Background. The microwave tissue coagulator (2450 MHz) has been used clinically in the treatment of hepatocellular carcinoma (HCC) to transection of the liver parenchyma and has proven an excellent method for hemostasis. There are, however, few reports on the application of this coagulator to the induction of tumor necrosis. Methods. Microwave tissue coagulation (MTC) was applied at laparotomy in eight patients with nonresectable multiple HCCs. All patients were treated with a combination of resection or intrahepato‐arterial chemotherapy and MTC. A total of 222 bouts of MTC were applied to 21 tumors, the largest of which was 65 mm in largest dimension. The monopolar needle electrode was inserted directly into the tumor and the procedure was repeated at approximately 5 mm intervals. Results. Levels of alpha‐fetoprotein in serum were found to have decreased in all patients one month after surgery with MTC. Contrast‐enhanced computerized tomography (CT) showed the complete absence of blood flow in all tumors subjected to MTC. Needle biopsy one month after MTC confirmed tumor necrosis in all cases. All patients are alive at the time of this report, with the longest survival period being 24 months. In three of eight patients, new tumors were confirmed by angiographic CT at sites separate from the treated tumors. MTC resulted in fewer adverse effects on liver function and less extensive inflammatory reactions than liver resection. Conclusion. Intraoperative MTC appears to be an effective method for inducing local tumor necrosis, and may be of use in combination with palliative surgery for multiple HCC when radical liver resection is not feasible. Cancer 1995;75:794‐800.

The biological malignancy of pancreatic carcinoma was evaluated by determining the score of the argyrophilic nucleolar organizer region (Ag-NOR) in resected specimens, and comparing it with the various clinicopathological factors and long-term results of 38 patients who underwent surgical resection for invasive ductal carcinoma of the pancreas between 1977 and 1992, in whom the Ag-NOR could be stained. The Ag-NOR analysis of pancreatic carcinomas from the 38 patients resulted in a mean Ag-NOR score of 3.82 +/- 0.62, which was significantly (P < 0.01) higher than the mean score of 1.72 +/- 0.28 observed in normal pancreatic tissues obtained from 20 of these patients. The mean Ag-NOR score significantly increased in patients with anterior capsular infiltration (s) (P < 0.01), posterior tissue infiltration (rp) (P < 0.01), and lymph node metastasis (n) (P < 0.05) compared to those without these factors. The rate of curability A or B was only 13.0% in patients with a high Ag-NOR score of > or = 3.80 in comparison to 66.7% in those with a low Ag-NOR score of < 3.80. The 3-year survival rate was significantly (P < 0.05) higher in the low Ag-NOR score group than in the high Ag-NOR score group. These results suggest that the Ag-NOR score can serve as an indicator of the biological malignancy of pancreatic carcinoma, and of the patients' prognosis.

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Background: Epithelial-mesenchymal transition (EMT) is considered a possible mechanism of distant metastasis or resistance of cancer cells to anticancer drugs. Several reports suggest that eribulin methylate (eribulin) promotes mesenchymal-epithelial transition (MET) both in vitro and in vivo and have shown its inhibition of distant metastasis of engrafted carcinoma. However, no reports have examined the effects of eribulin in a clinical setting. The EXPECT-study investigates EMT/MET markers in metastatic breast cancer (MBC) patients using pleural effusion as a method of liquid biopsy. Objectives: In MBC patients with malignant pleural effusion, we attempted to establish EMT/MET markers using the cancer cells in the pleural effusion, to assess the efficacy and safety of eribulin monotherapy, and to verify the EMT/MET markers as biomarkers in eribulin monotherapy. Study design and eligibility criteria: The EXPECT study is a multicenter, open-label, single-arm phase 2 translational study. Eribulin will be administered at 1.4 mg/m2 on Days (D) 1 and 8 for a 3-week cycle (C), and to obtain the cancer cells from the pleural effusion before and after eribulin administration, paired chest drainage will be performed on C1D1 and C1D8. MBC patients, regardless of their subtype, with pleural effusion are eligible for enrollment, and eribulin monotherapy in the study will be administered based on clinical practice. Therefore, there are no special inclusion/exclusion criteria except for the requirement that all patients be naïve to eribulin. Methods: Spun-down cancer cells in the plural effusion will be processed via the cell block method and embedded in paraffin. An immunohistochemical analysis will be performed using candidate antibodies for EMT/MET markers, such as E-cadherin, cytokeratin (CK) 19, and 34betaE12 (CK1, CK5, CK10, CK14) as epithelial markers and N-cadherin, vimentin, Snail, Slug, Twist-1, ZEB1, ZEB2, ALDH1, and HIF-1alpha as mesenchymal markers, which are all concurrently being assessed in another confirmatory study. The changes in EMT/MET marker expression between pre- and post-treatment will be measured, and the relationship between these changes and the clinical outcome, such as the clinical benefit rate (CBR), progression-free survival, and overall survival, will be assessed. Present and target accrual: The study was just approved by the institutional review board in March 2016 and is open for enrollment. The target accrual is 48 patients total, or 4 patients per month. The sample size calculation was not based on statistical consideration, such as power or type I error. As an illustration for the analysis, the relationship between the changes in the EMT/MET markers and the clinical outcome may be investigated by comparing the CBRs in the two groups with substantial and small changes in the marker expression. If we demonstrate CBRs of 38% and 13% in each group, respectively, then statistical significance will be demonstrated with a 0.10 significance level (2-sided). Citation Format: Watanabe J, Ohtani S, Ikeda M, Takahashi M, Moriya T. A phase II, open-label, multicenter, translational study for biomarkers of eribulin mesylate: Evaluation of the utility of monitoring epithelial-to-mesenchymal transition (EMT) markers on tumor cells in the malignant plural effusion of patients with metastatic breast cancer (EXPECT-study) [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr OT1-01-01.

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