title: One-step nucleic acid amplification assay for intraoperative prediction of advanced axillary lymph node metastases in breast cancer patients with sentinel lymph node metastasis.
abstract: The one-step nucleic acid amplification (OSNA) assay is used to semiquantitatively measure the cytokeratin (CK)19 mRNA copy numbers of each sentinel lymph node (SLN) in breast cancer patients. The aim of the present study was to evaluate whether the diagnosis of ≥4 LN metastases is possible using the OSNA assay intraoperatively. Between May, 2010 and December, 2014, a total of 134 patients who underwent axillary lymph node dissection (ALND) of positive SLNs were analyzed. The total tumor load (TTL) was defined as the total CK19 mRNA copies of all positive SLNs. The correlation between TTL and ≥4 LN metastases was evaluated. Of the 134 patients, 31 (23.1%) had ≥4 LN metastases. TTL ≥5.4×104copies/µl evaluated by receiver operator characteristic curve analysis was examined along with other clinicopathological variables. In the multivariate analysis, only TTL ≥5.4×104copies/µl was correlated with ≥4 LN metastases (odds ratio = 2.95, 95% confidence interval: 1.17-7.97, P=0.022). Therefore, TTL assessed by the OSNA assay has the potential to be a predictor of ≥4 LN metastases and it may be useful for the selection of patients with positive SLNs in whom ALND may be safely omitted.
authors.affiliation: Department of Surgery, Kinki University Faculty of Medicine, Osaka-sayama, Osaka 589-8511, Japan.
authors.forename: Michiyo
authors.initials: M
authors.lastname: Kubota
authors.affiliation: Department of Surgery, Kinki University Faculty of Medicine, Osaka-sayama, Osaka 589-8511, Japan.
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Komoike
authors.affiliation: Department of Surgery, Kinki University Faculty of Medicine, Osaka-sayama, Osaka 589-8511, Japan.
authors.forename: Mika
authors.initials: M
authors.lastname: Hamada
authors.affiliation: Department of Surgery, Kinki University Faculty of Medicine, Osaka-sayama, Osaka 589-8511, Japan.
authors.forename: Wataru
authors.initials: W
authors.lastname: Shinzaki
authors.affiliation: Department of Surgery, Kinki University Faculty of Medicine, Osaka-sayama, Osaka 589-8511, Japan.
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Azumi
authors.affiliation: Department of Surgery, Kinki University Faculty of Medicine, Osaka-sayama, Osaka 589-8511, Japan.
authors.forename: Yukihiko
authors.initials: Y
authors.lastname: Hashimoto
authors.affiliation: Department of Breast Surgery, Kyorin University School of Medicine, Tokyo 192-8508, Japan.
authors.forename: Shigeru
authors.initials: S
authors.lastname: Imoto
authors.affiliation: Department of Surgery, Kinki University Faculty of Medicine, Osaka-sayama, Osaka 589-8511, Japan.
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Takeyama
authors.affiliation: Department of Surgery, Kinki University Faculty of Medicine, Osaka-sayama, Osaka 589-8511, Japan.
authors.forename: Kiyotaka
authors.initials: K
authors.lastname: Okuno
keywords: axillary lymph node dissection; breast cancer; one-step nucleic acid amplification; sentinel lymph node; total tumor load