Groups of untested patients in cancer immunotherapy trials also showed benefits

CHICAGO (May 30, 2019) – Immunotherapy is a breakthrough treatment for cancer, but it was not known if patients with cancer with HIV or viral hepatitis could also benefit from the benefits of this therapy because they had been excluded from most clinical trials.

In an "encouraging" study presented on June 1st at the ASB 2019 annual meeting in Chicago by the Georgetown Lombardi Comprehensive Cancer Center, doctors say that these patients as well as African-Americans, who were underrepresented in the trials, benefit at the same pace as the patients. tested in clinical trials.

The immunotherapies examined are specifically known as Immune Control Point Inhibitors (ICIs), which inhibit immune cells – originally activated by cancer exposure – so that the immune system of the person can attack the cancer.

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

"What we found is good news for patients and oncologists, and we have solid evidence from real-world cancer care that immunotherapy is also beneficial and safe for this group of patients. than for other cancer patients, "he says.

Shah added that this study lays the foundation for examining underrepresented patients in national and international cancer clinical trials.

In this study, investigators reviewed the records of 765 patients treated with ICI for various malignant tumors from 2011 to 2018 in five MedStar Health hospitals (MedStar Health is Georgetown's clinical partner). These patients were either infected with HIV, hepatitis B or hepatitis C, were African American or had low performance status according to the ECOG preventing them from participating in trials. The ECOG performance status measures the patient's functional status from 0 to 4, 0 being fully active and able to continue all activity prior to the disease without restriction and 4 remaining bedridden.

In the interest of minimizing the complications of comorbidities, most clinical trials are only for patients with good functional status (ECOG 0 or 1) or those without concomitant diseases such as HIV or viral hepatitis. .

African Americans were included in this badysis because, depending on various factors, clinical trials often show under-representation of minorities in relation to lived experience.

Patients with lung cancer, melanoma or kidney cancer generally respond better to ICI treatment, and this trend is reflected in the study of underrepresented populations.

"This retrospective badysis of patient databases from five MedStar Health hospitals of populations receiving ICI for their advanced cancers was rebaduring in establishing that these novel treatments appeared to be safe and effective in patient populations that were generally underrepresented or excluded from trials. Clinics ", Michael Atkins, MD, Deputy Director of Georgetown Lombardi and the lead author of this work.

"These results are likely to influence the care of these patients, who make up a significant proportion of cancer patients in the Washington area as well as in other major cities in the United States and around the world," he said. he declares.

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In addition to Shah and Atkins, co-authors of the study include members of Georgetown Lombardi, Chul Kim, MD, MPH; Subha Madhavan, PhD; and Stephen V. Liu, MD; and MedStar Health residents Matthew Blackburn, MD, Michael Cook, MD, and Athanasios Bikas, MD. Other authors include Anas Belouali, MS, of Georgetown, William J. Kelly, MD of MedStar Health; and Michael T. Sezran, MD, of the MedStar Internal Residency Program.

The study was funded by the Georgetown University Medical Center.

Atkins says he has served on the advisory boards of BMS, Merck, Novartis, Arrowhead, Pfizer, Galactone, Werewolf (with stock options) and Fathom. He is a consultant for BMS, Merck, Novartis, Pfizer, Genentech-Roche, Exelixis, Eisai, Aveo, Array, ImmunoCore, Iovance, Newlink, Surface and Cota.

The Georgetown Lombardi Cancer Center is designated by the National Cancer Institute (NCI) as a center for the fight against cancer. Part of the Georgetown University Medical Center, Georgetown Lombardi is the only comprehensive cancer center in the Washington DC area. He serves as a search engine for MedStar Health, a clinical partner of Georgetown University. Georgetown Lombardi is also a consortium recognized by the NCI with the John Theurer Cancer Center / Hackensack Meridian Health in Bergen County, New Jersey. The consortium reflects an integrated cancer research enterprise with scientists and medical researchers from both sites. Georgetown Lombardi strives to improve the diagnosis, treatment and prevention of cancer through ground-breaking basic, translational and clinical research, patient care, community education and community-based services in the Washington, DC area. Consortium member, John Theurer Cancer Center / Hackensack Meridian Health serves communities in northern New Jersey. Georgetown Lombardi is funded in part by a support grant from the National Cancer Institute Cancer Center (P30CA051008).

Connect with Georgetown Lombardi on Facebook (Facebook.com/GeorgetownLombardi) and Twitter (@LombardiCancer).

The Georgetown University Medical Center (GUMC) is a world-renowned university health and science center with four streams of research, education, patient services and care (via MedStar Health). The mission of GUMC is implemented with a strong emphasis on public service and dedication to the catholic cura personalis Jesuit principle – or "care of the whole person". The medical center includes the School of Medicine and the School of Nursing and Health, both of which are nationally clbadified; The Georgetown Lombardi Cancer Center, designated as a cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which represents the majority of externally-funded research at GUMC, including a National Institutes of Health Clinical and Translational Science Award. Connect with GUMC on Facebook (Facebook.com/GUMCUpdate), Twitter (@gumedcenter).