Lack of expertise, poor adherence to standard operating procedures (SOPs) and lack of awareness regarding quality standards during tests among path labs are leading to erroneously low Estrogen and Progesterone Receptor (ER/PgR) positivity rates in the country. The estrogen receptor is the most important bio-marker in breast cancer.

Though there is growing incidence of breast cancer in India, estimated to be at around 30 per 100,000 populations, the (ER/PgR) positivity rates are on the lower side, compared to international figures.

These hormone negative reports are a cause for concern, since many patients miss out on receiving hormonal therapy, according to leading pathologists from the Tata Memorial Hospital (TMC), Mumbai.

"There is a need to review our methodologies in view of low rates of ER/PgR positivity levels among women who underwent breast biopsy," stated Dr M Udaya Kumar Maiya, director and chief oncologist, The Bangalore Hospital.

In order to understand the reason for this low positivity, The Bangalore Hospital doctors Dr Maiya and Dr M S N Prasad, consultant pathologist organized a seminar on 'ER/PR and role of pathologist in breast cancer'. The event was sponsored by Pfizer, which has two drugs Tamoxifen and Aromasin for breast cancer.

Two experts from Tata Memorial Hospital, Dr Roshan Chinoy, head, department of pathology and Dr Tanuja Shet, professor, department of pathology, said that low rates of ER/PgR levels was attributable to factors like lack of expertise in many hospitals in India. As most labs outsource this test, the pathologist who handles the biopsy initially is not aware and is not concerned about important technical procedures that have to be undertaken in order not to loose the 'labile' hormonal receptors present in the specimen. Only a handful of centres in Bangalore undertake Immunohistochemical (IHC). The list included Wellsprings, Dabur OnQuest, SRL, Kidwai Memorial Institute of Oncology, Anand Lab, Gokul Metropolis and Manipal Hospital.

The five major prognostic factors in breast cancer are age at presentation, tumour size, axillary nodal status, histopathology and ER/PgR status. The single most important predictive factor regarding outcome to hormonal therapy is ER/PgR status. Oncologists are dependent on the estrogen receptor readings which is a key determinant of outcome to hormone therapy in breast cancer for the last 30 years, stated Dr Chinoy while addressing the 'Methodology of ER/PR through IHC'. "Incidence of ER positivity is 62 percent for patients aged 35 and 72 per cent for 49 year-old patients," she added.

Dr Tanuja Shet, who delved into the techniques and principles of IHC demonstration of ER/PgR in breast cancer going by the TMC experience, referred to this method as a gold standard in ER/PgR tests.

Dr Shet called for the need of highest quality standards to be maintained in the areas of procuring quality reagent kits, correct fixation of tissue and a dedicated team of technicians to do ERPgR studies.

"Although the number of breast cancer cases is increasing and is common among urban women and certain ethnic population in the world, the incidence is lower among the younger age group. In India a large number of women who get breast cancer are young compared to the west. The lower detection of ERPgR is deterring oncologists from treating the patients with hormonal therapy, Dr Chinoy told Pharmabiz.

The Indian Council of Medical Research's (ICMR) population-based National Cancer Registry information (1999-2000) culled from Mumbai, Bangalore, Chennai, Thiruvananthapuram and Dibrugarh centres reports 35,072 cancer patients. Of these, 8,446 cases suffer from breast cancer alone.