Article Text

Download PDFPDF

Can multigene assays widen their clinical usefulness in early breast cancer treatment choice during the current COVID-19 outbreak in Italy?
  1. Alberto Zambelli,
  2. Carlo Alberto Tondini
  1. Department of Oncology, ASST Papa Giovanni XXIII, Bergamo, Italy
  1. Correspondence to Dr Alberto Zambelli; alberto.zambelli{at}

Statistics from

The European severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has had its first epicentre in Italy. Although a relative slowdown of the contagion spread has been anticipated, we are very far from resuming our regular activities, including those related to the healthcare organisation. Rather, we will have to rearrange our healthcare system to mitigate the risk of SARS-CoV-2 particularly in the frail population, including breast cancer (BC).

As a matter of fact, one of the issues for the breast units in the near future might be the convenience to defer surgery and to spare chemotherapy (CT), whenever endocrine therapy (ET) could be considered an optimal treatment. Multigene assays (MGAs), including the Oncotype DX, MammaPrint/BluePrint, EndoPredict and Prosigna/PAM50, have been endorsed for few years by different scientific cancer societies, including ESMO,1 as part of the decision process in selecting adjuvant treatment for luminal early BC. Actually, the clinical utility of MGAs is fully established in the adjuvant setting while it is suggested in the neoadjuvant setting.

In the emergency phase of the COVID-19 outbreak, the role of neoadjuvant endocrine therapy (NET) is somehow perceived of relevant importance. Herein, the clinical studies evaluating the role of MGAs in HR+/HER2− early BC treated with NET are briefly described (table 1). Two of these MGAs, Oncotype DX and EndoPredict, have shown a correlation between test results and response to NET suggesting a clinical utility to guide NET treatment decisions.

Table 1

Principal clinical trials evaluating the role of MGAs in patients receiving NET in early BC

The Oncotype DX has been validated in the neoadjuvant setting to predict clinical response to NET in HR+/HER2− early BC. The TransNEOS study of recurrence score (RS) demonstrated that a significant higher proportion of patients with RS <18 had a clinical response with preoperative Letrozole (55%) versus patients with RS ≥31 (22%) (p<0.001).2 Moreover, results of ABCSG34 study with EndoPredict (EP) have shown that HR+/HER2− early BC patients with a low risk EP score had a higher probability to respond to NET (27%) as compared with only 8% for high risk EP score (p=0.024).3 Results observed in a cohort of HR+/HER2− early BC, in the context of the NBRS Trial, showed that 68% of patients with BluePrint Luminal tumours receiving NET reached a clinical response.4 Finally, in the CORALLEEN study, the activity of neoadjuvant Letrozole+Ribociclib (NET/TT) obtained similar ROR molecular downstaging as compared with standard NAC (46.9% vs 46.1%, respectively).5

Therefore, it seems that MGAs can now provide clinical utility to select early BC luminal patients who might be considered for NET with the aim of reducing risks of infection during pandemic. Currently, in Italy, only 2 out of 20 regions provide reimbursement for MGAs in selected HR+/HER2− early BC patients. This condition causes an evident missed opportunity which, although hardly justifiable in ordinary healthcare conditions, becomes even more unacceptable in this pandemic, when optimisation of care should be a top priority. We wonder whether this should be the right time for Italy to promptly provide national reimbursement for MGAs in selected patients to support optimal BC treatment choices during pandemic.


View Abstract


  • Contributors Authors equally contributed to the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests AZ reports honoraria fees from Roche, Pfeizer, Eli Lilly, Novartis, Genomic Health and Astra Zeneca, outside the submitted work. CAT reports personal fees from Roche, Pfeizer, Eli Lilly, Novartis, Genomic Health and Astra Zeneca outside the submitted work

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; internally peer reviewed.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.