“I believe this is the first time this has happened in the history of cancer. ”
Writing | Ling JunSource | “Medical Community” official account< /strong>No radiotherapy, chemotherapy, no surgery, 12 patients with rectal cancer disappeared after immunotherapy and achieved clinical complete remission(CCR) , and have not reported cancer progression or recurrence for up to 2 years. A phase 2 drug clinical trial published in the New England Journal of Medicine on June 5 announced the blockbuster progress of the PD-1 inhibitor dotalizumab in the field of cancer immunotherapy . After the 6-month course of treatment, 12 patients did not require any other treatment for an average of up to one year and were undetectable by digital rectal examination or biopsy, endoscopy, PET and MRI scans tumor. “It is an oncologist’s dream to see results like this,” the researchers told the media. Another researcher said, “I believe this is the first time this has happened in the history of cancer.”Unprecedented “cancer remission”According to the New York Times, Sascha Roth, 38, of Maryland, USA, was the first cancer patient to be enrolled in the trial. In 2019, she developed rectal bleeding, and after a series of tests, she was diagnosed with stage II/III mismatch repair deficiency(dMMR) Rectal cancer. Sascha Roth was planning to undergo conventional chemotherapy, but after being recommended by a friend, she contacted the doctor of this clinical trial, who told her that dMMR rectal cancer may not be sensitive to chemotherapy. Sascha Roth was enrolled because the trial was designed to test whether dotalimumab could save patients with dMMR rectal cancer from radiation, chemotherapy and subsequent surgery. As originally planned, Sascha Roth plans to travel to New York to continue her usual care after the trial. In order to avoid the effect of radiotherapy on her reproductive function, she has even had an ovarian transposition surgery to remove the ovaries and put them back under her ribs. But in the end, the researchers told her, “You are completely tumor-free, and you don’t need any more treatment.” The results have continued to this day, with no signs of recurrence for 2 years. As lucky as Sascha Roth were 15 other participating patients. The study published in the New England Journal of Medicine showed:Response to treatment was rapid, with 81% of patients experiencing symptom resolution within 9 weeks of starting dotalimumab. At the 3-month assessment, 5 patients had complete remission on endoscopy and 2 had complete radiographic remission. Among the 12 patients who had completed 6 months of treatment, the percentage of patients in a clinical complete response was 100%. (The results of the other 4 patients will be updated later);During a median follow-up period of 1 year after the end of treatment, no patients received radiotherapy, chemotherapy and surgical resection, and none All 16 enrolled patients survived in the event of cancer progression or recurrence. In terms of safety, 16 patients reported no serious grade 3 or higher adverse events, with the most common grade 1 or 2 adverse events including rash or dermatitis(31%). ), itching(25%), fatigue and nausea(19%) . “Another surprising finding was that none of the patients had significant complications,” said Dr. Alan P. Venook, a colorectal cancer specialist at the University of California, San Francisco. Response is unheard of.”A milestone, but also a challenge“The findings may change current patients with rectal cancer The clinical diagnosis and treatment model.” Professor Li Xinxiang, director of the Second Department of Colorectal Surgery, Fudan University Affiliated Cancer Hospital, told the “medical community”. Professor Li Xinxiang introduced that for patients with advanced rectal cancer, neoadjuvant chemoradiotherapy is usually used in clinical treatment, that is, radiotherapy combined with chemotherapy to control the disease, followed by surgery. Among them, patients with dMMR rectal cancer have microsatellite instability that cannot be repaired, and the chemotherapy effect is not satisfactory. It is estimated that about 5%-10% of rectal cancer patients are dMMR, that is, a microsatellite (a DNA sequence) is unstable and cannot be repaired, However, because there is no specific treatment method in the past, special screening is not routinely performed before surgery.“In addition, the current treatment method also has a certain degree of side effects and complications, especially It is the impact on the patient’s anus.” Professor Li Xinxiang said. The study noted that side effects and complications related to the bowel and urinary system, sexual dysfunction and infertility, while some patients required permanent colostomy after proctotomy. Just in 2021, dotarizumab will be approved by the US FDA for adult patients with dMMR relapsed or advanced solid tumors, but it does not specifically target a specific cancer. “According to the results of this clinical trial, dMMR examination may be added before treatment in the future. Patients with dMMR rectal cancer can directly use immunotherapy, eliminating the need for radiotherapy, chemotherapy, or even surgery, and the quality of life will be greatly improved. This has greatly improved.”“Although the proportion of dMMR in all rectal cancers is not high, a large number of patients are also involved in the total population.” Professor Li Xinxiang said. Professor Li Xinxiang reminded, however, that the sample size of this trial is small and the follow-up time needs to be extended. If the current clinical diagnosis and treatment plan is ultimately to be changed, a larger-scale study is needed. It is estimated that the 5-year survival rate of patients with stage II/III rectal cancer can reach 50% to 80% after treatment, and it is relatively risky to stop all other treatments and switch to immunotherapy alone plan. Because of this, according to the “New York Times” report, some companies in the early stage rejected the sponsorship application for this trial. “Once the effect is not satisfactory after 6 months, it may be possible to resume conventional treatmentIt’s too late. But luckily, the researchers ended up with surprising results.“The trial results were ‘significant’ and ‘unprecedented,’ but more validation is needed. According to Dr. Kimmie Ng, a colorectal cancer specialist at Harvard Medical School. According to the FDA’s approval, dotalizumab is currently only used for replacement therapy, that is, cancer patients who have not received satisfactory results after conventional treatment. At the same time, changes in treatment options will also challenge long-term disease management models. “If we don’t have surgery, will there be a recurrence in 5, 10 years? How to conduct long-term follow-up of patients, and formulate monitoring frequency and duration? “Professor Li Xinxiang said, “Immunotherapy is a new thing, I think, the story has just begun. “In addition, the affordability of the drug also attracts attention. At present, dotalimab has not been marketed in China. Based on the dosage of this trial, it will take about 560,000 yuan to complete the half-year treatment. RMB.
References:[1]A Cancer Trial’s Unexpected Result: Remission in Every Patient, https://www.nytimes.com/2022/06/05/health/rectal-cancer-checkpoint-inhibitor.htmlthink Get more hot features?
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