Small rectal cancer drug testing sees the tumor disappear in 100 percent of patients

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A small drug test is having a seismic effect in the oncology world: after six months of experimental treatment, all 14 patients diagnosed with early stage of rectal cancer had no tumors, which were completed before the study was published.

Researchers in the field of colorectal cancer see the study, published Sunday in the New England Journal of Medicine, as an innovative development that could lead to new treatments for other cancers.

Andrea Sercek, an oncologist at the Memorial Sloan Kettering Cancer Center in New York and co-author of the study, said: “I don’t think anyone has seen this before, when every patient has a tumor that has disappeared.

All patients have the same genetic predisposition to rectal cancer and have not yet been treated. Each was given nine doses of dostarlimab intravenously, a relatively new drug designed to block a specific protein in a cancer cell, and when it is expressed, the immune system can stop the cancer-fighting reaction.

Six months later, instead of scanning for nodular, discolored tumors, a smooth, pink tissue was found. Scanning, biopsy or physical examination showed no signs of cancer.

“A total of 14 patients? The chances are very low and unprecedented in oncology, ”said Cherchek.

The results were so successful that none of the 14 patients who completed the trial needed routine follow-up with chemotherapy or surgery, and none had significant drug complications. Four more patients in the test are still showing the same treatment, but so far the results are promising.

Sasha Roth, the first patient to enter the experimental study in late 2019, said she knows with her own eyes how big the deal is, but since the news came out on Sunday, she and her family have begun to understand. the biggest impact.

“My cousin in Brussels said he was in the newspaper there,” Roth said Tuesday. “It’s affecting everyone.”

The results show a promising option for the treatment of rectal cancer, which can often change the lives of patients.

Although rectal cancer can survive treatment in its early stages, the most effective traditional treatments of radiation, chemotherapy, and surgery can also leave patients with persistent bowel and bladder, sexual dysfunction, and infertility. For young women, treatment can cause scarring of the uterus and prevent pregnancy; Other patients with low-grade rectal tumors should use the colostomy sac permanently after surgery.

There are caveats in the study: the sample size of the patients was small, although they varied in age, race, and ethnicity. The earliest patients in the test are assured that the tumors will not recur or metastasize elsewhere for several years. The results also apply only to those with certain abnormalities in colorectal cancer, known as malformations, which prevent the cells from dividing to normalize the body’s function or “correct” the anomalies and instead lead to mutations. Deficiency occurs in approximately 5-10 percent of all colorectal cancer patients who are resistant to chemotherapy.

“Are we, of course, asking, ‘Is this drug for me?’ We are seeing an influx of people calling. “Cherchek said, ‘Oh my God, they’ve got cancer, now look at them.’ It’s a very emotional reaction.”

U.S. Food and Drug Administration Commissioner Scott Gottlieb elaborated on the steps the U.S. government is taking to approve new and innovative drugs, therapies, and clinical trials for cancer. (Video: Washington Post Live)

David Ryan, director of clinical oncology at Massachusetts General Hospital, said the results change the game for cancer patients with a lack of proper correction. The study was sponsored by the biotechnology company Tesaro – which GlaxoSmithKline purchased in 2019 when the first patient began treatment.

“It’s a very big deal,” said Ryan, who was not involved in the study. “It’s hard not to think about it for the next patient who walks in the door:‘ Do I need chemotherapy and radiation or do I need this immunotherapy? ”

Ryan said the trial participants will continue to be closely monitored by a team of experts who will monitor the recurrence or spread of the tumor and will intervene with immediate treatment if necessary. According to him, the need may be a problem for patients who do not live close to the place where they can easily and regularly access the help of specialists.

“If there are recurrences, we are concerned that they should be taken away as soon as possible to give people the best chance,” he said.

However, Ryan and Cherchek separately suggested that tests with other types of tumors, such as pancreatic, gastric, or bladder problems, could be effectively treated with the same drug as Serchek’s study.

For Ryan, the study also reinforces the importance of knowing the corrective status of cancer patients.

“We always knew about it, but we didn’t know that these types of tumors had a bandit reaction to immunotherapy and that the tumors would dissolve like fat,” he said.

Cercek presented the paper at the annual meeting of the American Society of Clinical Oncology in Chicago on Sunday. He had not finished his 10-minute presentation when the audience burst into applause. Bold, white, underlined letters appeared on the blue screen, and the main conclusion of his study was: “The first 14 consecutive patients responded 100% CLINICALLY FULLY.”

Simply put, it was like scattering football after a touch.

Roth, now 41, also feels victorious. He described his visit to the trial as “surprising”.

“All the stars come together in a wonderful way, which allowed me to do this test,” he said. “If I did an infusion of chemotherapy, it would disqualify me.”

Roth, who lives in Bethesda (Md.) And runs a furniture store, was diagnosed in September 2019 at the age of 38. He suffered from rectal bleeding and was exposed to anti-inflammatory drugs, including occasional cycling and soccer, as a result of his active lifestyle.

“I thought they would tell me I was allergic to gluten,” Roth said. “I wasn’t expecting a cancer diagnosis.”

He talked to a friend who had colorectal cancer a year and a half ago and advised him: the Sloan Kettering Memorial or the bust. Three days before he began chemotherapy in the Washington area, he met with an MSK doctor and recalled that he had “thrown a gun” in the examination room.

“First, you are not a candidate for surgery because of the location of the cancer,” he said, adding that chemotherapy – usually standard treatment – would not be an effective option given his cancer status.

The doctor believed he was a “Lynch” patient or a person with hereditary cancer syndrome associated with anomalies. Roth’s doctor introduced him to Cercek, and he soon became the first patient on the test.

Roth had to wait another two months for FDA approval before starting experimental treatment.

“I think I’m getting crazy with my eyes widening every day,” she said, fearing her cancer could escalate from stage 3 to stage 4 while waiting. “But I assured him that the cancer would not grow overnight.”

Roth was closely monitored to ensure that he was safe to wait for treatment and leave it in court. He started experimental therapy in December 2019. After his first infusion, he said he went on vacation to Florida and felt no side effects. He even ran.

By the time he was halfway through the trial, Roth’s tumor was noticeably smaller. At the age of six months, when Roth underwent chemotherapy, Cercek called him on Friday night and told him to cancel his move to New York. Researchers were going to adjust the court; Chemotherapy – along with radiation or surgery – would be unnecessary now, at least for now.

Roth’s family jokes that he is a living example of a medical miracle, the “one-horned horn.” Roth’s feelings are for doctors and nurses, and for those who urge her to defend herself and seek a second opinion.

He is also grateful for the scientific advances that have been made in the family, given the prevalence of cancer. Roth’s father died of brain cancer in 1999, and her mother is currently battling cancer “in the last days of her life.” Thanks to field innovations, he is optimistic about his future.

“I feel a general sense of gratitude, but I also hope for others,” he said. “Hope for all cancers.”

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