Current attitudes and practice of American Society of Clinical Oncology-member clinical oncologists regarding cancer prevention and control.

PURPOSE AND METHODS: A nationwide needs assessment survey including a validated Cancer Prevention and Early Detection Attitude Inventory of 1,500 randomly selected American Society of Clinical Oncology (ASCO)-member clinical oncologists was conducted via a 67-item, mailed questionnaire to assess practice and attitudes regarding cancer prevention and control. RESULTS: Responses of 729 physicians from 48 states representing medical (57%), radiation (17%), surgical (16%), and pediatric oncology (6%), and hematology/other (4%) fields were obtained. Except for ambivalence regarding an important role for diet in cancer causation, cancer prevention and control recommendations were widely endorsed despite skepticism about their impact on reducing deaths from cancer. Surprisingly, a significantly (P less than .001) more favorable attitude for cancer prevention and control issues was found in physicians with greater than 20 years practice compared with younger oncology colleagues, as measured by a 22-item Cancer Prevention and Early Detection Attitude Inventory. Among all physicians, participation in cancer therapy trials exceeded that in cancer prevention and control trials (91% v 27%, P less than .01). Formal instruction during postgraduate training in cancer screening (34%) or prevention (23%) was received by few oncologists; nonetheless, 69% considered themselves a resource for cancer prevention and control issues in their practice communities. Of potential barriers to cancer prevention and control activity, only lack of patients without cancer (53%) and difficulty in including such activity economically into clinical practice (65%) were majority selections. Importantly, 64% agreed they could "motivate their patients to change lifestyle to reduce cancer risk." CONCLUSION: Clinical oncologists may represent a potential resource for implementation of cancer prevention and control objectives if economically feasible models for their use in practice settings can be identified.     

Evaluating the financial impact of clinical trials in oncology: results from a pilot study from the Association of American Cancer Institutes/Northwestern University clinical trials costs and charges project.

PURPOSE: Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials. METHODS: Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer. RESULTS: The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P =.4) CONCLUSION: Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning and coordination among cancer center directors, finance department personnel, economists, and health services researchers.     

Expanding Public‐Private Collaborations to Enhance Cancer Drug Development: A Report of the Institute of Medicine's Workshop Series, “Implementing a National Cancer Clinical Trials System for the 21st Century”

Since their inception in the 1950s, the National Cancer Institute‐funded cancer cooperative groups have been important contributors to cancer clinical and translational research. In 2010, a committee appointed by the Institute of Medicine (IOM) of the National Academy of Sciences completed a consensus review on the status of the U.S. publicly funded cancer clinical trials system. This report identified a need to reinvigorate the cooperative groups and provided recommendations for improving their effectiveness. Follow‐up workshops to monitor progress were conducted by the IOM's National Cancer Policy Forum and the American Society of Clinical Oncology (ASCO) in 2011 and 2013. One of the key recommendations of the IOM report was a call for greater collaboration among stakeholders in cancer research. In particular, more active engagement and better alignment of incentives among the cooperative groups, the National Cancer Institute, the U.S. Food and Drug Administration, and the biopharmaceutical industry were identified as essential to achieving the promise of oncology drug development. This review, based on presentations and discussion during the IOM‐ASCO workshops, outlines the progress and remaining challenges of these collaborations.     

American Society of Clinical Oncology‐recommended surveillance and physician specialty among long‐term breast cancer survivors

BACKGROUND:

It is unclear whether it is appropriate to transfer the follow‐up care of breast cancer (BrCa) survivors from cancer specialists to primary care physicians (PCPs). This contemporary study compared physician specialty and documented the long‐term surveillance of survivors who underwent surgery at an American academic center.

METHODS:

Women in this institutional review board‐approved study underwent breast surgery between 1996 and 2006. Data were collected for 270 patients with stage I to III BrCa (mean follow‐up, 6 years). Charts were reviewed based on American Society of Clinical Oncology (ASCO) guidelines for recommended surveillance frequency and care.

