Advisory Committee Members Present:
John Niederhuber, M.D., M.P.H., Acting Director, NCI (Acting Chair)

Advisory Committee Members Participating in the Teleconference:
Theodore S. Lawrence, Ph.D., M.D., Chairman, Department of Radiology/Oncology, University of Michigan, Chair Board of Scientific Counselors for Clinical Sciences & Epidemiology
Carolyn D. Runowicz, M.D., Director, Carole and Ray Neag Comprehensive Cancer Center, University of Connecticut Health Center, Chair National Cancer Advisory Board
Harinder Singh, Ph.D., Professor, Department of Molecular Genetics and Cell Biology, Howard Hughes Medical Institute, The University of Chicago, Chair Board of Scientific Counselors for Basic Sciences
Douglas E. Ulman, Director of Survivorship, Lance Armstrong Foundation, Chair Director’s Consumer Liaison Group
Robert C. Young, M.D., President, Fox Chase Cancer Center, Chair Board of Scientific Advisors

Ex Officio Members Participating in the Teleconference:
Alan Rabson, M.D., Deputy Director, NCI

Executive Secretary Participating in the Teleconference:
Cherie Nichols, M.B.A., Director, Office of Science Planning and Assessment (OSPA), NCI

Adolescent and Young Adult Oncology Progress Review Group Members Participating in the Teleconference:
Barry Anderson, M.D., Cancer Therapy Evaluation Program, NCI
Michael Caligiuri, M.D., Ohio State University
Douglas E. Ulman, Director of Survivorship, Lance Armstrong Foundation

NCI Staff
Jamelle Banks, Health Science Analyst, OSPA, NCI
Tina Hamilton, Lance Armstrong Foundation
Devon McGoldrick, Lance Armstrong Foundation
Joy Wiszneauckas, Program Analyst, OSPA, NCI
Kathleen Schlom, Special Assistant to the Director, NCI
Anne Tatem, DCB, NCI

Other Participants:
James Ingram, American Society for Clinical Oncology
Craig Lustig, Children’s Cause for Cancer Advocacy
Beth Mathews-Bradshaw, SAIC
Suzanne Reuben, Progressive Health Systems
Ed Rorie, NOVA Research Company (Science Writer)

Purpose of the Teleconference

The purpose of the teleconference was to discuss and present for acceptance the report of the Adolescent and Young Adult Oncology Progress Review Group (AYAO PRG), Closing the Gap: Research and Care Imperatives for Adolescents and Young Adults with Cancer. The ACD was asked to approve the report as written or to make recommendations for revisions. Accepting the report means that the Institute can respond to the findings and recommendations contained in the report.

Ms. Cherie Nichols reminded participants of the purpose of the teleconference and confirmed that no conflict of interest existed that would prevent any ACD members from discussing the recommendations of the AYAO PRG. She noted that a summary of the teleconference will be posted on the public NCI Web site.

Presentation by the AYAO PRG

The AYAO PRG was established to address unique cancer-related problems among those aged 15 to 39. About 68,000 people in this population were diagnosed with cancer in 2002, representing approximately 6 percent of all new cancer cases. Among those aged 25 to 35, cancer survival has not improved in more than two decades.

Progress in AYAO has been hampered because cancer risk and adverse cancer outcomes have been under-recognized in this population. These patients often fall into a “no-man’s land” between pediatric oncology and adult oncology. Adolescents and young adults are often underinsured; both they and their doctors often underestimate their cancer risks. AYAO research is constrained by low levels of participation in clinical research by members of this population. Psychosocial support and related services for AYAs are limited.

The AYAO PRG identified three objectives for its deliberations: (1) define and describe issues related to AYAO; (2) identify gaps in knowledge and services and prioritize opportunities to address those gaps through research and intervention development; and (3) facilitate the adoption and implementation of cancer research, policy, community programs, and clinical interventions and evaluate their impact on issues specific to AYAO.

The PRG is a three-phase process: (1) development of recommendations; (2) implementation of those recommendations: and (3) data collection, analysis, reporting and discussing progress, and adjustment of implementation strategies as needed.

Following, a December 2005 planning meeting, the PRG brought together a larger group in April 2006 to address eleven primary and cross-cutting topics in breakout groups. Primary topics included biology; prevention, cancer control, epidemiology, and risk assessment; insurance; clinical care models; psychosocial and behavioral factors; and long-term effects. Cross-cutting topics included access to care; clinical research; health-related quality of life; special populations; and cancer awareness.

The AYAO PRG identified five overarching priority recommendations:

Identify the characteristics that distinguish the unique cancer burden in the AYAO patient.
• Elucidate unique biologic characteristics of AYA cancers and AYA patients that affect disease outcome in this population.
• Elucidate AYA life-stage/developmental characteristics that influence care seeking, adherence to treatment, and medical and psychosocial outcomes.
• Identify and ameliorate health disparities experienced by AYA cancer patients and survivors.
Provide culturally competent education, training, and communication to improve awareness, prevention, access, and quality cancer care to AYAs.
• Raise awareness of AYA cancer issues as a first step toward increasing national focus and resource allocation to address the AYA cancer problem.
• Provide targeted education to patients, families/caregivers, and the public about AYA cancer issues.
• Educate multidisciplinary providers who work with AYAs to improve referrals and services to this population.
Create the tools needed to study the AYA cancer problem.
• Create a large prospective database of AYA cancer patients to facilitate research on this age group.
• Increase the number of annotated specimens to support research progress.
• Create/modify needed assessment tools specific to AYA cancer issues.
• Improve grant coding and search term standardization to enable evaluation of research efforts and progress.
• Expand clinical trials for AYAs to increase treatment choices and accelerate treatment advances.
Ensure excellence in service delivery across the cancer control continuum (i.e., prevention, screening, diagnosis, treatment, survivorship, and end of life).
• Develop, evaluate, and disseminate standards of care for AYA cancer patients and survivors to improve outcomes.
• Establish a national network or coalition of providers and advocates seeking to achieve a standard of excellence in AYA cancer care
Strengthen and promote advocacy and support of the AYA cancer patient.
• Address the subjective experience of AYA patients.
• Build the capacity of existing resources to address AYA psychosocial needs.
• Evaluate existing programs and develop new interventions

