Abstract
BackgroundRamucirumab has recently proved to be effective for advanced or recurrent gastric cancer (AGC). Ascites and peritoneal metastasis are among the most common complications of AGC. However, there are few data on the safety and efficacy of paclitaxel plus ramucirumab in patients with AGC with ascites. The purpose of this retrospective study was to evaluate the safety and efficacy of paclitaxel plus ramucirumab in patients with AGC with ascites.MethodsWe retrospectively evaluated the safety and efficacy of paclitaxel plus ramucirumab in patients with AGC with ascites in comparison with patients without ascites in a single institution from June 2015 to May 2016. The median progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method, and differences evaluated using the Log-lank test. The differences in baseline characteristics and response rates of each ascites group were calculated for homogeneity by chi-square tests and for trends by Fisher’s exact test.ResultsEighty-three patients were analyzed in this study. Ascites was detected in 40 patients, 26 patients (31%) had small to moderate ascites and 14 (17%) had massive ascites. The proportion of patients who started with a reduced dose of paclitaxel was higher for patients with massive ascites than others. The frequencies of any grade 3 or 4 hematological toxicity were 51% in patients without ascites, 77% in patients with small to moderate ascites, and 71% in patients with massive ascites. The frequencies of common ramucirumab-related adverse events were also not significantly different among ascites groups, however one patient had a tumor hemorrhage, and one patient had a gastrointestinal perforation. PFS and OS were shorter in patients with massive ascites than in patients with small or moderate ascites or patients without ascites.ConclusionsThe use of paclitaxel and ramucirumab in patients with AGC with large amounts of ascites was tolerable with adequate dose modification. However, we should pay attention to the risks of ramucirumab-related toxicity in patients with bleeding tumors or intestinal stenosis.
Highlights
Ramucirumab has recently proved to be effective for advanced or recurrent gastric cancer (AGC)
The first-line treatments for advanced or recurrent gastric cancer (AGC) are combination chemotherapy regimens consisting of fluoropyrimidines and platinum, with or without a third agents [2, 3], but the prognosis for patients with AGC remains poor, with median overall survival (OS) of 12–15 months in Asia [4, 5]
In the RAINBOW trial, which compared paclitaxel plus placebo with paclitaxel plus ramucirumab, patients treated with paclitaxel plus ramucirumab showed significantly longer OS, longer progression-free survival (PFS), and higher response rate (28% vs. 16%) than those treated with paclitaxel alone
Summary
Ramucirumab has recently proved to be effective for advanced or recurrent gastric cancer (AGC). In the RAINBOW trial, which compared paclitaxel plus placebo with paclitaxel plus ramucirumab, patients treated with paclitaxel plus ramucirumab showed significantly longer OS (median, 9.6 vs 7.4 months), longer progression-free survival (PFS) (median, 4.4 vs 2.9 months), and higher response rate (28% vs 16%) than those treated with paclitaxel alone. Based on these results, paclitaxel plus ramucirumab became the standard secondline treatment for AGC. We retrospectively evaluated the safety and efficacy of paclitaxel plus ramucirumab in patients with AGC with ascites
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