Concurrent combination chemotherapy of human solid tumors: experience with a three-drug regimen and review of the literature.
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Adolescent↗
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Ménière's disease associated with serous retinopathy.
A case history is presented of a patient suffering from classical Ménière's disease who concurrently developed central serous retinopathy. On review, these conditions are found to have several features in common and on the basis of the changes seen by fluorescein angiography in the eye, an hypothesis is presented for the development of endolymphatic hydrops.
Edema↗
Proceedings of the Symposium on Designs for Clinical Cancer Research. Summary views: A statistician's perspective.
This paper outlines some broad issues concerning the role of statistical methods, and argues for flexibility of approach. It reviews the controversies concerning historical versus concurrent controls, and randomization versus extensive balancing. Finally, it proposes directions in which further developments of statistical technique would be desirable.
Forecasting↗
Gemcitabine and radiation therapy for non-small cell lung cancer.
Patients with stage III non-small cell lung cancer (NSCLC) frequently progress either within the irradiated field or systemically, due to uncontrolled microscopic dissemination present before the time of initial diagnosis. The use of combined modality therapy has led to improved survival rates in recent years. In particular, the use of cisplatin and vinblastine as induction chemotherapy is supported by two large randomized clinical trials. Nevertheless, the large majority of patients still die of progressive disease, thus providing a rationale for the integration of new active agents into the overall treatment plan of these patients. Gemcitabine has demonstrated significant single-agent activity in NSCLC. In addition, preclinical and early clinical data indicate that it is a powerful radiation enhancer. Clinical trials investigating this drug with concurrent radiation therapy in NSCLC are reviewed.
Antimetabolites, Antineoplastic↗
Effect of concurrent medications on cisplatin-induced nephrotoxicity in patients with head and neck cancer.
The goal of this study was to identify clinical characteristics and concurrent medications associated with an increased or decreased incidence of cisplatin-induced nephrotoxicity. The medical records for 62 subjects with head and neck cancer who received cisplatin 100 mg/m2 (day 1) plus fluorouracil 1000 mg/m2 (days 1-5) with or without radiation therapy were reviewed from three medical centers. The demographics, concurrent medication therapy, co-existing illnesses and clinical laboratory values were extracted from the medical records. Nephrotoxicity was defined as a minimum rise in serum creatinine of 0.5 mg/dl or above. The concurrent use of hydrochlorothiazide or multivitamins was associated with a higher incidence of nephrotoxicity after cycle 1. Use of albuterol, atenolol or hydrochlorothiazide was also associated with a higher incidence of nephrotoxicity after cycle 1 or 2. In contrast, subjects prescribed dexamethasone or ondansetron were less likely to experience nephrotoxicity. None of these medications affected treatment response. Race/ethnicity was independently correlated with the incidence of nephrotoxicity; African-American subjects were more likely to develop nephrotoxicity independent of the influence of these concurrent medications. Medications may modulate cisplatin-induced nephrotoxicity by altering the metabolic activation of cisplatin to a nephrotoxin. Genetic differences in the drug-metabolizing enzymes may contribute to the correlation with race. The results from this retrospective study provide data to support a larger prospective study to further investigate the associations between these concurrent medications and cisplatin-induced nephrotoxicity.
Albuterol↗
Qualitative issues in developing educational diagnostic instruments and assessment procedures for diabetic patients.
With one exception, psychometric analyses of the quality of instrumentation and educational assessment procedures for diabetic patients have not been reported in the literature. Following an extensive internal review process, a pilot test of 56 diabetic patients found that the newly developed instrument had a high degree of internal consistency for the major indexes, 0.89 and 0.85, respectively. An item analysis found individual questions to be of an acceptable quality. An analysis of interrater reliability of patient assessment procedures produced an r = 0.93. Some support for content and concurrent validity was noted. Using an external review by an expert panel, a revised instrument and protocol was used to conduct a formal field test of 100 diabetic patients. Levels of internal consistency similar to the pilot, 0.87 adn 0.86, were found. An item analysis produced similar positive results. While some support for concurrent validity of the data was found, little support for discriminant validity was evident. The instrument and assessment procedures need to undergo more extensive and rigorous examination of its psychometric characteristics, particularly stability and predictive validity.
Diabetes Mellitus↗
Renal disease audit and drug usage evaluation for all patients.
