bluuebunny/crossref_metadata_2025_split huggingface dataset:
EC4 European Syllabus for Post-Graduate Training in Clinical Chemistry. Version 2 – 1999
Authors: Bousquet B. , Brombacher P. J. , Zérah S. , Beastall G. H. , Blaton V. , Charret J. , Gurr E. , Halpern M. , Jansen R. T. , Kenny D. , Kohse K. P. , Köller U. , Lund E. , McMurray J. , Opp M. , Parviainen M. , Pazzagli M. , Queraltó J. M. , Sotiropoulou G. , Sanders G. T. 
Published: October 2004

Abstract
In modern medicine the undeniable value and indispensability of scientific investigations are now universally recognized both for diagnostic purposes and monitoring of disease and in basic epidemiology. The direct treatment of patients is an undeniable task of doctors in medicine. Progress in laboratory science is largely the result of contributions by scientists with an adequate education and specialisation in the field, i.e. by clinical chemists. Clinical laboratory science has developed on a broad front throughout the European Community, resulting in significant differences in what constitutes a national clinical chemistry service in each state. Clinical chemistry is the medical discipline devoted to obtain, explore and employ chemical knowledge and chemical methods of investigation, in order to procure knowledge about normal and abnormal chemical processes in man. These processes are studied on a general level, in order to get insight into human health and disease, and on a patient-specific level for diagnostic or monitoring purposes. The delimitation of clinical chemistry varies from country to country, since there is no sharp boundary to haematology, immunology, molecular biology and microbiology. One of the main tasks of the clinical chemist is direction and supervision of a laboratory department in a hospital or health service (public or private), where his role involves bridging the gap between rapidly developing laboratory science and technology and the growing knowledge on characteristics of disease. He must possess fundamental biochemical knowledge and have the ability to use this knowledge most appropriately as applied to clinical requirements, i.e. diagnosis of disease and planning and monitoring of therapy. Apart from providing a competent laboratory service, the clinical chemist must be able to function as a consultant to his clinical colleagues and liaise with them in the interpretation of laboratory results. His advice and professional consultation have at least three aspects, i.e. choosing the most appropriate laboratory investigation in a certain case, ensuring that the analyses are performed in the best possible way and correctly reported and, finally, providing information and (most important) interpretation on the significance and consequences of the laboratory data obtained. As the results of laboratory investigations and the consultation of the clinical chemist have a direct and important influence on the treatment of the patient, it is to the benefit of the public that the profession of the clinical chemist is duly regulated.
FDA Drug Approval Summaries: Pemetrexed (Alimta®)
Authors: Hazarika Maitreyee , White Robert M. , Johnson John R. , Pazdur Richard 
Published: October 2004

Abstract

Learning Objectives
After completing this course, the reader will be able to:
Explain the mechanism of action of a recently approved new cancer drug, pemetrexed. Describe the adverse-event profile of pemetrexed and a novel approach for toxicity reduction. Discuss the rationale for the FDA approval of pemetrexed.
Access and take the CME test online and receive 1 hour of AMA PRA category 1 credit at CME.TheOncologist.com
The purpose of this report is to summarize information on pemetrexed (LY231514; MTA; Alimta®; Eli Lilly and Company; Indianapolis, IN), a drug recently approved by the U.S. Food and Drug Administration (FDA). The review of the efficacy and safety of pemetrexed is summarized below. Pemetrexed is a pyrrolopyrimidine antifolate. It inhibits thymidylate synthase, glycinamide ribonucleotide formyltransferase, and dihydrofolate reductase. In a single, randomized, single-blind, multicenter phase III trial, the efficacy and safety of pemetrexed combined with cisplatin (Platinol®; Bristol-Myers Squibb; Princeton, NJ) were compared with those of single-agent cisplatin in 448 patients with malignant pleural mesothelioma. Two hundred twenty-six patients were randomized to receive pemetrexed and cisplatin, while 222 patients were randomized to receive cisplatin alone. The primary study end point was survival. Median survival times were 12.1 months for the pemetrexed plus cisplatin treated arm and 9.3 months for the cisplatin alone arm. Pemetrexed causes myelosuppression. The most common adverse events were neutropenia, fatigue, leukopenia, nausea, dyspnea, and vomiting.
On February 4, 2004, pemetrexed was approved by the FDA in combination with cisplatin for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. The recommended dose of pemetrexed is 500 mg/m2 administered as an i.v. infusion over 10 minutes on day 1 of each 21-day cycle together with cisplatin at a dose of 75 mg/m2 infused over 2 hours beginning 30 minutes after the pemetrexed infusion. Patients must receive oral folic acid and vitamin B12 injections prior to the start of therapy and continue these during therapy to reduce severe toxicities. Patients should also receive corticosteroids with chemotherapy to reduce the risk of skin rashes. Approval was based on superior survival as a clinical benefit.
Superiority of Letrozole to Tamoxifen in the First-Line Treatment of Advanced Breast Cancer: Evidence from Metastatic Subgroups and a Test of Functional Ability
Authors: Mouridsen H. , Sun Y. , Gershanovich M. , Perez-Carrion R. , Becquart D. , Chaudri-Ross H.A. , Lang R. 
Published: October 2004

