PMID- 28901323 OWN - NLM STAT- MEDLINE DCOM- 20180510 LR - 20180510 IS - 1998-4138 (Electronic) IS - 1998-4138 (Linking) VI - 13 IP - 4 DP - 2017 TI - Human epidermal growth factor receptor 2 amplification detection by droplet digital polymerase chain reaction in formalin-fixed paraffin-embedded breast and gastric cancer samples. PG - 730-734 LID - 10.4103/jcrt.JCRT_587_17 [doi] AB - OBJECTIVE: Human epidermal growth factor receptor 2 (HER2) is an important biomarker for the precise individualized treatment including trastuzumab of HER2-positive breast and gastric cancer. Immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) are the routine analyses for formalin-fixed paraffin-embedded (FFPE) samples. However, IHC is variable and depends on the evaluator, and FISH is a labor intensive and expensive method. We evaluated the feasibility of droplet digital polymerase chain reaction (ddPCR) as a precise and quantitative method for HER2 amplification test. MATERIALS AND METHODS: We used ddPCR to confirm HER2 amplification status in 24 breast cancer and 29 gastric cancer samples to validate the HER2 cutoff value in ddPCR. After setting cutoff value, all the above-mentioned samples were tested by IHC. Afterward, another 51 equivocal IHC 2+ gastric cancer samples were further determined by FISH and ddPCR, respectively, and the concordance between ddPCR and FISH was calculated. RESULTS: We set the HER2 cutoff value at 1.8. The concordance rate of HER2 status between ddPCR and IHC was 94.4% (17 out of 18) in 24 breast cancer samples. In 29 gastric cancer specimens, the concordance rate of HER2 amplification between ddPCR and IHC was 100% (22 out of 22). At last, compared with FISH determined HER2 status, ddPCR HER2 scores correctly classified 44 of 51 cases with 86.3% concordance in 51 equivocal IHC 2+ gastric cancer samples. CONCLUSIONS: ddPCR was able to identify HER2 amplification status in breast and gastric cancers with precise correlation with IHC and FISH results. This method might become a standard method for testing FFPE samples. However, the technology requires further research. FAU - Wang, Xingwen AU - Wang X AD - Cancer Center, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, Shandong, China. FAU - Wu, Yunyan AU - Wu Y AD - Department of Ophthalmology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, Shandong, China. FAU - Song, Xueling AU - Song X AD - Clinical Skill Training Center, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, Shandong, China. FAU - Sun, Chengtao AU - Sun C AD - Department of Otorhinolaryngology, Center for Radiation Oncology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, Shandong, China. FAU - Wu, Changshun AU - Wu C AD - Department of Bone and Joint Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, Shandong, China. FAU - Feng, Hong AU - Feng H AD - Cancer Center, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, Shandong, China. LA - eng PT - Journal Article PL - India TA - J Cancer Res Ther JT - Journal of cancer research and therapeutics JID - 101249598 RN - 0 (Biomarkers, Tumor) RN - 1HG84L3525 (Formaldehyde) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Aged MH - Aged, 80 and over MH - Biomarkers, Tumor/genetics MH - Breast Neoplasms/*genetics/pathology MH - Female MH - Formaldehyde/chemistry MH - Gene Amplification/*genetics MH - Humans MH - In Situ Hybridization, Fluorescence MH - Male MH - Middle Aged MH - Paraffin Embedding MH - Receptor, ErbB-2/*genetics/isolation & purification MH - Stomach Neoplasms/*genetics/pathology EDAT- 2017/09/14 06:00 MHDA- 2018/05/11 06:00 CRDT- 2017/09/14 06:00 PHST- 2017/09/14 06:00 [entrez] PHST- 2017/09/14 06:00 [pubmed] PHST- 2018/05/11 06:00 [medline] AID - JCanResTher_2017_13_4_730_214480 [pii] AID - 10.4103/jcrt.JCRT_587_17 [doi] PST - ppublish SO - J Cancer Res Ther. 2017;13(4):730-734. doi: 10.4103/jcrt.JCRT_587_17.