The object of this study was to develop a concurrent automated screening system to identify patients with a glomerular filtration rate (GFR) less than 50 mL per minute who might need dose or interval adjustment of drugs that are excreted primarily renally. The design of this investigation was a concurrent study of all patients in a level II trauma 317-bed community health center. The data were extracted after daily monitoring of patient laboratory values, specifically, blood urea nitrogen, serum creatinine, creatinine clearance, and chart review. It was concluded that, in 1991, a total of 70 pharmacy-initiated interventions were made on the basis that potentially harmful side effects might have occurred if drugs that primarily are excreted renally were administered to patients identified with a calculated GFR less than 50 mL per minute.
Clinical Pharmacy Information Systems↗
Concurrent chemotherapy (CT) and radiotherapy (RT) in locally advanced non-small cell lung cancer (NSCLC): a review.
Stage III or locally advanced non-metastatic, non-small cell lung cancers comprise about 40% of all NSCLC. A proportion of patients with Stage III NSCLC can be treated by induction RT/CT followed by surgery, but the majority, in particular all Stage IIIB, are not candidates for this approach. For these patients, RT alone is generally considered as the standard treatment. RT has a modest, but definitive curative potential, with 1-, 2-, and 5-year survivals of about 40%, 20% and 5%, respectively, and median survival of 9-12 months. Combination CT-RT, depending on its type and rationale, is aimed at improving survival via a decrease of local or distant failure rates or both. Combined modality (CM) can be subdivided into 3 categories: sequential, concomitant and alternated regimes. Concomitant and alternated CT-RT have some common characteristics and rationale, the overall time playing a central role. This paper reviews studies of inoperable NSCLC treated with these CM, excluding sequential CT-RT trials, which would require a separate discussion. Numerous Phase I-II studies have been recently published on concomitant or alternated schemes and 33 of them are presented in this paper. Although it is hazardous to readily compare their results with those of RT-alone studies, several trials using platin-based combination chemotherapy, concurrently or alternated with RT, have shown impressive response rates and encouraging survivals, at a price of significant toxicity. Seven randomized trials comparing RT alone versus concomitant CT-RT are now available: the 3 non-cisplatin trials have failed to show any improvement in survival with CM, whereas among the 4 cisplatin trials, only one demonstrated a benefit with low-dose cisplatin added to RT. Implications for future clinical research will be discussed.
Carcinoma, Non-Small-Cell Lung↗
Concurrent administration of clozapine and electroconvulsive therapy in clozapine-resistant schizophrenia.
OBJECTIVE: The aim of this article is to critically review all published studies regarding the efficacy and safety of the concurrent administration of clozapine (CLZ) and electroconvulsive therapy (ECT) in CLZ-resistant schizophrenic or schizoaffective patients. METHOD: A MEDLINE search from January 1980 to July 2005 was conducted. RESULTS: One open-label trial and 6 case studies were located, comprising 21 schizophrenic and 1 schizo affective patients (12 men and 10 women) with a mean age of 41.9 years. The duration and dosage of CLZ monotherapy before ECT were reported at least 12 weeks and 300 mg/d, respectively, in 10 patients (45.4%). Plasma CLZ levels before ECT were assessed in 12 patients (54.5%), in which only 7 (31.8%) were reported to be higher than 350 ng/mL. The CLZ dosage during ECT ranged from 200 to 900 mg/d (mean, 518.2 +/- 203.3 mg/d). The number of ECT sessions ranged from 2 to 20 (mean, 11.5 +/- 5.4). Application of electrodes was unilateral in 7 patients, bilateral in 10 patients, and mixed in 2 patients. Sixteen patients (72.7%) showed marked improvement whereas 6 patients (27.3%) had moderate, minimal, or no improvement. No predictors of outcome could be isolated. Side effects reported by 5 patients (22.7%) were nausea, tachycardia, hypertension, memory problems, and confusion. Ten patients (45.4%) relapsed during follow-up. Substantial improvement persisted beyond 4 months in only 5 patients (22.7%). CONCLUSION: Preliminary evidence exists for the safety and short-term efficacy of the concurrent administration of CLZ and ECT in CLZ-resistant schizophrenic or schizoaffective patients.
Antipsychotic Agents↗
Concurrent thrombotic thrombocytopenic purpura and immune thrombocytopenic purpura in an HIV-positive patient: case report and review of the literature.
Immune thrombocytopenic purpura (ITP) and thrombotic thrombocytopenic purpura (TTP) have each been associated with HIV infection. Sequential occurrence of these two diseases with a disease-free interval has been occasionally reported in the literature, whereas simultaneous manifestations of these two diseases have not been described. Here, we report an AIDS patient who was initially diagnosed as having TTP and showed an apparent partial response to plasmapheresis but was found to have a clinical course similar to ITP. Although precise mechanisms for the development of TTP and ITP in these patients are unclear, we offer several hypotheses. It is important to recognize that these two processes may be seen concurrently.
