12-Dec-2022: A commonly available and inexpensive drug, carboplatin, increases cure rate and survival in triple-negative breast cancer, an aggressive type of breast cancer

The results of the study by the Tata Memorial Centre show that a commonly available and inexpensive drug, carboplatin, increased the cure rate and survival of a very aggressive type of breast cancer, called triple-negative breast cancer, especially among young women who have this disease. Until the results of this study there was no conclusive evidence that this drug should be routinely used as part of the treatment of this disease.

Dr Sudeep Gupta, Professor of Medical Oncology at Tata Memorial Centre, presented, as a podium presentation, the results of the landmark ‘TMC Study - Platinum in TNBC’ at the ongoing San Antonio Breast Cancer Symposium, which is the largest and most important breast cancer conference in the world. Dr Rajendra A Badwe, Director TMC, is the Principal Investigator of this study, which was conducted by the Breast Cancer Working Group of Tata Memorial Centre, Mumbai.

The study was a randomized controlled trial which enrolled women with stage II-III triple negative breast cancer from 2010 to 2020 who were divided into two groups, both of whom received chemotherapy to downstage the disease prior to surgery. Women in the standard treatment group received standard chemotherapy comprised of once per week paclitaxel for 8 weeks followed by doxorubicin plus cyclophosphamide every 3 weeks for 4 cycles.

In the platinum group, women received the same chemotherapy with the addition of injection carboplatin once per week for 8 weeks, given with paclitaxel. Women in both groups underwent surgery after the last cycle of chemotherapy followed by radiotherapy. They were then followed up once every 6 months.

Dr Badwe explained the four main findings from this study. First, in the whole study population cure rate (5-year disease-free survival) increased by 6.6% from 64.1% in the standard arm to 70.7% in the platinum arm and the overall survival increased by 7.6% from 66.8% in the standard arm to 74.4 % in the platinum arm, which was statistically significant. Second, when the results were analyzed by age, the benefit of weekly carboplatin was almost exclusively confined to women younger than 50 years who had a large 12.5% increase in cure rate (5-year DFS 61.7% to 74.2%) and an 11.2% gain in overall survival (5-year overall survival 65.9% to 77.1%). Third, platinum-based chemotherapy wiped the tumor clean as assessed by pathologists in the operated breast specimen (pathological complete response) in 61% of younger (</=50 years) patients compared with 41% by standard chemotherapy. Fourth, carboplatin-based chemotherapy was well tolerated without high rate of toxicity.

The results were hailed by oncologists worldwide as immediately practice defining. A commonly available and inexpensive treatment like carboplatin will now be routinely offered as part of pre-operative chemotherapy regimen to women with TNBC which is the most aggressive type of breast cancer. Given that TNBC constitutes about 30% of breast cancer in India and about 45% of breast cancer in women younger than 50 years, the implications of this result are very important.

13-Sep-2022: Dr Mansukh Mandaviya launches National Lists of Essential Medicines (NLEM) 2022

“Union Health Ministry is taking various steps under vision of Hon. Prime Minister Shri Narendra Modi ji towards Sabko Dawai, Sasti Dawai. In this direction, National List of Essential Medicines (NLEM) plays an important role in ensuring accessibility of affordable quality medicines at all levels of healthcare. This will give boost to cost-effective, quality medicines and contribute towards reduction in Out of Pocket Expenditure on healthcare for the citizens.” This was stated by Dr Mansukh Mandaviya, Union Minister for Health and Family Welfare as he launched National Lists of Essential Medicines (NLEM) 2022, here today.

384 drugs have been included in this list with addition of 34 drugs, while 26 from the previous list have been dropped. The medicines have been categorized into 27 therapeutic categories.

Speaking on the occasion, Union Health Minister stated that the “essential medicines” are those that satisfy the priority health care needs, based on efficacy, safety, quality and total cost of the treatment. The primary purpose of NLEM is to promote rational use of medicines considering the three important aspects i.e., cost, safety and efficacy. It also helps in optimum utilization of healthcare resources and budget; drug procurement policies, health insurance; improving prescribing habits; medical education and training  for UG/PG; and drafting pharmaceutical policies. In NLEM, the medicines are categorized based on level of healthcare system as-      P- Primary; S- Secondary and T- Tertiary.

He elaborated that the concept is based on the premise that a limited list of carefully selected medicines will improve quality of health care, provide cost-effective health care and better management of medicines. He added that the NLEM is a dynamic document and is revised on a regular basis considering the changing public health priorities as well as advancement in pharmaceutical knowledge. The National List of Essential Medicines was first formulated in 1996 and it was revised thrice earlier in 2003, 2011, and 2015.

“The independent Standing National Committee on Medicines (SNCM) was constituted by Union Health Ministry in 2018. The Committee after detailed consultation with experts and stakeholders has revised the NLEM, 2015 and submitted its report on NLEM, 2022 to the Ministry of Health & Family Welfare. The Government of India has accepted the recommendations of the Committee and adopted the list”, he stated. He also noted that the process of creation of NLEM depends on the feedback backed by scientific sources from stakeholders and inclusion/exclusion principle followed.

While congratulating the stakeholders for the revised NLEM which takes the country forward in the direction of provisioning of affordable healthcare to its citizens, Dr Bharati Pravin Pawar, Union Minister of State stressed on enhancing awareness regarding Antimicrobial Resistance (AMR) which “is emerging as a big challenge for our scientists and community and we need to create awareness in the society about AMR”.

Revision of NLEM 2022 has been done after constant consultation with stakeholders spanning from academia, industrialists and public policy experts etc., and crucial documents like WHO EML 2021.

The following criteria are followed for inclusion in NLEM:

1. be useful in diseases which is a public health problem in India
2. be licensed/ approved Drugs Controller General (India) (DCGI)
3. have proven efficacy and safety profile based on scientific evidence
4. be comparatively cost effective
5. be aligned with the current treatment guidelines
6. recommended under National Health Programs of India. (e.g. Ivermectin part of Accelerated Plan for Elimination of  Lymphatic Filariasis 2018).
7. when more than one medicine are available from the same therapeutic class, one prototype/ medically best suited medicine of that class to be included.
8. price of total treatment is considered and not the unit price of a medicine
9. fixed dose combinations are usually not included
10. vaccines as and when are included in Universal Immunization Program (e.g. Rotavirus vaccine).

NLEM 2022 can be accessed here: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTAxMQ==