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Quantitative PCR and HER2 Testing in Breast Cancer
A Technical and Cost-Effectiveness Analysis

Massimo Barberis MD, Caterina Pellegrini PhD, Maria Cannone PhD, Carmelo Arizzi MD, Guido Coggi MD, Silvano Bosari MD
DOI: http://dx.doi.org/10.1309/1AKQDQ057PQT9AKX 563-570 First published online: 1 April 2008


We performed a technical and cost-effectiveness analysis of quantitative reverse transcription–polymerase chain reaction (Q-RT-PCR) for the assessment of HER2 in breast cancer. We evaluated 44 frozen and 55 formalin-fixed paraffin-embedded (FFPE) breast carcinoma specimens by Q-RT-PCR, immunohistochemical analysis, and fluorescent in situ hybridization (FISH). Immunohistochemical and FISH analyses were performed on individual slides and on tissue microarray. Costs of techniques were calculated to study 1 case and 10 or 40 cases. Q-RT-PCR provided reliable data in frozen and FFPE specimens, which were significantly correlated. HER2 messenger RNA levels were significantly stratified in agreement with immunohistochemical data (P < .05). There was complete concordance between Q-RT-PCR and immunohistochemical results for negative and strongly positive (3+) cases. The intermediate immunohistochemical group (2+), including FISH+ and FISH– cancers, could also be stratified by Q-RT-PCR. Cost analysis documented the advantage of Q-RT-PCR in all US Food and Drug Administration–approved assays. Our data support the use of Q-RT-PCR for testing breast cancer specimens to select patients for HER2 inhibitory therapy.

Key Words:
  • Breast cancer
  • Fluorescent in situ hybridization
  • FISH
  • HER2
  • Immunohistochemistry
  • Quantitative real-time RT-PCR
  • Reverse transcription–polymerase chain reaction
  • Tissue microarray