Mumbai, Sep 13 (Representative) The city-based Tata Memorial Centre has conducted a decade-long clinical trial on women undergoing breast cancer treatment across the country and the results of this trial showed that this simple, low-cost intervention significantly and substantially increases the cure and survival rates among the patients after surgery. The results of a landmark multi-centre Indian breast cancer study were presented on Monday by Dr Rajendra Badwe, director at Tata Memorial Centre, at ongoing European Society of Medical Oncology (ESMO) Congress in Paris, one of the most prestigious cancer conferences in the world held annually in Europe. Simultaneously, the results of the trial were announced in a press conference via live streaming by Dr Sudeep Gupta, Professor of Medical Oncology at Tata Memorial Centre. He said the trial in women undergoing breast cancer surgery involved the injection of a commonly used drug around the tumor on the operating table, just prior to surgery.
The injection requires no additional expertise, is inexpensive, and can result in saving up to one lakh lives annually globally, he said and informed that the cost of this intervention was just Rs 100 per patient. The study included 1,600 women with early breast cancer who were planned to be treated with surgery, he said. Half of these patients, constituting the control group, received standard surgery followed by standard post-operative treatment including chemotherapy, hormone therapy and radiotherapy as per guidelines, he noted. The other half, constituting the intervention group, received an injection of a commonly used local anaesthesia agent, 0.5 per cent lidocaine, all around the tumor, just prior to surgery, he informed. They then underwent standard surgery followed by the same post-operative treatment as was given in the control group, he said. After completion of treatment patients were followed up regularly for several years to compare the rates of cure and survival between the control group and local anaesthesia group, Dr Gupta said.
It was found that the six-year disease-free survival (cure rate) was 81.7 per cent in the control group and 86.1 per cent in the local anaesthesia group for a 26 per cent relative reduction in the risk of cancer relapse or death with the local anaesthesia injection, which was statistically significant, he informed. Similarly the six-year overall survival was 86.2 per cent versus 89.9 per cent in the two groups for a 29 per cent reduction in the risk of death with the local anaesthetic injection, which was also statistically significant, he said. The study, called ‘Effect of Peri-tumoral Infiltration of Local Anaesthetic Prior to Surgery on Survival in Early Breast Cancer’, was a randomised controlled trial, conceived and designed by Dr Badwe, who is the principal investigator. The study was conducted by investigators at 11 cancer centres in India, including Tata Memorial Centre in Mumbai, over an 11-year period between 2011 and 2022, he added. Joining from Paris immediately after his presentation, Dr Badwe commented, “This is the first study of its kind globally, that has shown a sizable benefit by single intervention prior to surgery. If implemented across the world, it has the capability to save over 1,00,000 lives annually…”