Abstract
Aim: To determine the relationship between gene expression profile (GEP) and overall survival (OS) by NanoString following treatment with Vigil. Patients and Methods: Recurrent ovarian cancer patients (n = 21) enrolled in prior clinical trials. Results: GEP stratified by TISHIGH vs. TISLOW demonstrated OS benefit (NR vs. 5.8 months HR 0.23; p = 0.0379), and in particular, MHC-II elevated baseline expression was correlated with OS advantage (p = 0.038). Moreover, 1-year OS was 75% in TISHIGH patients vs. 25% in TISLOW (p = 0.03795). OS was also correlated with positive γ-IFN ELISPOT response, 36.8 vs. 23.0 months (HR 0.19, p = 0.0098). Conclusion: Vigil demonstrates OS benefit in correlation with TISHIGH score, elevated MHC-II expression and positive γ-IFN ELISPOT in recurrent ovarian cancer patients.
Highlights
Ovarian cancer remains a complex and difficult condition to treat, in part because of the advanced stage at presentation
We explored tumor inflammation score (TIS) profiles and other gene expression signatures in 12 of the 21 recurrent ovarian cancer patients to assess the ability to detect immune-responsive (“hot”) tumors and how it correlates with clinical outcomes in response to Vigil
Continued evidence of overall survival (OS) advantage of more than 6 years was demonstrated in a homogenous group of recurrent/refractory ovarian cancer patients treated with Vigil who had a positive γ-IFN-ELISPOT response
Summary
Ovarian cancer remains a complex and difficult condition to treat, in part because of the advanced stage at presentation. With optimal standard of care treatment, including surgical debulking and adjuvant or neoadjuvant chemotherapy consisting of paclitaxel and carboplatin with or without bevacizumab in newly diagnosed patients with advanced surgically resectable disease, 5-year survival rates are only 48% [2,3]. Patients with stage IV disease have even worse survival, with 5-year rates below 20% [4]. Prognosis in recurrent disease patients is much worse; median survival is near 2 years and focus of management is on quality of life support. Recurrent disease patients are rarely curable, a recent comparison of platinum-sensitive recurrent ovarian cancer patients with the BRCA1/2 mutation in the SOLO-2 study revealed a 5-year overall survival (OS) of 41.6% with the use of olaparib as second-line or greater maintenance compared to standard of care of 33.3% [11]
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