RESULTS:

The majority of patients (90%; n = 242) were followed by specialists with 10% (n = 28) followed by PCPs. Patients with advanced disease and a greater risk of disease recurrence more often received specialist care. Patients followed by specialists were more often seen at ASCO‐recommended intervals (eg, 89% vs 69% of patients followed by a PCP at follow‐up Year 6; P < .01); however, many patients were followed inconsistently. Breast disease was often not the focus of PCP visits or mentioned in clinic notes (18% patients). Women seen by specialists were more likely to have documented clinical examinations of the breast (93% vs 44% at Year 6), axilla (94% vs 52%), or annual mammograms (74% vs 48%; P = .001‐.02).

CONCLUSIONS:

Consistent compliance with surveillance guidelines and chart documentation needs improvement among all providers; however, specialists more consistently met ASCO guidelines. If transfer of care to a PCP occurs, it should be formalized and include follow‐up recommendations and defined physician responsibilities. Providers and patients should be educated regarding surveillance care and current guidelines incorporated into standard clinical practice. Cancer 2010. © 2010 American Cancer Society.     

Cancer in the Elderly: a Societal Perspective from the United States

Cancer is the second leading cause of death in the USA and will probably surpass heart disease, the current leader, over the next few years. As in other affluent nations, cancer in the USA is a disease of ageing, with a median age at diagnosis of 67 years. Moreover, men and women in average health who reach age 65 years will probably live an average of 20 more years and it is estimated that by 2025 20% of Americans will be 65 years and older compared with 12% of the present population. This will place an increasing burden on providers of cancer care and complicate the medical management of many elders. There is now great interest in educating primary care physicians about the management of cancer care of the elderly. Professional groups, such as the American Society of Clinical Oncology, the American Association of Cancer Research, National Cancer Institute-sponsored co-operative groups and the National Institutes on Aging, continue to support programmes to improve geriatric training of physicians and provide research money for those interested in geriatric oncology. Access to cancer care varies in the USA and older patients have not had the same standard of care as younger patients. This has probably resulted in poor outcomes for many. Also, clinical trial participation by elders has been poor. Several more recent trials focusing on older patients have been more successful, but accrual remains a major issue. Financial constraints have limited trial opportunities for elders and hopefully will improve in the future. A major challenge for those in North America will be to provide the health care for elders with cancer and other diseases in the coming years. To meet this challenge we must expand and train the number of health care providers at all levels.     

American Society of Clinical Oncology provisional clinical opinion: the integration of palliative care into standard oncology care

