ES5-1: Breast Cancer Trials in Developing Countries - Opportunities and Challenges.
Authors: Gupta S , Badwe RA , Mittra I , Nag S , Dawood S , Munshi A 
Published: June 2012

Breast cancer (BC) incidence is low, but increasing in the urban areas of many developing countries (DC) because of adoption of western lifestyle, including reproductive and fertility patterns. Because of large populations in DC, the absolute number of BC patients is high. Distinctive features of BC in DC include younger median age (population pyramid effect), advanced stage at presentation, absence of screen detected cancers, higher fraction of triple negative and lower fraction of hormone responsive tumors and higher mortality/incidence ratio.

Several common themes emerge when considering the design/implementation of BC trials in DC:

1. Many DC have established population-based cancer registration process with good quality data on BC incidence. However data on patterns of care and long term outcome is sparse. This affects the accuracy of baseline assumptions while designing BC trials.

2. There is lack of unique identification numbers for citizens with linked national health/death registers in DC that creates difficulties in follow-up. Ensuring adequate follow-up in BC trials requires special efforts in DC.

3. There is deficient cooperative group trials culture in most DC with consequent inefficient recruitment, retention and follow-up in clinical trials, despite large absolute numbers of BC patients. Investment in creating such a culture is likely to be very productive in the long term.

4. Healthcare community, civil society and governments in DC are insufficiently sensitized to the importance of clinical trials as drivers of improvement in health delivery, in addition to providing solutions for topical problems in BC. Sustained effort in this area is likely to result in better acceptance of clinical trials.

5. There are cultural differences with western countries (paternalistic healthcare systems with passive acceptance of healthcare by consumers) that makes informed consent (IC) process difficult. The complexity of IC documents prepared by western researchers in collaborative projects, coupled with the desire for literal translation into local languages, makes the IC process daunting, even for experienced researchers.

6. Regulatory and ethical oversight of BC trials in DC is variable, ranging from sophisticated to rudimentary. Several tertiary care academic centers have well organized institutional review boards that ensure proper conduct of BC trials. Approval of international collaborative projects, especially those that involve transfer of biological material for translational science, is difficult in many countries.

7. Since BC patients in DC receive fewer lines of therapy as a routine standard, there are opportunities to research new interventions in less heavily treated patients.

8. There is opportunity to research technology that has not yet been widely adopted in DC (such as sentinel lymph node technique versus other forms of reduced axillary surgery, newer radiation delivery techniques) in randomized trials.

9. Testing neoadjuvant therapies in large tumors is very feasible in DC beacuse of large numbers.

There are other research opportunities in DC that can be themes of collaborative research with developed countries. Simplicity of design and ease of implementation will facilitate such collaborations. These will be discussed in the final presentation.

Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr ES5-1.