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Journalism of Courage
In a breakthrough trial of 12 rectal cancer patients who took the same drug for six months, cancer ‘vanished’ in all of them. The patients underwent a series of medical exams — physical exam, endoscopy, bioscopy, PET scans, and MRI scans — but none of the reports showed any signs of the tumour at a median follow-up of one year.
Published in the New England Journal of Medicine, the paper said that that the small but compelling study brings “two treatment advances together” of non-operative management. The compelling results were presented at the 2022 ASCO Annual Meeting by Andrea Cercek, MD, Head of the Colorectal Cancer Section and Co-Director of the Center for Young-Onset Colorectal and Gastrointestinal Cancers at Memorial Sloan Kettering Cancer Center (Abstract LBA5).
Rectal cancer affects the lower part of the large intestine. It is treated traditionally with chemotherapy, radiation, and surgery.
In the study, immunotherapy with the programmed death 1 (PD-1) inhibitor dostarlimab was followed by non-operative care in patients with mismatch repair–deficient stage II or III rectal cancer. All 12 patients received dostarlimab for six months with careful monitoring of clinical response by magnetic resonance imaging, F-fluorodeoxyglucose–positron-emission tomography, and endoscopy.
It is not experimental drug, it comes under the paradigm of immunotherapy, informed Dr Mandeep Singh Malhotra, Department of Oncology, CK Birla Hospital, Delhi.
“In scientific terms, we call it as check point inhibitors. Such drug types are being used in lung, breast and other cancer subtypes. The drug removes or uncovers the checks which inhibit our immune cell i.e. T cell to kill or take out the cancer cell,” he described.
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The paper analysed patients who did not have a complete response and were to receive subsequent standard radiation therapy and chemotherapy; however, all 12 patients had complete tumor resolution with dostarlimab. At a median follow-up of 1 year, none of the 12 patients had needed other treatment, and none had had cancer regrowth. None of the patients had adverse events of grade 3 or higher.
However, since chances of regrowth increase by 20-30 per cent in non-operative patients, the study authors note that “very little is known about the duration of time needed to find out whether a clinical complete response to dostarlimab equates to cure”.
The study author, Hanna K Sanoff, also 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”.
Why is this trial significant for cancer research and treatment?
The result of this report is very encouraging, but we cannot read too much into it until a larger trial is done, Dr Ashok Kumar Vaid, chairman, Medical and Haemato Oncology, Cancer Institute, Medanta Hospital Gurugram, told indianexpress.com. “Only once a larger trial is done, will the findings be validated. However, for now, in these cases, the results are very good and promising. The drug is a type of immunotherpay – known as an immune checkpoint inhibitor – it works through the immune system of the body. We do not know if it will work for other cancers, apart from rectal cancer because testing and trials have not been done,” he explained.
Stressing that the study holds promise, Dr Malhotra mentioned that it is important to understand that it was used in patients whose colorectal cancer had high tumour mutation burden and the cancer used these check points to evade the immune system. “It is not that all cancers and all colorectal cancers will be using these check points to evade immune system, survive, or grow. A cancer uses multiple pathways and methodologies to survive and grow, he added indicating that a big trial would be more appropriate for a larger understanding.
It is not known whether these patients with clinical complete response had a pathological complete remission too, highlighted Dr Suhas Aagre, oncologist and hemato-oncologist, Asian Cancer Institute.
The human microbiome is a new addition to cancer treatment that tends to suppress an overactive immune system in inflammatory diseases and enhance the response of a suppressed immune system in cancers, Dr Aagre expressed.
According to Dr Anil Thakwani, senior consultant oncologist, Fortis Noida Vejovis Superspeciality Clinic, the trial may not work for all types of cancers. “It seems to be effective only in the case of rectal cancers, which have deficient mismatch repair gene, and in those who are resistant to chemotherapy. The pitfall of the trial is that it is very short — six months. We should wait for sometime and do a follow-up of these patients. We should not be too happy,” he said, while stressing that different types of rectal cancer patients should be compared in a big trial in the future.
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