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PubMed1994

NIH conference. HIV vaccine development: a progress report.

The development of a safe, effective preventive vaccine for human immunodeficiency virus (HIV) infection remains an area of vigorous research. Several highly innovative vaccine candidates are being developed, and more than 13 vaccine candidates have been tested in human phase I or II trials. All have produced antibody and several have produced modest neutralizing titers, but to date no reproducible evidence has suggested prolonged, high-titer neutralization across a diversity of HIV strains. Furthermore, only the live recombinant vector approaches have produced some evidence of cytotoxic T-cell responses. The principal obstacle to progress is the lack of definitive information on what constitutes a protective immune response. There is no animal model for HIV-induced disease. Hence, the identification of the correlates of immunity and more useful animal models is among the highest priorities for HIV vaccine research. Large-scale efficacy trials raise daunting scientific, ethical, and resource issues. Nonetheless, preparation in such trials is underway in order to be in a position to evaluate the most promising vaccine candidate.

AIDS Vaccines↗

PubMed1999

Research guidelines for chronic prostatitis: consensus report from the first National Institutes of Health International Prostatitis Collaborative Network.

OBJECTIVES: The National Institutes of Health (NIH) organized the first International Prostatitis Collaborative Network workshop (November 5 and 6, 1998, Washington, DC) to address the confusion surrounding the diagnostic and treatment strategies in chronic prostatitis. METHODS: A panel of North American and international urologic researchers, interested physicians, medical industry representatives, and patients were invited to participate and reviewed current definitions, classification systems, and recent epidemiologic and both published and "in progress" treatment studies. RESULTS: A general concensus was developed for adoption of the following criteria for clinical studies in chronic prostatitis/chronic pelvic pain syndrome: (a) the NIH definition of chronic prostatitis/chronic pelvic pain syndrome; (b) the 1995 NIH Classification System; (c) the eligibility (inclusion/exclusion) criteria developed by the NIH Chronic Prostatitis Clinical Research Network; (d) the NIH Chronic Prostatitis Symptom Index. It was agreed that clinical treatment trials involving presently available, experimental, and theoretical therapeutic modalities be prioritized according to maximum potential benefits and that regulatory authorities (ie, Food and Drug Administration in the United States) consider major changes in the approval process for treatment modalities in chronic prostatitis. CONCLUSIONS: Chronic prostatitis is a major health care issue. Standardization of definitions, classification, study design, and outcome parameters will promote rational and comparative evaluation of diagnostic and therapeutic strategies.

Chronic Disease↗

PubMed1997

Report of the National Institutes of Health (NIH) Workshop on the Development of Research Priorities in Eating Disorders.

The National Institutes of Health (NIH) Workshop on the Development of Research Priorities in Eating Disorders was convened in New York on April 24 and 25, 1996. The goals of the workshop were (1) to identify important unanswered questions in the study and treatment of eating disorders, (2) to discuss potentially fruitful approaches to answering these questions through basic and clinical research, and (3) to assist the NIH and other funding agencies in assigning priorities for research on eating disorders. The program consisted of a series of brief presentations by moderators, each followed by facilitated discussion of the topic with members of the audience. Three reporters (CMG, MJD, FMC) took detailed notes of the proceedings, which have been incorporated into this article. A summary of this workshop is presented, along with recommendations for future research that were identified by workshop participants.

Feeding and Eating Disorders↗

PubMed1990

NIH conference. Neurofibromatosis 1 (Recklinghausen disease) and neurofibromatosis 2 (bilateral acoustic neurofibromatosis). An update.

