American Society Of Clinical Oncology Board Research Articles

First Person Profile: Clifford Hudis, MD: The chief executive officer of the American Society of Clinical Oncology previously had an esteemed career as a physician-scientist and executive at the Memorial Sloan Kettering Cancer Center's Breast Medicine Service: The chief executive officer of the American Society of Clinical Oncology previously had an esteemed career as a physician-scientist and executive at the

First Person Profile: Clifford Hudis, MD: The chief executive officer of the American Society of Clinical Oncology previously had an esteemed career as a physician-scientist and executive at the Memorial Sloan Kettering Cancer Center's Breast Medicine Service: The chief executive officer of the American Society of Clinical Oncology previously had an esteemed career as a physician-scientist and executive at the

First Person Profile: Smita Bhatia, MD, MPH

First Person Profile: Smita Bhatia, MD, MPH

The American Society of Clinical Oncology's Efforts to Support Global Cancer Medicine.

Despite much progress in the management of malignant diseases, the number of new cases and cancer-related deaths continues to rise around the world. More than half of new cases occur in economically developing countries, where more than two thirds of cancer deaths are expected. However, implementation of all necessary steps to accomplish the dissemination of state-of-the-art prevention, diagnosis, and management will require increased allocation of resources, and, more importantly, harmonization of the efforts of hundreds of national and international public health agencies, policy-setting bodies, governments, pharmaceutical companies, and philanthropic organizations. More than 30% of the members of the American Society of Clinical Oncology (ASCO) reside and practice outside US borders, and more than half of attendees at all of the scientific congresses and symposia organized by ASCO are international. As cancer has become an increasingly global disease, ASCO has evolved as a global organization. The ASCO Board of Directors currently includes members from France, Brazil, and Canada. In 2013, the ASCO Board of Directors identified a number of strategic priorities for the future. Recognizing the importance of non-US members to the society, their first strategic priority was improving the society's service to non-US members and defining these members' identity in the international oncology community. This article reviews current ASCO activities in the international arena and its future plans in global oncology.

American Society of Clinical Oncology Clinical Practice Guidelines: Formal Systematic Review–Based Consensus Methodology

The American Society of Clinical Oncology (ASCO) guidelines program employs a systematic review-based methodology to produce evidence-based guidelines. This is consistent with the stance of the Institute of Medicine on guideline development, which is that high-quality evidence syntheses form the basis for recommendation development. In the absence of high-quality evidence, recommendation development becomes more complex. One option is to provide no recommendations or withdraw a guideline topic. However, it is often the areas of greatest uncertainty in which the evidentiary base is incomplete, and thus, guidelines are needed most. To provide recommendations in such circumstances, an explicit methodology is needed to ensure that a credible process is undertaken, and rigorous, reliable advice is provided. In 2010, the ASCO Board of Directors approved development of guideline recommendations using consensus methodology. A modified Delphi approach to recommendation development, based on the best available data identified in a systematic review, was piloted with an ASCO guideline. Consensus was achieved through the rating of a series of recommendations by a large group of clinicians, including academic and community-based content and methodology experts. A prespecified threshold of agreement was determined to indicate when consensus was achieved. Consensus was defined as agreement by ≥ 75% of raters. The formal consensus methodology used by ASCO enabled development of guideline recommendations on a challenging clinical issue based on limited evidence using a rigorous, transparent, and explicit method. This methodology is proposed for development of future ASCO guidelines on topics for which limited evidence is available.

