[A phase I/II study of docetaxel/TS-1 with radiation for esophageal cancer patients--step 1].

Abstract

The therapy 5-FU and CDDP with radiation is thought to be the standard therapy for esophageal cancer patients by now. However, the therapy is associated with a comparatively high incidence of gastrointestinal disorders and requires hospitalization. We have proposed a new regimen of Docetaxel and TS-1 with radiation for maintaining of QOL and improving outcome. Step 1 of the clinical phase I/ II study was conducted for 10 cases from May 2004 to March 2006. Treatment could be accomplished in all cases, and no treatment-related deaths or adverse events of grade 4 were observed in any case. As for hematotoxicity, one case had leucopenia of grade 3 and neutropenia of grade 2. As for non-hematotoxic adverse events, anorexia of grade 3 was recognized in one case of level 3. The response rate evaluated by RECIST was 66% (CR in 2 cases, PR in 4 cases), and the rate based on the Guide Lines for the Clinical and Pathologic Studies on Carcinoma of Esophagus by the Japanese Society for Esophageal Cancer was 70% (CR in 3 cases, PR in 4 cases). We assumed that the recommended dosage of TXT was 30 mg/m(2) and that of TS-1 was 60 mg/m(2) with radiotherapy of 60 Gy. This combination therapy may be recommended because of fewer adverse events and a higher responsive rate than the standard therapies. We intend to continue this study to step 2 and 3, and to reveal the response rate and adverse events for more esophageal cancer patients.

• Authors: Hideo Matsumoto, Toshihiro Hirai, Youko Hirabayashi, Haruaki Murakami, Masaharu Higashida, Yukiko Kawabe, Atsushi Urakami, Kazuki Yamashita, Jyunichi Hiratsuka, Yoshinari Imajyo, Tsukasa Tsunoda
• Journal: Gan to kagaku ryoho. Cancer & chemotherapy (Gan To Kagaku Ryoho) Vol. 33 Issue 13 Pg. 2021-6 (Dec 2006) ISSN: 0385-0684 [Print] Japan
• PMID: 17197746 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article)

Chemical References

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

Topics

• Aged
• Anorexia (chemically induced)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Combined Modality Therapy
• Docetaxel
• Drug Administration Schedule
• Drug Combinations
• Esophageal Neoplasms (drug therapy, radiotherapy)
• Humans
• Leukopenia (chemically induced)
• Male
• Maximum Tolerated Dose
• Middle Aged
• Oxonic Acid (administration & dosage)
• Radiotherapy Dosage
• Radiotherapy, Adjuvant
• Taxoids (administration & dosage)
• Tegafur (administration & dosage)