Abstract

Learning Objectives
After completing this course, the reader will be able to:
Identify which advanced breast cancer patients in the three subsets studied (with nonvisceral metastases, with visceral metastases without liver involvement, and with liver metastases) responded most favorably to first-line therapy. Describe the limitations of first-line treatment in the three subsets of patients with advanced breast cancer. Explain how KPS assessment correlates with overall survival in patients with advanced breast cancer with different sites of metastatic lesions.
Access and take the CME test online and receive 1 hour of AMA PRA category 1 credit at CME.TheOncologist.com
Purpose. The letrozole study 025 is a large (n = 907), international, double-blind, randomized, phase III trial in postmenopausal women with advanced breast cancer. This subanalysis compares the efficacies of letrozole and tamoxifen as first-line therapy in postmenopausual women with advanced breast cancer according to site of metastatic lesions and Karnofsky Performance Status (KPS).
Materials and Methods. Nine hundred seven patients with advanced breast cancer were randomly assigned to once-daily oral letrozole (2.5 mg; Femara®; Novartis Pharma AG; Basel, Switzerland) or tamoxifen (20 mg; Tamofen®; Leiras OY; Turku, Finland). Time to progression (TTP) was estimated using the Kaplan-Meier product-limit method. Treatments were compared by Cox proportional hazards regression models.
Results. Letrozole treatment significantly prolonged TTP in all subsets of patients: those with nonvisceral metastases, those with visceral metastases without liver involvement, and those with liver metastases. The reduction in risk of progression ranged from 25%, for patients with nonvisceral metastases, to 36%, for patients with liver metastases. The distributions of baseline KPS scores for both treatment groups were similar (57% had KPS scores ≥90). Time to worsening of 20 points or more in KPS score was significantly longer with letrozole than with tamoxifen, but modest numbers of patients experienced such deterioration (letrozole, 20%, tamoxifen, 22%, in patients without visceral metastases; 23%–24% in patients with liver metastases; and letrozole, 14%, tamoxifen, 30%, in patients with visceral metastases without liver involvement).
Conclusion. These data demonstrate the consistent superiority of letrozole over tamoxifen and support the use of letrozole as a new standard of endocrine therapy in postmenopausal women with advanced breast cancer.
Efficacy of First-Line Letrozole Versus Tamoxifen as a Function of Age in Postmenopausal Women with Advanced Breast Cancer
Authors: Mouridsen H. , Chaudri-Ross H.A. 
Published: October 2004

