent favorable factor (p = 0.038; OR = 0.42; 95% CI, 0.18-0.95); more than two metastases and a low Karnofsky performance status were independent unfavorable factors for brain disease-free survival (p = 0.046; OR = 2.15; 95% CI, 1.01-4.58 and p = 0.003; OR = 30.4; 95% CI, 3.1-296, respectively). Local control rates were 98% +/- 2% and 91% +/- 8.5% at 6 and 24 months. Out of the 61 patients presenting symptoms before radiosurgery, complete symptomatic response was achieved in 12 patients (20%), partial improvement in 25 (41%), stabilization in 7 (11%), and worsening in 4 (6%) related to a progression of the irradiated metastasis. Seven cases of radionecrosis were described and were related to the margin dose (p = 0.03). CONCLUSION: Radiosurgery for elderly patients was effective and safe. Age alone should not be a criterion for denying radiosurgery to any patient with brain metastases.

Aged↗

Heart surgery and quality of life: a prospective study on ischemic patients.

OBJECTIVE: Recently, an interest has developed in the use of quality of life instruments to provide a more comprehensive assessment of the impact of disease and treatments on patients' everyday lives over time, particularly in the cardiovascular field. To evaluate changes in quality of life of patients with a coronary heart disease and undergoing heart surgery and to identify patients on which to concentrate stronger rehabilitative intervention, an observational prospective study with repeated measurements has been designed. METHODS: A total of 259 consecutive coronary heart disease patients (211 males, 48 females, aged 63 (S.D., 9 years) are included into the study. Quality of life has been assessed by means of Karnofsky Performance Status Scale and Nottingham Health Profile (6 dimensions of quality of life) preoperatively, at 2 and 6 months. Changes in quality of life scores at short and mid term and the influence of possible predictors have been investigated. Separate scores have been considered for each dimension of quality of life as well as a global statistics accounting for the multidimensionality of quality of life. RESULTS: Quality of life increased by 57, 64, 72, 52, 23, 44 and 56% for Karnofsky Performance Status Scale, energy, pain, emotion, sleep, social and mobility respectively at 2 months; at 6 months a further increase of 18% in sleep only occurred. Global scores appeared to be significantly influenced by sex, age class, preoperative NYHA, type of angina, associated procedure and complication at surgery. CONCLUSIONS: The increase of quality of life concentrates mainly at an early stage of post-operative period. The preoperative factors tested, allow to stratify patients based on quality of life and to identify those on which to concentrate stronger rehabilitative intervention.

Coronary Artery Bypass↗

Usefulness of the Thai modified functional living index--cancer (T-FLIC) and the Thai modified quality of life index (T-QLI) for advanced non-small cell lung cancer.

Serial assessment of Karnofsky performance status (KPS), the Thai modified Functional Living Index Cancer (T-FLIC) and the Thai modified Quality of Life Index (T-QLI) have been used to estimate the quality of life of advanced non-small cell lung cancer patients. This is a prospective randomized trial of best supportive care (BSC) versus best supportive care plus combination chemotherapy given to patients with Stage III b or IV, ECOG 0-1 or 2. There was a good correlation between Karnofsky performance status (KPS) and T-FLIC scores, between T-FLIC and T-QLI scores as the study began. Thus the T-FLIC and T-QLI were useful instruments for the quality of life assessment in Thai patients.

Adult↗

Cardiac valve surgery in octogenarians: improving quality of life and functional status.