AIDS-Related Opportunistic Infections↗
Quality management in mental health. II. Managing risk of dangerousness.
In 1995 R. L. Coleman and D. E. K. Hunter described a quality management approach that produced measurable improvements in quality of care in a state-operated psychiatric hospital. Continued evolution of this approach has subsequently enabled the development and implementation of effective processes for managing risk of dangerousness among patients throughout the hospital. Supported by management principles that promote hospital-wide quality improvement, clinicians and managers produced an environment that was conducive to promoting quality. The hospital-wide quality improvement context involved integrating multiple activities designed to promote quality of care, including significant collaborations with other health care organizations. The hospital's mission as an acute care psychiatric facility has required that it focus on assessing and managing risk of dangerousness in a systematic manner. This was done through developing and utilizing a predictive risk assessment instrument and indicators for managerial oversight. This was accomplished in these steps. First, clinical leaders rated potential criteria according to estimates of their ability to predict dangerousness behavior and reviewed their estimates in relation to clinical findings. Second (and concurrently), clinicians and managers implemented procedures to monitor clinical risk and performance. Finally, outcome data were reviewed. They suggested that this approach was effective in reducing risk of dangerous behavior among patients on all psychiatric wards.
Dangerous Behavior↗
[Concurrent chemotherapy and radiation therapy for unresectable locally advanced carcinoma of the esophagus. Phase II study and clinical review on literature].
BACKGROUND: Neither surgical advances nor those in therapeutic radiology have been able to significantly reduce the mortality related to esophageal carcinomas. The results of combining: first surgery, then radiation therapy, which have been unsatisfactory for decades, encourage therapeutic concepts involving a variety of modalities. PATIENTS AND METHODS: For 50 patients with unresectable locally advanced esophageal carcinomas, a palliative concurrent chemotherapy and radiation therapy was carried out according to the "intent to treat" principle. The aim was a minimal dose of 40 Gy. The concurrent chemotherapy was carried out using cisplatin/5-FU during the 1st and 4th weeks of radiation therapy. In the case of partial or complete remission, the chemotherapy was to be continued as maintenance therapy with a maximum of four cycles. In the case of no change or minor response, instead of maintenance chemotherapy, the dose of local radiation was to be increased by means of brachytherapy. RESULTS: The median survival rate for the entire population under study was 8.7 months. The survival rates of 1, 2, 3, 4, and 5 years were, respectively, 38%, 20.5%, 13.7%, 6.8%, and 6.8%. The remission rates were as follows: NC: 14 patients (28%), PR: 32 patients (64%), CR: 4 patients (8%). 17 patients (34%) tolerated the full concurrent chemotherapy; only twelve patients (24%) tolerated supportive chemotherapy. The following factors exhibited a significant correlation to survival: the intensity of the chemotherapy, the Karnofsky index, the age of the patients, and the improvement of oral food intake. CONCLUSIONS: The concurrent chemotherapy was toxic and the benefit to the patients questionable. At best, meta-analyses of randomized studies along the lines of "evidence-based medicine" demonstrate for concurrent chemotherapy and radiation therapy an improvement of 2-year survival rates, but with these also involving a high level of toxicity. Due to the heterogeneous data available, the value of the primary, sequential treatment combining chemotherapy and radiation therapy is uncertain.
Adult↗
Radiation and simultaneous cisplatin in non-small cell lung cancer.