Abstract

Learning Objectives
After completing this course, the reader will be able to:
Identify those patients in both age groups who responded most favorably to first-line therapy with letrozole. Describe the advantages of first-line treatment with letrozole in older patients with advanced breast cancer. Discuss the role of first-line therapy with letrozole in the management of advanced breast cancer.
Access and take the CME test online and receive 1 hour of AMA PRA category 1 credit at CME.TheOncologist.com
Purpose. To compare the efficacy, in regard to time to progression (TTP) and objective response rate (ORR), of letrozole (Femara®; Novartis Pharma AG; Basel Switzerland), an oral aromatase inhibitor, with that of tamoxifen (Tamofen®; Leiras OY; Turku, Finland) as first-line therapy in younger (&lt;70 years) and older (≥70 years) postmenopausal women with advanced breast cancer.
Materials and Methods. Nine hundred seven patients with advanced breast cancer were randomly assigned to receive 2.5 mg letrozole (n = 453) or 20 mg tamoxifen (n = 454) once daily in a double-blind, multicenter, international trial. Among the prospectively planned analyses were analyses of TTP and ORR by age (&lt;70 and ≥70 years). The results of these prospectively planned analyses are reported here.
Results. Letrozole was as effective in older postmenopausal women (≥70 years of age) as it was in younger postmenopausal women (&lt;70 years of age). The overall ORR in the older subgroup was significantly higher in patients treated with letrozole (38%) than in patients treated with tamoxifen (18%). In the younger subgroup of postmenopausal patients, the ORRs were not significantly different (letrozole, 26%; tamoxifen, 22%). TTP was significantly longer for letrozole than for tamoxifen in both age groups (younger: letrozole median TTP, 8.8 months; tamoxifen, 6.0 months; older: letrozole median TTP, 12.2 months; tamoxifen, 5.8 months). Although age was independently prognostic of TTP, there was no significant effect of age on ORR in the presence of other factors.
Conclusion. The data show that letrozole, 2.5 mg once daily, is as effective in older, postmenopausal women as it is in younger postmenopausal women with advanced breast cancer. In addition, letrozole was more effective than tamoxifen in both younger and older patients.
What Is the Role of Ovarian Ablation in the Management of Primary and Metastatic Breast Cancer Today?
Authors: Prowell Tatiana M. , Davidson Nancy E. 
Published: October 2004

Abstract

Learning Objectives
After completing this course, the reader will be able to:
Discuss the pros and cons of various methods of ovarian ablation, including oophorectomy, radiation therapy, and luteinizing hormone releasing hormone (LHRH) analogues. Recall the frequency of chemotherapy-related amenorrhea with commonly used regimens in adjuvant breast cancer treatment. Discuss the evidence supporting the use of ovarian ablation in premenopausal women with early-stage breast cancer. Discuss the evidence supporting the use of ovarian ablation in premenopausal women with locally advanced and metastatic breast cancer.
Access and take the CME test online and receive 1 hour of AMA PRA category 1 credit at CME.TheOncologist.com
Ovarian ablation has been used for more than a century in the treatment of breast cancer. Methods of irreversible ovarian ablation include surgical oophorectomy and ovarian irradiation. Potentially reversible castration can be accomplished medically using luteinizing hormone releasing hormone (LHRH) analogues. In addition, cytotoxic chemotherapy unpredictably produces amenorrhea and primary ovarian failure in 10%–95% of premenopausal women as a function of patient age, cumulative dose, and the specific agents used. In the metastatic setting, ovarian ablation and tamoxifen monotherapies produce comparable outcomes and may be more effective when used together. While many early adjuvant trials of ovarian ablation were methodologically flawed, a more recent meta-analysis by the Early Breast Cancer Trialists’ Collaborative Group of 12 properly designed randomized trials found significantly greater disease-free and overall survival rates for women under the age of 50, regardless of nodal status, receiving ovarian ablation as a single adjuvant therapy. Several important issues regarding the role of ovarian ablation in the treatment of breast cancer remain unresolved. Data suggest that ovarian ablation followed by some years of tamoxifen produces similar results to those seen with adjuvant chemotherapy in women with hormone-receptor positive breast cancer; however, the value of combining these modalities is still unclear. Other areas of ongoing investigation include the appropriate duration of therapy with LHRH analogues in the adjuvant setting, the long-term sequelae of ovarian suppression among young breast cancer survivors, and refinement of the population most likely to benefit from ovarian ablation or suppression.
Carboplatin in Combination Therapy for Metastatic Breast Cancer
Authors: Perez Edith A. 
Published: October 2004

