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Second-Line Treatment of Advanced Gastric Cancer: Where Do We Stand?

Amit Mahipal, Minsig Choi, and Richard Kim

Gastric cancer is a leading cause of cancer death and is associated with poor prognosis. The treatment of advanced gastric cancer is changing with the development of novel agents. Until recently, no standard treatment was available for patients with advanced gastric cancer in the second-line setting. Single-agent chemotherapy with docetaxel or irinotecan has been shown to improve survival and quality of life in patients whose disease has progressed while on prior chemotherapy. Combination chemotherapy is associated with a modest benefit at the expense of increased toxicity. Recently, ramucirumab, a monoclonal antibody targeting vascular endothelial growth factor (VEGF) receptor-2, has been approved for the treatment of refractory advanced gastric cancer as a single agent or in combination with paclitaxel. Apatinib, a small molecule tyrosine kinase inhibitor targeting VEGF, has demonstrated activity in Asian populations whose disease has progressed on 2 lines of therapy. However, much work is still needed, including the development of biomarkers that could predict response to therapy.

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A Novel Clinically Based Staging System for Gallbladder Cancer

Siddhartha Yadav, Sri Harsha Tella, Anuhya Kommalapati, Kristin Mara, Kritika Prasai, Mohamed Hamdy Mady, Mohamed Hassan, Rory L. Smoot, Sean P. Cleary, Mark J. Truty, Lewis R. Roberts, and Amit Mahipal

Background: Current staging systems for gallbladder cancer (GBC) are primarily based on surgical pathology and therefore are not relevant for unresectable patients and those undergoing neoadjuvant chemotherapy. Methods: Patients with a confirmed diagnosis of GBC managed at a tertiary referral center (2000–2016) were included. Independent predictors of overall survival (OS) were identified using multivariable analysis (MVA). A combination of these variables was then assessed to identify a set of factors that provided maximal accuracy in predicting OS, and a nomogram and a new staging system were created based on these factors. Harrell’s C-statistic was calculated to evaluate the predictive accuracy of the nomogram and staging system. Results: A total of 528 patients were included in the final analysis. On MVA, factors predictive of poor OS were older age, ECOG performance status, hemoglobin level <9 g/dL, presence of metastases, and alkaline phosphatase (ALP) level >200 U/L. A nomogram and a 4-tier staging system predictive of OS were created using age at diagnosis, ECOG status, tumor size, presence or absence of metastasis, and ALP level. The C-statistic for this novel staging system was 0.71 compared with 0.69 for the TNM staging system (P=.08). In patients who did not undergo surgery, the C-statistics of the novel and TNM staging systems were 0.60 and 0.51, respectively (P<.001). Conclusions: We created a novel, clinically based staging system for GBC based on nonoperative information at the time of diagnosis that was superior to the TNM staging system in predicting OS in patients who did not undergo surgery, and that performed on par with TNM staging in surgical patients.

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CLO23-030: MC200402-Single-Arm Phase 2 Study of the FGFR Inhibitor Futibatinib (Futi) in Combination With Pembrolizumab (Pem) in Patients With FGF19 Expressing Advanced or Metastatic Hepatocellular Carcinoma (aHCC)

Nguyen H. Tran, Joseph J Larson, Fang-Shu Ou, Amit Mahipal, Shaylene A. McCue, Rondell P. Graham, Martin E. Fernandez-Zapico, Alexander Revzin, Lionel A. Kankeu Fonkoua, Lynn M. Flickinger, Sean P. Cleary, Tanios S. Bekaii-Saab, Mitesh J. Borad, Robert R. McWilliams, Aminah Jatoi, and Wen Wee Ma

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CLO22-088: Phase II Trial of Trifluridine/Tipiracil in Combination With Irinotecan in Advanced Biliary Tract Cancers (BTCs)

Sri Harsha Tella, Jaclynn Wessling, Foster Nathan, Shi Qian, Tran Nguyen, Robert McWillimas, Alberts Steven, Minetta Liu, Mitesh Borad, Wen Wee Ma, Mindy Hartgers, Leslie Washburn, Fruth Briant, Martin Fernandezzapico, Tara L Hogenson, Henry Pitot, Zhaohui Jin, and Amit Mahipal