A small clinical trial of seismic impact on the world of oncology: After six months of experimental treatment, tumors disappeared in all 14 patients who participated in the study to date of publication.
Researchers in the field of colorectal cancer shed light on a study published Sunday in the scientific journal New England Journal of MedicineAn important discovery that could pave the way for new treatments for other types of cancer.
Andrea Sersek, an oncologist and lead author of the study at the Memorial Sloan Kettering Cancer Center in New York, says, “I don’t think anyone has seen this before, where every patient has seen the tumor disappear.”
With all patients Rectal cancer Shared similar genetic instability and have not yet been treated. Each received nine doses of intravenous dostarlimab, a relatively recent drug designed to block specific cancer cell proteins, which, when expressed, can inhibit the immune system’s response to fight cancer.
Six months later, the scan showed a smooth, deformed tumor, rather than a once-smooth, pink tissue. Examination, biopsy or physical examination showed no signs of cancer.
“All 14 patients? The chances are very low in oncology and not really heard, “says Andrea Cersack.
“It’s affecting everyone”
The results were so successful that none of the 14 patients who completed the clinical trial required further planned treatment of chemo and radiation or surgery. Also no patients had any significant complications after taking the drug. The other four patients in the clinical trial are still undergoing treatment, but so far the same promising results have been seen.
Sascha Roth, the first patient to enter the experimental study in late 2019, knows for herself how important the results are, but she says that since the news broke on Sunday, she and her family have come to understand the widespread impact of the study.
“My cousin in Brussels told me it was in the newspaper,” he explains. Sasha Roth. “It’s affecting everyone.”
The results suggest a promising option in the treatment of rectal cancer, which can have life-threatening consequences for patients.
Although the survival rate is higher when treating rectal cancer at an early stage, more effective traditional treatments such as radiation, chemotherapy, and surgery can leave patients with permanent bowel and bladder dysfunction, sexual dysfunction, and infertility. For young women, the treatment can stain the uterus, making it impossible for them to conceive; Depending on the location of the rectal tumor, other patients may need to have a permanent colostomy bag inserted after surgery.
But there are some caveats in the study: the size of the patient’s sample, while varying in age and ethnicity, was small. And even the first patients who participated in the clinical trial have been monitored for several years to ensure that the tumor did not recur or metastasize elsewhere in the body. The results are also relevant only to those who have a specific rectal cancer abnormality that is related to a deficiency in the DNA repair system, which prevents the body from normalizing or “repairing” the abnormality when cells divide and mutate instead. This lesion occurs in 5 to 10% of all rectal cancer patients and they resist chemotherapy.
“We are definitely watching the flow of people and asking: ‘Is this medicine good for me?'” Cerseck highlights. “It’s a very emotional reaction, ‘Oh my God, they had cancer and now look at them.'”
“This treatment melts the lumps like butter.”
David Ryan, director of clinical oncology at Massachusetts General Hospital, notes that the consequences are serious for cancer patients who have specific anomalies. The study was sponsored by biotechnology company Tesaro – which was acquired by GlaxoSmithKline in 2019 when the first patient began treatment.
“It’s very important,” says Ryan, who was not involved in the study. “It will be very difficult for the next patient walking through the door not to consider this option: ‘Should I take chemotherapy and radiation or should I take this immunotherapy?'”
Ryan noted that the clinical trials will be closely monitored by a team of experts who will be able to monitor the possible recurrence of tumors or their spread, and will intervene in treatment quickly if necessary. Oncologists also point out that patients who do not live close to a place where they can easily and regularly access specialist health care can be challenged.
“We’re concerned that if there is a recurrence, people should be caught as soon as possible to give them a better chance,” he added.
But Ryan and Cersack agree that the results of clinical trials increase the likelihood of abnormalities in the DNA repair system in other types of tumors, such as the pancreas, stomach or bladder, which can be effectively treated with the same drug. Cercek practice.
For Ryan, the study also emphasizes the importance of knowing the medical condition and type of tumor in cancer patients. “We’ve always known this, but we didn’t know it was the type of tumor that responds most effectively to immunotherapy, and with this treatment the tumor melts like butter,” he says.
“All stars are aligned”
Sersek presented the paper Sunday at the annual meeting of the American Society for Clinical Oncology in Chicago. Her ten-minute presentation was not even complete when the room started clapping. The appearance of bold, white, underlined letters on the blue screen caused the audience to sigh and burst into tears: “100% complete clinical response in the first 14 patients in a row.” To the common man, it was worth making Touchdown.
Sasha Roth, now 41, seems equally victorious. During clinical teaching, the woman described her passage as “strange.” “All the stars were aligned in a precise way that allowed me to take part in this clinical trial,” he explains. “If I had received the chemotherapy infusion, it would have disqualified me.”
Roth, who lives in Bethesda, Maryland and owns a furniture store, was diagnosed in September 2019, when he was 38 years old. He had some rectal bleeding and his active lifestyle was to blame for the anti-inflammatory drugs he was taking, including occasional bicycle accidents and collisions in football.
“I thought I’d be told I had a gluten allergy,” says Roth. “I was definitely not expecting a cancer diagnosis.”
The woman spoke to a friend who was diagnosed with colorectal cancer a year and a half ago, who advised her: Memorial Sloan Kettering Cancer Center. Three days before the start of chemotherapy in the Washington area, he met doctors at the Memorial Sloan Kettering Cancer Center, who recalls “throwing his gloves to the ground” in the examination room.
He said, “First of all, she is not a candidate for surgery because of the location of the cancer,” and also advised that chemotherapy – the usual treatment – was not an effective option because she had cancer. Abnormalities that oppose this treatment.
Doctors were almost certain that Roth would be a patient of Lynch syndrome or a genetic cancer syndrome associated with the disorder. Roth’s doctors introduced her to CERSEC and she quickly became the first patient in a clinical trial.
Gratitude and hope
Sasha Roth will have to wait another two months for approval from the US Food and Drug Administration (FDA) before starting experimental treatment.
The patient remembers that she feared that her cancer could progress from stage 3 to stage 4 during this waiting period. “But they assured me that cancer doesn’t grow overnight.”
Sasha Roth was closely monitored to make sure it was safe to wait for treatment and keep her in a clinical trial. He started experimental therapy in December 2019. After his first infusion, he went on vacation to Florida and stated that he did not experience any side effects. Just kept walking.
Halfway through the clinical trial, Roth’s tumor was clearly reduced. Six months later, when Roth was switching to chemotherapy, he received a phone call from Cersack on Friday night asking him to cancel his trip to New York. Investigators will adjust clinical trials; Chemotherapy, including radiation therapy or surgery, will no longer be necessary, at least for now.
Roth’s family jokes that she is a “unicorn”, a living example of a medical miracle. Roth is grateful – for the doctors and nurses and for encouraging her to take a second opinion.
Roth is grateful for the scientific progress that has been made in her family, given the prevalence of cancer. Roth’s father died in 1999 of a brain tumor, and his mother is currently battling cancer “in the last days of her life.” Thanks to innovations in the field, she feels optimistic about her own future.
“I feel a universal sense of gratitude – but hope for others,” he says. “Hope for all cancers.”
Public Exclusive / Washington Post