III study of S-1bined with weekly docetaxel in patients with metastatic gastric carcinoma S R Park1, H K Kim1, C G Kim1, I J Choi1, J S Lee1, J H Lee1, K W Ryu1, Y-W Kim1, J-M Bae1 and N K Kim1 1Department of Gastric Cancer, Research Institute and Hospital, National Cancer Center, 809 Madu1, Ilsan, Goyang, Gyeonggi 410-769, Republic of Korea Correspondence to: Dr SR Park, E-mail: Received 4 October 2007; revised 28 January 2008; accepted 24 February 2008; published online 25 March 2008 WE DESIGNED A PHASE III TRIAL OF S-1BINED WITH WEEKLY DOCETAXEL TO DETERMINE THE MAXIMUM TOLERATED DOSE (MTD) AND RMENDED DOSE (RD) AND TO EVALUATE THE EFFICACY AND TOXICITY IN METASTATIC GASTRIC CARCINOMA (MGC).WITH MEASURABLE DISEASE RECEIVED S-1 ORALLY B.ON DAYS 114 AND DOCETAXEL INTRAVENOUSLY ON DAYS 1 AND 8 EVERY 3 WEEKS.PHASE I (_N_=30), EACH COHORT RECEIVED ESCALATING DOSES OF S-1 (3045 MG M-2 B.AND DOCETAXEL (2540 MG M-2); MTD WAS 45 MG M-2 B.MG M-2 DOCETAXEL AND RD WAS 40 MG M-2 B.S-135 MG M-2 DOCETAXEL.TOXICITIES INCLUDED GRADE 3 ELEVATED LIVER ENZYMES, GASTRIC PERFORATION, GRADE 3 DIARRHOEAFATIGUE, FEBRILE NEUTROPENIA WITH GRADE 3 ANOREXIAFATIGUE, AND NEUTROPENIC INFECTION WITH GRADE 3 STOMATITISANOREXIA.PHASE II (_N_=52), THE OVERALL RESPONSE RATE WAS 66.CONFIDENCE INTERVAL (CI): 53.AND THE MEDIAN TIME TO PROGRESSION AND OVERALL SURVIVAL WERE 6.(95% CI: 4.AND 13.(95% CI: 9.RESPECTIVELY.MOSTMON GRADE 34 TOXICITY WAS NEUTROPENIA (29.FEBRILE NEUTROPENIANEUTROPENIC INFECTION OCCURRED IN 19.PATIENTS.WERE GENERALLY MILD.Read more UK valuer wants to crack Aussie market
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