A person’s HIV status should not be the sole reason they are excluded from a cancer clinical trial, according to recent research.
Cancer clinical trials have been notoriously exclusive, and for years there has been no exception when it comes to patients with HIV. However, according to recent research, patients with lymphoma, Kaposi sarcoma, and liver cancer who were HIV-positive benefitted from treatment with pembrolizumab (Keytruda), and had a similar adverse event (AE) profile. This highlights the fact that many trials can be expanded to include patients with HIV.
“In the past 20-plus years, there have been substantial advances in both HIV care and cancer care. For people with HIV on antiretroviral therapy who are healthy from the HIV perspective, cancer care, including care with a clinical trial, is generally feasible,” said Tom Uldrick, MD, MS, study researcher and deputy head of global oncology at the Fred Hutchinson Cancer Research Center, in an interview with Oncology Nursing News.
“This is important because several cancers occur more commonly in people with HIV, even when they are actively on antiretroviral therapy.”
Uldrick also mentioned that before there was an effective therapy for HIV, the outcomes for patients with cancer and HIV — particularly AIDS – were poor. Not to mention, early HIV medicines had drug-drug interactions with cancer therapies that could alter outcomes. Thus, they tended to be left out of clinical trials.
But now that there are more effective treatments for HIV, many individuals may be able to safely participate in a clinical trial. This is the case with a phase I study being conducted by the Cancer Immunotherapy Trials Network analyzing pembrolizumab in patients with HIV and advanced cancer.
“Pembrolizumab is an immunotherapy that targets PD-1,” Uldrick explained. “Final results demonstrate that pembrolizumab has an acceptable safety profile in people with HIV and CD4 count as low as 100 cell/uL. Clinical benefit was noted in lymphoma, Kaposi sarcoma, and liver cancer. One participant with metastatic lung cancer now has no evidence of disease.”
However, there are some concerns with this patient population that oncology nurses should keep in mind, and it is crucial that healthcare teams openly communicate with one another.
“When treating a patient with HIV and cancer, it is important to make sure that the HIV care providers and the oncology care providers are in communication and agree on which medications the patient should be taking. In some case, cancer patients with HIV need to be on additional antibiotics to prevent infections,” Uldrick said. “If there are questions about medications, it is always best to check with the pharmacist.”
Uldrick hopes that there will soon be a change in the way clinical trial recruiters see patients with HIV.
Leading oncology organizations such as the American Society of Clinical Oncology (ASCO), and the Friends of Cancer Research have published recommendations on appropriate inclusion criteria for clinical trials. Also, the National Cancer Institute promotes the inclusion of patients with HIV on clinical trials, when appropriate. The FDA is developing industry guidance on the topic as well, according to Uldrick.
“I hope there is a culture change in the way cancer clinical trials are conductive to be more inclusive of people living with HIV,” Uldrick said.
Read more: How to Double Clinical Trial Eligibility in Advanced Lung Cancer