BACKGROUND: Although cardiac valve procedures are being performed more frequently in the elderly, long-term functional outcomes have not been well characterized. OBJECTIVE: To evaluate changes in quality of life and functional status in octogenarians after cardiac valve surgery. DESIGN: Retrospective medical record review and patient telephone interview. Median follow-up 30 months (range, 6-95 months). SETTING: Tertiary care university hospital. PATIENTS: Octogenarians undergoing cardiac valve surgery (N = 61; mean age, 83.5 years; range, 80-89 years). INTERVENTIONS: Forty-seven patients had aortic valve replacement, 14 had mitral valve replacement and/or repair, and 27 had a combined procedure with coronary artery bypass grafting. OUTCOMES: Actuarial survival, morbidity, length of hospital stay, and discharge disposition were evaluated. Functional status, using the New York Heart Association classification, and Karnofsky performance status were evaluated preoperatively and postoperatively at 1 and 3 months after hospital discharge. RESULTS: Operative (<30 days) mortality occurred in 7 (11.4%) of 61 patients. Preoperative intensive care unit stay (P < .001) and New York Heart Association class 4 (P < .02) were independent predictors of early death by multivariable analysis. Among hospital survivors, there were no major complications in 34 patients (63%), and this group had a mean (+/- SD) postoperative hospital stay of 12.2 +/- 5.5 days. Twenty patients (37%) incurred significant complications, the most common of which were bleeding, pneumonia, and renal insufficiency. The mean (+/- SD) postoperative hospital stay in this group was 25 +/- 17 days. Although significant complications were associated with an increased postoperative stay, this was not predictive of disposition to a skilled nursing facility or the final score on the postoperative Karnofsky performance scale. Actuarial survival was 85% at 1 year and 66% at 5 years. Patients with perioperative complications had significantly decreased actuarial survival by the Cox proportional hazards regression model (P < .001). Among hospital survivors, the score on the Karnofsky performance scale 1 month after discharge had improved 50% from a preoperative median score of 30% (severely disabled, requiring special care) to a postoperative median score of 80% (being able to perform normal activity with only moderate symptoms). The New York Heart Association classification improved a median of 2 classes in this group. These benefits were sustained at the 3-month follow-up. CONCLUSION: Although greater resource expenditure is required for the initial perioperative convalescence, octogenarians can be expected to have an excellent functional outcome and long-term performance status after cardiac valve surgery.

Aged↗

Microvessel density is a prognostic indicator for patients with astroglial brain tumors.

BACKGROUND: Microvessel density in tumors, a measure of angiogenesis, has been shown to be a prognostic indicator that correlates with an increased risk of metastasis in various epithelial cancers and with overall and relapse free survival in patients with breast cancer. Astrocytic brain tumors, particularly malignant astrocytomas, are recognized to be highly vascular tumors with potent angiogenic activity. However, the prognostic significance of microvessel density in these tumors is not known. METHODS: Sections from formalin fixed paraffin embedded tumor tissue from 93 unselected adult patients with supratentorial astrocytic brain tumors were immunostained for factor VIII-related antigen in order to highlight microvessel endothelial cells. Microvessels were counted at 200x and 400x magnification. Microvessel density was graded as 1+ to 4+ on 1 low power field, without knowledge of clinical outcome. Microvessel count and microvessel grade were correlated with postoperative survival using the Cox proportional hazards regression model. The prognostic significance of microvessel count and grade were also compared with established prognostic indicators, including patient age, Karnofsky performance status, and tumor histology using multivariate analyses. RESULTS: Both microvessel grade and microvessel count correlated significantly with postoperative survival by univariate analysis in both previously untreated and treated patients. Patients with tumors containing a microvessel Grade of 3+ or 4+ had significantly shorter survival time than patients with a microvessel Grade of 1+ or 2+ (P = 0.0022). Likewise, patients with microvessel counts of 70 or greater had significantly shorter survival than those with microvessel counts of fewer than 70 (P = 0.041). Patient age, Karnofsky performance status, tumor histology, and extent of resection were also correlated with survival by univariate analysis. Microvessel count was further shown to be an independent prognostic indicator by multivariate analyses. There were correlations between microvessel density and patient age and between microvessel density and astrocytic tumor grade. CONCLUSIONS: These findings support the importance of microvessel density as a prognostic indicator of postoperative survival of patients with astroglial brain tumors. Regional tumor heterogeneity may limit the use of these techniques for routine pathologic examination.

Adult↗

Quality of life of women with ovarian cancer.

