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[Phase I study of S-1. S-1 Study Group]
T Taguchi1, Y Inuyama, R Kanamaru
1Osaka University, Japan Society for Cancer Chemotherapy.
Gan to Kagaku Ryoho. Cancer & Chemotherapy
|January 9, 1998
Summary
This Phase I study evaluated S-1, an oral antitumor agent. The recommended dose for further studies is 75 mg twice daily, with myelosuppression as the main dose-limiting toxicity.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- S-1 is a novel oral antitumor agent comprising tegafur (FT), 5-chloro-2,4-dihydroxypyridine (CDHP), and potassium oxonate (Oxo).
- Fluoropyrimidines are a critical class of chemotherapeutic agents used in cancer treatment.
Purpose of the Study:
- To determine the maximum tolerated dose (MTD) and safety profile of S-1 in cancer patients.
- To establish the recommended dose and administration schedule for Phase II clinical trials.
Main Methods:
- A multi-center Phase I clinical trial involving 16 institutions nationwide.
- Evaluation of two administration schedules: once daily and twice daily.
- Assessment of dose-limiting toxicities (DLTs) and adverse events.
Main Results:
- The maximum tolerated dose (MTD) was established at approximately 150-200 mg/day for once-daily dosing and 75-100 mg twice daily for twice-daily dosing.
- Myelosuppression, primarily leukopenia, was the main dose-limiting toxicity for both administration schedules.
- Adverse events like rash and vomiting necessitated treatment discontinuation in some cases, while others like diarrhea and stomatitis were generally mild.
Conclusions:
- Twice-daily administration of S-1 at 75 mg/body for 28 consecutive days with a 14-day rest period was determined as the recommended dose and schedule for Phase II studies.
- S-1 demonstrates a manageable safety profile, with myelosuppression being the primary concern.
- Further investigation in Phase II trials is warranted to evaluate the efficacy of S-1.