The second phase of the PRG’s work will begin with an Implementation Meeting on November 10-12, 2006, in Austin, Texas. The cross-disciplinary nature of the PRG process will be continued at this meeting, where diverse stakeholders from all backgrounds will meet, including clinicians and researchers (AYA specialists, pediatricians, gerontologists, and disease-specific experts); cancer survivors; advocacy groups; statisticians; pharmaceutical industry representatives; insurance providers; and government agencies such as NCI and the Department of Defense.

Discussion

Dr. Lawrence asked how the age range was selected, noting that 15- and 39-year-olds are very different. Dr. Young agreed that the top of the age range may be too high, adding that people in their thirties are usually considered to be adults. Dr. Runowicz added that many medical schools have established adolescent medicine departments, which usually work with a population whose upper age limit is 23 to 25.

The physicians directing these departments would probably not support an upper range of 35 or 39. Dr. Caligiuri stated that there was vigorous debate on this issue during the roundtable meeting with input from all 11 roundtable groups. The top of the age range was the most difficult to decide on. Data on the lack of progress in outcomes throughout this age range was considered an important factor. Page 5 of the report presents relevant data. Some roundtable participants were in favor of reducing the top of the range to 35. It was acknowledged that at the lower end of the age range, some pediatric tumors are seen whereas, at the high end, some cancers seen mostly in older adults are encountered.

Dr. Young observed that the report does not say much about long-term consequences of treatment in this group. The pediatric oncology field has done a good job of adjusting treatment based on data from studies of long-term impact. AYAs are less likely to be followed. Not enough is known about late consequences in this population.

Dr. Caligiuri replied that this issue is mentioned in recommendation 3. Appropriate databases are needed, trials for this population need to be expanded, and coding for survivorship data is needed. Accrual will be slow. Participants from this age group in existing trials could be stratified to address some questions; other questions will require new trials.

Dr. Runowicz asked whether input was obtained from the Society for Adolescent Medicine. If not, she recommended bringing this group into the Implementation Meeting as a resource on insurance and psychosocial issues.

Dr. Niederhuber said that he would like to see more emphasis on the importance of studying this group in clinical trials, especially through correlative research to identify genomic differences. Dr. Caligiuri noted that this issue is relevant to recommendation 1, in which biologic factors are briefly mentioned.

Dr. Lawrence asked whether the PRG discussed the idea of providing formal training and/or certification for specialists working with this population.

Dr. Anderson replied that the PRG discussed current levels of specialization in the United Kingdom and North America, including trends toward treatment of AYAs in special wards, but the group did not identify specialization or certification as a formal recommendation.

Dr. Young noted that little is known about this group in terms of outcomes. The PRG might consider recommending the harvesting of initial information through a rigorous analysis of existing large databases. This could elucidate issues that should be taken into consideration in setting up a prospective trial, which will be difficult to design and accrue. With its electronic records, the Department of Defense is a possible source of data, as well as cooperative groups and cancer centers.

Dr. Caligiuri said that the PRG examined the NCI research portfolio to identify relevant trials. Due to the lack of adequate indexing for this population, this review required painstaking research using grant abstracts.

Dr. Runowicz noted that the mission statement of the Children’s Oncology Group addresses cancer in both childhood and adolescence. This group has a large database that includes long-term follow-up.

Dr. Anderson identified several limitations in using data from the Children’s Oncology Group: the numbers are not large; the top of the age range age is 19 or 20; and most of the questions addressed focus on pediatric issues.

Mr. Craig Lustig (who participated in the roundtable meeting) noted that he has struggled with issues related to efforts to improve survival rates; many of the diseases that affect this population have high survival rates, so that changes are harder to achieve and measure. The PRG may want to consider placing an emphasis on diseases with lower survival rates.

Returning to the age-range issue, Dr. Runowicz suggested rethinking the upper end of the age range. Other ACD members agreed that the age range identified by the PRG can be broken down into smaller groups with respect to various factors (e.g., fertility issues differ greatly between older young adults and adolescents).

Dr. Lawrence pointed out that it may be difficult to recruit advocates from among professionals and other stakeholders if the 15-to-39 age range is used. Those involved in adolescent medicine will advocate for the lower end of the range but not the high end.

Mr. Ulman observed that questions about the age range are less likely to be a cause of concern for the advocacy community than for those addressing medical issues.

Ms. Nichols asked ACD members to consider the fact that over 100 people debated the age range question many times during the roundtable meeting; enough of a consensus was achieved to include this age range for the purposes of the report. She asked whether the ACD could accept the report with the understanding that the issue will continue to be addressed during the implementation phase.

Dr. Niederhuber concluded that serious concerns about the age range have been heard and should be taken into consideration in the implementation phase.

Mr. Ulman replied that the PRG leadership will make this concern a major topic of discussion during the group’s weekly conference calls.

Dr. Niederhuber moved that the ACD accept the report of the AYAO PRG. The motion was seconded by Dr. Lawrence. The ACD unanimously accepted the report.

Adjournment

The teleconference adjourned at 2:00 p.m. (EST).