A small clinical trial has made a huge difference in the oncology world: After six months of an experimental treatment, all 14 patients who participated in the study with a diagnosis of early-stage rectal cancer had their tumors gone by the date of publication.
Researchers in the field of colorectal cancer highlighted the study, which was published in the journal Science on Sunday New England Journal of Medicinea groundbreaking discovery that could pave the way for new treatments for other types of cancer.
“I don’t think anyone has seen this before, where every patient sees the tumor disappear,” said Andrea Cercek, an oncologist at Memorial Sloan Kettering Cancer Center in New York and the study’s lead author.
Very proud of our research published in @NEJM100% clinical complete remission in locally advanced patients with mismatch repair deficiency treated with dostarlimab alone #rectal cancer. No radiation or surgery! @ASCO #ASCO22 @MSK Cancer Center https://t.co/sZypoHBtj7
— Andrea Cercek (@AndreaCercek) June 5, 2022
all suffering from rectal cancer Has the same genetic instability and has not been treated. Each received nine intravenous doses of dostarlimab, a relatively new drug designed to block a specific cancer cell protein that, when expressed, causes the immune system to suppress its response to fight cancer.
Six months later, scans that once showed a lumpy, discolored tumor showed smooth pink tissue. No trace of cancer was found on examination, biopsy or physical examination.
“All 14 patients? The odds are extremely low, unheard of in oncology,” said Andrea Cercek.
“It impresses everyone”
The results were so successful that none of the 14 patients who completed the clinical trial required their next planned chemotherapy and radiation therapy or surgery. No patients experienced significant complications after taking the drug. Four other patients in the clinical trial are still being treated but have shown equally promising results so far.
Sascha Roth, the first patient to enter the experimental study in late 2019, knew firsthand the importance of the results, but said she and her family have begun to understand the study’s wider impact since the news broke Sunday. .
“My cousin from Brussels said it was in the newspapers there,” he explained. Sasha Ross. “It impresses everyone.”
The results point to promising options for treating rectal cancer, which often leaves patients with life-threatening sequelae.
Although rectal cancer has a high survival rate when treated early, more effective traditional treatments such as radiation, chemotherapy and surgery can also leave patients with permanent bowel and bladder dysfunction, sexual dysfunction and infertility. For younger women, this treatment can scar the uterus, making it impossible for them to become pregnant; other patients may also need to wear a colostomy bag permanently after surgery, depending on the location of the rectal tumor.
But the study had some caveats: The sample size of patients, which varied in age and race, was small. And even for the first patients to participate in clinical trials, they have a few years of observation to make sure the tumor doesn’t recur or metastasize to other parts of the body. The results also apply only to those with a specific rectal cancer abnormality that corresponds to a defect in the DNA repair machinery that prevents the body from normalizing or “repairing” the abnormality when cells divide, instead causing mutations. This abnormality occurs in about 5% to 10% of all rectal cancer patients and tends to be resistant to chemotherapy.
“We’re definitely going to see a lot of people calling and asking, ‘Will this drug be good for me?'” Cercek emphasized. “It was a very emotional response, ‘Oh my God, they have cancer, look at them now.'”
“With this treatment, the tumor melts like butter”
The results are critical for cancer patients with this specific abnormality, noted David Ryan, director of clinical oncology at Massachusetts General Hospital. The study was sponsored by biotech company Tesaro, which was acquired by GlaxoSmithKline in 2019 when the first patient started treatment.
“It’s very important,” said Ryan, who was not involved in the study. “It’s hard for the next patient to walk in the door without thinking about the choice: ‘Should I get chemotherapy and radiation or should I get this immunotherapy?'”
Rectal cancer disappeared in all patients enrolled in the clinical immunotherapy study. https://t.co/ztO9qd2n26 via @MSK Cancer Center pic.twitter.com/M3sSbojrE9
— Enrique Coperías (@CienciaDelCope) June 7, 2022
Ryan noted that participants in clinical trials will continue to be closely monitored by a team of experts who will be able to watch for possible tumor recurrence or spread and intervene quickly if necessary. The oncologist also explained that patients who do not live near places with easy and regular access to specialist healthcare may face challenges.
“We are concerned that if a repeat offense occurs, it must be detected as soon as possible to give people a better chance,” he added.