PURPOSE: Phase III non-small cell lung cancer trials comparing radiation and simultaneous single agent cisplatin-radiation, as well as, Phase II trials of cisplatin containing combination regimens and concurrent thoracic radiation used as preoperative or as definitive therapy in stage III non-small cell lung cancer are reviewed. METHODS AND MATERIALS: The prognostic significance of the new international staging system with respect to clinical Stage III disease is described and discussed in this review because it has important implications for clinical trials. The results of four randomized Phase III trials and one Phase II trial which evaluated radiation therapy and single agent cisplatin are reviewed. The data from studies of combination chemotherapy and concurrent thoracic radiation observed in two consecutive Rush University Phase II trials and in a randomized Phase II Mayo Clinic trial are described. Eight phase two studies in which thoracic radiation and simultaneous cisplatin containing combination chemotherapy were given as preoperative treatment are compared. RESULTS: Studies evaluating the prognostic significance of the new staging system (IIIa vs IIIb) have shown conflicting results. In Rush University trials there has been a significant difference for IIIa versus IIIb and in particular the tumors which are invading the mediastinum or chest wall without obvious mediastinal lymph node metastases appear to have the best prognosis. Similarly randomized trials evaluating curative doses of thoracic radiation therapy with or without current single agent cisplatin have shown contradictory results. One of the four randomized trials have shown superior survival with patients treated with radiation and simultaneous daily cisplatin. Toxicity with cisplatin combination chemotherapy regimens and split course radiation has been acceptable. In Phase II non-surgical trials preoperative treatment consisting of cisplatin containing combination regimens given simultaneously with thoracic radiation have shown that this type of combined modality therapy is feasible and that the rates of resectability appear to be higher than would be expected with surgery alone. Survival results from six of these studies appear to be superior to results reported for radiation or surgery alone. CONCLUSION: Additional data are needed to determine the prognostic significance of the new staging system for clinical Stage III non-small cell lung cancer patients. Similarly, additional Phase III trials will be required to determine the role of thoracic radiation and concurrent single agent cisplatin, as well as, concurrent cisplatin combination regimens. Treatment with preoperative radiation and concurrent cisplatin containing combination therapies is feasible and relatively safe. Phase III trials are needed to determine the impact of neoadjuvant chemoradiation therapy and surgery in Stage III patients.
Adult↗
Tricyclic antidepressants in prepubertal depressed children: review of the literature.
Other studies have reported the use of TCA antidepressants in the treatment of depressed children (Frommer 1967; Ossofsky 1974; Stack 1972; Polvan and Cebiroglu 1972). However, these studies did not meet criteria for inclusion in this review. In studies, other medicines were given concurrently with TCAs. Several did not specify the number of subjects and/or the number who responded. Sometimes subjects who were not diagnosed as depressed were included. Also studies of childhood depression tend to include adolescents; thus many samples were a mixture of adolescents and prepubertal children with the adolescents frequently predominating. As the purpose of this review was depression in prepubertal children, only studies comprised predominantly of prepubertal children were included. Although not included in this review, many such studies reported TCAs were useful in treating depression in children. After reviewing these studies, it is obvious that their sophistication has improved dramatically in recent years. Standard diagnostic criteria such as Feighner's Research Diagnostic Criteria, the Research Diagnostic Criteria, and more recently DSM-III (all of which are similar) have permitted a more objective and standardized diagnosis of depression. Likewise, the development of the Children's Depression Inventory and the Childhood Depression Rating Scale have allowed more objective measurement of severity of depression and of improvement in depression in children. Plasma drug level monitoring has allowed for pharmacokinetic studies of TCAs, more precise dose adjustment and equivalent drug treatment of subjects involved in clinical research studies. Studies to date indicate TCAs were helpful in treating depressed prepubertal children. However, double-blind placebo/control studies of tricyclic antidepressants in depressed prepubertal school-aged children have not been published. Ideally a study of antidepressants in children should include: objective standardized diagnostic criteria for diagnosing depression; objective rating of severity of depression; explicit exclusion criteria; steady-state plasma blood level monitoring; assured compliance; adequate duration of treatment so sufficient time is allowed for response to occur; a double-blind study design. Unfortunately the ideal study has not been done. TCAs may be an effective treatment for prepubertal major depressive disorder. However, further study is necessary to clearly establish their efficacy.
Amitriptyline↗
Celecoxib and radiation therapy in non-small-cell lung cancer.
Overexpression of cyclooxygenase-2 (COX-2) is frequently present in lung cancer and may play a significant role in carcinogenesis, invasion, and metastasis. It has been associated with shortened survival in patients with resected early-stage adenocarcinoma of the lung. COX-2 inhibition decreases tumor cell proliferation in vivo and has been shown to enhance tumor radiosensitivity. Additionally, COX-2 inhibition may protect normal pulmonary tissue from radiation fibrosis. Clinical studies are under way to assess the potential benefits and risks of COX-2 inhibition in the treatment of lung cancer. The rationale for COX-2 inhibitors in the treatment of lung cancer will be reviewed. The results of a phase II study assessing the acute toxicity of concurrent celecoxib (Celebrex) and thoracic irradiation in patients with non-small-cell lung cancer (NSCLC) are reported, and an ongoing Radiation Therapy Oncology Group study using celecoxib and concurrent radiation therapy for NSCLC in patients with intermediate prognostic factors is reviewed.
