CME – Wanted: Older Adults in Cancer Trials

CME – Wanted: Older Adults in Cancer  Trials
Author Information (click to view)

Arti Hurria, MD

Director
Cancer and Aging Research Program
City of Hope National Medical Center

Arti Hurria, MD, has indicated to Physician’s Weekly that she works as a consultant or in an advisory role for GTx, On Q Health, and Boehringer Ingelheim and has received research funding from GlaxoSmithKline and Celgene.

Figure 1 (click to view)
Target Audience (click to view)

This activity is designed to meet the needs of physicians.

Learning Objectives(click to view)

Upon completion of the educational activity, participants should be able to:

 

  1. Discuss the American Society of Clinical Oncology’s landmark recommendations to improve the evidence base for treating older adults with cancer.

Method of Participation(click to view)

Statements of credit will be awarded based on the participant reviewing monograph, correctly answer 2 out of 3 questions on the post test, completing and submitting an activity evaluation.  A statement of credit will be available upon completion of an online evaluation/claimed credit form at www.akhcme.com/pwFeb3.  You must participate in the entire activity to receive credit.  If you have questions about this CME/CE activity, please contact AKH Inc. at dcotterman@akhcme.com.

Credit Available(click to view)

AKH

CME Credit Provided by AKH Inc., Advancing Knowledge in Healthcare

Physicians
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AKH Inc., Advancing Knowledge in Healthcare and Physician’s Weekly’s.  AKH Inc., Advancing Knowledge in Healthcare is accredited by the ACCME to provide continuing medical education for physicians.

 

AKH Inc., Advancing Knowledge in Healthcare designates this enduring activity for a maximum of 0.5 AMA PRA Category 1 Credit(s)™.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Commercial Support(click to view)

There is no commercial support for this activity.

Disclosures(click to view)

It is the policy of AKH Inc. to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The author must disclose to the participants any significant relationships with commercial interests whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflicts of interest are resolved by AKH prior to accreditation of the activity and may include any of or combination of the following: attestation to non-commercial content; notification of independent and certified CME/CE expectations; referral to National Author Initiative training; restriction of topic area or content; restriction to discussion of science only; amendment of content to eliminate discussion of device or technique; use of other author for discussion of recommendations; independent review against criteria ensuring evidence support recommendation; moderator review; and peer review.

Disclosure of Unlabeled Use & Investigational Product(click to view)

This educational activity may include discussion of uses of agents that are investigational and/or unapproved by the FDA. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer(click to view)

This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH Inc. specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through participant’s misunderstanding of the content.

Faculty & Credentials(click to view)

FACULTY DISCLOSURES

Keith D’Oria, Editorial Director
Discloses no financial relationships with pharmaceutical or medical product manufacturers.
Arti Hurria, MD
Discloses the following financial relationships with pharmaceutical or medical product manufacturers:
Consultant:  Boehringer Ingelheim Pharmaceuticals; GTx, Inc.; Carevive Systems
Research Funding:  Celgene Corporation; GlaxoSmithKline
 AKH and PHYSICIAN WEEKLY’S STAFF/REVIEWERS

Dorothy Caputo, MA, BSN, RN- CE Director of Accreditation
Discloses no financial relationships with pharmaceutical or medical product manufacturers.

AKH planners and reviewers have no relevant financial relationships to disclose.

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Arti Hurria, MD (click to view)

Arti Hurria, MD

Director
Cancer and Aging Research Program
City of Hope National Medical Center

Arti Hurria, MD, has indicated to Physician’s Weekly that she works as a consultant or in an advisory role for GTx, On Q Health, and Boehringer Ingelheim and has received research funding from GlaxoSmithKline and Celgene.

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The American Society of Clinical Oncology has issued recommendations that call for federal agencies and the cancer research community to broaden clinical trials to include older adults. These efforts may help ensure that all patients will receive high-quality, evidence-based cancer care.
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Studies have shown that older adults account for most of the cancer diagnoses and deaths that occur in the United States and make up the majority of cancer survivors. More than 50% of cancers in the U.S. occur in people aged 65 and older, a demographic that is expected to grow exponentially in the coming years. However, the evidence base for treating this patient group is lacking. In addition, few policy initiatives have targeted the lack of evidence on older adults with cancer.