PURPOSE: An American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO) offers timely clinical direction to ASCO's membership following publication or presentation of potentially practice-changing data from major studies. This PCO addresses the integration of palliative care services into standard oncology practice at the time a person is diagnosed with metastatic or advanced cancer. CLINICAL CONTEXT: Palliative care is frequently misconstrued as synonymous with end-of-life care. Palliative care is focused on the relief of suffering, in all of its dimensions, throughout the course of a patient's illness. Although the use of hospice and other palliative care services at the end of life has increased, many patients are enrolled in hospice less than 3 weeks before their death, which limits the benefit they may gain from these services. By potentially improving quality of life (QOL), cost of care, and even survival in patients with metastatic cancer, palliative care has increasing relevance for the care of patients with cancer. Until recently, data from randomized controlled trials (RCTs) demonstrating the benefits of palliative care in patients with metastatic cancer who are also receiving standard oncology care have not been available. RECENT DATA: Seven published RCTs form the basis of this PCO. PROVISIONAL CLINICAL OPINION: Based on strong evidence from a phase III RCT, patients with metastatic non-small-cell lung cancer should be offered concurrent palliative care and standard oncologic care at initial diagnosis. While a survival benefit from early involvement of palliative care has not yet been demonstrated in other oncology settings, substantial evidence demonstrates that palliative care-when combined with standard cancer care or as the main focus of care-leads to better patient and caregiver outcomes. These include improvement in symptoms, QOL, and patient satisfaction, with reduced caregiver burden. Earlier involvement of palliative care also leads to more appropriate referral to and use of hospice, and reduced use of futile intensive care. While evidence clarifying optimal delivery of palliative care to improve patient outcomes is evolving, no trials to date have demonstrated harm to patients and caregivers, or excessive costs, from early involvement of palliative care. Therefore, it is the Panel's expert consensus that combined standard oncology care and palliative care should be considered early in the course of illness for any patient with metastatic cancer and/or high symptom burden. Strategies to optimize concurrent palliative care and standard oncology care, with evaluation of its impact on important patient and caregiver outcomes (eg, QOL, survival, health care services utilization, and costs) and on society, should be an area of intense research. NOTE: ASCO's provisional clinical opinions (PCOs) reflect expert consensus based on clinical evidence and literature available at the time they are written and are intended to assist physicians in clinical decision making and identify questions and settings for further research. Because of the rapid flow of scientific information in oncology, new evidence may have emerged since the time a PCO was submitted for publication. PCOs are not continually updated and may not reflect the most recent evidence. PCOs cannot account for individual variation among patients and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It is the responsibility of the treating physician or other health care provider, relying on independent experience and knowledge of the patient, to determine the best course of treatment for the patient. Accordingly, adherence to any PCO is voluntary, with the ultimate determination regarding its application to be made by the physician in light of each patient's individual circumstances. ASCO PCOs describe the use of procedures and therapies in clinical trials and cannot be assumed to apply to the use of these interventions in the context of clinical practice. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of ASCO's PCOs, or for any errors or omissions.     

Erythropoietin pharmacology

Anaemia is a frequent complication in cancer patients and may be multifactorial in origin. Treatment with recombinant human erythropoietin (rHuEPO) is an alternative to red blood cell transfusion. The evidence from clinical trials has established that patients with chemotherapy-induced anaemia with a haemoglobin concentration below 10 g/dl benefit from epoetin therapy. The native glycoprotein hormone consists of 165 amino acids with three N-glycosylation and one O-glycosylation sites. Epoetin and darbepoetin bind to the EPO receptor to induce intracellular signalling by the same intracellular molecules as native EPO. There are some differences in the glycosylation pattern which lead to variations in the pharmacokinetics and pharmacodynamics profiles. Pharmacokinetic and therapeutic studies have examined the use of rHuEPO administered intravenously and subcutaneously and there is accumulating evidence that the latter route has several advantages in cancer patients. After subcutaneous administration, the bioavailability of epoetin is about 20–30% and has a plasma half-life of >24 h. Darbepoetin has a longer half-life after subcutaneous administration of 48 h. The general recommendations are based on evidence from trials in which epoetin was administered 150 U/kg thrice weekly. The recommended initial dose for darbepoetin alpha is 2.25 μg/kg per week. The most serious adverse effects are hypertension, bleeding and increased risk of thrombotic complications. Caution is advised when used in patients who are at high risk for thromboembolic events. In the management of anaemic cancer patients, physicians should closely follow the National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ASCO)/American Society of Hematology (ASH) guidelines.     

Use of hematopoietic colony-stimulating factors: comparison of the 1994 and 1997 American Society of Clinical Oncology surveys regarding ASCO clinical practice guidelines. Health Services Research Committee of the American Society of Clinical Oncology.