Abstract

Learning Objectives
After completing this course, the reader will be able to:
Describe the single-agent activity of carboplatin for metastatic breast cancer. Discuss the results of phase II trials of taxanes with platinum agents for breast cancer. Explain the hypothesis for the preclinical interaction between trastuzumab and platinum agents.
Access and take the CME test online and receive 1 hour of AMA PRA category 1 credit at CME.TheOncologist.com
Background. Anthracycline-based regimens have a limited role in patients with metastatic breast cancer due to cumulative cardiotoxicity and their common use in adjuvant chemotherapy. New nonanthracycline regimens are, therefore, needed for metastatic disease. Single-agent carboplatin is active in patients with previously untreated metastatic breast cancer, producing response rates of 20%–35%. Preclinical studies have demonstrated synergistic antitumor efficacy of carboplatin and trastuzumab in HER2+ models.
Methods. Phase II and III clinical trial data of combination therapy with carboplatin (Paraplatin®; Bristol-Myers Squibb; Princeton, NJ), a taxane, and/or trastuzumab (Herceptin®; Genentech, Inc.; South San Francisco, CA) in metastatic breast cancer were identified from multiple sources, including: A) clinical trial data published in peer-reviewed journals within the last 5 years; B) preliminary clinical trial data from abstracts recently presented at national meetings; and C) phase III protocols currently evaluating carboplatin-based combination regimens.
Results. In several phase II studies, combination carboplatin and paclitaxel (Taxol®; Bristol-Myers Squibb) therapy was active and reasonably well tolerated in the first-line treatment of metastatic breast cancer, producing objective response rates of 53%–62%—substantially higher rates than those seen in other phase II trials of either drug alone. Similar phase II data for carboplatin with docetaxel (Taxotere®; Aventis; Bridgewater, NJ) have been reported, and recent phase III data suggest that adding carboplatin to a paclitaxel/trastuzumab regimen produces superior efficacy than paclitaxel/trastuzumab alone for patients with HER2+ metastatic disease. Drug scheduling plays an important role in the therapeutic ratio of this combination treatment.
Conclusions. Incorporation of carboplatin as a standard agent in first-line treatment of metastatic breast cancer has support from several recent studies. Preliminary results of combination carboplatin/taxane therapy with trastuzumab in metastatic disease are encouraging, and other carboplatin combinations are also being investigated in other phase II and III trials in patients selected based on the HER2 status of their cancer. Results are eagerly awaited.
Dynamic Magnetic Resonance Perfusion Imaging of Brain Tumors
Authors: Covarrubias Diego J. , Rosen Bruce R. , Lev Michael H. 
Published: October 2004

Abstract

Learning Objectives
After completing this course, the reader will be able to:
Understand the rationale and validity of using MR perfusion techniques for selecting the optimal biopsy site for brain neoplasms. Understand the rationale and validity of using MR perfusion techniques to differentiate tumor recurrence from radiation necrosis. Understand the technical difficulties and limitations of this technique in the setting of high-grade neoplasms with severe blood-brain barrier breakdown, as well as the multiple methods available to address this problem.
Access and take the CME test online and receive 1 hour of AMA PRA category 1 credit at CME.TheOncologist.com
In this paper, we review the technique of contrast-enhanced magnetic resonance (MR) perfusion imaging of brain neoplasms, with an emphasis on its clinical applications and utility. We start with a discussion of MR perfusion techniques available today and their relative merits and shortcomings. Next, the ability of MR perfusion to provide a preoperative assessment of tumor histology is examined. We also discuss the role of MR perfusion in helping guide tumor biopsy, and its advantages over more conventional methods. We will scrutinize the use of MR perfusion for assessing true lesion extent, in contrast to conventional MR imaging and other MR techniques. We will discuss the role of MR perfusion in differentiating treatment effects, such as radiation necrosis, from tumor recurrence. Finally, the future potential applications of this technology in the setting of novel antiangiogenic therapies for brain tumors will be addressed.
Practical Aspects of Weekly Docetaxel Administration Schedules
Authors: Hainsworth John D. 
Published: October 2004

