The American Society of Clinical Oncology (ASCO) and Friends of Cancer Research recently released a joint recommendation to promote inclusiveness for cancer clinical trial enrollment criteria, published in the Journal of Clinical Oncology (online October 2, 2017; doi:10.1200/JCO.2017.73.7916).
ASCO and Friends of Cancer Research began a joint project in 2016 to address cancer clinical trial eligibility criteria. While eligibility criteria are intended to protect the safety of trial participants, stringent criteria can impede patient accrual and reduce the generalizability of trial results.
The latest recommendations focus on inclusiveness within five areas:
- Minimum age for enrollment: 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: Patients with HIV who have a low risk for AIDS-related outcomes should be included in cancer clinical trials. 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 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: 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: Older patients with a prior history of cancer or two concurrent diagnoses 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.
“This joint initiative provides a roadmap for how to safely employ broader eligibility criteria for cancer clinical trials and promote a culture of inclusion,” said Bruce E Johnson, MD, FASCO, ASCO President, in a press release (October 2, 2017). “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.”
Promoting clinical trial enrollment is also one of the criteria in ASCO’s guidelines for quality clinical pathways.—Zachary Bessette