The primary objectives of this study were to determine the nature and extent of physical problems and psychological distress experienced by women with ovarian cancer and to identify medical and sociodemographic factors that were predictive of distress. Quality of life was assessed at 3-month intervals, for a maximum of 12 months in 151 ovarian cancer patients, most with advanced-stage disease (86%). Patients' pain, other physical symptoms, level of physical functioning, psychological state, and social functioning were evaluated using the following measures: a detailed pain questionnaire, Memorial Pain Assessment Card, Memorial Symptom Assessment Scale, Mental Health Inventory (MHI), Functional Living Index--Cancer (FLIC), and the Karnofsky Performance Status. Upon entry, 33% of patients reported significant psychological distress, as indicated by MHI Psychological Distress scores (MHI-PD) equal or greater to 1.5 standard deviations above the mean of a nationwide community sample. Impaired physical functioning (FLIC subscale) was the most important predictor of heightened psychological distress (MHI-PD) at baseline (1.5 SD or greater above the norm) (P = 0.0004) in a stepwise logistic regression involving medical/physical and sociodemographic variables as predictors. Further, significant differences were found in all quality of life scales between patients with Karnofsky Performance Status scores of < or = 80, and those with ratings of 90 or greater (P = 0.036 to P < 0.0001). These data suggest the need for an improved and more frequent assessment of ovarian cancer patients' psychological status, particularly as physical functioning declines, to improve early detection and referral to treatment of those suffering from psychiatric sequelae of cancer.

Adult↗

Assessing the quality of life--a study in newly-diagnosed breast cancer patients.

Quality of life (QL) assessment is an increasingly important component of clinical research, especially with cancer patients. The literature strongly supports the view that QL should be assessed by the patient rather than the clinician. While clinical parameters such as performance status or toxicity ratings may bear some relationship to QL, they are not a substitute for its measurement. In spite of these observations, clinicians have been reluctant to accept the need for patient-rated measures of QL. In this paper, data from a sample of 109 newly-diagnosed breast cancer patients were used to examine the relationship between expert-rated measures and a patient-rated measure of QL; to determine whether the Cancer Rehabilitation Evaluation System (CARES), an instrument for assessing the rehabilitation needs of cancer patients, is a measure of QL; to explore whether there are any medical, social or demographic variables which the clinician can use to predict how patients assess their QL; and to determine which variables (expert-rated scales, medical, social or demographic variables, or rehabilitation needs) have the most effect on how patients evaluate their QL. In this sample, patient ratings of QL were widely distributed and were only moderately correlated with the expert-rated Karnofsky Performance Status (r = 0.53) and Global Adjustment to Illness Scale (r = 0.59). In addition, there were no significant correlations between important clinical variables (axillary node status, type of surgery, receipt of chemotherapy) and patient-rated QL. Among the clinical variables and instruments studied, the Global CARES score demonstrated the best correlation (r = -0.74) with the patient-rated assessment of QL. A stepwise multiple linear regression procedure was performed with QL as the dependent variable in order to identify which factors accounted for the most variance in patient assessment of QL. The potential predictor variables used in this procedure were chosen from among those that would be available to a clinician. The Global CARES score was the best single predictor of QL, accounting for 55% of the variance, followed by Karnofsky Performance Status, the Medical Interaction and Sexual summary scales of the CARES, and the patient's educational status. Data from the CARES provided additional descriptive information about the type and frequency of rehabilitation problems experienced by these patients in relation to their ratings of QL.(ABSTRACT TRUNCATED AT 400 WORDS)

Activities of Daily Living↗

Relationship between functional status and health-related quality-of-life after myocardial infarction.