The neurofibromatoses comprise at least two autosomal dominant disorders affecting an estimated 100,000 Americans with clinical manifestations that may require care from every type of clinician. Neurofibromatosis 1 and neurofibromatosis 2 have in common the occurrence of many neurofibromas but are distinctly different clinical disorders. The disease genes are on different chromosomes. Magnetic resonance imaging, particularly with gadolinium enhancement, has generally supplanted other techniques for visualizing brain, spinal, and other neural tumors in both disorders. The technique has rekindled the controversy over the nature and frequency of optic pathway tumors in patients with neurofibromatosis 1 and has revealed, throughout the brains of young patients, bright lesions that have uncertain clinical consequences and unknown pathologic bases. In patients with neurofibromatosis 2, small acoustic neuromas can be seen, leading to the possibility of excision with preservation of hearing and facial nerve function. Abnormal hearing may occur to excess in patients with neurofibromatosis 1, but acoustic neuroma has never been documented. In patients with neurofibromatosis 2, a battery of audiologic tests has a high positive predictive power. Lisch nodules or iris hamartomas, probably a universal sign in adults with the neurofibromatosis 1 gene, cause no problem with vision. Posterior capsular lens opacity in patients with neurofibromatosis 2 is a helpful diagnostic sign and a potential source of additional handicap in persons at risk for impaired hearing. Progress in the clinical delineation of the disorders has been matched with considerable research into the still obscure pathogenesis of the disorders. Such rapid advances may necessitate reconsideration of the conclusions of the National Institutes of Health Consensus Development Conference on Neurofibromatosis, especially those on the categories of persons in which a neurofibromatosis should be considered and the need for caution in recommending surgery. Watchful waiting may often be the best management for acoustic neuromas in neurofibromatosis 2.

Chromosome Aberrations↗

PubMedDate not supplied

Traumatic brain injury research since the 1998 NIH Consensus Conference: accomplishments and unmet goals.

In 1998, an NIH sponsored Consensus Conference on Traumatic Brain Injury (TBI) Rehabilitation identified 30 different areas of needed research. A comprehensive review of recently generated research knowledge in the field of TBI has shown that a large number of Class III and IV evidence studies have been published, but relatively few of the more scientifically rigorous Class I or II studies. A rapid growth of publications on TBI rehabilitation has generated new knowledge in the epidemiology of TBI, the management of TBI and its secondary medical complications, rehabilitation of cognitive impairment, impact of TBI on community integration and quality of life, incidence of psychiatric dysfunction, and how caregivers and family members are affected. However, there is need to replicate many of these studies using more scientifically rigorous methodologies, while other areas of important TBI research remain largely unexplored.

Brain Injuries↗

PubMedDate not supplied

Nursing implications of the 2006 NIH State of the Science Conference Statement: Cesarean Delivery on Maternal Request.

Will the nation's higher rate of cesarean deliveries (CDs) (over 29%) lead to increased health risks for mothers and their babies? In March 2006, a National Institutes of Health State of the Science Conference was convened to assess available research on the topic. The focus was to identify outcomes from research studies addressing "cesarean delivery on maternal request" (CDMR), defined as CD without a medical indication for either the mother or the fetus. This conference concluded that it is currently unknown whether CDMR is really a trend in the United States, or whether the emergence of this phenomenon is associated with any specific benefits and harms to mothers and babies. More research is needed to determine if a trend exists. On the basis of systematic review of studies, no "strong quality-evidence" was found comparing CD and normal vaginal delivery outcomes. Future research was recommended to develop studies for this purpose in areas such as placental abnormalities (placenta previa and accreta) and various neonatal outcomes. Research on "modifiable" factors during labor and delivery which might decrease maternal and neonatal complications, including the risk for future pelvic floor disorders, was also recommended in the 2006 Conference Statement.

Cesarean Section↗

PubMed1994

NIH Consensus 1994: screening.

Frequently, the medical and lay community has assumed that earlier diagnosis of cancer of any type automatically confers benefit and that any diagnostic test that can identify early stages of disease must therefore be useful for screening. However, there is an emerging science of screening which affords a more rigorous approach to public health recommendations in the application of new technologies to screening and early detection. A number of public health groups and agencies are using an evidence-based approach in making recommendations. Using this approach, early detection methods for ovarian cancer would meet only the weakest level of evidence to support their routine application in asymptomatic women. For this reason, the National Cancer Institute has recently launched a large randomized clinical trial to test the effectiveness of screening for ovarian cancer.

Aged↗

PubMed2004

Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS).

Since the 1990 NIH-sponsored conference on polycystic ovary syndrome (PCOS), it has become appreciated that the syndrome encompasses a broader spectrum of signs and symptoms of ovarian dysfunction than those defined by the original diagnostic criteria. The 2003 Rotterdam consensus workshop concluded that PCOS is a syndrome of ovarian dysfunction along with the cardinal features hyperandrogenism and polycystic ovary (PCO) morphology. PCOS remains a syndrome and, as such, no single diagnostic criterion (such as hyperandrogenism or PCO) is sufficient for clinical diagnosis. Its clinical manifestations may include: menstrual irregularities, signs of androgen excess, and obesity. Insulin resistance and elevated serum LH levels are also common features in PCOS. PCOS is associated with an increased risk of type 2 diabetes and cardiovascular events.