Entering My Final Year As Editor-in-Chief of Journal of Clinical Oncology

After the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting, I knew why Mark Twain felt compelled to write “The reports of my death are greatly exaggerated.” It was wonderful for so many people to congratulate me on a job well done and for them to inquire about what I would do with my time. The time to answer that question has not yet come. Perhaps a few words of explanation are required. I was appointed by Joseph S. Bailes, who was then president of ASCO, in early 2000 after a search by the publications committee, and I assumed the role of Editor-in-Chief of Journal of Clinical Oncology (JCO) at the 2001 ASCO Annual Meeting. The ASCO bylaws limit the term of the editors of ASCO journals to a maximum of two 5-year terms, and my tenure will end a year from now. The past 9 years have been a great honor and pleasure for me, and I am glad to have a 10th year to lead JCO. To ensure continuity of JCO, a similar search was completed in the fall of last year, and Stephen A. Cannistra, a former associate editor and a current consultant editor for JCO’s Biology of Neoplasia section, was selected as the fourth Editor-in-Chief of JCO, with his term starting at the 2011 ASCO Annual Meeting. During the next year, we will be working together to continue to improve JCO as the irreplaceable resource for oncology that it has become. JCO is a much more complex enterprise than it was a decade ago, and much work will be required to make next year’s transition as seamless as possible. Everyone involved is dedicated to making my 10th year as Editor-in-Chief as productive as possible in recognition of the fact that the readers of JCO deserve nothing less. Meanwhile, as I reported to the ASCO Board of Directors at its recent meeting, JCO has never been stronger. Submissions steadily increase, and the quality of the manuscripts is better than ever. Given the limitations in space, the increase in submissions has inevitably led to a more stringent acceptance rate as we strive to keep the quality of JCO high and keep it competitive with the best medical journals. In recognition of our success, we learned just after the 2010 ASCO Annual Meeting that JCO’s impact factor increased again to 17.793— more than a 4-point increase during the last 4 years. JCO remains innovative among its peers with translated editions in many languages, the broadest possible range of published topics, and the ability to seek improvements in coverage of the entire landscape of oncology. As an example of this, we have increased the number of articles published on the subject of hematologic malignancies by more than 30% in the last 2 years, attracting a new audience of international authors and readers. The future looks just as bright or even brighter as the editors and I look ahead to and plan for the coming year. Changes will include making randomized phase II and III protocols available to readers, podcasting, continuing medical education credits for our dedicated reviewers, and many other enhancements. The only aspect of JCO that should not change is the continued publication of that which is new, true, and practice changing in clinical oncology.

ASCO Clinical Practice Guidelines: Past, Present and Future

American Society of Clinical Oncology (ASCO) clinical practice guidelines have been viewed as among the most valuable benefits of ASCO membership, surpassed only by the Annual Meeting and Journal of Clinical Oncology (JCO). Five of the top ten most frequently accessed in JCO are ASCO clinical practice guidelines. During the past 15 years, ASCO has published some 25 guidelines or technology assessments under the auspices of the Health Services Committee (HSC) and the approval of the ASCO Board of Directors. Though clearly a valuable component of ASCO membership, important limitations of the guidelines have also been pointed out, including their limited number, lack of frequent updates, and difficult implementation in daily practice, among other weaknesses. The strengths and limitations of ASCO clinical practice guidelines along with efforts recently initiated or planned to enhance the ASCO guideline process were recently summarized in a Special Article by Somerfield et al1 in the August 20 issue of JCO. The authors note that ASCO guidelines are often viewed as out of date, difficult to locate, and awkward to implement in everyday clinical oncology practice. Though these limitations are not unique to ASCO guidelines, the HSC has taken steps to improve the ASCO guideline process and final product.

ASCO Clinical Practice Guidelines and Beyond

Venous thromboembolism and its complications, including pulmonary embolism and death, are increasingly recognized as important complications of cancer and cancer treatment.1,2 A summary of the most recent American Society of Clinical Oncology (ASCO) guidelines entitled “Recommendations for Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer”is presented in this issue of the Journal of Oncology Practice (JOP).3 Continuing in the tradition of ASCO guidelines, this heavily evidence-based compendium of recommendations from an expert panel will be published in full in the Journal of Clinical Oncology (JCO).4 Guideline Summaries published routinely in JOP distill the full guideline down to the major recommendations and other essential issues.5 Since their initiation in 1994, the ASCO clinical practice guidelines have been well received and represent one of the major benefits of ASCO membership along with the Annual Meeting and JCO. In 2006, five of the top 10 article downloads from the JCO were ASCO clinical practice guidelines. The process of developing ASCO guidelines is rigorous and summarized in a Methodology Manual available at ASCO.org.6 Following review and approval of a guideline proposal, an extensive systematic literature review is conducted often culminating in a metaanalysis of the evidence followed by a lengthy development process with a panel of both content and methodology experts producing a document with explicit recommendations that undergoes exhaustive internal and external review before final approval by the Panel, the Health Services Committee and the ASCO Board of Directors before publication in JCO.

