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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

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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.

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Acknowledgments

This study was partially supported by a grant of the Korea Health 21 R&D Project, Ministry of Health & Welfare, Republic of Korea (0412-CR01-0704-0001)

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Authors and Affiliations

  1. Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Republic of Korea

    Jae Jin Lee & Si-Young Kim

  2. Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea

    Hyun-Cheol Chung

  3. Department of Internal Medicine, Yeungnam University Medical Center, Taegu, Republic of Korea

    Kyung-Hee Lee

  4. Department of Internal Medicine, Dongsan Medical Center, Keimyung University, Taegu, Republic of Korea

    Hong-Suk Song

  5. Department of Internal Medicine, Samsung Medical Center, Seoul, Republic of Korea

    Won-Ki Kang

  6. Department of Internal Medicine, Kangnam St. Mary’s Hospital, Seoul, Republic of Korea

    Young-Seon Hong

  7. Department of Internal Medicine, Boramae Hospital, Seoul, South Korea

    In-Sil Choi

  8. Department of Internal Medicine, Hanyang University, Seoul, Republic of Korea

    Young Yeul Lee

  9. Department of Internal Medicine, St. Mary’s Hospital, Seoul, Republic of Korea

    In-Sook Woo

  10. Department of Internal Medicine, Ajou University Hospital, Suwon, Republic of Korea

    Jin-Hyuk Choi

  11. Department of Internal Medicine, Division of Medical Oncology and Hematology, Kyung Hee University Hospital, Wheygee-Dong 1 Dongdaemun-Gu, Seoul, 130-701, Republic of Korea

    Si-Young Kim

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  1. Jae Jin Lee
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  9. Young Yeul Lee
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Corresponding author

Correspondence to Si-Young Kim.

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Lee, J.J., Kim, SY., Chung, HC. et al. 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 Chemother Pharmacol 63, 1083–1090 (2009). https://doi.org/10.1007/s00280-008-0818-3

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  • DOI: https://doi.org/10.1007/s00280-008-0818-3

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