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Second-line chemoimmunotherapy with nivolumab and paclitaxel in immune-related biomarker-enriched advanced gastric cancer: a multicenter phase Ib/II study by Choong-kun Lee; Jii Bum Lee; Se Jung Park; Jingmin Che; Woo Sun Kwon; Hyo Song Kim; Minkyu Jung; Seulkee Lee; Sook Ryun Park; Dong-Hoe Koo; Hyun Woo Lee; Woo Kyun Bae; Hei-Cheul Jeung; In Gyu Hwang; Hyunki Kim; Chung Mo Nam; Hyun Cheol Chung; Sun Young Rha is a Medicine article available to read on EtoBox.
What is Second-line chemoimmunotherapy with nivolumab and paclitaxel in immune-related biomarker-enriched advanced gastric cancer: a multicenter phase Ib/II study about?
Background We conducted a trial to evaluate the efficacy and safety of nivolumab and paclitaxel as second-line therapy for immune-related biomarker-enriched advanced gastric cancer (AGC). Methods This open-label, single-arm, phase Ib/II study was a part of multi-institutional, biomarker-integrated umbrella study conducted in Korea. In phase Ib, patients received nivolumab (3 mg/kg) on Days 1 and 15 and paclitaxel (dose level 1, 70 mg/m 2 or dose level 2, 80 mg/m 2 ) on Days 1, 8, 15 every four weeks. In phase II, patients with Epstein-Barr virusrelated, deficient mismatch repair or programmed cell death-ligand-1-positive AGC were enrolled. The primary endpoints were recommended phase II dose (RP2D, phase Ib) and progression-free survival (PFS, phase II). Secondary endpoints included objective response rate (ORR), overall survival (OS), safety, and exploratory biomarker analysis. Results Dose level 2 was selected as RP2D. In phase II, 48 patients were enrolled. The median PFS and OS were 3.9 and 11.2 months, respectively. The ORR was 23.3%, and the median response duration was 16.7 months. Grade 3 or higher treatment-related adverse events, mainly neutropenia, occurred in 20 patient
Who reads Second-line chemoimmunotherapy with nivolumab and paclitaxel in immune-related biomarker-enriched advanced gastric cancer: a multicenter phase Ib/II study?
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- Author
- Choong-kun Lee; Jii Bum Lee; Se Jung Park; Jingmin Che; Woo Sun Kwon; Hyo Song Kim; Minkyu Jung; Seulkee Lee; Sook Ryun Park; Dong-Hoe Koo; Hyun Woo Lee; Woo Kyun Bae; Hei-Cheul Jeung; In Gyu Hwang; Hyunki Kim; Chung Mo Nam; Hyun Cheol Chung; Sun Young Rha
- Publisher
- Springer Science and Business Media LLC
- Published
- 2023
- Language
- EN
- Field
- Medicine (Health Sciences)