In December 2017, the National Cancer
Institute (NCI) announced that preliminary results from an NCI-sponsored
phase I clinical trial showed it can
be safe to treat HIV-positive cancer
patients with the immunotherapy drug
The NCI’s HIV and AIDS Malignancy
Branch and the Cancer Immunotherapy
Trials Network launched the trial in
2016 at 10 medical centers in California,
Connecticut, Louisiana, Maryland, New
York and Washington state. The trial
is enrolling HIV-positive patients with
recurrent non-small cell lung cancer,
melanoma and Hodgkin lymphoma. It
is also open to HIV-positive patients
with other types of cancers that are not
responding to standard treatments.
The trial aligns with ongoing efforts
by the American Society of Clinical
Oncology, Friends of Cancer Research
and the U.S. Food and Drug Administration
(FDA) to include more patients in clinical
trials who are HIV-positive or have stable
brain metastases, kidney problems or more
than one type of cancer.
Keytruda is approved by the FDA for
treating metastatic non-small cell lung
cancer, advanced melanoma, head and neck
squamous cell cancer, Hodgkin lymphoma,
microsatellite instability-high cancers,
advanced stomach cancer and advanced
bladder and other urothelial cancers.
Like some other immunotherapies,
Keytruda works by getting the body’s
immune system to see and target cancer
cells. In some patients, these drugs have
been found to also stimulate immune
cells to attack healthy cells and organs.
Because the HIV virus disrupts the
immune system, doctors were unsure
of the risks of using an immunotherapy
to treat cancers in these patients.
The preliminary clinical trial results,
which included data on the initial 17 patients
enrolled in the study, showed the drug
was safe. There are now about 40 patients
enrolled in the study. All have HIV infec-
tion that is controlled by HIV medications.
Patients are being monitored closely for
side effects while the drug’s effectiveness
is being evaluated.
People need to be aware of “the potential for drug interactions and overlapping
toxicities” of cancer therapies and HIV
treatments, says Erin Reid, a hematologist
at the UC San Diego Moores Cancer Center
in California who specializes in treating
people with HIV.
An estimated 1. 1 million HIV-positive
people are living in the U.S. In a 2015
study that used cancer rates from 2010,
researchers estimated about 7,760 HIV-positive individuals also had received a
Lack of access to clinical trials is not the
only problem HIV-positive patients face.
“The disparity in cancer care is large and
significant,” says Gita Suneja, a radiation
oncologist at the Duke Cancer Institute in
Durham, North Carolina. Up to 30 percent
of HIV-positive people with cancer receive
no cancer treatment. In contrast, about
10 percent of HIV-negative people with
cancer do not receive any treatment.
In February 2018, the National
Comprehensive Cancer Network (NCCN)
released new clinical practice guidelines
on cancer care for people living with
HIV. The guidelines emphasize that most
HIV-positive cancer patients should be
offered the same cancer therapies as
Reid, who along with Suneja co-chaired
the NCCN panel that developed the new
guidelines, suggests that “funding and
regulatory agencies can help” get more
HIV-positive patients into clinical trials by
encouraging cancer researchers to work
with HIV experts as they develop and
design new studies. “This will open up
trials that otherwise would have unnecessarily excluded people living with HIV,”
she says. —ANDY KOPSA
Opening Clinical Trials to
HIV-Positive Cancer Patients
INCLUSION IS PART OF LARGER EFFORT TO BROADEN
CLINICAL TRIAL ELIGIBILITY
Cancer is a leading cause of death for people living with HIV—yet being HIV-positive is often a barrier to enrollment in a cancer clinical trial. Now, efforts are underway to both
remove this hurdle and study cancer drugs in trials specifically for
people living with HIV.
When patients begin receiving immunotherapy, tumors may shrink slowly or get
larger—even when the treatment will ultimately be effective. For that reason, initial
scans may not provide an accurate assessment of whether the drug is working. A study
of 28 patients with non-small cell lung cancer found that a blood test that analyzed
circulating tumor DNA was an early indicator of treatment response and survival,
suggesting it could be used along with standard imaging to gauge treatment response.
LEARN MORE IN THE APRIL 15, 2018, CLINICAL CANCER RESEARCH.
A Blood Test to Assess Lung Cancer Response to Immunotherapy