Clinical Trials as Topic↗

PubMed2002

Diagnosis of gastrointestinal stromal tumors: a consensus approach.

As a result of major recent advances in understanding the biology of gastrointestinal stromal tumors (GIST), specifically recognition of the central role of activating KIT mutations and associated KIT protein expression in these lesions, and the development of novel and effective therapy for GISTs using the receptor tyrosine kinase inhibitor STI-571, these tumors have become the focus of considerable attention among pathologists, clinicians, and patients. Stromal/mesenchymal tumors of the gastrointestinal tract have long been a source of confusion and controversy with regard to classification, line(s) of differentiation, and prognostication. Characterization of the KIT pathway and its phenotypic implications has helped to resolve some but not all of these issues. Given the now critical role of accurate and reproducible pathologic diagnosis in ensuring appropriate treatment for patients with GIST, the National Institutes of Health (NIH) convened a GIST workshop in April 2001 with the goal of developing a consensus approach to diagnosis and morphologic prognostication. Key elements of the consensus, as described herein, are the defining role of KIT immunopositivity in diagnosis and a proposed scheme for estimating metastatic risk in these lesions, based on tumor size and mitotic count, recognizing that it is probably unwise to use the definitive term benign for any GIST, at least at the present time.

Antineoplastic Agents↗

PubMedDate not supplied

NIH Consensus Statement on Management of Hepatitis C: 2002.

OBJECTIVE: To provide health care providers, patients, and the general public with a responsible assessment of currently available data regarding the management and treatment of hepatitis C. PARTICIPANTS: A non-Federal, nonadvocate, 12-member panel representing the fields of infectious diseases, gastroenterology, medical oncology, molecular genetics, geriatrics, internal medicine, and the public. In addition, experts in these same fields presented data to the panel and to a conference audience of approximately 300. EVIDENCE: Presentations by experts; a systematic review of the medical literature provided by the Agency for Healthcare Research and Quality; and an extensive bibliography of hepatitis C research papers, prepared by the National Library of Medicine. Scientific evidence was given precedence over clinical anecdotal experience. CONFERENCE PROCESS: Answering predefined questions, the panel drafted a statement based on the scientific evidence presented in open forum and the scientific literature. The draft statement was read in its entirety on the final day of the conference and circulated to the experts and the audience for comment. The panel then met in executive session to consider these comments and released a revised statement at the end of the conference. The statement was made available on the World Wide Web at http://consensus.nih.gov immediately after the conference. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government. CONCLUSIONS: The incidence of newly acquired hepatitis C infection has diminished in the United States. This decline is largely due to a decrease in cases among IDUs for reasons that are unclear and, to a lesser extent, to testing of blood donors for HCV. The virus is transmitted by blood and such transmission now occurs primarily through injection drug use, sex with an infected partner or multiple partners, and occupational exposure. The majority of infections become chronic, and therefore the prevalence of HCV infections is high, with about 3 million Americans now estimated to be chronically infected. HCV is a leading cause of cirrhosis, a common cause of HCC and the leading cause of liver transplantation in the United States. The disease spectrum associated with HCV infection varies greatly. Various studies have suggested that 3 to 20 percent of chronically infected patients will develop cirrhosis over a 20-year period, and these patients are at risk for HCC. Persons who are older at the time of infection, patients with continuous exposure to alcohol, and those co-infected with HIV or HBV demonstrate accelerated progression to more advanced liver disease. Conversely, individuals infected at a younger age have little or no disease progression over several decades. The diagnosis of chronic hepatitis C infection is often suggested by abnormalities in ALT levels and is established by EIA followed by confirmatory determination of HCV RNA. Several sensitive and specific assays are now partly automated for the purposes of detecting HCV RNA and quantifying the viral level. Although there is little correlation between viral level and disease manifestations, these assays have proven useful in identifying those patients who are more likely to benefit from treatment and, particularly, in demonstrating successful response to treatment as defined by an SVR. Liver biopsy is useful in defining baseline abnormalities of liver disease and in enabling patients and healthcare providers to reach a decision regarding antiviral therapy. Noninvasive tests do not currently provide the information that can be obtained through liver biopsy. Information on the genotype of the virus is important to guide treatment decisions. Genotype 1, most commonly found in the United States, is less amenable to treatment than genotypes 2 or 3. Therefore, clinical trials of antiviral therapies require genotyping information for appropriate stratification of subjects. Recent therapeutic trials in defined, selected populations have clearly shown that combinations of interferons and ribavirin are more effective than monotherapy. Moreover, trials using pegylated interferons have yielded improved SVR rates with similar toxicity profiles. However, results continue to show that the SVR rate is less common in patients with genotype 1 infections, higher HCV RNA levels, or more advanced stages of fibrosis. Genotype 1 infections require therapy for 48 weeks, whereas shorter treatment is feasible in genotype 2 and 3 infections. In genotype 1, the lack of an early virologic response (< 2 log decrease in HCV RNA) is associated with failure to achieve an SVR. The SVR is lower in patients with advanced liver disease than in patients without cirrhosis. Ongoing trials are exploring the usefulness of combination therapy in various populations. Preliminary experience in IDUs, individuals co-infected with HIV, children, and other special groups suggests similar responses are achievable in these populations. Patients with acute hepatitis C may be treated, but specific recommendations for antiviral treatment must await further evaluation of the rate of spontaneous clearance of the virus and determination of the optimal time to initiate treatment. Preventive measures beyond blood-banking practices include prompt identification of infected individuals, awareness of the potential for perinatal transmission, implementation of safe-injection practices, linkage of drug users to drug treatment programs, and implementation of community-based education and support programs to modify risk behavior. Some of these measures have been successfully implemented in the control of HIV infections, and it stands to reason that they would be valuable for reducing HCV transmission. Future advances in the diagnosis and management of hepatitis C require continued vigilance concerning the transmission of this infection, extending treatment to populations not previously evaluated in treatment trials, and the introduction of more effective therapies.

