Quantitative PCR and HER2 testing in breast cancer: a technical and cost-effectiveness analysis.
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.
Barberis
Massimo
M
Department of Pathology, Multimedica, IRCCS, Milan, Italy.
Pellegrini
Caterina
C
Cannone
Maria
M
Arizzi
Carmelo
C
Coggi
Guido
G
Bosari
Silvano
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001050:Apocrine Glands / Q000378:metabolism / Q000473:pathology; D001943:Breast Neoplasms / Q000235:genetics* / Q000378:metabolism; D018270:Carcinoma, Ductal, Breast / Q000235:genetics* / Q000378:metabolism; D018275:Carcinoma, Lobular / Q000175:diagnosis / Q000235:genetics / Q000378:metabolism; D002291:Carcinoma, Papillary / Q000175:diagnosis / Q000235:genetics / Q000378:metabolism; D003362:Cost-Benefit Analysis; D005260:Female; D015870:Gene Expression; D006801:Humans; D017404:In Situ Hybridization, Fluorescence / Q000191:economics / Q000379:methods; D008875:Middle Aged; D012333:RNA, Messenger / Q000032:analysis; D012334:RNA, Neoplasm / Q000032:analysis; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics* / Q000378:metabolism; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000191:economics* / Q000379:methods; D013544:Sweat Gland Neoplasms / Q000235:genetics / Q000378:metabolism / Q000473:pathology; D046888:Tissue Array Analysis / Q000191:economics / Q000379:methods
D012333:RNA, Messenger; D012334:RNA, Neoplasm; D018719:Erb-b2 Receptor Tyrosine Kinases