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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Karnataka cabinet approves formation of separate Dharwad Municipal Corporation
Bengaluru: The Karnataka Cabinet has approved a formation of separate Dharwad city corporation. Alongside, a 15% hike in fares across the four state transport corporations was also approved. The revised fares will come into effect on January 5.
Law and Parliamentary Affairs Minister H.K. Patil, addressing the media at the Committee Hall of Vidhana Soudha, provided details about the decision. He explained that the last fare revision for BMTC was a decade ago when diesel cost Rs 60.98 per litre. Since then, operational costs have risen significantly.
Diesel expenditure for the four corporations has increased from Rs 9.16 crore to Rs 13.21 crore, and personnel costs have grown from Rs 12.85 crore to Rs 18.36 crore. The daily operational burden now stands at Rs 9.56 crore. The fare hike is expected to generate an additional Rs 74.85 crore in monthly revenue without burdening the state exchequer, as Rs 5,015 crore has already been allocated for the Shakti Yojana this fiscal year.
Minister Patil announced that the Cabinet has decided to bifurcate the Hubballi-Dharwad Municipal Corporation into two independent municipal bodies.
The Cabinet approved the construction of a fishing port in Hejamady village, Udupi, with a revised estimate of Rs 209.13 crore. Additionally, Rs 84.57 crore has been sanctioned for the modernization and dredging of fishing ports.
In a move to strengthen cow shelters, Rs 10.50 crore has been allocated for projects in 14 districts. The Cabinet also approved constructing a building for Visvesvaraya Technical University in Chikkaballapur district at Rs 149.75 crore.
The Cabinet sanctioned a state-of-the-art bus stand in Bannimantap, Mysuru, at a cost of Rs 120 crore. Spread over 14 acres, the facility will include a divisional office, bus units, and commercial shops.
Approval was also granted to utilize Rs 137.85 crore, provided by the Union Finance Ministry under the Special Capital Assistance Scheme, for capital expenditure.
The Kalyana Karnataka Regional Development Board will use Rs 56.92 crore from its SCP/TSP scheme to supply bed sheets, mosquito nets, and clothing to government residential schools and hostels.
The Cabinet approved Rs 100 crore to construct new buildings for 200 veterinary institutions currently housed in rented or dilapidated structures, using NABARD assistance.
In Davangere, a site was allotted to the Karnataka Working Journalists' Association for constructing a civic facility. A plot in Avaragere village was also leased for 30 years at a concessional rate to Nayaka Vidyarthi Nilaya.
