Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2006-06-13

AUTHORS

K Yamaguchi, T Shimamura, I Hyodo, W Koizumi, T Doi, H Narahara, Y Komatsu, T Kato, S Saitoh, T Akiya, M Munakata, Y Miyata, Y Maeda, H Takiuchi, S Nakano, T Esaki, F Kinjo, Y Sakata

ABSTRACT

The aims of this phase I/II study of docetaxel and S-1 were to determine the dose-limiting toxicity (DLT), maximum-tolerated dose (MTD), and recommended dose (RD) in the phase I part and to explore the tumour response, survival and safety in the phase II part. Patients with histologically- or cytologically confirmed unresectable or recurrent gastric cancer were eligible. Treatment consisted of intravenous docetaxel on day 1 (starting dose 50 mg m−2) and oral S-1 at a fixed dose of 40 mg m−2 twice daily on days 1–14, every 4 weeks up to six cycles. Nine patients took part in the phase I portion of the study. The MTD of docetaxel was determined to be 50 mg m−2, with the DLTs of grade 3 infection associated with grade 3 neutropenia and grade 4 neutropenia during S-1 administration. The RD of docetaxel was 40 mg m−2 in combination with S-1 40 mg m−2 b.i.d. The efficacy and safety of this regimen was therefore assessed in 46 patients with at least one measurable lesion. The overall response rate and estimated median overall survival were 46% (95% CI, 31–61%) and 14.0 months (8.3–17.3 months), respectively. The most common grade 3/4 toxicity was neutropenia (67% of patients), which was predictable and manageable. This regimen showed promising activity with moderate toxicities in advanced gastric cancer. More... »

PAGES

1803-1808

Journal

TITLE

British Journal of Cancer

ISSUE

12

VOLUME

94

Author Affiliations

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/sj.bjc.6603196

DOI

http://dx.doi.org/10.1038/sj.bjc.6603196

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1024588610

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/16773074


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