Abstract

Learning Objectives
After completing this course, the reader will be able to:
Describe the efficacy of weekly docetaxel in various solid tumors, particularly in comparison with docetaxel administered every 3 weeks. List the common treatment-related toxicities of weekly docetaxel. Effectively manage the common toxicities related to weekly docetaxel.
Access and take the CME test online and receive 1 hour of AMA PRA category 1 credit at CME.TheOncologist.com
Docetaxel (Taxotere®; Aventis Pharmaceuticals Inc.; Bridgewater, NJ) is a highly effective chemotherapeutic agent with proven efficacy in a number of solid tumors. However, myelosuppression can be a substantial concern when docetaxel is administered every 3 weeks. Myelosuppression can be particularly problematic in older patients and those being treated with palliative intent. Weekly dosing of docetaxel has been investigated in an effort to reduce toxicity and has been identified as a safe and effective regimen in clinical trials. Weekly docetaxel is generally administered at doses ranging from 30–40 mg/m2/week for 6 of 8 weeks or for 3 of 4 weeks. With weekly dosing, though efficacy is comparable, myelosuppression is substantially less, and the overall tolerability profile is better than with every-3-week dosing. Fatigue is a common toxicity associated with weekly docetaxel; other adverse effects that are seen in a minority of patients include hyperlacrimation, nail toxicity, and alopecia. These side effects are dose related and can generally be managed through dose reductions or alterations in the weekly schedule. Because of the favorable tolerability profile, weekly docetaxel is under investigation in combination with other chemotherapeutic agents and with novel targeted agents in a variety of tumor types. The results of these ongoing studies will further define the place of weekly docetaxel in cancer therapy.
Hypersensitivity Reactions to Oxaliplatin and the Application of a Desensitization Protocol
Authors: Gammon David , Bhargava Pankaj , McCormick Michael J. 
Published: October 2004

Abstract
Oxaliplatin (Eloxatin®; Sanofi-Synthelabo Inc.; New York, NY) is a third-generation platinum agent indicated for the treatment of colorectal cancer. Severe hypersensitivity reactions to oxaliplatin rarely occur; however, they do represent a threat to the small number of patients that are occasionally affected. We developed a desensitization protocol and successfully applied it to a patient with severe, grade 3, hypersensitivity to oxaliplatin. For patients who have mild sensitivity to oxaliplatin, slowing the run rate down and giving an antihistamine and/or a steroid usually suffice. Desensitization will help to provide the small number of patients who experience severe hypersensitivity reactions with the ability to further receive an effective therapy for their colorectal cancer. The desensitization protocol is described in detail.
Superior Sulcus Tumors: A Mini-Review
Authors: Archie Victor C. , Thomas Charles R. 
Published: October 2004

AbstractLearning ObjectivesAfter completing this course, the reader will be able to:Describe the diagnostic work-up for superior sulcus (Pancoast) tumors of the lung. List the major prognostic factors pertaining to outcome in patients with superior sulcus (Pancoast) tumors. Discuss the recent (SWOG 94-16) and current (SWOG-0220) intergroup trials for superior sulcus (Pancoast) tumors.Access and take the CME test online and receive 1 hour of AMA PRA category 1 credit at CME.TheOncologist.comThe management and outcome for superior sulcus tumors have remained unchanged for 40 years. The rarity of these tumors has led to varying treatment techniques spanning decades, from which no solid conclusions can be drawn. Recent advances in combined-modality therapy have offered the first inkling that a paradigm shift is on the horizon. Here, we review the history and new advances in treating this challenging pulmonary neoplasm.
Non-Small Cell Lung Cancer in the Elderly
Authors: Makrantonakis Paris D. , Galani Eleni , Harper Peter G. 
Published: October 2004

Abstract

Learning Objectives
After completing this course, the reader will be able to:
Describe the difference between chronologic and biologic age in patients with NSCLC. Discuss how clinical trials establish biologic rather than chronologic age in patients with NSCLC. Explain the effectiveness of surgery, radiation, and chemotherapy in geriatric patients with NSCLC.
Access and take the CME test online and receive 1 hour of AMA PRA category 1 credit at CME.TheOncologist.com
The population is aging both in developing and developed countries. What is clear is that currently over 50% of all patients with non-small cell lung cancer (NSCLC) are 65 years of age or older. When deciding a treatment strategy, the biological rather than the chronological age should be carefully assessed, and treatment should only be modified or withheld for very good reason. This applies equally to surgery, radiation therapy, and chemotherapy. Fortunately, recently published studies have focused on the issue and have provided strong evidence of improved progression-free survival, overall survival, and quality of life in elderly patients with appropriately treated NSCLC.