ASCO and Friends of Cancer Research today released recommendations to broaden eligibility criteria for cancer clinical trials.
These recommendations — and a corresponding special series of articles published in Journal of Clinical Oncology — specifically focus on minimum age requirements, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.
“This joint initiative provides a roadmap for how to safely employ broader eligibility criteria for cancer clinical trials and promote a culture of inclusion,” Bruce E. Johnson, MD, FASCO, ASCO President, said in a press release. “Allowing more patients to participate in clinical trials will ultimately enhance our understanding of how a given treatment should be utilized to treat the diverse patients we see in everyday clinical practice.”
ASCO and Friends of Cancer Research launched a joint project in 2016 to address trial eligibility criteria which, although intended to protect the safety of trial participants, can impede patient accrual and reduce the generalizability of trial results.
Working groups made recommendations within five target areas:
- Minimum age for enrollment: Patients aged younger than 18 years traditionally are excluded from adult clinical trials. The recommendations state pediatric patients should be considered for later-phase trials of cancers that affect both children and adults, and children aged 12 years and older should be routinely included in these trials. Also, children should be included in early-stage trials that assess dosing, safety and pharmacokinetics when there is rationale to do so.
- HIV: Cancer is now the leading cause of death among patients with HIV, many of whom have a normal life expectancy. Patients with HIV who have a low risk for AIDS-related outcomes should be included in cancer clinical trials — especially those associated with HIV — should be treated according to the same standards as other patients with comorbidities, and should be allowed to receive concurrent antiretroviral therapy.
- Brain metastases: Patients with brain metastases are often excluded from trials, even though they represent a large proportion of patients of certain cancer populations. Thus, these patients should be regularly included in early trials of drugs indicated for cancers where brain metastases are common, as well as in trials of all phases if patients have stable brain metastases 4 weeks before enrolling.
- Organ dysfunction: Comorbidities are increasingly common among the aging cancer population. When renal toxicity is not a direct concern related to the trial, liberal criteria for creatinine clearance should be used for patients with renal disease. Enrollment should include standard clinical assessment of patients with liver dysfunction, and patients with cardiac disease should not be excluded from trials if the drug is not linked to cardiac risks.
- Prior/concurrent malignancies: Many older patients with cancer have a prior history of cancer or two concurrent diagnoses. These patients should be included in trials when there is low risk the second malignancy will interfere with safety or efficacy endpoints, and when natural history or treatment of the malignancy will not interfere with treatments or safety and efficacy.
Widening eligibility criteria will provide clinicians with data that apply to real-world patients with cancer.
“Historically, access to clinical trials has been limited to relatively few patients,” Jeff Allen, PhD, president and CEO of Friends of Cancer Research, said in the release. “Broadening the eligibility criteria for clinical trials will provide the opportunity for more people to participate in research studies. Not only will this improve access, it will make the trial results more reflective of the people who will ultimately use the drug.”