But Ryan and Cercek agree that the results of the clinical trials raise the possibility that anyone with abnormalities in DNA repair mechanisms in other types of tumors, such as pancreatic, gastric or bladder tumors, could be effectively treated with the same drugs that are used to treat them. Secek Research.
For Ryan, the study also underscores the importance of cancer patients understanding their clinical status and tumor type. “We’ve always known this, but we didn’t know that these are the types of tumors that respond effectively to immunotherapy, where tumors melt like butter,” he said.
“All the stars are aligned”
Cercek presented the paper Sunday at the annual meeting of the American Society of Clinical Oncology in Chicago. She hadn’t even finished her ten-minute speech when the applause started in the room.Viewers filled with sighs and tears as the bold, white, underlined letters appeared on the blue screen, the key finding of their study: “The first 14 consecutive patients achieved a 100% clinical response.” In layman’s terms , which is like making a ground.
Sasha Ross, 41, is similarly triumphant. The woman described her path in clinical teaching as “bizarre”. “All the stars are lined up in a perfect way to allow me to participate in this clinical trial,” he explained. “If I had a chemotherapy infusion, that would disqualify me.”
A well-deserved applause to Dr. @AndreaCercek and the GI Onc team @MSK Cancer Center . Yes, you read well: 100% cCCR in pts w/ MSI-H/ dMMR LA rectal cancer w/ IO. This could mean no CT, RT or surgery! This is a game changer for our patients! pic.twitter.com/oLPD36TsfW
— Alan Burguete-Torres, MD (@dralanburguete) June 5, 2022
Ross, who lives in Bethesda, Maryland, and owns a furniture store, was diagnosed in September 2019, when he was 38. He had some rectal bleeding and blamed it on anti-inflammatory drugs he was taking as a result of his active lifestyle, which included an occasional bike accident and hitting a football.
“I thought I was going to be told I was allergic to gluten,” Ross said. “I definitely didn’t expect to be diagnosed with cancer.”
The woman spoke to a friend who was diagnosed with colorectal cancer a year and a half ago and who advised her: Memorial Sloan Kettering Cancer Center. Three days before chemotherapy began in the Washington area, he met with a doctor at Memorial Sloan Kettering Cancer Center, where he recalled “throwing gloves on the floor” in the exam room.
“He said, ‘First of all, she’s not a candidate for surgery because of the location of the cancer,'” and also suggested that chemotherapy — conventional treatment — wouldn’t be an effective option because she had cancer that tended to resist this treatment. abnormal.
Doctors were almost certain that Ross would be a patient with Lynch syndrome, or a hereditary cancer syndrome associated with the abnormality. Roth’s doctor introduced her to Cercek, and she soon became the first patient in the clinical trial.
With the right molecular signals, cancer drugs can work in every patient https://t.co/BF6R51Gfcc via @statnews @AndreaCercek #ASCO22
— Memorial Sloan Kettering Cancer Center (@MSKCancerCenter) June 5, 2022
thanks and hope
Sasha Ross will have to wait another two months for approval from the U.S. drug regulator, the Food and Drug Administration (FDA), before starting the experimental treatment.
The patient recalled that she was concerned that her cancer might progress from stage 3 to stage 4 during this waiting period. “But they assured me that the cancer doesn’t grow in a day.”
Sasha Rose is closely monitored to ensure it is safe to wait for treatment and allow her to continue clinical trials. He started the experimental treatment in December 2019. After the first infusion, he went on vacation to Florida and said there were no side effects. It even kept running.
Halfway through the clinical trial, Rose’s tumor had shrunk significantly. Six months later, while Ross was undergoing chemotherapy, he got a call from Secek on Friday night, telling him to cancel plans to move to New York. Researchers will adjust clinical trials; chemotherapy — along with radiation or surgery — will no longer be necessary, at least for now.
Rose’s family joked that she was a “unicorn,” a living example of medical miracles. What Rose felt was gratitude—thanks to the doctors and nurses, to those who encouraged her to seek a second opinion.
Given the prevalence of cancer in her family, Rose is also grateful for scientific advances. Rose’s father died of a brain tumor in 1999, and his mother is currently in the “last days of her life” battling cancer. She is optimistic about her future due to innovations in the field.
“I feel a general sense of gratitude — but also hope for others,” he said. “Hope all cancers.”
Public Exclusive/Washington Post
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