PURPOSE: The American Society of Clinical Oncology (ASCO) Health Services Research Committee sought to assess whether more appropriate patterns of colony-stimulating factor (CSF) use occurred after the publication of ASCO evidence-based practice guidelines in 1994 and 1996 for patients with solid tumors or lymphoma. METHODS: In 1994 and 1997, questionnaires describing clinical scenarios were mailed to ASCO members who practiced medical oncology. Physicians were asked the extent to which they preferred to use a CSF for primary prophylaxis, secondary prophylaxis, or treatment of neutropenic complications. Multiple regression analyses were used to determine predictors of overall propensity to use CSFs and, when using a CSF, propensity to support longer schedules of CSF use. RESULTS: Decreased use of CSFs was shown in the following situations: (1) treatment for febrile neutropenia without localizing signs (39% in 1994 v 29% in 1997) or with a right lower lobe infiltrate (54% v 46%); (2) primary prophylaxis with paclitaxel for ovarian cancer (20% v 11%) or cyclophosphamide, doxorubicin, and vincristine chemotherapy for small-cell lung cancer (8.4% v 4.6%); and (3) secondary prophylaxis after afebrile neutropenia following chemotherapy for germ cell tumors (44.5% v 36.0%). One third fewer physicians supported the extended use of CSFs until an absolute neutrophil count >/= 10,000/mm(3) or a WBC count >/= 10,000/mm(3) was reached, both counts serving as criteria for stopping CSF therapy. However, we observed high rates of CSF use despite ASCO guideline recommendations against use in the following clinical situations: (1) primary prophylaxis in patients at low risk of febrile neutropenia (6% v 16%); (2) secondary prophylaxis late in the course of curative and palliative therapy (80% v 53%); and (3) treatment of afebrile and uncomplicated febrile neutropenia (30% v 60%). In 1994 and 1997, fee-for-service physicians were more likely than other physicians to prefer use of CSF support while maintaining treatment dose and schedule instead of using dose-reduction strategies, and, when using a CSF, they were more likely to support longer CSF treatment schedules (P <.05 for both scenarios). CONCLUSION: Decreased use and more appropriate use of CSFs in accordance with ASCO guideline recommendations occurred from 1994 to 1997, but there remain many opportunities to reduce CSF use with no clinical harm. Many oncologists continue to support the use of CSFs in scenarios and with scheduling criteria that the guidelines and evidence do not support. ASCO's evidence-based guidelines should be linked with formal continuous quality improvement initiatives to substantially improve the quality of supportive oncology care.     

2011 Focused Update of 2009 American Society of Clinical Oncology Clinical Practice Guideline Update on Chemotherapy for Stage IV Non-Small-Cell Lung Cancer

PURPOSE: An American Society of Clinical Oncology (ASCO) focused update updates a single recommendation (or subset of recommendations) in advance of a regularly scheduled guideline update. This document updates one recommendation of the ASCO Guideline Update on Chemotherapy for Stage IV Non-Small-Cell Lung Cancer (NSCLC) regarding switch maintenance chemotherapy. CLINICAL CONTEXT: Recent results from phase III clinical trials have demonstrated that in patients with stage IV NSCLC who have received four cycles of first-line chemotherapy and whose disease has not progressed, an immediate switch to alternative, single-agent chemotherapy can extend progression-free survival and, in some cases, overall survival. Because of limitations in the data, delayed treatment with a second-line agent after disease progression is also acceptable. RECENT DATA: Seven randomized controlled trials of carboxyaminoimidazole, docetaxel, erlotinib, gefitinib, gemcitabine, and pemetrexed have evaluated outcomes in patients who received an immediate, non-cross resistant alternative therapy (switch maintenance) after first-line therapy. RECOMMENDATION: In patients with stage IV NSCLC, first-line cytotoxic chemotherapy should be stopped at disease progression or after four cycles in patients whose disease is stable but not responding to treatment. Two-drug cytotoxic combinations should be administered for no more than six cycles. For those with stable disease or response after four cycles, immediate treatment with an alternative, single-agent chemotherapy such as pemetrexed in patients with nonsquamous histology, docetaxel in unselected patients, or erlotinib in unselected patients may be considered. Limitations of this data are such that a break from cytotoxic chemotherapy after a fixed course is also acceptable, with initiation of second-line chemotherapy at disease progression.     