Acute Disease↗

PubMed1999

Methods to encourage the use of antenatal corticosteroid therapy for fetal maturation: a randomized controlled trial.

CONTEXT: Antenatal corticosteroids for fetal maturation have been underused, despite evidence for their benefits in cases of preterm birth. OBJECTIVE: To evaluate dissemination strategies aimed at increasing appropriate use of this therapy. DESIGN AND SETTING: Twenty-seven tertiary care institutions were randomly assigned to either usual dissemination of practice recommendations (n = 14) or usual dissemination plus an active, focused dissemination effort (n = 13). SUBJECTS: Obstetricians and their preterm delivery cases at participating hospitals. INTERVENTION: Recommendations by a National Institutes of Health (NIH) Consensus Conference held in late February-early March 1994 were disseminated in early May 1994. Usual dissemination was publication of the recommendations and endorsement by the American College of Obstetricians and Gynecologists. Active dissemination was a year-long educational effort led by an influential physician and a nurse coordinator at each facility, consisting of grand rounds, a chart reminder system, group discussion of case scenarios, monitoring, and feedback. MAIN OUTCOME MEASURE: Use or nonuse of antenatal corticosteroids was abstracted from medical records of eligible women delivering at the participating hospitals in the 12 months immediately prior to release of the NIH recommendations (average number of records abstracted, 130) and in the 12 months following their release (average number of records abstracted, 122). RESULTS: Active dissemination significantly increased the odds of corticosteroid use after the conference. Use increased from 33.0% of eligible patients receiving corticosteroids to 57.6%, or by 75% over baseline, in usual dissemination hospitals. Use increased from 32.9% to 68.3%, oran 108% increase, in active dissemination hospitals. Gestational age and maternal diagnosis affected use of the therapy in complex ways. CONCLUSION: An active, focused dissemination effort increased the effectiveness of usual dissemination methods when combined with key principles to change physician practices.

Anti-Inflammatory Agents↗

PubMed1995

NIH conference. Myositis: immunologic contributions to understanding cause, pathogenesis, and therapy.

The myositis syndromes, the most common forms of which are polymyositis and dermatomyositis, are defined by idiopathic chronic inflammation in skeletal muscle. Although initially described more than a century ago, these diseases are so rare and heterogeneous that we have only a limited understanding of their causes and treatment. Recently, autoimmune responses to nuclear and cytoplasmic autoantigens that are unique to patients with myositis, the myositis-specific autoantibodies, have proved clinically useful in helping predict signs and symptoms of myositis, immunogenetics, responses to therapy, and prognosis. We summarize this new information on the variety and nature of these autoantibodies, their target epitopes, and their possible use in identifying causes, pathogenetic mechanisms, and better therapies for these increasingly recognized disorders.

