1. Use of nDx 1 Software is only available to partners who are registered separately in Novomics.
2. You must pass the certification procedure on the next screen before you can use the software.
3. Click the "Certification" button to install it automatically on your connection PC.
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The safety and effectiveness of Novomics' nProfiler® 1 Stomach Cancer Assay has been evaluated and validated through clinical trials. The results of the clinical utility were published in the Lancet Oncology and Journal of Gastric Cancer in 2018 and Yonsei Medical Journal in 2019.
Overall survival in the validation cohort by SPC, (A) Overall survival by SPC-prognosis groups. (B) Overall survival by treatment (D2 gastrectomy plus adjuvant chemotherapy or D2 gastrectomy only). (C-D) Overall survival by treatment according to SPC-prediction (C) No benefit group and (D) chemotherapy-benefit group. Abbreviation: SPC, Single Patient Classifier.
CLASSIC (Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy) trial is a phase 3, open-label, randomized, prospective study done at 35 cancer centers, medical centers, and hospitals in China, South Korea, and Taiwan with 1,035 gastric cancer patients between 2006 and 2009 (ClinicalTrials.gov Identifier: NCT03403296).
Of the 1,035 patients with gastric cancer randomized in CLASSIC trial, 629 tumor specimens were obtained and used to evaluate the prognosis classification associated with 5-year overall survival to assess the clinical validity of nProfiler® 1. Using nProfiler® 1, 5-year overall survival was 83.2% in the Low risk group, 74.8% in the Intermediate risk group, and 66.0% in the High risk group (p-value =0.012).
In chemotherapy response prediction with nProfiler® 1, 5-year overall survival was 64.5% in patients who received surgery only versus 80.0% in those who received adjuvant chemotherapy. By contrast, among patients assigned to the no-benefit group by the single patient classifier, 5-year overall survival was similar between patients who received adjuvant chemotherapy and those who did not, as 72.9% and 72.5%, respectively.
In case of patients who assigned into Low risk and no-benefit group, the hazard rates with or without chemotherapy-treated were calculated as 1.12 (p-value=0.72) and 1.65 (p-value=0.40) through the multivariate Cox analysis, in conclusion, patients in Low risk with good prognosis do not benefit from chemotherapy.
Cheong JH, Yang HK, Kim H, Kim WH, Kim YW, Kook MC, Park YK, Kim HH, Lee HS, Lee KH, Gu MJ, Kim HY, Lee J, Choi SH, Hong S, Kim JW, Choi YY, Hyung WJ, Jang E, Kim H, Huh YM, Noh SH. Predictive test for chemotherapy response in resectable gastric cancer: a multi-cohort, retrospective analysis. Lancet Oncol. 2018 May;19(5):629-638.
The prognostic performance of the modified TNM staging system based on nProfiler® 1 was validated in multiple cohorts, which were used in previous studies.
· Discovery Clinical Trial approved by *MFDS (n=307)
· Confirmatory Clinical Trial approved by MFDS (n=652)
· NCT03403296 Clinical Trial (n=625)
* MFDS: Ministry of Food and Drug Safety
187 (11.8%) patients who were classified into Low risk out of 1,584 patients according to nProfiler® 1 underwent one-grade down-staging in the modified TNM staging system to validate prognostic performance.
|TNM Staging System|
Using Harrell's C-index, the prognostic performance of the modified TNM system was evaluated, and the results showed that its prognostic performance was better than that of the TNM staging system in terms of overall survival (0.635 vs. 0.620, p-value<0.001).
With the increase in the knowledge on cancer biology, classic TNM staging, which was only based on anatomical factors, has been modified to include biologic factors that are associated with patient prognoses, and such modified staging systems have been proposed for various cancers. Along with the trend, as well as in gastric cancer, there is the need for an improved predictive test for prognosis and chemotherapy response.
Choi YY, Jang E, Seo WJ, Son T, Kim HI, Kim H, Hyung WJ, Huh YM, Noh SH, Cheong JH. Modification of the TNM Staging
System for Stage II/III Gastric Cancer Based on a Prognostic Single Patient Classifier Algorithm. J Gastric Cancer.
From a total of 1,035 patients enrolled in CLASSIC trial, the medical records of 586 patients, for whom it was possible to identify SPC, MSI and EBV statuses, were reviewed to investigate and evaluate disease-free survival (DFS) in MSI-High, MSS/MSI-Low, EBV-positive and EBV-negative.
MSI-High patients showed a relevantly good prognosis compared to MSS/MSI-Low patients, however, there was no significant difference in prognosis between EBV-positive and EBV-negative. In the analysis of the combinatory prognostic factors; SPC and MSI, different prognoses of Low-, Intermediate-, and high-risk groups obtained from SPC-prognosis were significantly well-preserved in MSS/MSI-Low patients. Low risk/MSS/MSI-Low patients had as good a prognosis as MSI-High patients. Additionally, a combination of SPC and EBV statuses revealed a distinct trend whereby the survival by SPC-prognosis was well-stratified regardless of EBV status.
Kaplan-Meier survival curves for DFS in patients with stage II/III gastric cancer according to (A) status of MSI and (B) status of SPC-prognosis among MSS/MSI-L patients. Abbreviation: DFS, Disease-free survival; MSI, Microsatellite-instability; SPC, Single Patient Classifier; MSS, Microsatellite-stable; MSI-L, Microsatellite instability-Low.
The proportion of MSI-High or EBV-positive patients was slightly higher as 18.6% (13 patients, p-value<0.001) and 31.9% (22 patients, p-value<0.001), respectively, in Low risk than other groups, indicating a positive association with MSI and EBV in Low risk.
MSI is known as a prognostic biomarker in gastric cancer and can be used as a combined marker with the prognosis classification result of nProfiler® 1 Stomach Cancer Assay for a more precise prognostic performance. MSI-High patients in colon cancer are suggested receiving chemotherapy by treatment guidelines in the U.S. and Europe. Thus, a new treatment for MSI-High/no-benefit/Low risk patients is required in treatment guideline for gastric cancer.
Roh CK, Choi YY, Choi S, Seo WJ, Cho M, Jang E, Son T, Kim HI, Kim H, Hyung WJ, Huh YM, Noh SH, Cheong JH. Single Patient Classifier Assay, Microsatellite Instability, and Epstein-Barr Virus Status Predict Clinical Outcomes in Stage
II/III Gastric Cancer: Results from CLASSIC Trial. Yonsei Med J. 2019 Feb;60(2):132-139.