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- W2897717900 abstract "Background: We conducted a phase II study to evaluate the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-PTX) plus ramucirumab (RAM) in patients with pre-treated advanced/recurrent gastric cancer (AGC) (trial registration: JapicCTI-153088). The overall response rate (ORR) assessed by the Independent Review Committee (IRC) was 54.8% (90% confidence interval [CI] 41.0-68.0), and the primary endpoint was met (Bando H, et al. Eur J Cancer. 2018; 91:86-91.). Here we report the results of the final analysis (cutoff date: October 31, 2017). Methods: The eligibility criteria were as follows: histologically confirmed unresectable advanced/recurrent gastric adenocarcinoma, refractory to fluoropyrimidine (FU)-containing first-line chemotherapy regimen, and a measurable lesion assessed by RECIST v1.1. Patients received nab-PTX (100 mg/m2 on days 1, 8, and 15 of a 28-day cycle) and RAM (8 mg/kg on days 1 and 15 of a 28-day cycle). Results: Forty-five patients were enrolled, 43 of whom received the study treatment. The median treatment cycle was 6 (range 1-21).The median follow-up time at this final analysis was 13.0 months (range 4.3-20.6 months). The ORR (54.8%) and disease control rate (92.9%) were the same as those in the primary analysis. Median progression-free survival (PFS) assessed by the IRC was 7.6 months (95% CI 5.4-8.1) and median overall survival (OS) was 13.0 months (95% CI 11.3-14.6). Median PFS and OS were 6.3 (95% CI 4.7-9.8) and 12.8 (95% CI 9.7-16.0) months in 30 patients after FU plus platinum as first-line chemotherapy. No unexpected safety signals were observed after long-term follow up. Conclusion: The activity and safety of nab-PTX plus RAM in patients with pre-treated AGC was confirmed in this final analysis. This combination therapy could be a useful second-line treatment option." @default.
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- W2897717900 date "2018-10-01" @default.
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- W2897717900 title "A phase II study of nab-PTX in combination with RAM in patients with pre-treated AGC: results of final analysis" @default.
- W2897717900 doi "https://doi.org/10.1093/annonc/mdy375.005" @default.
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