Tumour vanishes in all 12 rectal cancer patients in rare medical trial result
New Delhi, Jun 8: A group of 12 rectal cancer patients showed no signs of a tumour after taking an antibody drug for six months, according to a surprise finding from an ongoing medical trial in the US that experts termed optimistic.
Besides their tumours disappearing completely, none of the participants reported any severe side-effects either, says the research paper published in the New England Journal of Medicine recently.
The patients underwent a series of medical exams -- physical, endoscopy, bioscopy, PET scans and MRI scans -- and none of the reports showed a tumour.
All 12 patients had a clinical complete response, with no evidence of tumour on magnetic resonance imaging, the authors of the study said.
Longer follow-up is needed to assess the duration of response, they added.
The researchers set out to find whether dostarlimab, an antibody drug, followed by standard chemoradiotherapy and standard surgery is an effective treatment for advanced deficient MisMatch Repair' (dMMR) solid tumours.
MisMatch repair (MMR) deficient cells usually have many DNA mutations that lead to cancer. MMR deficiency is most common in colorectal cancer, other types of gastrointestinal cancer, and endometrial cancer, the Journal said.
Participants of the trial conducted at the Memorial Sloan Kettering Cancer Center in New York with mismatch repair-deficient stage II or III rectal adenocarcinoma were given the drug every three weeks for six months.
Adenocarcinoma is a type of cancer that develops in the glands that line our organs.
According to the initial plan, the treatment was to be followed by standard chemotherapy and surgery, and patients who had a clinical complete response would proceed without both.
After at least six months of follow-up, all 12 patients showed a clinical complete response with no signs of the tumour.
These results are cause for great optimism yet these are early days for the trial as well as for the patients who wish to embark on this treatment. This approach cannot supplant current curative multimodality treatment approach, said Dr. Nikhil S Ghadyalpatil, senior consultant, medical oncologist and hemato-oncologist at Hyderabad's Yashoda Hospitals.
Clinical complete response as an end point used in this study is an imperfect surrogate for long term cure and hence should be interpreted cautiously. We need larger placebo controlled studies with longer follow up in this setting to confidently consider using this approach in routine practice, Ghadyalpatil told PTI.
The treatment, the oncologist said, surely provides an early glimpse of a revolutionary approach in rectal cancer patients and authors of this study should be congratulated for this effort.
There have been no similar trials in India so far, he added.
Another similar international study with the drug pembrolizumab showed only 70 per cent patients had long term response at three years unlike 100 per cent response in the current study, he added.
Ghadyalpatil said pembrolizumab is available in India but dostarlimab used in the current study is not.
The cost of dostarlimab is not known in India but is expected to be a couple of lakhs per dose, he added.
Commenting on the trial, Dr. Hannah K. Sanoff of the North Carolina Cancer Hospital, said the results are optimistic but the treatment procedure used in the study cannot replace the current curative treatment approach.
Patients who have a clinical complete response after chemotherapy and radiation therapy have a better prognosis than those who do not have a clinical complete response, yet cancer regrowth occurs in 20 to 30 per cent of such patients when the cancer is managed nonoperatively, she wrote in an editorial on the trial.
Whether the results of this small study will be generalisable to a broader population of patients with rectal cancer is also not known, Sanoff said in the editorial printed in the New England Journal of Medicine.
She added that in order to provide further information on patients who might benefit from immunotherapy, subsequent trials should aim for heterogeneity in age, coexisting conditions, and tumour bulk .
The medical trial was supported by the Simon and Eve Colin Foundation, GlaxoSmithKline, Stand Up to Cancer, Swim Across America, and the National Cancer Institute of the National Institutes of Health.
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Trouble ‘Miyas’ everywhere only then they will leave Assam: Himanta Biswa Sarma
Says “Himanta Biswa Sarma, BJP are openly against them, we are saying it openly
New Delhi: Assam Chief Minister Himanta Biswa Sarma on Tuesday said that four to five lakh “Miya voters” would be removed from the electoral rolls in the state once the Special Intensive Revision (SIR) of voter lists is carried out. He also made a series of controversial remarks openly targeting the Miya community, a term commonly used in Assam in a derogatory sense to refer to Bengali-speaking Muslims.
Speaking to reporters on the sidelines of an official programme in Digboi in Tinsukia district, Sarma said it was his responsibility to create difficulties for the Miya community and claimed that both he and the BJP were “directly against Miyas”.
“Four to five lakh Miya votes will have to be deleted in Assam when the SIR happens,” Sarma said, adding that such voters “should ideally not be allowed to vote in Assam, but in Bangladesh”. He asserted that the government was ensuring that they would not be able to vote in the state.
The chief minister was responding to questions about notices issued to thousands of Bengali-speaking Muslims during the claims and objections phase of the ongoing Special Revision (SR) of electoral rolls in Assam. While the Election Commission is conducting SIR exercises in 12 states and Union Territories, Assam is currently undergoing an SR, which is usually meant for routine updates.
Calling the current SR “preliminary”, Sarma said that a full-fledged SIR in Assam would lead to large-scale deletion of Miya voters. He said he was unconcerned about criticism from opposition parties over the issue.
“Let the Congress abuse me as much as they want. My job is to make the Miya people suffer,” Sarma said. He claimed that complaints filed against members of the community were done on his instructions and that he had encouraged BJP workers to keep filing complaints.
“I have told people wherever possible they should fill Form 7 so that they have to run around a little and are troubled,” he said, adding that such actions were meant to send a message that “the Assamese people are still living”.
In remarks that drew further outrage, Sarma urged people to trouble members of the Miya community in everyday life, claiming that “only if they face troubles will they leave Assam”. He also accused the media of sympathising with the community and warned journalists against such coverage.
“So you all should also trouble, and you should not do news that sympathise with them. There will be love jihad in your own house.” He said.
The comments triggered reactions from opposition leaders. Raijor Dal president and MLA Akhil Gogoi said the people of Assam had not elected Sarma to keep one community under constant pressure. Congress leader Aman Wadud accused the chief minister of rendering the Constitution meaningless in the state, saying his remarks showed a complete disregard for constitutional values.
According to the draft electoral rolls published on December 27, Assam currently has 2.51 crore voters. Election officials said 4.78 lakh names were marked as deceased, 5.23 lakh as having shifted, and 53,619 duplicate entries were removed during the revision process. Authorities also claimed that verification had been completed for over 61 lakh households.
On January 25, six opposition parties the Congress, Raijor Dal, Assam Jatiya Parishad, CPI, CPI(M) and CPI(M-L) submitted a memorandum to the state’s chief electoral officer. They alleged widespread legal violations, political interference and selective targeting of genuine voters during the SR exercise, describing it as arbitrary, unlawful and unconstitutional.