“Older adults are largely underrepresented in clinical trials, and it’s rare when these trials are designed specifically for older adults,” says Arti Hurria, MD. “This patient population tends to have different experiences and outcomes with cancer treatment than younger counterparts. We’re also expecting a doubling of the U.S. population that is 65 and older, and we project a 67% increase in cancer incidence among this age group. These data emphasize the importance of involving older adults in clinical trials so that we can optimize treatment for these patients.”

In response to this issue, the American Society of Clinical Oncology (ASCO) recently released landmark recommendations to improve the evidence base for treating older adults with cancer. The call-to-action statement was developed by ASCO’s Cancer Research Committee and published in the Journal of Clinical Oncology. It made five overarching recommendations to improve the evidence base for treating older adults with cancer (Table).

Improving Trial Designs

The first recommendation from ASCO is to use clinical trials to improve the evidence base for treating older adults. There is growing recognition that eligibility criteria in clinical trials could be relaxed without compromising scientific rigor. Efforts should also be made to gather additional data elements in trials, such as the impact of treatment on function or cognition. The statement notes that government groups should encourage and incentivize more involvement of older adults in trials. “The goal should be to make it possible to enroll more adults who are older into clinical trials, even if they have comorbidities,” says Dr. Hurria.

ASCO also recommends leveraging research designs and infrastructure to improve the evidence base for treating older adults by extended trial designs and adaptive trials. Innovative designs are needed to fill knowledge gaps.

Help Needed From Stakeholders

Another key recommendation, according to Dr. Hurria, is to increase the FDA’s authority to incentivize and require research on older cancer patients. “The FDA has issued guidance that encourages manufacturers to generate evidence on the effectiveness of their products in older adults, but it doesn’t require it,” she says. “Laws are needed to change this so that we can better capture information regarding older patients.”

The ASCO statement also recommends that clinicians aim to increase recruitment of older adults with cancer into clinical trials. One of the biggest predictors of whether patients decide to enroll into a clinical trial is if their clinician has discussed and recommended it. “Educational programs will be necessary to reduce clinicians’ reluctance to enroll older adults into trials,” Dr. Hurria says. Increasing reimbursement for clinicians who enroll patients into clinical trials may also improve recruitment.

The final overarching recommendation made by ASCO is to utilize journal policies to incentivize researchers to consistently report on age distribution and health risk profiles of clinical trial participants. “Researchers collect a substantial amount of data about older adults that are not being analyzed or reported,” says Dr. Hurria. “This represents an easily addressed but often missed opportunity to identify differences in safety, efficacy, and dosing that is associated with age. Using journal policies could improve the reporting of data as it relates to the treatment of older adults.”

The ASCO recommendations detail 16 specific action steps that should be implemented in order to achieve the five overarching themes discussed in the call-to-action statement. These include asking regulatory agencies, research funders, and researchers to carefully consider if there is evidence to support eligibility criteria based on age, performance status, or comorbid conditions. These are three critical reasons that older adults are excluded from clinical trials.

Looking Ahead

“The ASCO position statement has given clinicians a roadmap to conduct a multipronged approach that will help expand participation of older adults with cancer in clinical trials,” says Dr. Hurria. “While some of these recommendations are achievable in the short term, others will require longer-term commitments and collaboration from multiple stakeholders who are involved in clinical research. Considering how rapidly our population is aging, it’s clear that now is the time to take action to ensure that all patients with cancer—regardless of age—receive high-quality, evidence-based care.”

 

Readings & Resources (click to view)

Hurria A, Levit LA, Dale W, et al. Improving the evidence base for treating older adults with cancer: American Society of Clinical Oncology statement. J Clin Onc. 2015 Jul 20 [Epub ahead of print]. Available at: http://jco.ascopubs.org/content/early/2015/07/14/JCO.2015.63.0319.full.

Hurria A, Dale W, Mooney M, et al: Designing therapeutic clinical trials for older and frail adults with cancer: U13 conference recommendations. J Clin Oncol. 2014;32:2587-2594.

Scher KS, Hurria A: Under-representation of older adults in cancer registration trials: Known problem, little progress. J Clin Oncol. 2012;30:2036-2038.

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