Department of Pharmacy, National Cancer Center Hospital East, Japan, Kashiwa, Japan
Mashiro Okunaka , Daisuke Kotani , Ken Demachi , Akihito Kawazoe , Takayuki Yoshino , Kohei Shitara
Background: Nanoparticle albumin-bound (nab)- paclitaxel (PTX) was non-inferiority to solvent-based paclitaxel as second-line for advanced gastric cancer (AGC) with fewer infusion-related reactions and a trend toward improved overall survival (OS) in patients (pts) with peritoneal metastasis (PM) or ascites in ABSOLUTE trial (Shitara K et al. Lancet Gastroenterol Hepatol. 2017). Furthermore, safety and efficacies of nab-PTX plus ramucirumab (RAM) was reported in a phase II trial (Bando H, et al. EJC 2018), although no randomised trial with PTX plus RAM is reported so far. Methods: We retrospectively reviewed consecutive pts with AGC receiving nab-PTX plus RAM or PTX plus RAM as second-line chemotherapy from June 2015 to January 2019 at the National Cancer Center Hospital East. Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Progression-free survival (PFS) was calculated using the Kaplan-Meier method, and the differences were evaluated using the log-rank test. Results: A total of 257 pts were included for analysis with 118 pts treated with nab-PTX plus RAM and 139 pts with PTX plus RAM. 151 pts (59%) had peritoneal metastasis and 76 pts (30%) were associated with moderate or massive amounts of ascites. Objective response rates were similar between two groups (nab-PTX plus RAM 34.1% vs. PTX plus RAM 28.0%, p = 0.36). There were no significant differences in PFS (median 3.9 vs. 3.9 months, log-rank p = 0.34; hazard ratio [HR] = 1.14). HR of PFS was 0.96 in pts with PM and 0.79 in pts with moderate or massive ascites. The major grade 3 or higher adverse events were neutropenia (nab-PTX plus RAM 55.1% vs. PTX plus RAM 55.4%), leucopenia (28.8 vs. 35.3%), thrombocytopenia (5.1 vs. 2.9%), and febrile neutropenia (5.1 vs 9.4%). Conclusions: Efficacy and safety of nab-PTX plus RAM were comparable to those of PTX plus RAM in pts with AGC in clinical practice. nab-PTX plus RAM is a treatment option as second-line treatment in pts with AGC.
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