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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London (PTI): Bollywood stars Shah Rukh Khan and Kajol huddled under an umbrella on a rainy Thursday in London to unveil their bronze likeness from an iconic ‘Dilwale Dulhania Le Jayenge’ scene.

The sculpture of the duo joins Leicester Square’s ‘Scenes in the Square’ trail depicting memorable shots from some of the world’s most famous films, with ‘DDLJ’ marking a Bollywood first and the 30th anniversary of the 1995 box-office hit. It is in this popular London square that SRK as Raj and Kajol as Simran first cross paths unknowingly.

“DDLJ was made with a pure heart. We wanted to tell a story about love, how it can bridge barriers and how the world would be a better place if it had a lot of love in it, and I think this is why 'DDLJ' has had a lasting impact for over 30 years now," said Khan.

“Personally, 'DDLJ' is part of my identity, and it is humbling to see film, and Kajol and me, receiving so much love since it was released,” he said.

He expressed his gratitude to the Heart of London Business Alliance, behind the cinematic trail at Leicester Square, for celebrating ‘DDLJ’ and “immortalising” its lead stars.

“Seeing ‘DDLJ’ become the first Indian film to be honoured in the iconic Scenes in the Square trail is an emotional moment and has brought back so many memories.

"I feel immense pride knowing the film has been embraced around the world, and I want to share this moment with the entire cast and crew of ‘DDLJ’, my friend and director Aditya Chopra and the Yash Raj Films family. This is a moment I will never forget,” added Khan.

Kajol, joined by her daughter Nysa and son Yug, posed with Khan in front of the statue as she braved the rain in a green saree.

“It’s incredible to see ‘Dilwale Dulhania Le Jayenge’ continue to receive so much love, even 30 years later. Watching the statue being unveiled in London felt like reliving a piece of our history - a story that has truly travelled across generations,” said Kajol.

“Seeing it find its rightful place in Leicester Square, a location of such enormous significance to ‘DDLJ’, makes this moment even more special. For the film to be honoured in this way in the UK – the first Indian film to receive such recognition – is something that will forever stay in the hearts and minds of all the ‘DDLJ’ fans across the world,” she said.

Their statue, captured in a dancing pose from the hit song ‘Mehndi Laga Ke Rakhna’, joins the likes of Harry Potter, Bridget Jones, Mary Poppins, and Batman in what is dubbed as an ever-growing celebration of movie magic in a square packed with multiplex cinema screens.

“When ‘Dilwale Dulhania Le Jayenge’, DDLJ, was released 30 years ago, the film became a defining moment for Indian cinema and changed the face of the industry, capturing the hearts of everyone who saw it all over the globe," said Akshaye Widhani, CEO of Yash Raj Films.

“We’re thrilled to be the first Indian film to be represented in ‘Scenes in the Square’. It also marks 30 years of DDLJ, a film that has spread love and joy globally, and shows the cultural impact it has had in UK.

“We are honoured that our superstars and our film are being recognised on the world stage alongside the Hollywood elite, from Gene Kelly to Laurel & Hardy to Harry Potter. This statue will be a great way to express the international appeal of Indian movies and build bridges amongst communities through cinema,” he said.

Since its release in 1995, ‘DDLJ’ has become the longest-running film in Hindi cinema history.

Ros Morgan, Chief Executive at Heart of London Business Alliance, said: “We’re proud to welcome global megastars Shah Rukh Khan and Kajol to our Scenes in the Square trail.

"Dilwale Dulhania Le Jayenge is a cinematic phenomenon that has shaped generations, and London’s first tribute to Indian cinema honours a story whose magic continues to captivate audiences worldwide.”

It is a particularly special year for the film, with a musical based on the romance playing to packed houses at Manchester’s Opera House earlier this year. Aditya Chopra reprised his role as director of the English language stage production, ‘Come Fall In Love – The DDLJ Musical’, which revolved around the love story of Simran and Roger.

The script was a nod to the original as it followed Simran as a young British Indian woman who finds herself engaged to a family friend in India in an arranged marriage. However, the plot thickens when she falls in love with a British man named Roger.