Analytical and clinical performance of progesterone receptor antibodies in breast cancer

作者：Calhoun Benjamin C^*; Mosteller Brian; Warren Daniel; Smith Margie; Rowe J Jordi; Lanigan Christopher P; Mrazeck Karen C; Walker Espen; Newell Amy Hanlon; Jones Raymond^*

来源：Annals of Diagnostic Pathology, 2018, 35: 21-26.

DOI：10.1016/j.anndiagpath.2018.02.007

• Progesterone receptor
• Hormone receptor
• Breast cancer
• Diagnosis
• Pathology
• Monoclonal antibody
• Clone 1E2
• Clone 636
• Clone 1A6
• Clone 16

Objective: Comparison of analytical and immunohistochemical performance of progesterone receptor (PR) antibodies with correlation to recurrence of invasive breast cancer treated with endocrine therapy.
Methods: The binding-affinity kinetics of PR clones 1E2, 1A6, 16 and 636 were compared using synthetic peptides derived from identified epitopes on a Biacore T200. A cohort of 351 cases (Hormone Receptor (HR) +/HER2-) were stained for PR expression with immunohistochemistry (IHC) and scored according to ASCO/CAP criteria.
Results: The stability of the antigen/antibody complex was greater for the 1E2 clone compared to 1A6, 16 and 636 clones. PR IHC on archival tissue resulted in 94.3% (299/317) concordance with clones.
Conclusion: Clones evaluated in this study had a high level of concordance with IHC despite PR (1E2) demonstrating higher analytical binding properties than other clones. In a minority of cases (1.3% for 1E2 and 2.5% for 636) IHC results could convert estrogen receptor (ER)-/PR- to ER-/PR+ tumors, making these patients potentially eligible for endocrine therapy.

• 出版日期2018-8