Guidelines for the adjuvant treatment of postmenopausal women with endocrine-responsive breast cancer: past, present and future recommendations

Treatment guidelines are useful tools that enable physicians to integrate the latest clinical research into their practices. The large volume of rapidly evolving clinical data in breast cancer has been summarised and incorporated into treatment recommendations by well-known and reliable institutions, including the National Comprehensive Cancer Network, the American Society for Clinical Oncology, the European Society for Medical Oncology and the St. Gallen International Consensus Panel. Adjuvant therapy is a key component of breast cancer treatment, and many of the current consensus guidelines now recognise the important role of the aromatase inhibitors as an alternative to or in sequence after tamoxifen, hitherto the standard adjuvant treatment of choice for receptor-positive women. Data from ongoing trials such as the Breast International Group 1-98 trial and those still in the accrual phase will be forthcoming and will likely result in a further refinement of treatment recommendations over the course of the next few years. Despite the availability of such guidelines, however, there is evidence that adherence to and implementation of treatment recommendations is less than optimal. Further research is needed to determine more effective means of disseminating those clinical recommendations that can have a significant impact on treatment strategies and ultimately improve outcomes in breast cancer.     

Evaluating organizational design to assure technology transfer: the case of the Community Clinical Oncology Program

Current theories of organizational performance are used to guide researchers at the Health Services Research Center of the University of North Carolina at Chapel Hill and the University of Illinois Survey Research Laboratory in the evaluation of the National Cancer Institute's Community Clinical Oncology Program (CCOP) and to derive policy options to enhance program operations. CCOP represents an innovative mechanism designed to improve the accrual of patients to phase III clinical trials, involve community-based oncologists in clinical research, and potentially to disseminate new information on the state-of-the-art cancer treatment to areas distant from cancer centers and research-oriented medical centers. Examined in this evaluation of the second phase of the CCOP are the ability of the 52 currently funded CCOPs and 17 research bases to accrue patients to cancer treatment and cancer control research protocols, their influence on the patterns of practice for cancer treatment in CCOP communities, and their influence on cancer control awareness and activity among primary care physicians. The evaluation applies selected organizational perspectives to describe the intraorganizational and interorganizational characteristics of the CCOPs, research bases, and the Institute that may affect the performance of the CCOP. This organizational approach relates the accrual and influence of the CCOP to controllable aspects of the program's design and management strategies that can be changed through policies directed by the National Cancer Institute. These policies include the criteria used to select CCOPs, the role of research bases in the development and implementation of treatment and cancer control research protocols, and the use of accrual credits.     

Clinical practice guidelines for the psychosocial care of adults with cancer

Clinical practice guidelines are increasingly being developed in medical settings to provide evidence-based recommendations to guide the clinical care of patients. The development of Clinical practice guidelines for the psychosocial care of patients with medical illness is a newer initiative, and more complex as the target audience includes health care professionals from diverse backgrounds. In Australia, the National Breast Cancer Centre and National Cancer Control Initiative have collaborated to develop Clinical practice guidelines for the psychosocial care of adults with cancer, funded by the Australian Government Department of Health and Ageing. This paper outlines the development of these guidelines in the international context, gives an overview of their content, and describes strategies for their implementation and evaluation.     

Valeur juridique des recommandations de bonne pratique : cas de l’hormonothérapie des cancers du sein

