A phase II study of S-1 monotherapy as second-line treatment for advanced non-small cell lung cancer.
OBJECTIVE
To assess the efficacy and toxicity of an oral anticancer fluoropyrimidine derivative, S-1, for previously treated patients with advanced non-small cell lung cancer (NSCLC).


METHODS
Patients with advanced (clinical stage IIIB-IV) NSCLC who had previously received one platinum-based chemotherapy were enrolled. S-1 was administered orally at the dosage decided by using the nomogram based on patient BSA b.i.d. for 28 consecutive days, repeated every 6 weeks.


RESULTS
Between August 2005 and July 2007, 50 patients were entered into this study. Six patients achieved partial response (PR), and the overall response rate of eligible patients was 12.5% (6/48) (95% confidence interval (95%CI), 3.1-21.9%). Disease control rate was 39.6% (19/48) (95%CI, 25.7-53.4%). Median progression-free survival was 2.5 months. Median survival time was 8.2 months, and 1-year survival rate was 29.6%. No grade 4 toxicities were encountered. Grade 3 hematological toxicities comprised neutropenia in one patient (2.1%) and anemia in one patient (2.1%). Grade 3 non-hematological toxicities were observed in only five patients (10.4%). Treatment-related death did not occur.


CONCLUSIONS
S-1 is an active and well-tolerated monotherapy for second-line treatment of advanced NSCLC.
Division of Respirology and Allergology, Department of Internal Medicine, School of Medicine, Fujita Health University, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake City, Aichi 470-1192, Japan. totani@fujita-hu.ac.jp
Yoshitaka
Y
Totani
Yuji
Y
Saito
Masamichi
M
Hayashi
Toshihiko
T
Tada
Yasuo
Y
Kohashi
Yuki
Y
Mieno
Atsushi
A
Kato
Hiromi
H
Imizu
Yukiko
Y
Yoneda
Tami
T
Hoshino
Yasuhiro
Y
Uchiyama
Yasuo
Y
Takeuchi
Mitsushi
M
Okazawa
Hiroki
H
Sakakibara
D000284:Administration, Oral; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D004338:Drug Combinations; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid