[Clinical phase trial of concurrent chemoradiotherapy combined TS-1 and nedaplatin].

Abstract

We have treated head and neck carcinoma by concurrent chemoradiotherapy combined with 5-fluorouracil (5-FU) and cisplatin (CDDP). However,this chemoradiotherapy could not show an enormous effect in the advanced carcinoma of Stage III and IV. Therefore,we changed the contents of the chemotherapy, i.e., we replaced 5-FU, one of the agents with time dependency, to continuous administration of TS-1 for 2 weeks,also replacing CDDP, one of the agents with dose dependency, to nedaplatin (CDGP) in order to reduce kidney dysfunction. In this concurrent chemoradiotherapy, oral TS-1 was continued for 2 weeks and CDGP was administered on the 4 th day from the start of TS-1. In addition, radiotherapy was performed concurrently. In this way,we performed a phase I clinical trial of concurrent chemoradiotherapy combining TS-1 and nedaplatin (CDGP). As for the incidence of adverse events,grade 3 mucositis due to radiation was observed in two patients. As a result of the phase I clinical trial,we decided the maximum-tolerated dose (MTD) of TS-1 to be 80 mg/m2 (maximum 120 mg/body) and 100 mg/m2 for CDGP, and then determined the recommended dose(RD) of TS-1 as 80 mg/m2 (maximum 120 mg/ body) TS-1 and of CDGP as 9 0 mg/m2 CDGP.

• Authors: Hideki Takemura, Sei Kobayashi, Masahiro Katsuno, Rie Asano, Masato Morimoto, Shinya Tachibana, Hayato Kubota, Masaki Iida, Yoshiyuki Kadokura, Takeyuki Sanbe
• Journal: Gan to kagaku ryoho. Cancer & chemotherapy (Gan To Kagaku Ryoho) Vol. 32 Issue 13 Pg. 2065-9 (Dec 2005) ISSN: 0385-0684 [Print] Japan
• PMID: 16352930 (Publication Type: Clinical Trial, Phase I, English Abstract, Journal Article)

Chemical References

• Drug Combinations
• Organoplatinum Compounds
• Pyridines
• S 1 (combination)
• Tegafur
• Oxonic Acid
• nedaplatin

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carcinoma, Squamous Cell (drug therapy, radiotherapy)
• Combined Modality Therapy
• Drug Administration Schedule
• Drug Combinations
• Female
• Head and Neck Neoplasms (drug therapy, radiotherapy)
• Humans
• Male
• Maximum Tolerated Dose
• Middle Aged
• Organoplatinum Compounds (administration & dosage)
• Oxonic Acid (administration & dosage)
• Pyridines (administration & dosage)
• Radiotherapy Dosage
• Tegafur (administration & dosage)