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A multi-center phase II study of S-1 plus paclitaxel as first-line therapy for patients with advanced or recurrent unresectable gastric cancer.

Lee, JJ; Kim, SY; Chung, HC; Lee, KH; Song, HS; Kang, WK; Hong, YS; Choi, IS; Lee, YY; Woo, IS; Choi, JH
Cancer chemotherapy and pharmacology, 63(6):1083-1090, 2009
Journal Title
Cancer chemotherapy and pharmacology
PURPOSE: This study was conducted to evaluate the safety and efficacy of S-1 and paclitaxel combination therapy for patients with advanced gastric cancer. METHODS: Eligible patients had previously untreated advanced or relapsed gastric cancer with measurable lesion(s) and an ECOG PS of 0-2. Treatment consisted of S-1 35 mg/m(2) p.o. b.i.d. on days 1-14 followed by a 7-day off plus paclitaxel 70 mg/m(2) i.v. on days 1 and 8 of a 21-day cycle. RESULTS: Fifty-six patients (M/F = 37/19) were enrolled. The median age was 59 years. The median number of cycles administered was six (range 1-18). Out of the 53 patients evaluated, there was 1 (1.9%) CR, 20 (37.7%) confirmed PRs, 5 (9.4%) unconfirmed PRs, 21 (39.6%) SDs, and 6 (11.3%) PDs. The objective tumor response was 39.6%. The median time to progression was 29 weeks. The median survival was 51 weeks. All 56 patients were assessed for treatment safety. The treatment was well tolerated with grade 3/4 neutropenia in 20%/13%, grade 3 febrile neutropenia in 7%, grade 2/3 diarrhea in 9%/4%, vomiting in 11%/0%, stomatitis in 4%/4%, and neuropathy in 4%/0% of patients. CONCLUSIONS: S-1 and paclitaxel combination treatment is an effective regimen with a favorable toxicity profile in patients with advanced gastric cancer.
MeSH terms
AdultAgedAntineoplastic Combined Chemotherapy Protocols/administration & dosageAntineoplastic Combined Chemotherapy Protocols/adverse effectsAntineoplastic Combined Chemotherapy Protocols/therapeutic use*Drug Administration ScheduleDrug CombinationsFemaleHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasm InvasivenessNeoplasm Recurrence, Local/drug therapy*Neoplasm Recurrence, Local/mortalityNeoplasm Recurrence, Local/pathologyOxonic Acid/administration & dosageOxonic Acid/adverse effectsOxonic Acid/therapeutic usePaclitaxel/administration & dosagePaclitaxel/adverse effectsPaclitaxel/therapeutic useProspective StudiesStomach Neoplasms/drug therapy*Stomach Neoplasms/mortalityStomach Neoplasms/pathologyTegafur/administration & dosageTegafur/adverse effectsTegafur/therapeutic use
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Journal Papers > School of Medicine / Graduate School of Medicine > Hematology-Oncology
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