On April 27th 2011, the French Supreme Administrative Court (Conseil d’État) granted the Recommendations for Good Practice set out by the French National Authority for Health (Haute Autorité de santé - [HAS]) a legal status, considering that they “must be regarded as (…) decisions which may be subject to an action for annulment”. The judge came to this conclusion through a quasi-syllogistic reasoning. Firstly, the French Code of Medical Ethics requires physicians to care for their patients in accordance with established scientific knowledge. Secondly, the HAS recommendations recall in particular this established scientific knowledge. Treating patients according to established scientific knowledge requires then that physicians follow the HAS recommendations. While the case at bar does not directly involve liability for medical malpractice – since the applicant only sought to have an HAS recommendation declared void – it is nonetheless necessary to examine the impact of this ruling for health professionals. Indeed, this decision raises a number of concerns for everyday medical practice. Guidelines concerning the endocrine treatment of hormonodependant breast cancers are plentiful. In January 2010, the HAS and the French National Institute for Cancer (Institut national du cancer) issued a “Guide for long-term illnesses – Breast cancer” (Guide ALD - Cancer du sein). In addition to these nation-wide guidelines, the Regional Networks for Cancer (réseaux régionaux de cancérologie) issued their own recommendations. Other guidelines are also set out in the framework of consensus conferences, such as the Nice Saint-Paul-de-Vence (France) and St. Gallen (Switzerland) conferences. In the United States, the National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO), and in Europe, the European Society of Medical Oncology (ESMO) make recommendations as well. Therefore, the HAS recommendations are hardly the sole source of information for physicians and these documents sometimes contradict each other. Besides, these can quickly become obsolete, what still limits their relevance. Nevertheless, in the judge's mind, there is no place for conflicting interpretations; scientific knowledge must be consistent, homogeneous and objective. However, the reality is quite the opposite. This simplistic vision shared by judges does not seem to grasp the complexity of everyday medical practice. After a critical reading of the Conseil d’État judgment, we shall consider the potential issues and concerns raised by this ruling in medical practice using the example of hormone therapy for breast cancer patients.     

Breast cancer and aging: results of the U13 conference breast cancer panel

Breast cancer is predominantly a disease of older women, yet there is a knowledge gap due to the persisting misalignment between the age distribution of women with breast cancer and the age distribution of participants in clinical trials. The purpose of this report is to state the U13 conference breast cancer panel’s recommendations regarding therapeutic clinical trials that will fill gaps in knowledge regarding the care of older patients with breast cancer. The U13 conference was a collaboration between the Cancer and Aging Research Group and the National Institute on Aging and the National Cancer Institute (NCI). Clinical trials should be developed for frail and vulnerable patients who would not enroll on the standard phase III trials, as well as efforts need to be made to increase enrollment of fit older patients on standard phase III trials. As a result of this conference, panel members are working with the NCI and cooperative groups to address these knowledge gaps. With the aging population and increasing incidence of breast cancer with age, it is essential to study the feasibility, toxicity, and efficacy of cancer therapy in this at-risk population.     

Measuring the incremental cost of clinical cancer research.

PURPOSE: To summarize evidence on the costs of treating patients in clinical trials and to describe the Cost of Cancer Treatment Study, an ongoing effort to produce generalizable estimates of the incremental costs of government-sponsored cancer trials. METHODS: A retrospective study of costs will be conducted with 1,500 cancer patients recruited from a randomly selected sample of institutions in the United States. Patients accrued to either phase II or phase III National Cancer Institute-sponsored clinical trials during a 15-month period will be asked to participate in a study of their health care utilization (n = 750). Costs will be measured approximately 1 year after their trial enrollment from a combination of billing records, medical records, and an in-person survey questionnaire. Similar data will be collected for a comparable group of cancer patients not in trials (n = 750) to provide an estimate of the incremental cost. RESULTS: Evidence suggests insurers limit access to trials because of cost concerns. Public and private efforts are underway to change these policies, but their permanent status is unclear. Previous studies found that treatment costs in clinical trials are similar to costs of standard therapy. However, it is difficult to generalize from these studies because of the unique practice settings, insufficient sample sizes, and the exclusion of potentially important costs. CONCLUSION: Denials of coverage for treatment in a clinical trial limit patient access to trials and could impede clinical research. Preliminary estimates suggest changes to these policies would not be expensive, but these results are not generalizable. The Cost of Cancer Treatment Study is an ongoing effort to provide generalizable estimates of the incremental treatment cost of phase II and phase III cancer trials. The results should be of great interest to insurers and the research community as they consider permanent ways to finance cancer trials.     

American Society of Clinical Oncology technology assessment on breast cancer risk reduction strategies: tamoxifen and raloxifene.

