Shut out for decades, veterans slowly gaining access to innovative cancer treatments

WEST HAVEN, Conn. — Veterans have less access to cutting-edge cancer treatments today than at any point in recent history, but a new initiative aims to change that.

A major cancer research group is seeking to enroll veterans in clinical trials of experimental therapies. The initiative is in its early stages, and so far only patients with lung cancer can participate.

But for veterans like Jerry Valentino, it’s already having a significant effect.

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Valentino was an Army staff sergeant at the massive Cam Ranh Bay military base in Vietnam, managing supplies and ammunition, and surviving, among other moments, a massive rocket attack by North Vietnamese troops during the Tet Offensive in early 1968.

Now 69 years old and a retired cabinetmaker in Waterbury, Conn., Valentino last year suddenly found himself unable to control his left hand and leg. The diagnosis was grim: The squamous-cell lung cancer doctors had identified the previous year had spread to his brain.

“One of those little cancer cells flew the coop,” he said.

Valentino’s first-line treatment failed to stop the cancer. In most Veteran’s Administration hospitals, he’d have moved on to a second-line chemotherapy protocol that typically helps less than the first.

Valentino’s doctors at the VA hospital in West Haven, Conn., however, had more promising options. They’d recently signed onto one of the country’s most ambitious and innovative cancer trials, known as Lung-MAP.

Lung-MAP, which is being conducted at roughly 730 treatment centers in the US, is unusual in that it’s multiple trials in one. Most trials test a single drug, but Lung-MAP is comparing five.

Three groups are being treated with drugs from the revolutionary, and much-hyped, realm of precision medicine. Doctors test the DNA of a patient’s cancer to find mutant genes that act as the cancer’s control switch, and deliver a drug that snaps the switch to the “off” position. Two other groups are being treated with immunotherapy drugs, which aim to unleash a patient’s own immune cells against a tumor.

Only a minority of patients respond to precision medicine, but when they do, the results can be dramatic. Precision cancer drugs have been known to erase tumors in weeks, and since these drugs don’t kill cells indiscriminately like chemo, many patients experience few side effects.

There’s a major downside: With a few exceptions, precision cancer drugs generally lose effect in less than a year, as other mutations emerge in a patient’s tumor.

Which is why trials like Lung-MAP are critical to both patients and researchers.

Scientists are rapidly identifying new genetic mutations that could drive malignancies, and drug makers are almost as quickly developing treatments to potentially disable the mutations.

It’d be easy enough to test those drugs if, say, dozens of squamous-cell lung cancer patients with a mutation in the FGFR gene lived in a particular place. But oncologists still don’t widely recommend genetic testing of their patients’ malignancies, and some of the mutations are themselves rare. So researchers can struggle to fill a drug trial for a particular set of patients.

One-quarter of new drug trials shut down because they can’t attract enough patients.

Enter the US Department of Veterans Affairs. In sharp contrast to the patchwork of alliances at the nation’s 5,000 non-military hospitals, the VA includes 152 hospitals and 1,400 clinics that serve 55,000 cancer patients — all with electronic health records that can be searched from any location.

In theory, for VA-affiliated researchers, finding candidates for a new trial could be as simple as searching the organization’s database.

Steven G. Smith for STATValentino’s treatment includes a once-daily medication.

A shift back to cancer research

That idyllic scenario is still years away, however, because the VA has only recently begun shifting its attention back to cancer research. Just 20 years ago, most VA hospitals participated in cancer trials. Now, a small minority conduct such research. The reasons for that shift were partly bureaucratic, partly financial, and partly medical.

Bureaucratically, the VA got left behind when in 2001, the National Cancer Trials Network, which oversees all five cancer research groups, changed the way it regulated the ethics and safety of human experiments. The network created a single panel to review submissions; the VA balked because of concerns about veterans’ privacy, among other things.

Financially, because most VAs are affiliated with universities, they’ve suffered from cuts in university research funding in recent decades. With less funding, VA doctors couldn’t hire assistants to help enroll patients in trials.

“The VA is so busy,” Dr. Charles Blanke said, “the last thing physicians had time to do was sit and explain a clinical trial for a half hour.”

And medically, veterans can pose challenges to cancer researchers. VA oncologists acknowledge that their patients often have many “co-morbidities” — like liver damage from substance abuse, or psychological disorders from wartime trauma — that in recent decades have made it harder to qualify for trials. Patients who lack such co-morbidities tend to respond better to experimental treatments, so drug makers favor those patients for trials.

“We’re not offering our veterans the best possible cancer treatment, that’s the bottom line, and that’s completely unfair to them,” said Blanke, an oncologist at Oregon Health & Science University and chairman of SWOG, one of five major cancer research consortiums in the US funded by the National Cancer Institute.

Steven G. Smith for STATValentino is part of an innovative lung cancer trial called Lung-MAP.

‘Each day I’m improving’

Blanke aims to change that. Before becoming chairman of SWOG three years ago, he worked for years in VA hospitals. Among his top priorities in his new role: “Get veterans back on trials.”

“It’s good for research, and we’re hoping it benefits our veterans as well,” he said.

That push is already bearing some fruit. Late last year, SWOG collaborated with a research-intensive group of VA hospitals headquartered in Massachusetts to open membership to VAs with no university affiliation.

It also arranged small grants for five other VA locations to hire research assistants, and created a research coordinator position to help VA hospitals open cancer trials. Meanwhile, the VA headquarters is in the process of adapting to the National Cancer Trials Network’s ethical review process.

Jerry Valentino is one of the first vets to benefit from the changes. As part of the Lung-MAP trial at the West Haven VA, a gray monolith rising over Interstate 95 in coastal Connecticut, he gets a bottle of 21 reddish capsules to bring home with him. He takes one capsule every morning with breakfast.

“So far I haven’t noticed any side effects,” he said. “And I don’t have to sit in a chair for three and a half hours getting chemo.” It’s a trial he wouldn’t have had access to before the West Haven VA joined SWOG.

SWOG plans to give grants to another five VA hospitals this year. Such an incremental approach won’t soon change the face of cancer research for veterans, but Blanke said that if the early group of VAs can show success, institutions might continue the programs with their own funding.

The fate of veterans like Valentino may rest on that possibility. After his initial three weeks round of daily treatments, he said he noticed the difference.

“This is a great opportunity for me,” he said. “Each day I’m improving.”


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