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ESMO Breast Cancer 2019: ONCOLLEGE-001: Global Survey of HER2 Testing

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Key Points

  • In the survey, 42% of respondents from upper middle-income countries (UMICs) and 34% from low- and middle-income countries (LMICs) reported that HER2 testing was available only in a private setting or abroad, compared to 5% of those working in high-income countries (HICs).
  • 30% of LMIC respondents reported significant affordability issues related to HER2 testing, compared to 12% of respondents from UMICs and none from HICs.

A global survey of HER2 testing has raised questions about how resources should be spent on potentially lifesaving HER2-targeted therapies for breast cancer, especially in lower-income countries. These results will be presented at the European Society for Medical Oncology (ESMO) Breast Cancer Congress 2019 (Abstract 42P_PR).

ONCOLLEGE-001

The ONCOLLEGE-001 internet-based survey of HER2 testing in 45 countries has highlighted major access and affordability issues in low- and middle-income countries (LMICs), with some issues extending to upper middle-income countries (UMIC) too.

“Even when HER2 testing was available, it was too expensive and inaccessible for many women, suggesting that governments need better information to set planning priorities for investing in infrastructure, testing and treatment,” said study author Sara Altuna, MD, of the Department of Medical Oncology, Unidad Oncológica Venezuela CA and Oncomédica CA, Caracas, Venezuela.

In the survey, 42% of respondents from UMICs and 34% from LMICs reported that HER2 testing was available only in a private setting or abroad, compared to 5% of those working in high-income countries (HICs). Thirty percent of LMIC respondents reported significant affordability issues related to HER2 testing, compared to 12% of respondents from UMICs and none from HICs.

“You can have the microscopes, the antibodies and probes, and the certified laboratories, but if patients cannot afford the tests or do not have insurance, they won’t be done,” added Altuna.

HER2 testing is needed to identify the 15% to 20% of women with breast cancer who have HER2-positive disease, so they can receive anti-HER2 treatment with trastuzumab—which has been on the World Health Organization’s List of Essential Medicines since 2015—and other HER2-targeted therapies.

Commentary

Commenting for ESMO, Fatima Cardoso, MD, Director of the Breast Unit of the Champalimaud Clinical Center in Lisbon, Portugal, explained that in recent decades, HER2-targeted therapies have transformed the outcomes for women with this subgroup of breast cancer.

“Without accurate, high-quality HER2 testing, women with HER2-positive tumors may miss out on potentially lifesaving treatment. There is also a risk that women with HER2-negative tumors may be exposed to the toxicity and unnecessary expense of HER2 treatment they don’t need. We don’t want to spend resources on treating tumors that won’t respond to HER2-targeted therapies,” she said.

Dr. Cardoso pointed to the lack of basic pathology services in some low-income countries, with women undergoing mastectomy for benign breast lumps because biopsy services were not available to make the diagnosis before surgery. She also questioned the wisdom of spending resources on HER2 testing in countries where anti-HER2 therapy is unavailable or unaffordable.

“Testing and treatment must go hand in hand. If you have access to anti-HER2 treatment, it makes sense to spend money on testing. But if you already know there is no access to treatment, it is debatable whether to use resources for HER2 testing. Let’s first focus on ensuring that treatment is available as recommended by the WHO, by ESMO’s and other international guidelines, for both primary and metastatic HER2-positive breast cancer,” she said.

“ONCOLLEGE-001 is an important study in raising awareness of the heterogeneity of availability and quality of HER2 testing. The results probably underestimate the access and affordability problems facing many patients, and not just in [LMICs]. But they remind us of the need for clinicians, regulators, and governments to work together in addressing these inequalities,” said Dr. Cardoso.

An ongoing ONCOLLEGE-001 analysis is investigating global prioritization and access to anti-HER2 medicines, and, as Dr. Altuna concluded, such research demonstrates the value of international cooperation. “We have shown it is possible to create a network of clinicians from very different countries to share practice and experiences and paint a picture of what is really happening in breast cancer care around the globe, so we can identify where improvements are most needed.”

Disclosure: For full disclosures of the study authors, visit cslide.ctimeetingtech.com/breast2019.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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