OBJECTIVE: To conduct an evidence-based technology assessment to determine whether tamoxifen and raloxifene as breast cancer risk-reduction strategies are appropriate for broad-based conventional use in clinical practice. POTENTIAL INTERVENTION: Tamoxifen and raloxifene. OUTCOME: Outcomes of interest include breast cancer incidence, breast cancer-specific survival, overall survival, and net health benefits. EVIDENCE: A comprehensive, formal literature review was conducted for tamoxifen and raloxifene on the following topics: breast cancer risk reduction; tamoxifen side effects and toxicity, including endometrial cancer risk; tamoxifen influences on nonmalignant diseases, including coronary heart disease and osteoporosis; and decision making by women at risk for breast cancer. Testimony was collected from invited experts and interested parties. VALUES: More weight was given to publications that described randomized trials. BENEFITS/HARMS/COSTS: The American Society of Clinical Oncology (ASCO) Working Group acknowledges that a woman's decision regarding breast cancer risk-reduction strategies will depend on the importance and weight attributed to the information provided regarding both cancer and non-cancer-related risks. CONCLUSIONS: For women with a defined 5-year projected risk of breast cancer of >/= 1.66%, tamoxifen (at 20 mg/d for up to 5 years) may be offered to reduce their risk. It is premature to recommend raloxifene use to lower the risk of developing breast cancer outside of a clinical trial setting. On the basis of available information, use of raloxifene should currently be reserved for its approved indication to prevent bone loss in postmenopausal women. Conclusions are based on single-agent use of the drugs. At the present time, the effect of using tamoxifen or raloxifene with other medications (such as hormone replacement therapy), or using tamoxifen and raloxifene in combination or sequentially, has not been studied adequately. The continuing use of placebo-controlled trials in other risk-reduction trials highlights the current unanswered issues concerning the use of such interventions, especially when the influence on net health benefit remains to be determined. Breast cancer risk reduction is a rapidly evolving area. This technology assessment represents an ongoing process with existing plans to monitor and review data and to update recommendations in a timely matter. (See VALIDATION: The conclusions of the Working Group were evaluated by the ASCO Health Services Research Committee and by the ASCO Board of Directors. SPONSOR: American Society of Clinical Oncology.     

Breast Cancer Diagnosis and Treatment in Low- and Mid-Resource Settings: the Role of Resource-Stratified Clinical Practice Guidelines

Purpose of Review

One of the most important recent advances in the management of cancer patients have become the development of guidelines. Guidelines are usually evidence-based or international consensus guidelines. Those guidelines may not be applicable worldwide, especially where resources are limited. This prompted initiatives for the development of resource-stratified guidelines so that health care providers and authorities can do the best they can with the resources they have, while working on improving their resources. We will describe the process of development of those guidelines and briefly review recommendations for awareness, screening, diagnosis, and treatment of breast cancer, focusing on countries and special populations with limited resources.

Recent Findings

The World Health Organization (WHO) described three resource scenarios (low-resource, middle-resource, and high-resource scenarios) in order to facilitate the establishment of national cancer control plans. The Breast Health Global Initiative (BHGI), as an initiative group with goals to improve the care of patients with breast cancer in low- and mid-resource settings, identified four levels of resource availability (basic, limited, enhanced, and maximal) with comprehensive sets of recommendations for each. BHGI published resource-stratified breast cancer guidelines starting in 2006, and later on updated them and focused on implementation and health systems. The National Comprehensive Cancer Network (NCCN) initiated a program, building upon the BHGI experience to resource stratify cancer treatment guidelines across multiple cancer types and published NCCN Framework for resource stratification in breast cancer in 2016. Subsequently, the NCCN has published multiple additional resource stratification frameworks that use slightly different definitions of resource level than use by the BHGI. The American Society of Clinical Oncology (ASCO) has also assembled a Guidelines Advisory Group for Resource Stratification for different cancers, and published its first comprehensive resource-stratified guidelines for cancer of the cervix.

