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Performance of outpatient regimen of S-1 in combination with fractional cisplatin for advanced or recurrent gastric cancers: a phase I study.

Abstract：

BACKGROUND:We designed an outpatient regimen consisting of fractional cisplatin in combination with S-1, a novel oral fluoropyrimidine derivative for the treatment of recurrent or advanced gastric cancer and conducted a phase I study to determine the dose limiting toxicities (DLTs) and recommended dose (RD). METHODS:Escalating dosages of cisplatin (15, 20, and 25 mg/m(2), as levels 1, 2, and 3, respectively) were administered over 2 h on days 1, 8, and 15, with a fixed dose of S-1 for 3 consecutive weeks (days 1-21), repeated every 5 weeks. National Cancer Institute common toxicity criteria(NCI-CTC) grade 2 toxicities required treatment delay. Primary first cycle DLTs were defined as NCI-CTC grade 3 or 4 toxicities (except for hemoglobin levels, nausea, and vomiting). RESULTS:Nine patients were initially enrolled, and DLTs did not appear; however, one level-3 patient experienced grade 3 anemia. An additional three patients were enrolled in level 3 to confirm the toxicity profiles, and none experienced DLTs. Toxicity evaluations throughout a total of 62 cycles revealed that grade 1 or 2 hematological toxicities were common, although mostly transient, with recovery without specific treatment. One patient each in levels 1 and 3 required hospitalization due to grade 3 toxicities in the later cycles. Mean dose intensities for S-1 and cisplatin were both more than 91%. There were no treatment-related deaths. The preliminary response rate was 44%. CONCLUSIONS:It was concluded that the RD of cisplatin in this regimen was 25 mg/m(2) (level 3). S-1 in combination with fractional cisplatin is a promising regimen that allows repeated drug administration, in an outpatient setting, for advanced or recurrent gastric cancers. A phase II study of the RD is now under way.

journal_name

Int J Clin Oncol

journal_title

International journal of clinical oncology

authors

Shimoyama S,Imamura K,Hiki N,Yamaguchi H,Mafune K,Kaminishi M

doi

10.1007/s10147-005-0505-x

subject

Has Abstract

pub_date

2005-08-01 00:00:00

pages

251-5

issue

eissn

1341-9625

issn

1437-7772

journal_volume

pub_type

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Performance of outpatient regimen of S-1 in combination with fractional cisplatin for advanced or recurrent gastric cancers: a phase I study.