Initial Hormonal Management of Androgen-Sensitive Metastatic, Recurrent, or Progressive Prostate Cancer: 2007 Update of an American Society of Clinical Oncology Practice Guideline

To update the 2004 American Society of Clinical Oncology (ASCO) guideline on initial hormonal management of androgen-sensitive, metastatic, recurrent, or progressive prostate cancer (PCa). The writing committee based its recommendations on an updated systematic literature review. Recommendations were approved by the Expert Panel, the ASCO Health Services Committee, and the ASCO Board of Directors. Seven randomized controlled trials (four new), one systematic review, one meta-analysis (new), one Markov model, and one delta-method 95% CI procedure for active controlled trials (new) informed the guideline update. Bilateral orchiectomy or luteinizing hormone-releasing hormone agonists are recommended initial androgen-deprivation treatments (ADTs). Nonsteroidal antiandrogen monotherapy merits discussion as an alternative; steroidal antiandrogen monotherapy should not be offered. Combined androgen blockade should be considered. In metastatic or progressive PCa, immediate versus symptom-onset institution of ADT results in a moderate decrease (17%) in relative risk (RR) for PCa-specific mortality, a moderate increase (15%) in RR for non-PCa-specific mortality, and no overall survival advantage. Therefore, the Panel cannot make a strong recommendation for early ADT initiation. Prostate-specific antigen (PSA) kinetics and other metrics allow identification of populations at high risk for PCa-specific and overall mortality. Further studies must be completed to assess whether patients with adverse prognostic factors gain a survival advantage from immediate ADT. For patients electing to wait until symptoms for ADT, regular monitoring visits are indicated. For patients with recurrence, clinical trials should be considered if available. Currently, data are insufficient to support use of intermittent androgen blockade outside clinical trials

American Society of Clinical Oncology Clinical Practice Guideline for the Use of Larynx-Preservation Strategies in the Treatment of Laryngeal Cancer

To develop a clinical practice guideline for treatment of laryngeal cancer with the intent of preserving the larynx (either the organ itself or its function). This guideline is intended for use by oncologists in the care of patients outside of clinical trials. A multidisciplinary Expert Panel determined the clinical management questions to be addressed and reviewed the literature available through November 2005, with emphasis given to randomized controlled trials of site-specific disease. Survival, rate of larynx preservation, and toxicities were the principal outcomes assessed. The guideline underwent internal review and approval by the Panel, as well as external review by additional experts, members of the American Society of Clinical Oncology (ASCO) Health Services Committee, and the ASCO Board of Directors. Evidence supports the use of larynx-preservation approaches for appropriately selected patients without a compromise in survival; however, no larynx-preservation approach offers a survival advantage compared with total laryngectomy and adjuvant therapy with rehabilitation as indicated. All patients with T1 or T2 laryngeal cancer, with rare exception, should be treated initially with intent to preserve the larynx. For most patients with T3 or T4 disease without tumor invasion through cartilage into soft tissues, a larynx-preservation approach is an appropriate, standard treatment option, and concurrent chemoradiotherapy therapy is the most widely applicable approach. To ensure an optimum outcome, special expertise and a multidisciplinary team are necessary, and the team should fully discuss with the patient the advantages and disadvantages of larynx-preservation options compared with treatments that include total laryngectomy.

