NEWS DESK- For the first time in the history of cancer, tumours have disappeared from every patient involved in a drug trial. As many as 18 rectal cancer patients participated in the trial, and each of them was given the same drug.
Surprisingly, the cancer had vanished in every single patient, and was undetectable by physical examination, endoscopy, or Magnetic Resonance Imaging (MRI) scans. The study describing the results was recently published in the New England Journal of Medicine.
According to a report published by The New York Times (NYT), Dr Luis A. Diaz Jr of Memorial Sloan Kettering Cancer Center, said he knew of no other study in which a treatment completely obliterated a cancer in every patient.
“I believe this is the first time this has happened in the history of cancer,” the report quoted Dr Diaz as saying.
The trial was funded by pharmaceutical company GlaxoSmithKline. 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, and that a complete remission in every single patient is “unheard-of”.
According to the report, the rectal cancer patients had undergone gruelling treatments, such as chemotherapy, radiation and surgery that could result in bowel, urinary and sexual dysfunction. Some cancer patients even required colostomy bags, which are plastic bags that collect faecal matter from the digestive tract through an opening in the abdominal wall called stoma.
The cancer patients participated in the trial thinking that they would have to undergo the procedures again after the study was over because they did not expect their tumours to disappear.
However, they were surprised when they found that their cancer had vanished, and that no further treatment was necessary.
Dr Andrea Cercek, an oncologist at Memorial Sloan Kettering Cancer Center and a co-author on the paper, said that there were a lot of happy tears, according to the report. The paper was presented at the annual meeting of the American Society of Clinical Oncology on June 5, 2022.
Dr Venook added that another surprise was that none of the patients had clinically significant complications.
HOW THE DRUG WORKS
The patients were administered dostarlimab every three weeks for six months. The medication aimed to unmask cancer cells, allowing the body’s immune system to identify and destroy them naturally.
Such drugs, known as ‘checkpoint inhibitors’, usually have some kind of adverse reaction in 20% of patients who undergo the treatments. Nearly 60% of patients have severe complications, including muscle weakness. But no negative reaction was seen in the patients involved in the dostarlimab study.
Rectal cancer in the patients was locally advanced — tumors that had spread in the rectum and, in some cases, to the lymph nodes but not to other organs.
COST OF TREATMENT
The drug, if approved for mass use in future, is not going to come cheap as the trial doses cost $11,000 each or nearly Rs 8.55 lakh per dose.
The study found that on average, one in five patients have some sort of adverse reaction to dostarlimab, the drug the patients took. Dostarlimab is also known as a checkpoint inhibitor.
‘FURTHER TRIALS REQUIRED’
Most adverse reactions are easily managed, the report said. However, as many as three to five per cent of patients who take checkpoint inhibitors have more severe complications. In some cases, these complications can result in muscle weakness and difficulty swallowing and chewing.
According to Dr Venook, the absence of significant side effects means either they did not treat enough patients, or somehow, these cancers are just plain different, the report said.
Dr Hanna K Sanoff of the University of North Carolina’s Lineberger Comprehensive Cancer Center, who was not involved in the study, said in an editorial accompanying the paper that it is not clear if the patients are cured. She added that very little is known about the duration of time needed to find out whether a clinical complete response to dostarlimab equates to cure.
According to Dr Kimmie Ng, a colorectal cancer expert at Harvard Medical School, the results were remarkable and unprecedented, but would need to be replicated.
According to the report, the first patient to join the trial was Sascha Roth, who was 38 years of age at that time. Roth noticed some rectal bleeding for the first time in 2019, but otherwise felt fine. Her gastroenterologist, who conducted a biopsy on her tumour said it is definitely cancer. Roth said that on hearing this, she completely melted down.
Roth decided to participate in the trial, but was not expecting a complete response to dostarlimab, and had planned to move to New York for radiation, chemotherapy and possible surgery after the trial ended, according to the report. She also had her ovaries removed and put back under her ribs to preserve her fertility after the expected radiation treatment.
After the trial was complete, Dr Cercek told Roth that the researchers looked at her scans, and there is absolutely no cancer. Also, she did not need any further treatment. When Roth informed her family of this, they did not believe her, she said.
Two years after the trial, Roth still does not have a trace of cancer.