title: Phase I/II study of oxaliplatin with oral S-1 as first-line therapy for patients with metastatic colorectal cancer.
abstract: Two phase II studies of S-1 monotherapy have shown promising response rates (RR) of 35-40% with good tolerability in patients with untreated metastatic colorectal cancer. To investigate the usefulness of S-1 plus oxaliplatin (SOX) as an alternative to infusional 5-fluorouracil/leucovorin plus oxaliplatin, the recommended dose (RD) of SOX was determined, and its safety and preliminary efficacy were evaluated in a phase I/II study. Oxaliplatin was administered at a dose of 100 mg m(-2) (level 1) or 130 mg m(-2) (level 2) on day 1, and S-1 (80-120) was given twice daily for 2 weeks followed by a 1-week rest. This schedule was repeated every 3 weeks. Level 2 was determined to be the RD. For the 28 patients who received the RD, the median treatment course was 6.5 cycles (2-14), RR of 50% (1 CR and 13 PR: 95% CI 31-69%), with a median progression-free survival of 196 days. Survival rate (1 year) was 79%. Peripheral neuropathy was observed in all patients but with no functional disorders. Major grade 3 or 4 adverse reactions at the RD were neutropaenia (14%), thrombocytopaenia (28%), and diarrhoea (3%). SOX regimen is effective and easily manageable without central vein access.
authors.affiliation: Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo, Japan. yayamada@ncc.go.jp
authors.forename: Y
authors.initials: Y
authors.lastname: Yamada
authors.forename: M
authors.initials: M
authors.lastname: Tahara
authors.forename: T
authors.initials: T
authors.lastname: Miya
authors.forename: T
authors.initials: T
authors.lastname: Satoh
authors.forename: K
authors.initials: K
authors.lastname: Shirao
authors.forename: Y
authors.initials: Y
authors.lastname: Shimada
authors.forename: A
authors.initials: A
authors.lastname: Ohtsu
authors.forename: Y
authors.initials: Y
authors.lastname: Sasaki
authors.forename: Y
authors.initials: Y
authors.lastname: Tanigawara
mesh_terms: D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D004333:Drug Administration Routes; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000077150:Oxaliplatin; D015996:Survival Rate; D013997:Time Factors
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin