Patient groups untested in cancer immunotherapy trials found to also benefit

Immunotherapy is a revolutionary cancer treatment, but it was unknown if cancer patients with HIV or viral hepatitis could also reap the benefits of this therapy because they had been excluded from most clinical trials.

In an "encouraging" study to be presented June 1 at the 2019 ASCO Annual Meeting in Chicago by Georgetown Lombardi Comprehensive Cancer Center, physicians say these patients along with African Americans, who were underrepresented in the trials, actually benefit at the same rate as patients tested in the clinical trials.

The immunotherapies examined are specifically known as immune checkpoint inhibitors (ICIs), which take the brakes off the immune cells—originally activated by exposure to the cancer—so that the person's immune system can attack the cancer.

"Oncologists want to give their patients the best possible care, so some prescribe checkpoint inhibitors without knowing if the treatment will work in the setting of immunodeficiency caused by HIV or liver inflammation caused by viral hepatitis," says the study's lead investigator, Neil J. Shah, MD, a fellow at Georgetown Lombardi's clinical partner, MedStar Georgetown University Hospital.

"What we found is good news for both patients and oncologists. We have strong data, from real world cancer care, that immunotherapy is as beneficial and safe for this group of patients as it is for other cancer patients," he says.

Shah added that this study lays the groundwork for examining underrepresented patients in cancer clinical trials on both a national and international basis.

In this study, the investigators examined records from 765 patients treated with ICIs for various malignancies from 2011 to 2018 at five MedStar Health hospitals (MedStar Health is Georgetown's clinical partner). These patients were either infected with HIV, hepatitis B, hepatitis C, were African American, or had a low ECOG performance status preventing them from participating in trials. The ECOG performance status measures the patient's functional status from 0-4, with 0 being fully active and able to carry on all pre-disease activity without restriction and 4 being bedridden.

In the interest of minimizing complications stemming from co-morbidities most clinical trials include only patients with good functional status (ECOG 0 or 1) or those without concomitant illnesses such and HIV or viral hepatitis.

African-Americans were included in this analysis because, based on a variety of factors, clinical trials often have an under representation of minorities relative to the real-world experience.

Patients with lung cancer, melanoma and kidney cancer usually respond best to ICI therapy and that trend was reflected in the study of the underrepresented populations.

"This retrospective analysis of patient databases from five MedStar Health hospitals of populations receiving ICIs for their advanced cancers was reassuring in establishing that these groundbreaking treatments appeared to be safe and effective in patient populations that have typically been under represented or excluded from clinical trials," says Michael Atkins, MD, deputy director of Georgetown Lombardi and the senior author on this work.

"These results will likely influence the care of such patients who make up a significant proportion of patients with cancer within the Washington area as well as in other major cities across the U.S. and around the world," he says.