Autoantibodies↗

PubMed1998

NIH Consensus Conference. Acupuncture.

OBJECTIVE: To provide clinicians, patients, and the general public with a responsible assessment of the use and effectiveness of acupuncture to treat a variety of conditions. PARTICIPANTS: A nonfederal, nonadvocate, 12-member panel representing the fields of acupuncture, pain, psychology, psychiatry, physical medicine and rehabilitation, drug abuse, family practice, internal medicine, health policy, epidemiology, statistics, physiology, biophysics, and the representatives of the public. In addition, 25 experts from these same fields presented data to the panel and a conference audience of 1200. Presentations and discussions were divided into 3 phases over 2 1/2 days: (1) presentations by investigators working in areas relevant to the consensus questions during a 2-day public session; (2) questions and statements from conference attendees during open discussion periods that were part of the public session; and (3) closed deliberations by the panel during the remainder of the second day and morning of the third. The conference was organized and supported by the Office of Alternative Medicine and the Office of Medical Applications of Research, National Institutes of Health, Bethesda, Md. EVIDENCE: The literature, produced from January 1970 to October 1997, was searched through MEDLINE, Allied and Alternative Medicine, EMBASE, and MANTIS, as well as through a hand search of 9 journals that were not indexed by the National Library of Medicine. An extensive bibliography of 2302 references was provided to the panel and the conference audience. Expert speakers prepared abstracts of their own conference presentations with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in the open forum and scientific literature. The panel composed a draft statement, which was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after the conference. The draft statement was made available on the World Wide Web immediately following its release at the conference and was updated with the panel's final revisions within a few weeks of the conference. The statement is available at http://consensus.nih.gov. CONCLUSIONS: Acupuncture as a therapeutic intervention is widely practiced in the United States. Although there have been many studies of its potential usefulness, many of these studies provide equivocal results because of design, sample size, and other factors. The issue is further complicated by inherent difficulties in the use of appropriate controls, such as placebos and sham acupuncture groups. However, promising results have emerged, for example, showing efficacy of acupuncture in adult postoperative and chemotherapy nausea and vomiting and in postoperative dental pain. There are other situations, such as addiction, stroke rehabilitation, headache, menstrual cramps, tennis elbow, fibromyalgia, myofascial pain, osteoarthritis, low back pain, carpal tunnel syndrome, and asthma, in which acupuncture may be useful as an adjunct treatment or an acceptable alternative or be included in a comprehensive management program. Further research is likely to uncover additional areas where acupuncture interventions will be useful.

Acupuncture Therapy↗

PubMedDate not supplied

NIH-FDA Analgesic Drug Development Workshop: translating scientific advances into improved pain relief.

Analgesic drug development as currently undertaken is limited by a number of factors that contribute to the paucity of new analgesics introduced into clinical practice despite marked advances in delineating of the molecular-genetic mechanisms contributing to acute and chronic pain. The participants in this workshop explored the unmet need in analgesia and recommended strategies for enhancing analgesic drug development in the future. The workshop concluded that translating scientific advances into improved pain relief will require new thinking and a cooperative effort among the pharmaceutical industry, regulatory agencies, funding agencies, the biomedical research community, professional societies and clinicians. The workshop also recommended that a better understanding of the epidemiology of pain could contribute to improvement in clinical trial methodology and outcome measures.

Analgesics↗

PubMed2002

Results of the NIH consensus conference on "rehabilitation of persons with traumatic brain injury".

In 1998, the National Institute for Health (NIH) organized a consensus conference about the rehabilitation of persons with traumatic brain injury (TBI). The conference results are based on an extensive bibliography from the scientific literature and presentations at the conference. The focus of this conference was the evaluation of rehabilitative measures for the cognitive and behavioral consequences of TBI, and the extent to which specific interventions are supported by existing evidence. Specifically, the conference considered the following aspects and their implications for rehabilitation: the epidemiology of TBI in the United States, the consequences in terms of pathophysiology, impairments, functional limitations, disabilities, societal limitations, and economic impact, the mechanisms underlying functional recovery following TBI, the common therapeutic interventions for the cognitive and behavioral sequelae of TBI, and the models for comprehensive coordinated multi-disciplinary rehabilitation. Based on the answers to these questions, the conference tried to give recommendations regarding rehabilitation practices for people with TBI, and identified areas where further research is needed.

