Dose-finding study of docetaxel, oxaliplatin, and S-1 for patients with advanced gastric cancer.
OBJECTIVE
To determine the maximum tolerated dose (MTD), recommended dose (RD), and activity of combined docetaxel, oxaliplatin, and S-1 (DOS) chemotherapy on metastatic gastric cancer.


METHODS
Docetaxel and oxaliplatin were administered intravenously on day 1 and S-1 was administered orally on days 1-14 of every 21-day cycle. The doses of docetaxel/oxaliplatin/S-1 in the phase I study were level -1A, 52.5/80/60 mg/m(2); level -1B, 52.5/80/80 mg/m(2); level 1A, 52.5/105/80 mg/m(2); level 1B, 52.5/130/80 mg/m(2); level 2A, 60/105/80 mg/m(2); level 2B, 60/130/80 mg/m(2); level 3A, 67.5/105/80 mg/m(2); level 3B, 67.5/130/80 mg/m(2); level 4A, 75/105/80 mg/m(2); level 4B, 75/130/80 mg/m(2).


RESULTS
Nine patients were enrolled. One of six patients at level 1A and two of three patients at level 1B developed dose-limiting toxicity (febrile neutropenia) during the initial two cycles. Therefore, the doses used at levels 1B and 1A were defined as the MTD and RD, respectively. All patients were evaluated for toxicity and response. Six partial responses were noted, and the overall response rate was 67%.


CONCLUSIONS
The RD of the DOS regimen in patients with advanced gastric cancer was docetaxel 52.5 mg/m(2) and oxaliplatin 105 mg/m(2) on day 1 and S-1 80 mg/m(2) on days 1-14 of every 21-day cycle. A phase II study using the RD is currently underway.
Zang
Dae Young
DY
Department of Internal Medicine, Hallym University Medical Center and Hallym University College of Medicine, Anyang, South Korea. fhdzang@hallym.or.kr
Yang
Dae Hyun
DH
Kim
Min-Jeong
MJ
Jang
Kyung Mi
KM
Hwang
Se Won
SW
Yoo
Kyo-Sang
KS
Han
Taeho
T
Kim
Ho Young
HY
Kim
Hyo Jung
HJ
Kwon
Jung Hye
JH
Song
Hun Ho
HH
Park
Sarah
S
Jung
Joo Young
JY
Kim
Hyeong Su
HS
Kim
Jung Han
JH
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D005743:Gastrectomy; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000453:epidemiology; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010094:Oxonic Acid / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage
D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D004338:Drug Combinations; D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid