A feasibility trial of postoperative adjuvant chemotherapy with S-1, an oral fluoropyrimidine, for elderly patients with non-small cell lung cancer: a report of the Lung Oncology Group in Kyushu (LOGIK) protocol 0901.
BACKGROUND
The present study was designed to determine whether adjuvant chemotherapy with S-1 after surgical resection is feasible in elderly patients with non-small cell lung cancer (NSCLC), using a multi-institutional trial.


METHODS
From July 2009 to July 2011, 25 patients received the following regimen: 2 weeks of administration and 1 week of withdrawal of S-1 at 50-100 mg/body per day in an outpatient setting. The primary endpoint of this trial was the completion rate of eight cycles.


RESULTS
The completion rate of eight cycles was 70.8 % [95 % confidence interval (CI) 52.7-89.0 %]. The perfect completion rate of eight cycles on schedule with full doses without delays was 50 % (95 % CI 30.0-70.0 %). The reasons for incomplete cycles were: patient refusal in four cases, anorexia in two cases and thrombocytopenia in one case. As a consequence of delays and/or dose reductions, the relative dose intensity of S-1 was 76.3 %.


CONCLUSIONS
Adjuvant chemotherapy with S-1 at a reduced dose and schedule was therefore found to be a feasible treatment for elderly Japanese patients who had undergone surgical resection for NSCLC (UMIN Clinical Trials Registry number UMIN000002383).
Department of Chest Surgery, Steel Memorial Yawata Hospital, Kitakyushu, Japan, ri-maruyama@omutatenryo-hp.jp.
Riichiroh
R
Maruyama
Noriyuki
N
Ebi
Junji
J
Kishimoto
Masato
M
Kato
Tokujiro
T
Yano
Yoshinori
Y
Nagamatsu
Shuichi
S
Tsukamoto
Shinji
S
Akamine
Sho
S
Saeki
Yukito
Y
Ichinose
D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage*; D011013:Pneumonectomy; D011184:Postoperative Period; D016032:Randomized Controlled Trials as Topic; D005641:Tegafur / Q000008:administration & dosage*
D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid