Healthcare e-Compendium
A joint initiative of DPSRU & DRSC
Healthcare e-Compendium
A joint initiative of DPSRU & DRSC
Author: Medical Team (Alniche Life Sciences)
Blog
download ArticleAstonishing result shown by an ongoing Phase II clinical trial. Twelve rectal cancer patients were totally cured, and none of the medical trial participants experienced any significant adverse effects at the time of publication of the paper (June 5, 2022).
The new research was presented at the American Society of Clinical Oncology's annual meeting and was simultaneously published in the New England Journal of Medicine
The study's primary objective was to investigate if TSR-042 (commonly known as dostarlimab), in combination with routine chemoradiotherapy and surgery, was a successful therapy for advanced deficient MisMatch Repair (dMMR) solid tumours.
The Simon and Eve Colin Foundation, Stand Up to Cancer, GlaxoSmithKline, Swim Across America, and the National Cancer Institute of the National Institutes of Health all contributed to the medical trial.
Study Design
Researchers performed a prospective phase II study in which patients with mismatch repair-deficient stage 2 and 3 rectal cancer were given dostarlimab 500 mg intravenously, an anti-PD-1 monoclonal antibody, every three weeks for six months, followed by conventional chemoradiation and surgery. Chemoradiation and surgery were not required for patients who had a clinical complete response.
Results and Discussion
Twelve patients have finished dostarlimab therapy and have been followed for at least six months. There was no indication of malignancy on magnetic resonance imaging, digital rectal examination, biopsy, endoscopic assessment,18F-fluorodeoxyglucose-positron-emission tomography, in all 12 patients. No patients had chemoradiotherapy or surgery at the time of this report, and no cases of progression or recurrence had been recorded during follow-up (range, 6 to 25 months). There has been no grade 3 or higher adverse events recorded.
Following the discovery of tumour eradication after six months of PD-1 blocking treatment, researchers were able to forego chemoradiation and surgery in favour of observation alone.
The study also establishes a paradigm for evaluating highly active medicines in the neoadjuvant situation, in which patients are spared from chemoradiation and surgery while the tumour is being treated at its most responsive stage.
As this is a small scale study with surprising results but a larger-scale trial is needed to access the efficacy and safety of dostarlimab.
References