Carcinoma, Non-Small-Cell Lung↗
Toxicity potential of oral lidocaine in a patient receiving mexiletine.
OBJECTIVE: To report a case of toxicity from orally administered lidocaine in a patient with cardiomyopathy receiving concurrent mexiletine therapy. DATA SOURCES: Case reports, review articles, and studies identified by search of the MEDLINE database and Current Contents. STUDY SELECTION: All reports of toxicity from orally administered lidocaine were reviewed. DATA SYNTHESIS: Lidocaine, a local anesthetic, is widely used to treat cardiac arrhythmias. Toxicity with the parenteral form occurs frequently. In contrast, there are few reports of toxicity with oral lidocaine, most of them occurring in children receiving large doses relative to body weight. We report a case of intoxication in an adult with severe cardiomyopathy and concurrent mexiletine therapy who received only two doses of oral lidocaine. CONCLUSIONS: Although it is rarely reported in adults, clinicians must be alert to the possibility of toxicity from orally administered lidocaine. This is most likely to occur in patients with conditions known to reduce lidocaine clearance, when higher-than-usual doses are administered, or when concurrent therapy with oral lidocaine analogs may be present.
Administration, Oral↗
Octogenarians with contralateral carotid artery occlusion: a cohort at higher risk for carotid endarterectomy?
PURPOSE: Carotid angioplasty and stenting has been proposed as a treatment option for carotid occlusive disease in patients at high risk, including those 80 years of age or older or with contralateral carotid occlusion. We analyzed 30-day mortality and stroke risk rates of carotid endarterectomy (CEA) in patients aged 80 years or older with concurrent carotid occlusive disease. METHODS: From a retrospective review of 1000 patients undergoing 1150 CEA procedures to treat symptomatic and asymptomatic carotid lesions over 13 years, we identified 54 patients (5.4%) aged 80 years or older with concurrent contralateral carotid occlusion. These patients were compared with 38 patients (3.8%) aged 80 years or older with normal or diseased patent contralateral carotid artery and 81 patients (8.1%) younger than 80 years with contralateral carotid occlusion. All CEA procedures involved either standard CEA with patching or eversion CEA, and were performed by the same surgeon, with the patients under deep general anesthesia and cerebral protection involving continuous perioperative electroencephalographic monitoring for selective shunting. Shunting criteria were based exclusively on electroencephalographic abnormalities consistent with cerebral ischemia. RESULTS: The 30-day mortality and stroke rate in patients aged 80 years or older with concurrent contralateral carotid occlusion was zero. CONCLUSIONS: The concept of high-risk CEA needs to be revisited. Patients with two of the criteria considered high risk in the medical literature, that is, age 80 years or older and contralateral carotid occlusion, can undergo CEA with no greater risks or complications. Until prospective randomized trials designed to evaluate the role of carotid angioplasty and stenting have been completed, CEA should remain the standard treatment in such patients.
Aged↗
Concurrent radiation therapy and paclitaxel or docetaxel chemotherapy in high-risk breast cancer.
PURPOSE: Evidence supports the inclusion of the taxanes in the treatment of breast cancer. A recent randomized trial has shown a survival advantage to the addition of paclitaxel in the adjuvant treatment of node-positive patients. Several studies have suggested diminished local control if adjuvant radiation is delayed, while in vitro and in vivo studies have demonstrated a benefit of concurrent administration of taxanes with radiation. For these reasons, we began in 1995 to administer radiation therapy concurrently with the taxanes in advanced breast cancer. This retrospective review examines the feasibility of such treatment. METHODS AND MATERIALS: Forty-four patients were treated with concurrent radiation and either paclitaxel (29 patients) or docetaxel (15 patients). One patient received both paclitaxel and docetaxel. Eighteen patients were treated for recurrent disease, 9 had received prior radiation. Toxicity was assessed by the RTOG scale for acute and late effects. RESULTS: Concurrent radiation and taxane chemotherapy was well tolerated. Nine patients (20%) experienced Grade 3 acute skin toxicity. This was more likely with docetaxel than paclitaxel (p = 0. 04). Among patients undergoing breast conservation, there were no Grade 3 toxicities. With a median follow-up of 11 months, 1 patient has developed breast fibrosis. CONCLUSION: Concurrent administration of both paclitaxel and docetaxel with radiation resulted in acceptable toxicity. Overall, the acute skin toxicity seen with docetaxel was more pronounced. However, among patients undergoing breast conservation the taxanes were both well tolerated. Further study is necessary to assess the impact of concurrent treatment on long-term outcome.
Adult↗