American Society of Clinical Oncology Guideline Recommendations for Sentinel Lymph Node Biopsy in Early-Stage Breast Cancer

To develop a guideline for the use of sentinel node biopsy (SNB) in early stage breast cancer. An American Society of Clinical Oncology (ASCO) Expert Panel conducted a systematic review of the literature available through February 2004 on the use of SNB in early-stage breast cancer. The panel developed a guideline for clinicians and patients regarding the appropriate use of a sentinel lymph node identification and sampling procedure from hereon referred to as SNB. The guideline was reviewed by selected experts in the field and the ASCO Health Services Committee and was approved by the ASCO Board of Directors. The literature review identified one published prospective randomized controlled trial in which SNB was compared with axillary lymph node dissection (ALND), four limited meta-analyses, and 69 published single-institution and multicenter trials in which the test performance of SNB was evaluated with respect to the results of ALND (completion axillary dissection). There are currently no data on the effect of SLN biopsy on long-term survival of patients with breast cancer. However, a review of the available evidence demonstrates that, when performed by experienced clinicians, SNB appears to be a safe and acceptably accurate method for identifying early-stage breast cancer without involvement of the axillary lymph nodes. SNB is an appropriate initial alternative to routine staging ALND for patients with early-stage breast cancer with clinically negative axillary nodes. Completion ALND remains standard treatment for patients with axillary metastases identified on SNB. Appropriately identified patients with negative results of SNB, when done under the direction of an experienced surgeon, need not have completion ALND. Isolated cancer cells detected by pathologic examination of the SLN with use of specialized techniques are currently of unknown clinical significance. Although such specialized techniques are often used, they are not a required part of SLN evaluation for breast cancer at this time. Data suggest that SNB is associated with less morbidity than ALND, but the comparative effects of these two approaches on tumor recurrence or patient survival are unknown.

American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003.

The American Society of Clinical Oncology (ASCO) previously published evidencebased guidelines for the treatment of unresectable non–small-cell lung cancer (NSCLC) [1]. ASCO guidelines are updated periodically by the responsible Expert Panel (Appendix) [2]. For the 2003 update, a methodology similar to that applied in the original ASCO practice guidelines for treatment of unresectable NSCLC was used. Pertinent information published from 1996 through March 2003 was reviewed. The MEDLINE database (1996 through October 2002; National Library of Medicine, Bethesda, MD) was searched to identify relevant information from the published literature for this update. A series of searches was conducted using the medical subject headings, “carcinoma, non–small-cell lung,” “diagnostic imaging,” “neoplasm staging,” “mediastinoscopy,” “bone neoplasms,” “brain neoplasms,” “liver neoplasms,” “adrenal gland neoplasms,” “non–small-cell lung cancer,” “radionuclide imaging,” “bisphosphonates,” “radiotherapy,” “smoking,” “chemoprevention,” and the text words “chemotherapy,” “bone scan,” “PET,” and “zoledronic acid.” These terms were combined with the study design–related subject headings or text words “meta-analysis” and “randomized controlled trial.” Search results were limited to human studies and English-language articles. The Cochrane Library was searched in October 2002 using the phrase “lung cancer.” Directed searches based on the bibliographies of primary articles were also performed. Randomized trials published in the literature since October 2002, as well as data presented at ASCO Annual Meetings, were added to the evidence for these guidelines at the discretion of members of the Expert Panel. The entire update committee met once to discuss strategy and assign responsibilities for the update. A writing committee subsequently met to further review the literature searches, collate different sections of the update, and refine the manuscript. A draft update was circulated to the full Expert Panel for review and approval. The final document was also reviewed by ASCO’s Health Services Research Committee and the ASCO Board of Directors. Each recommendation from the 1997 guideline is listed below, and is followed by an updated (2003) recommendation, if applicable. “No change” is indicated if a particular recommendation has not been revised. A summary of the evidence follows thereafter. In order to preserve the framework of the 1997 guideline, information and recommendations regarding major topics, such as fluorodeoxyglucose positron emission tomography (FDGPET), have been divided and distributed to the appropriate section of the text. ASCO considers adherence to these guidelines to be voluntary. The ultimate determination regarding their application is to be made by the physician in light of each From the American Society of Clinical Oncology, Alexandria, VA.

