A decade-long study conducted by the researchers of Tata Memorial Centre, Mumbai has revealed the astonishing potential of local anaesthesia in breast cancer treatment. According to the scientists, a simple intervention of using local anaesthesia (0.5 percent lidocaine) as an anti-cancer agent right before breast cancer surgery can significantly lower the risk of death and recurrence by 29 pecent and 30 percent respectively.
Last week, Dr Rajendra Badwe, Director, Tata Memorial Centre, Mumbai presented the results of the landmark multi-centre Indian study on breast cancer.
“The results of this study show that this simple, low-cost intervention significantly and substantially increases the cure rates and survival of breast cancer patients, with a benefit that is ongoing for several years after surgery. The injection requires no additional expertise, is inexpensive, and can result in saving up to 100,000 lives annually globally. These substantial benefits were achieved with an intervention, the cost of less than Rs.100/- per patient,” the Department of Atomic Energy said in a statement.
The scientists claimed that usually positive outcomes but of comparatively lesser magnitude have been achieved in early breast cancer patients and through extremely expensive targetted drugs costing more than ten lakhs per patient.
“The clinical trial is an important milestone in treating breast cancer. The trial in women undergoing breast cancer surgery involved the injection of a commonly used drug around the tumour, on the operating table, just prior to surgery, the statement added.
Dr. Badwe presented these findings at the ongoing European Society of Medical Oncology (ESMO) Congress in Paris.
“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 100,000 lives annually. For scientists, it opens the window of peri-operative intervention to modulate the environment of cancer in such a way as to prevent its deleterious reaction to the act of surgery [observation]. Evolving low-cost interventions for cancer has been a mission of Tata Memorial Centre and Department of Atomic Energy for the benefit of Indian and global population and this study, supported by the Department of Atomic Energy, is a major step towards Atma nirbhar Bharat,” Dr Badwe said in a statement.
Meanwhile, Dr Sudeep Gupta, Professor of Medical Oncology at TMC and Director ACTREC, one of the co-investigators of the study said that this study provides an inexpensive and immediately implementable treatment in breast cancer which can be practised by every surgeon who treats this disease.
“The results from a large randomized trial, which is the gold-standard way of evaluating the worth of new treatments, provides the highest level of evidence to support the use of this technique. This study is proof that Indian centres can design and conduct studies which have a global impact,” he added.
The decade-long study was conducted in a randomised manner by investigators at 11 cancer centres in India including Tata Memorial Centre in Mumbai over an 11-year period between 2011 and 2022.
The study included 1,600 women with early breast cancer who were planned to be treated with surgery.
Half of these participants, including the control group, received standard surgery followed by standard postoperative treatment like chemotherapy, hormone therapy and radiotherapy as per guidelines. Meanwhile, the other half, constituting the intervention group, received an injection of a commonly used local anaesthesia agent, 0.5% lidocaine, all around the tumor, just before surgery. After this, these patients underwent standard surgery followed by the same postoperative treatment as was given in the control group.
Earlier, Dr Badwe had conducted research that suggested that there is a window of opportunity just prior to, during, and immediately after surgical removal of primary cancer when anti-cancer interventions could reduce the risk of development of disseminated stage 4 metastatic cancer later in the lifespan of the patient.
The scientists explained that Lignocaine, which is a commonly used, inexpensive, local anesthesia drug, was thought to be one such suitable intervention because of its inhibitory effects on cancer cell division, movement and other anti-cancer properties.
The team of researchers also stated that after the treatment, the patients were followed up regularly for several years to compare the rates of cure and survival between the control group and the local anaesthesia group.
“When enough follow-up had happened in both groups the data was analysed at a cut-off date of September 2021. As expected, there was no toxicity of lignocaine in patients who received it. The 6-year disease-free survival (cure rate) was 81.7% in the control group and 86.1% in the local anaesthesia group for a 26% relative reduction in the risk of cancer relapse or death with the local anaesthesia injection, which was statistically significant. Similarly the 6-year overall survival was 86.2% versus 89.9% in the two groups for a 29% reduction in the risk of death with the local anaesthetic injection, which was also statistically significant. Depicted below are the disease-free survival and overall survival in the two study groups over time,” the Department added.
According to the World Health Organization (WHO), the survival rate of breast cancer patients for at least five years after diagnosis ranges from more than 90 percent in high-income countries, to 66 percent in India. Reportedly, the team is planning to conduct similar studies with other agents including cannabis and these outcomes will be tested in other types of cancers too.