12-Sep-2022: Tata Memorial’s study suggests simple, low-cost intervention to significantly increase breast cancer cure rate and survival rate
Dr Rajendra Badwe, Director, Tata Memorial Centre, Mumbai today presented the results of a 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 benefits are substantial and were achieved with an intervention the cost of which was less than Rs.100/- per patient. 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 ten lakhs per patient. The clinical trial is hence an important milestone in the treatment of 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.
Dr. Badwe presented these findings at the ongoing European Society of Medical Oncology (ESMO) Congress in Paris, one of the most prestigious cancer conferences in the world held annually in Europe. A press conference to announce the results of the trial was arranged today, simultaneously with the live streaming of the presentation, followed by the address by Dr. Sudeep Gupta, Professor of Medical Oncology, Tata Memorial Centre/Hospital & Homi Bhabha National Institute and Director, ACTREC.
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 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 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.”
The study, ‘Effect of Peri-tumoral Infiltration of Local Anaesthetic Prior to Surgery on Survival in Early Breast Cancer’ is a randomized 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.
The study included 1,600 women with early breast cancer who were planned to be treated with surgery. 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.
Dr Badwe’s previous research has suggested that there is a window of opportunity just prior to, during, and immediately after surgical removal of the 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. 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. Depicted here is the diagrammatic representation of the technique of peri-tumoral injection which is simple and requires no additional expertise.
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. 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.
18-Dec-2019: WHO prequalifies first biosimilar medicine to increase access to breast cancer treatment
World Health Organization (WHO) prequalified its first biosimilar medicine – trastuzumab – in a move that could make this expensive, life-saving treatment more affordable and available to women globally.
Breast cancer is the most common form of cancer in women. 2.1 million women contracted breast cancer in 2018. 630 000 of them died from the disease, many because of late diagnosis and lack of access to affordable treatment.
Trastuzumab – a monoclonal antibody – was included in the WHO Essential Medicines List in 2015 as an essential treatment for about 20% of breast cancers. It has shown high efficacy in curing early stage breast cancer and in some cases more advanced forms of the disease.
Women in many cultures suffer from gender disparity when it comes to accessing health services. In poor countries, there is the added burden of a lack of access to treatment for many, and the high cost of medicines. Effective, affordable breast cancer treatment should be a right for all women, not the privilege of a few.
The global average cost of trastuzumab from originator companies is $20 000, a price that puts it out of reach of many women and healthcare systems in most countries. The biosimilar version of trastuzumab is generally 65% cheaper than the originator. With this WHO listing, and more products expected in the prequalification pipeline, prices should decrease even further.
The medicine, supplied by Samsung Bioepis NL B.V. (Netherlands), was assessed by WHO and found comparable to the originator product in terms of efficacy, safety and quality. That means it is eligible for procurement by United Nations agencies and for national tenders.
Biotherapeutic medicines, which are produced from biological sources such as cells rather than synthesized chemicals, are important treatments for some cancers and other non-communicable diseases. Like generic medicines, biosimilars can be much less expensive versions of innovator biotherapeutics while keeping the same effectiveness. They are usually manufactured by other companies once the patent on the original product has expired.
A few biosimilars of trastuzumab have come to market in the last five years, but none had been prequalified by WHO before today. WHO prequalification gives countries the assurance that they are purchasing quality health products.
A recent study of breast cancer in sub-Saharan Africa found that of 1325 women surveyed in three countries, cancer treatment had not been initiated within one year of diagnosis for 227 (17%) women and for 185 (14%) women with stage I-III disease. Self-reported treatment barriers confirmed treatment costs as a major contributor to not receiving treatment.
WHO’s International Agency for Research on Cancer estimates that by 2040 the number of diagnosed breast cancers will reach 3.1 million, with the greatest increase in low- and middle-income countries.
Biotherapeutics: Biotherapeutics are pharmaceutical products derived from biological and living sources. They include therapeutic vaccines, blood, blood components, cells, gene therapies, tissues and other materials. Several biologic medicines are ‘specialty drugs’, highly priced and effective in treating medical conditions for which no other treatments are available. Gene- and cell-based therapies are among these pharmaceuticals. Some biotherapeutics are effective treatments for certain forms of cancer, chronic diseases such as diabetes, Crohn’s disease and other autoimmune conditions, including lupus, and various forms of rheumatoid arthritis.
WHO Prequalification: Every year, billions of dollars’ worth of medicines and other health products are purchased by international procurement agencies for distribution in low-income countries. Prequalification is a service provided by WHO to assess the quality, safety and efficacy of those products that address global public health priorities. If the products meet international standards, they are listed on the WHO web site as eligible for procurement, giving purchasing agencies a range of quality-assured diagnostics, medicines and vaccines from which to choose. Many low-income countries also use WHO’s lists of prequalified products to guide their selection of medicines, vaccines and technologies for national procurement.
In July 2018, WHO launched a pilot project expanding the scope of prequalification to two biotherapeutic medicines, as a step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income countries. This is the first biotherapeutic to be prequalified as part of the pilot.