American Society of Clinical Oncology technology assessment of pharmacologic interventions for breast cancer risk reduction including tamoxifen, raloxifene, and aromatase inhibition.

To update an evidence-based technology assessment of chemoprevention strategies for breast cancer risk reduction. POTENTIAL INTERVENTIONS: Tamoxifen, raloxifene, aromatase inhibition, and fenretinide. Outcomes of interest include breast cancer incidence, breast cancer-specific survival, overall survival, and net health benefit. A comprehensive, formal literature review was conducted for relevant topics. Testimony was collected from invited experts and interested parties. The American Society of Clinical Oncology (ASCO) prescribed technology assessment procedure was followed. More weight was given to published randomized trials. BENEFITS/HARMS: A woman's decision regarding breast cancer risk reduction strategies is complex and will depend on the importance and weight attributed to information regarding both cancer- and noncancer-related risks and benefits. For women with a defined 5-year projected breast cancer risk of > or= 1.66%, tamoxifen (at 20 mg/d for 5 years) may be offered to reduce their risk. Risk/benefit models suggest that greatest clinical benefit with least side effects is derived from use of tamoxifen in younger (premenopausal) women (who are less likely to have thromboembolic sequelae and uterine cancer), women without a uterus, and women at higher breast cancer risk. Data do not as yet suggest that tamoxifen provides an overall health benefit or increases survival. In all circumstances, tamoxifen use should be discussed as part of an informed decision-making process with careful consideration of individually calculated risks and benefits. Use of tamoxifen combined with hormone replacement therapy or use of raloxifene, any aromatase inhibitor or inactivator, or fenretinide to lower the risk of developing breast cancer is not recommended outside of a clinical trial setting. This technology assessment represents an ongoing process and recommendations will be updated in a timely matter. The conclusions were endorsed by the ASCO Health Services Research Committee and the ASCO Board of Directors.

American Society of Clinical Oncology technology assessment on the use of aromatase inhibitors as adjuvant therapy for women with hormone receptor-positive breast cancer: status report 2002.

To conduct an evidence-based technology assessment to determine whether the routine use of anastrozole or any of the aromatase inhibitors in the adjuvant breast cancer setting is appropriate for broad-based conventional use in clinical practice. POTENTIAL INTERVENTIONS: Anastrozole, letrozole, and exemestane. Outcomes of interest include breast cancer incidence, breast cancer-specific survival, overall survival, and net health benefit. A comprehensive, formal literature review was conducted for relevant topics and is detailed in the text. Testimony was collected from invited experts and interested parties. The American Society of Clinical Oncology (ASCO)-prescribed technology assessment procedure was followed. BENEFITS/HARMS: The ASCO panel recognizes that a woman and her physician's decision regarding adjuvant hormonal therapy is complex and will depend on the importance and weight attributed to information regarding both cancer and non-cancer-related risks and benefits. The panel was influenced by the compelling, extensive, and long-term data available on tamoxifen. Overall, the panel considers the results of the Arimidex (anastrozole) or Tamoxifen Alone or in Combination (ATAC) trial and the extensive supporting data to be very promising but insufficient to change the standard practice at this time (May 2002). A 5-year course of adjuvant tamoxifen remains the standard therapy for women with hormone receptor-positive breast cancer. The panel recommends that physicians discuss the available information with patients, and, in making a decision, acknowledge that treatment approaches can change over time. Individual health care providers and their patients will need to come to their own conclusions, with careful consideration of all of the available data. (Specific questions addressed by the panel are summarized in Appendix 3.) The conclusions of the panel were endorsed by the ASCO Health Services Research Committee and the ASCO Board of Directors.

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

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. Tamoxifen and raloxifene. Outcomes of interest include breast cancer incidence, breast cancer-specific survival, overall survival, and net health benefits. 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. 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. 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 The conclusions of the Working Group were evaluated by the ASCO Health Services Research Committee and by the ASCO Board of Directors. American Society of Clinical Oncology.