‘Astonishing’ result in drug trial: First time, cancer vanishes in every patient

It was a small trial, just 18 rectal cancer patients, all taking the same drug. But the results were astonishing. The cancer resolved in each patient, undetectable by physical examination, endoscopy, PET scans, or MRI scans.

dr. Luis A Diaz Jr of Memorial Sloan Kettering Cancer Center, an author of an article published Sunday in the New England Journal of Medicine describing the results, which was sponsored by the drug company GlaxoSmithKline, said he was not aware of any other study in which one treatment completely obliterated a cancer in every patient.

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“I believe this is the first time this has happened in the history of cancer,” said Dr. diaz.

dr. Alan P. Venook, a colorectal cancer specialist at the University of California, San Francisco, who was not involved in the study, said he also thought this was a first.

A complete remission in any patient is “unheard of,” he said.

These rectal cancer patients had undergone grueling treatments — chemotherapy, radiation and, most likely, life-changing surgeries that could lead to bowel, urinary and sexual dysfunction. Some would need colostomy bags.

They went into the study thinking they would have to undergo those procedures when it was over, because no one really expected their tumors to go away.

But they got a surprise: No further treatment was needed.

“There were many happy tears,” said Dr. Andrea Cercek, an oncologist at Memorial Sloan Kettering Cancer Center and co-author of the paper, presented Sunday at the American Society of Clinical Oncology’s annual meeting.

Another surprise, added Dr. Adding to that, none of the patients had clinically significant complications.

On average, one in five patients has some type of side effect to drugs the patients were taking, dostarlimab, also known as checkpoint inhibitors. The drug was given every three weeks for six months and cost about $11,000 per dose. It unmasks cancer cells, allowing the immune system to identify and destroy them.

While most side effects are easily treatable, as many as 3 to 5 percent of patients taking checkpoint inhibitors have more serious complications, in some cases leading to muscle weakness and difficulty swallowing and chewing.

The absence of significant side effects, said Dr. Venook, means “either they haven’t treated enough patients, or somehow these cancers are just different.”

In an editorial accompanying the paper, Dr. Hanna K Sanoff of the University of North Carolina’s Lineberger Comprehensive Cancer Center, who was not involved in the study, called it “small but compelling.” However, she added that it is not clear whether the patients have been cured.

“Very little is known about the length of time it takes to find out whether a clinically complete response to dostarlimab equates to a cure,” said Dr. Sanoff.

dr. Kimmie Ng, a colorectal cancer expert at Harvard Medical School, said that while the results were “remarkable” and “unprecedented,” they needed to be replicated.

The inspiration for rectal cancer research came from a clinical trial that Dr. Diaz in 2017 and which funded Merck, the drugmaker. It involved 86 people with metastatic cancer that had developed in different parts of their bodies. But the cancers all shared a gene mutation that prevented cells from repairing damage to DNA. These mutations occur in 4 percent of all cancer patients.

The patients in that study took a Merck checkpoint inhibitor, pembrolizumab, for up to two years. Tumors shrank or stabilized in about a third to half of the patients, and they lived longer. Tumors disappeared in 10 percent of the study participants.

That led Dr. Cercek and Dr. Diaz to wonder: What would happen if the drug was used much earlier in the course of the disease, before the cancer could spread?

A small biotechnology company, Tesaro, agreed to sponsor their research. Tesaro was bought by GlaxoSmithKline.

Their first patient was Sascha Roth, who was 38 in 2019.

After discovering cancer, she was due to receive chemotherapy at Georgetown University, but a friend had insisted she see Dr. Philip Paty for the first time at Memorial Sloan Kettering. dr. Paty told her he was almost certain her cancer contained the mutation that made it unlikely that she would respond well to chemotherapy. Roth was eligible to participate in the clinical trial. If she had started chemotherapy, she wouldn’t have been.

After the trial, Dr. Cercek told her the news. “We’ve looked at your scans,” she said. “There is absolutely no cancer.” She needed no further treatment.

“I told my family,” said Mrs. Roth. “They didn’t believe me.” But two years later she still doesn’t

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