A Phase I Study of TS-1 Plus Carboplatin in Patients with Advanced Non-Small-Cell Lung Cancer

Abstract

TS-1 is a novel oral anticancer agent comprised of tegafur, a prodrug of 5- flurouracil, and two modulators. A phase i study of tS-1 plus carboplatin combination therapy was conducted to determine the maximum tolerated dose (MTD), recommended dose (RD), and dose limiting toxicities (DLT) in advanced non-small-cell lung cancer (NSClC). TS-1 was given orally at a dose of 80 mg/m(2)/day for 2 weeks, followed by a 2-week rest. Carboplatin was given intravenously on day 8 at a dose of 4.0, 5.0, 6.0 area under the curve (AUC) values. Fifteen patients with advanced NSClC were analyzed. the grade 3-4 toxicities observed during the first cycle were febrile neutropenia (6%), anemia (6%), anorexia (6%), and diarrhea (6%). these toxicities were reversible and manageable. The MTD for carboplatin was evaluated to be more than 6.0 AUC values, as one of six patients developed Dlt at this dose. the RD for carboplatin was estimated as 6.0 AUC values. Objective responses were seen in five patients (response rate 33%).

Feasibility Study of Adjuvant Chemotherapy of S-1 and Carboplatin for Completely Resected Non-Small Cell Lung Cancer

“…Therefore S-1 plus CBDCA is thought to be suitable for outpatient use as adjuvant chemotherapy. Based on the results of an earlier phase I study of S-1 plus CBDCA for advanced lung cancer, we selected a recommended dose of S-1 (40 mg/m 2 twice per day) on days 1-14 of every 4-week cycle, and a recommended dose of CBDCA [area under the curve (AUC) of 6] on day 8 [6]. The patients in this phase I study had a response rate of 29% and were able to stay on the regimen continuously without adverse events.…”

Efficacy of Paclitaxel plus TS1 against previously treatedEGFRmutated non-small cell lung cancer

“…TS-1 is an oral anticancer agent that contained tegafur, gimeracil, and oteracil potassium (Ohba et al, 2009; Yoshioka et al, 2013). As a pro-drug of 5-FU, the mechanism is to inhibit DNA synthesis during S phase of the cell cycle (Focaccetti et al, 2015).…”