Phase I/II study of docetaxel and S-1 in patients with previously treated non-small cell lung cancer.
BACKGROUND
The aim of this study was to determine and evaluate the recommended dose of docetaxel in combination with a novel oral 5-fluorouracil analogue S-1 and evaluate the efficacy and safety in patients with previously treated non-small cell lung cancer.


METHODS
In phase I, patients with previously treated non-small cell lung cancer were treated with docetaxel (starting dose 40 mg/m) intravenously on day 1 and oral administration of S-1 at a fixed dose of 80 mg/m on days 1 to14 every 3 weeks. The recommended dose was the dose level preceding the maximum tolerated dose; once determined, patients were enrolled in phase II.


RESULTS
The recommended dose of docetaxel was 40 mg/m in combination with S-1 80 mg/m/d. Of 30 patients enrolled in phase II part, 29 patients were eligible and analyzed. No complete response and 7 (24.1%) partial responses were observed, for an overall response rate of 24.1% (95% confidence interval, 10.3-43.5%). Median overall survival was 11.8 months. The 1-year survival rate was 42%. The grade 3 to 4 hematologic toxicities were neutropenia (34.5%), leukopenia (20.6%), and anemia (10.3%). The grade 3 to 4 nonhematological toxicities included fever 2 (6.9%), diarrhea 1 (3.4%), stomatitis 1 (3.4%), cerebral infarction 1 (3.4%), and pneumonitis 1 (3.4%). There was one treatment-related death due to relapse of drug induced pneumonitis.


CONCLUSIONS
This combination chemotherapy is highly active and well tolerated in previously treated patients with non-small cell lung cancer. These results are encouraging and warrant additional investigation.
Atagi
Shinji
S
National Hospital Organization Kinki-Chuo Chest Medical Center, 1180 Nagasone, Sakai, Osaka, 591-8555, Japan. s-atagi@kch.hosp.go.jp
Kawahara
Masaaki
M
Kusunoki
Yoko
Y
Takada
Minoru
M
Kawaguchi
Tomoya
T
Okishio
Kyoiti
K
Kubo
Akihito
A
Uehira
Kazutaka
K
Yumine
Katsuyuki
K
Tomizawa
Yoshio
Y
Saito
Ryusei
R
Fukai
Shimao
S
Komatsu
Hikotaro
H