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• W2250145019 abstract "e18097 Background: Recently, the elderly population, including the number of elderly patients with lung cancer, has increased. Among the cases with advanced cancers, there are a number of patients for whom potent chemotherapy cannot be applied. TS-1 is an oral antitumor agent that combines tegafur, a prodrug of 5-FU, with gimeracil which inhibits dihydropyrimidine dehydrogenase activity, and oteracil potassium which reduces gastrointestinal toxicity, in a molar ratio of 1:0.4:1. The rate of response to treatment with TS-1 was reported to be 22% in patients with advanced non-small cell lung cancer (NSCLC). Thus it has been concluded that TS-1 monotherapy is one of the promising therapeutic modalities that can be applied to NSCLC. The purpose of the present study was to evaluate the safety of TS- 1 monotherapy applied as the initial treatment for advanced NSCLC in the oldest old, determine its recommended dosage (RD), and investigate the efficacy and safety of this RD. Methods: The subjects were those patients aged 75 years or older suffering from advanced NSCLC with PS 0-1 but without a severe organ dysfunction. Phase I: For the initial treatment, TS-1 monotherapy was conducted to estimate its RD. Phase II: The efficacy and safety of this TS-1 monotherapy were evaluated at the dosage determined above. TS-1 was administered via the oral route continually for 14 days, followed by withdrawal for 7 days. This regimen constituted one course. Drug administration was continued in this manner until PD was occurred or the standard for adverse effects forced drug withdrawal or the condition warranted it. Results: Consequent to Phase I trial, RD was determined to be 80 mg/m2. The trial was followed by phase II trial. There were 23 patients who were composed of the following: males (15) and females (8); age, 77 to 88 years (mean, 81.2); adenocarcinoma (19) and squamous cell carcinoma (4); neoplasm stages of IIIA (2), IIIB (6) and IV (15); PR, 10.5% (2 of 19 patients); DCR, 89.5% (16 of 19 patients); MST, 210 days. No serious adverse effects were noted in any of the 23 patients. Conclusions: This therapeutic modality may be safe and effective when applied to aged patients with advanced NSCLC. No significant financial relationships to disclose." @default.
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• W2250145019 date "2010-05-20" @default.
• W2250145019 modified "2023-09-25" @default.
• W2250145019 title "Phase I/II trial on TS-1 monotherapy for aged patients with advanced non-small cell lung cancer." @default.
• W2250145019 doi "https://doi.org/10.1200/jco.2010.28.15_suppl.e18097" @default.
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