Despite increasing use in clinical and economic studies, no gold standard exists for the measurement of health-related quality of life (HRQL). One approach to assessing the validity of an HRQL instrument for a particular disease population is to examine the empirical relationship between HRQL patient scores and other accepted measures of health or functional status. In 185 patients (mean age 60 years, 79% male) at six months after myocardial infarction, we examined the relationship between patient responses to the Nottingham Health Profile (NHP), a generic HRQL instrument, and physician classification of patients by two widely used functional status indicators: the New York Heart Association (NYHA) classification and the Karnofsky Performance Status Scale. Analysis of NHP scores by NYHA strata confirms that lower HRQL is associated with poorer cardiac functional status (P < 0.0001) and this gradient is observed over all six NHP domains. Statistically significant (P < 0.001) associations were observed between patients' NYHA class and NHP domain scores for energy (Spearman r = 0.52), physical mobility (r = 0.45) and pain (r = 0.43). NHP scores for patients in NYHA Class I were similar to male population controls. A similarly consistent relationship was found between NHP and Karnofsky. We conclude that the NHP is able to discriminate between patients with differing levels of cardiac functioning as classified by NYHA and patient functioning as classified by Karnofsky. Demonstration of such discriminative properties is one important component in assessing the construct validity of HRQL measures.

Activities of Daily Living↗

Phase II study of topotecan plus cranial radiation for glioblastoma multiforme: results of Radiation Therapy Oncology Group 9513.

PURPOSE: A Phase II trial was conducted by the Radiation Therapy Oncology Group (RTOG) to compare the survival of patients with glioblastoma multiforme treated with topotecan combined with standard cranial radiotherapy (RT) for matched patients treated in prior RTOG studies. A secondary objective was to document the acute and late toxicities of this combination of chemotherapy and RT. METHODS AND MATERIALS: Eighty-seven patients with histologically confirmed glioblastoma multiforme received standard cranial RT (60 Gy/30 fractions in 6 weeks) plus topotecan 1.5 mg/m2 per day i.v. for 5 d/wk every 3 weeks for 3 cycles. Eighty-four patients were evaluated, of whom 60 (71%) were > or =50 years, 44 (52%) were men, and 61 (73%) had a Karnofsky performance status of > or =80. Twenty-nine percent of patients had undergone biopsies, 48% partial resections, and 21% gross total resections. Two resections were unspecified as to the extent of tumor removal. Fourteen percent of patients were recursive partitioning analysis Class III, 46% were Class IV, 35% were Class V, and 5% were Class VI. RESULTS: The median survival was 9.3 months. Sixty-seven patients (80%) had progression. The 1-year survival rate was 32%. One patient remained alive without recurrence. RTOG 9513 patients were matched with patients in an RTOG clinical trial database from previous clinical trials. The matching variables were age, Karnofsky performance status, mental status, and prior surgery. No statistically significant difference was found between the survival of the study patients and that of the matched patients from the RTOG database. Fifty-four percent of patients had Grade IV acute toxicity. The toxicity was primarily hematologic. Four patients had Grade III late central nervous system toxicities. CONCLUSION: Topotecan administered at a dose of 1.5 mg/m2 per day i.v. for 5 d/wk every 3 weeks for 3 cycles given concurrently with standard cranial RT for glioblastoma does not produce a statistically significant survival advantage over previously tested therapies. Other methods of administration of topotecan or other camptothecins may provide more effective radiosensitization.

Aged↗

Dimensions of symptom distress in women with advanced lung cancer: a factor analysis.

OBJECTIVE: To explore the structure of symptom distress in women with advanced lung cancer. DESIGN: Descriptive. SETTING: Oncology clinics and private offices. SUBJECTS: Sixty women with advanced lung cancer (71% non-small-cell); the majority received palliative treatment (88%). OUTCOME MEASURES: Symptom Distress Scale and Karnofsky Performance Status Scale. METHOD: Factor analytic techniques (principal components, varimax rotation) to investigate combinations of all symptoms in the Symptom Distress Scale and combinations of serious symptoms. RESULTS: Fatigue, disruptions in outlook, frequent pain, and difficulties in sleeping were rated the most distressing and were the most prevalent serious disruptions. A four-factor solution for the symptom distress ratings explained 63.3% of the variance and revealed groups of items representing emotional and physical suffering, gastrointestinal distress, respiratory distress, and malaise. Symptoms with a rating of serious distress were represented by five factors with emotional and physical suffering as separate factors. Symptoms were significantly related to Karnofsky Performance Status. CONCLUSIONS: Multiple symptoms formed distinct congregations of distress. Symptom control requires consideration as a multivariate approach.

Adult↗