Summary

International efforts to improve management and reduce disparities in the outcome of breast cancer patients’ worldwide focus on recommendations for better allocation of available resources in different countries. The WHO, BHGI, NCCN, ASCO, and other international initiatives issued various resource-stratified guidelines (RSG) based on levels of resources in different countries. We shed the light on the development of these guidelines and discuss awareness, prevention of advanced disease at presentation, and management. Future research is needed to update and improve dissemination and implementation of RSG, as well as building infrastructure, reforming of health systems, and better allocating resources.

     

Postmastectomy radiotherapy: clinical practice guidelines of the American Society of Clinical Oncology.

OBJECTIVE: To determine indications for the use of postmastectomy radiotherapy (PMRT) for patients with invasive breast cancer with involved axillary lymph nodes or locally advanced disease who receive systemic therapy. These guidelines are intended for use in the care of patients outside of clinical trials. POTENTIAL INTERVENTION: The benefits and risks of PMRT in such patients, as well as subgroups of these patients, were considered. The details of the PMRT technique were also evaluated. OUTCOMES: The outcomes considered included freedom from local-regional recurrence, survival (disease-free and overall), and long-term toxicity. EVIDENCE: An expert multidisciplinary panel reviewed pertinent information from the published literature through July 2000; certain investigators were contacted for more recent and, in some cases, unpublished information. A computerized search was performed of MEDLINE data; directed searches based on the bibliographies of primary articles were also performed. VALUES: Levels of evidence and guideline grades were assigned by the Panel using standard criteria. A "recommendation" was made when level I or II evidence was available and there was consensus as to its meaning. A "suggestion" was made based on level III, IV, or V evidence and there was consensus as to its meaning. Areas of clinical importance were pointed out where guidelines could not be formulated due to insufficient evidence or lack of consensus. RECOMMENDATIONS: The recommendations, suggestions, and expert opinions of the Panel are described in this article. VALIDATION: Seven outside reviewers, the American Society of Clinical Oncology (ASCO) Health Services Research Committee members, and the ASCO Board of Directors reviewed this document.     

Screening and early cancer detection

NCI is the primary research institution that has funded most of the research to establish evidence of benefit from mass cancer screening. A study of prostate, lung, and colorectal cancer is presently being planned. These trials are large, expensive, and require 10 to 15 years or longer to complete. RCST trials are only feasible in the three or four most common sites. While developing better evidence, NCI suggests the Working Guidelines for the Early Detection of Cancer in seven sites where direct and/or indirect evidence suggests benefit. The potential for early cancer detection to contribute to a decrease in cancer mortality is great. However, unless early detection is applied by the public and by physicians, it is useless. It is hoped that this chapter has been helpful to physicians and oncologists in judging these matters and applying the benefits to patients.     

Lung cancer highlights

Have we made any progress in the treatment of advanced non-small cell lung cancer (NSCLC) over the past 15 years? After hearing the Eastern Cooperative Oncology Group (ECOG) 1594 presented by Dr. Joan Schiller at the plenary session of the 36th Annual Meeting of ASCO, it is hard to be certain. SCHILLER: reported the results of one of the world's largest randomized trials in metastatic lung cancer comparing four platinum-based doublets. There were no differences in survival (primary endpoint) or response between these four regimens, although the cisplatin/gemcitabine arm had a superior time to progression. In her commentary on this study, Dr. Francis Shepherd concluded that progress in the treatment of metastatic lung cancer has occurred at "a snail's pace." Despite the disappointing results of ECOG 1594, there were notable trials describing new agents with novel mechanisms of action reported at this year's ASCO meeting. In small-cell lung cancer, the combination of cisplatin/ irinotecan was found to be superior to cisplatin/etoposide. For NSCLC, novel agents Iressa anti-epidermal growth factor receptor tyrosine kinase and anti-vascular endothelial growth factor monoclonal antibody appear promising.