Brain Injuries↗

PubMed1999

Therapeutic controversies in primary hyperparathyroidism.

There is little debate about the primacy of surgery in the management of classical PHPT. Rather, the question has been what to do about the many patients with nonclassical disease. A 1990 NIH consensus conference (55) clearly recommended surgery for patients with significant adverse effects of PHPT, for patients with complicating coexistent illnesses, for younger patients, and for those in whom consistent long-term follow-up could not be assured. It allowed that conscientious surveillance may be justified in patients with minimal hypercalcemia and no adverse effects, but it recognized that for many patients, the time and expense involved in rigorous follow-up would outweigh the burden of surgery. Nine years later, the demonstrated prevalence of nonclassical symptoms and their reversibility, the evidence of "asymptomatic" but harmful effects reversible by surgery, and the accumulating evidence for surgical reduction of increased long-term mortality risk substantially strengthen the argument for surgery in such patients. For these reasons, parathyroidectomy should generally be recommended for patients with a secure diagnosis of PHPT, even in the absence of classical symptoms.

Calcium↗

PubMed1994

NIH conference. Asthma.

Asthma is characterized by inflammation, reversible airway obstruction, and increased airway responsiveness to various stimuli. It has received wide public attention in recent years because of increasing morbidity and deaths, particularly among black persons. The important role of inflammation in the immunopathogenesis of asthma has led to a newer therapeutic approach directed at interrupting this inflammatory process. Among immune regulatory pathways involved in asthma pathogenesis, two lymphokines appear to be particularly important in controlling IgE production. Interleukin-4 is required for IgE production; without it, IgE production is inhibited. Interferon-gamma can diminish cell priming for interleukin-4 production. Thus, the interplay of these two cytokines will determine whether cells that can make interleukin-4 will be produced and, therefore, whether IgE will be produced in response to allergic stimuli. Further, in response to appropriate stimuli, mast cells and eosinophils are attracted to airways and release cytokines, lipid mediators, and preformed substances that cause inflammation. Modern asthma treatment is directed at interrupting this inflammatory process and places a much greater emphasis on use of anti-inflammatory agents, such as aerosolized or parenteral corticosteroids, and on non-steroidal anti-inflammatory agents, such as cromolyn sodium and nedocromil sodium. Research advances without therapeutic application, however, limit success. Projects such as the National Institute of Allergy and Infectious Diseases' National Cooperative Inner-City Asthma Study, which is directed toward underserved populations, are intended to identify more clearly the factors responsible for increasing morbidity and to develop appropriate therapeutic interventions.

Asthma↗

PubMedDate not supplied

Adjuvant systemic therapies in patients with colorectal cancer: an audit on clinical practice in Italy.

AIMS AND BACKGROUND: Rarely are conclusions from clinical trials summarized in international consensus conferences and promptly transferred to patient care. The adjuvant therapy for colorectal cancer used in daily clinical practice in Italy is described and compared with the recommendations of the 1990 NIH Consensus Conference. PATIENTS AND METHODS: We audited prescriptions of adjuvant systemic therapies for Italian colorectal cancer patients in 82 centers during a fixed one-week period. RESULTS: Among 434 patients receiving adjuvant chemotherapy there were 139 (42.5%) colon cancer patients with N- and 169 (51.7%) with N+ regional nodal involvement. Treatment at academic centers, a young age, T4 and a low total number of lymph nodes removed at surgery were the factors potentially justifying the decision for adjuvant chemotherapy in stage II colon cancer patients. The most common chemotherapy used was a bolus of 5-fluorouracil/folinic acid for 6 months (75.8%). Adjuvant radiotherapy was not administered to 37 (38.5%) of 96 patients with stage II and III rectal cancer. CONCLUSIONS: The study shows that a substantial proportion of patients on adjuvant treatment at a certain time point in a large enough sample of Italian centers are stage II (potential over-treatment) and that an under-treatment of stage II and III rectal cancer patients (lack of radiotherapy) occurs too often in daily clinical practice in this country.

Aged↗