Phase I/II trial with docetaxel and S-1 for patients with advanced or recurrent gastric cancer with consideration to age.
OBJECTIVE
To determine the dose-limiting toxicity (DLT) and activity of combination with docetaxel and S-1 on unresectable gastric cancer.


METHODS
Docetaxel was administered intravenously on day 1 and S-1 was administered orally on days 1-14, every 3 weeks. Doses of each drug in phase I study were docetaxel 60-75 mg/m(2) and S-1 60-80 mg/m(2). A phase II study was conducted with the recommended dose (RD) based on phase I.


RESULTS
Sixty-five patients (median age 54 years) were enrolled. The DLTs were neutropenia with fever or stomatitis. The RD was docetaxel 75 mg/m(2) and S-1 60 mg/m(2). Two patients (aged 66 and 64 years) developed septic shock during the initial part of phase II study. A phase I study at lower dose (docetaxel 60 mg/m(2) and S-1 80 mg/m(2)) was conducted for patients older than 60 years, and this dose was determined as the RD for these patients. In the phase II study, frequent grade 3/4 toxicities were neutropenia (47%) and febrile neutropenia (26%). The overall response rate was 50% (95% CI, 35-66%) and median survival was 15.3 months (95% CI, 10.0-20.6 months).


CONCLUSIONS
Combination with docetaxel and S-1 was active against advanced gastric cancer and gave manageable toxicities.
Zang
Dae Young
DY
Department of lnternal Medicine, Hallym University Medical Center and Hallym University College of Medicine, Anyang, South Korea. fhdzang@hallym.or.kr
Yang
Dae Hyun
DH
Lee
Hae Wan
HW
Hwang
Se Won
SW
Song
Hun Ho
HH
Jung
Joo Young
JY
Kwon
Jung Hye
JH
Kim
Hyo Jung
HJ
Kim
Jung Han
JH
Park
Sa Rah
SR
Kim
Min-Jeong
MJ
Jang
Kyung Mi
KM
Park
Choong Kee
CK
Kim
Jong Hyeok
JH
Lee
Bong Hwa
BH
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077143:Docetaxel; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage; D012008:Recurrence; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage
D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid