A phase I study of concurrent chemoradiotherapy using oral s-1 for head and neck cancer.

Abstract

AIM:

S-1 is a novel oral anticancer agent containing a combination of two modulators and tegafur. We conducted a phase I study of concurrent chemoradiotherapy with S-1 for head and neck cancer.

PATIENTS AND METHODS:

S-1 was administered once daily, and radiotherapy was performed by 2 Gy/day, five days/week, for a total of 30 fractions. S-1 dosage was started at level 1 (55.3 mg/m(2)/day), and was increased to level 2 (66.7 mg/m(2)/day).

RESULTS:

A total of 12 patients were registered. Concerning hematological toxicities, no grade ≥3 or more hematological toxicity was confirmed at any level. With regard to non-hematological toxicities, at level 2, three cases of grade 3 mucositis and two cases of grade 3 dermatitis were confirmed.

CONCLUSION:

The results showed that the maximum tolerated dose was level 2 and that dose-limiting toxicity was mucositis. Having determined that the recommended dose is level 1, we have begun the phase II clinical study.

• Authors: Yasushi Fujimoto, Satoshi Kato, Yoshiyuki Itoh, Shinji Naganawa, Tsutomu Nakashima
• Journal: Anticancer research (Anticancer Res) Vol. 34 Issue 1 Pg. 209-13 (Jan 2014) ISSN: 1791-7530 [Electronic] Greece
• PMID: 24403464 (Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Drug Combinations
• S 1 (combination)
• Tegafur
• Oxonic Acid

Topics

• Adenocarcinoma (pathology, therapy)
• Administration, Oral
• Adult
• Aged
• Carcinoma, Squamous Cell (pathology, therapy)
• Chemoradiotherapy
• Dose Fractionation, Radiation
• Dose-Response Relationship, Drug
• Drug Combinations
• Female
• Follow-Up Studies
• Head and Neck Neoplasms (pathology, therapy)
• Humans
• Male
• Maximum Tolerated Dose
• Middle Aged
• Neoplasm Staging
• Oxonic Acid (therapeutic use)
• Prognosis
• Tegafur (therapeutic use)
• Young Adult