Yamaguchi K, et al. - This study entailed an investigation of the efficacy and safety of ramucirumab monotherapy in Japanese patients with advanced gastric cancer. Findings unveiled that ramucirumab monotherapy exhibited clinical activity and a manageable safety profile in Japanese patients with gastric cancer after disease progression following first-line chemotherapy.

Methods

• The scheme of this research was a multicenter, open-label, nonrandomized phase 2 study.
• It was carried out at 16 Japanese sites.
• Herein, individuals with advanced gastric or gastroesophageal junction cancer after disease progression following first-line chemotherapy received intravenous ramucirumab 8 mg/kg every 2 weeks.
• The 12-week progression-free survival rate (PFS) served as the primary efficacy outcome.

Results

• Researchers recruited 36 subjects.
• It was determined that the 12-week PFS rate was 23.8% [90% confidence interval (CI) 12.4-37.2).
• Data revealed that the primary outcome was not met since the lower limit of the CI was outside the threshold of 16%.
• Median PFS was reported to be 6.6 weeks (90% CI 6.1-7.1).
• An objective response was not obtained from any patients, and 11 (31%) patients achieved disease control.
• It was reported that the median overall survival was 8.6 months (90% CI 5.7-10.7).
• Diarrhea (9/36; 25%) and decreased appetite (8/36; 22%) were discovered to be the most frequent treatment-emergent adverse events (TEAEs).
• Grade ≥ 3 ileus was found in 3 patients; all other Grade ≥ 3 TEAEs were reported by ≤ 2 patients.
• Findings demonstrated that the most frequent adverse events of special interest (AESIs) were hypertension (10/36; 28%), bleeding/hemorrhage (7/36; 19%), and proteinuria (7/36; 19%).
• As per the results, all Grade ≥ 3 AESIs were reported by ≤ 2 patients.