In patients with locally advanced gastric cancer, perioperative chemotherapy consisting of TAS-118 (S-1 and leucovorin) plus oxaliplatin shows promise with a tolerable safety profile, according to safety and efficacy results of the APOLLO-11 feasibility study to be presented this week at the 2021 Gastrointestinal Cancers Symposium.
While preoperative TAS-118 plus oxaliplatin followed by D2 gastrectomy has been shown to be feasible for patients with gastric cancer, the efficacy of this regimen in the perioperative setting has yet to be established. In the APOLLO-11 trial, a team of researchers led by Daisuke Takahari, MD, of Aichi Cancer Center Hospital in Tokyo, Japan, investigated the efficacy of TAS-118 plus oxaliplatin both before and after D2 gastrectomy.
The trial enrolled 45 patients with locally advanced gastric cancer. Patients received four preoperative courses of TAS-118 40-60 mg/kg, administered orally twice daily for seven days, in combination with 85 mg/m2 oxaliplatin, administered intravenously on the first day of each two-week cycle. After undergoing gastrectomy with D2 lymphadenectomy, patients received 12 courses of postoperative TAS-118 (Step 1) followed by eight courses of TAS-118 in combination with oxaliplatin (Step 2).
The rates of postoperative chemotherapy completion were 90.9% in Step 1 and 80.0% in Step 2. The median relative dose intensity was 83.3% for TAS-118 in Step 1, 69.9% for TAS-118 in Step 2, and 74.3% for oxaliplatin in Step 2. Patients experienced a recurrence-free survival rate of 91.1% and an overall survival rate of 100% at 12 months; at 24 months, the recurrence-free survival rate was 69.1%, and the overall survival rate was 95.5%. Grade 3 adverse events occurring in at least 10% of patients included weight loss (2 patients in Step 1 and 2 patients in Step 2), hypokalemia (3 patients), and neutropenia (2 patients). One patient discontinued postoperative treatment due to adverse events.
"Taken together with the feasibility and efficacy of preoperative chemotherapy, perioperative chemotherapy with TAS-118 plus oxaliplatin with D2 gastrectomy was well tolerated and showed promising efficacy," conclude Dr. Takahari and colleagues.
For More Information
Takahari D, Ohashi M, Takashima A, et al (2021). Feasibility study of TAS-118 plus oxaliplatin as perioperative chemotherapy for patients with locally advanced gastric cancer (APOLLO-11). J Clin Oncol (Gastrointestinal Cancers Symposium Abstracts), 39(suppl_3). Abstract 205.
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