A clinical trial conducted at the Tata Memorial Centre (TMC) has indicated that a simple, low-cost intervention can drastically increase the cure and survival rate among breast cancer patients. In the study, the TMC has used local anaesthesia - 0.5% lidocaine (Worth less than Rs 100) as anti-cancer agent and found 29% reduction in the risk of death and 26% reduction in relapse of cancer. It has now become the standard protocol for a treatment.
The multi-centre clinical trials were conducted in women undergoing breast cancer surgery and it emerged that injection of a commonly used drug around the tumour on the operation table — just before surgery — could significantly and substantially increase the cure rate and survival in the long run.
The study, ‘Effect of Peritumoral Infiltration of Local Anaesthetic Prior to Surgery on Survival in Early Breast Cancer’ is a randomized controlled trial, conceived and designed by Dr Rajendra Badwe, Director, TMC, the principal investigator. The study was conducted by investigators at 11 cancer centres in India including the TMC in Mumbai over an 11-year period between 2011 and 2022. The study included 1,600 women in early breast cancer stage who were scheduled to be treated with surgery.
Dr Badwe said the trial outcome shows that the injection needs no additional expertise, is affordable, barely Rs 100 per patient, but can result in saving at least 100,000 lives of breast cancer patients annually worldwide. For comparison, benefits of far lesser magnitude have been achieved in early breast cancer patients by much more expensive, targeted drugs which cost more than Rs 10 lakhs per patient.
“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 TMC and Department of Atomic Energy (DAE) for the benefit of Indian and global population and this study, supported by the DAE, is a major step towards Atma nirbhar Bharat,” he said.
Dr Sudeep Gupta, Professor of Medical Oncology at TMC and Director ACTREC, one of the co-investigators of the study said, “This study provides an inexpensive and immediately implementable treatment in breast cancer which can be practiced 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.”
Dr Badwe further added “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. 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 prior to surgery. They then underwent standard surgery followed by the same postoperative treatment as was given in the control group.”