• Nobuyuki Yamamoto, Yasumasa Nishimura, Kazuhiko Nakagawa, Kaoru Matsui, and Masahiro Fukuoka.
• Medical Oncology, Kinki University School of Medicine, Osaka, Japan. n.yamamoto@scchr.jp
• Cancer Chemother. Pharmacol. 2006 Sep 1; 58 (3): 285-91.

PurposeWe conducted a phase I study to determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLT) of weekly docetaxel and cisplatin (DOC/CDDP) with concurrent thoracic radiotherapy (TRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).Materials And MethodsThe DOC/CDDP administration schedules consisted of a split schedule (SS) with administration in 3 out of every 4 weeks, and a continuous schedule (CS) with administration every week. TRT was given to a total dose of 60 Gy at 2 Gy per fraction over 6 weeks.ResultsTwenty-one patients entered the study. The patient characteristics were: PS 0/1/2, 6/13/2; Sq/Ad, 16/5; stage IIIA/IIIB, 4/17. The principal DLT was grade3 esophagitis. The MTD of DOC on the SS and CS in combination with CDDP (25 mg/m2/week) was 25 and 20 mg/m(2)/week, respectively. We determined the RD and schedule of DOC/CDDP on the SS to be 20/25 mg/m(2)/week. The serum alpha-1-acid glycoprotein (AAG) concentration values were found to be negatively correlated with the grade of esophagitis. The median survival time was 23.1 months.ConclusionThe chemoradiation regimen tested in this study has promising activity and manageable toxicity. The continuous schedule could not be recommended due to excessive toxicity. The main DLT was esophagitis, and it significantly correlated with the plasma AAG concentration.

34 keywords...

hide…