The addition of apatinib to neoadjuvant chemotherapy was both safe and efficacious for locally advanced gastric cancer, according to the results from a study published in JAMA Network Open.
The single-group, open-label, phase 2 clinical trial included 48 patients with stage 2 to stage 4 locally advanced gastric cancer without metastasis (ClinicalTrials.gov Identifier: NCT03192735). Participants received 2 to 5 neoadjuvant cycles and 6 postoperative cycles of apatinib, S-1 (an oral fluoropyrimidine), and oxaliplatin.
The primary endpoint of the study was the rate of patients with a margin-free resection. Secondary endpoints assessed response rates, including radiologic response and pathological response, toxic effects of the drug regimen, and surgical outcomes.
In the per-protocol set, defined as those patients who completed neoadjuvant treatment and underwent surgery, the margin-free resection rate was 90.0% (36/40 patients; 95% CI, 76.3%-97.2%) compared with a rate of only 75.0% (36/48 patients; 95% CI, 60.4%-86.4%) in patients who completed at least one neoadjuvant cycle. A tumor degeneration area of at least one-third was noted in 54.2% (95% CI, 39.2%-68.6%) of patients. A major pathological response, indicating tumor regression greater than 90%, was noted in 25% (95% CI, 13.6%-39.6%) of patients.
The most common adverse events from the treatment regimen were neutropenia (45.8%), leukopenia (43.8%), and increased transaminase levels (41.7%). These adverse events are commonly associated with S-1 and oxaliplatin treatment, independent of the addition of apatinib.
This study was limited by its small sample size and single treatment arm. Additional studies would be needed to determine if similar results would occur with a regimen of apatinib, capecitabine, and oxaliplatin.
While a larger trial is necessary, researchers believe that the addition of apatinib to neoadjuvant S1 and oxaliplatin seems to be a safe and effective option for the treatment of locally advanced gastric cancer.
Lin J, Xu Y, Lin W, et al. Effectiveness and safety of apatinib plus chemotherapy as neoadjuvant treatment for locally advanced gastric cancer. JAMA Network Open. Published online July 9, 2021. doi.10.1001/jamanetworkopen.2021.16240
This article originally appeared on Gastroenterology Advisor