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

Jae Jin Lee, Si Young Kim, Hyun Cheol Chung, Kyung Hee Lee, Hong Suk Song, Won Ki Kang, Young Seon Hong, In Sil Choi, Young Yeul Lee, In Sook Woo, Jin Hyuk Choi

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Abstract

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/m2 p.o. b.i.d. on days 1-14 followed by a 7-day off plus paclitaxel 70 mg/m2 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.

Original languageEnglish
Pages (from-to)1083-1090
Number of pages8
JournalCancer Chemotherapy and Pharmacology
Volume63
Issue number6
DOIs
Publication statusPublished - 2009 May 1

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All Science Journal Classification (ASJC) codes

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

Cite this

Lee, J. J., Kim, S. Y., Chung, H. C., Lee, K. H., Song, H. S., Kang, W. K., Hong, Y. S., Choi, I. S., Lee, Y. Y., Woo, I. S., & Choi, J. H. (2009). A multi-center phase II study of S-1 plus paclitaxel as first-line therapy for patients with advanced or recurrent unresectable gastric cancer. Cancer Chemotherapy and Pharmacology, 63(6), 1083-1090. https://doi.org/10.1007/s00280-008-0818-3