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.
Let the Truth be known. If you read VB and like VB, please be a VB Supporter and Help us deliver the Truth to one and all.
Real Madrid fines Valverde and Tchouaméni half a million euros each for altercation
Barcelona (AP): Real Madrid slapped players Federico Valverde and Aurélien Tchouaméni with half-a-million-euro ($588,000) fines on Friday for their altercation during practice.
The massive fines came a day after the midfielders tussled when the team trained. Valverde said in a post on social media on Thursday that no punches were thrown. But Valverde knocked his head on a table and he suffered a small cut that required a brief hospital visit.
On social media, Valverde initially called it a “meaningless fight” with a teammate and said “everything has been blown out of proportion."
His employers, however, considered it a significant enough breach of team discipline to nail both Valverde and Tchouaméni with fines that bite even the bank account of a top soccer player. The half-a-million euro penalties reflect the reputational damage the club was enduring in a chaotic end to a disappointing season.
In a statement, the 15-time European champion said its disciplinary action was concluded after both players expressed to the club “their complete remorse for what happened and apologized to one another.”
Madrid added they also apologized to their teammates, the coaching staff and club supporters, as well as showing their willingness to accept whatever disciplinary action the club deemed “opportune.”
Tchouaméni was back training with Madrid on Friday, two days before they play at Barcelona in a clasico. Madrid has to win otherwise Barcelona will be crowned La Liga champion.
After being notified of the fine, he posted a public apology to the club and its fans on social media.
“What happened this week in training is unacceptable,” Tchouaméni wrote. "I say this while thinking about the example we are expected to set for young people, whether in football or at school.
“Above all, I am sorry for the image we projected of the club.”
Valverde was not at practice due to the head knock.
Both players are set to play in the World Cup next month, with Tchouaméni playing for France and Valverde for Uruguay.
Chaotic end to a poor season
===================
The run-in between the players, who for seasons have played side by side in Madrid's midfield, came after they argued this week in previous training sessions. But tempers boiled over on Thursday. Spanish media was rife with reports that the players previously disagreed over the club's decision to let coach Xabi Alonso go after just months on the job.
It was not the only altercation involving Madrid players during training this week. Álvaro Carreras confirmed he was in a “minor” incident with a teammate. Spanish media said he and fellow defender Antonio Rüdiger got into a scuffle.
Álvaro Arbeloa, the coach who was promoted from Madrid's reserve team when Alonso was fired in January, will face tough questions on what went wrong inside the changing room when he gives a press conference on Saturday ahead of the clasico at Camp Nou.
Madrid is facing a second consecutive campaign without a major trophy amid rumors in the Spanish media that club president Florentino Pérez is considering bringing back Jose Mourinho to straighten out his underperforming team.
