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A multicenter phase II study of biweekly paclitaxel and S-1 combination chemotherapy for unresectable or recurrent gastric cancer

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Abstract

Purpose

This Phase II study assessed the activity and safety of biweekly paclitaxel and oral S-1 as treatment for unresectable and recurrent gastric cancer. The maximum tolerated dose for this regimen had been established previously in a Phase I study performed in Japanese patients.

Patients and methods

Chemotherapy was performed using two anticancer agents, S-1 and paclitaxel. Oral S-1 (80 mg/m2) was administered twice a day after meals for two consecutive weeks from Day 1 to 14, followed by a 2 week recovery period; paclitaxel (120 mg/m2) was administered intravenously, biweekly, on Days 1 and 15. The patient received cycles of this regimen every 4 weeks (q 28-day cycles). The primary end point was the response rate according to the Response Evaluation Criteria in Solid Tumors.

Results

A total of 39 patients (median age, 65 years) were enrolled; 13 other patients were screened, but found to be ineligible. All patients had unresectable and recurrent gastric cancer. The most common treatment-related Grade 3/4 adverse events were neutropenia (37.5%), appetite loss, diarrhea, decreased sodium (each 5%), and anemia, increased alanine aminotransferase, general fatigue, and dizziness (each 2.5%). Almost all the patients experienced alopecia. Intent-to-treat analysis showed a response rate of 43.6%. With a median follow-up of 14 months (range 8–21 months), median survival was 256 days and the median time to progression was 4 months.

Conclusion

A combination regimen of biweekly paclitaxel and oral S-1 was well tolerated and showed promising activity against unresectable and recurrent gastric cancer.

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Acknowledgments

This study was supported by Non-Profit Organization ECRIN (Epidemiological and Clinical Research Information Network). We would like to thank Dr. Morita and Prof. Sakamoto for their support. We would also like to thank our clinical research coordinator (CRC) Miss Masayo Yonemitsu, and Miss Yumi Miyashita, Miss Kanae Nakamura, who are CRC of ECRIN, for their excellent work. And we listed the institutes and doctors participated in this research, and deeply appreciated their cooperation. First Department of Surgery-University of Miyazaki (Dr. Tadaaki Etoh), Kagoshima Kouseiren Hospital (Dr. Masahiro Hamanoue and Shigeho Maenohara), Kitakyushu medical center (Dr. Toshimitsu Iwashita), Sasebo City General Hospital (Dr. Hideaki Komatsu and Dr. Kazuya Yoshida), Department of Digestive Surgery-University of Saga (Dr. Kiyoharu Satoh), Saiseikai Sendai Hospital (Dr. Kuniaki Aridome), Department of Molecular Surgical Oncology- University of Kyushu (Dr. Hiroshi Inoue, Dr. Koshi Mimori), Department of Surgery-University of Ohita (Dr. Tsuyoshi Noguchi) Department of Surgical Oncology-University of Nagasaki (Dr. Tohru Yasutake), Kagoshima Nanpu Hospital (Dr. Toyokuni Suenaga, Dr. Futoshi Miyazono), Miyamikyushu National Hospital (Dr. Yoshito Ogura), Miyazaki social insurance Hospital (Dr. Kazusada Shirao), Isahaya General Hospital (Dr. Keiji Kajiwara), Ekisaikai Nagasaki Hospital (Dr. Hiroyuki Kusano), St. Francisco Hospital (Dr. Takeyuki Ohmagari), Nagasaki Saiseikai Hospital (Dr. Masaaki Zibiki), Imamura Hospital (Dr. Yuzo Kawasaki, Dr. Hidehiro Nomura), Imakiire General Hospital (Dr. Hiroshi Mure, Dr. Katsuo Uemura), Kanoya Medical center (Dr. Yusei Haraguchi), Nigigaoka Hospital (Dr. Haruhiko Nakao), Kumamoto City Hospital (Dr. Kenichiro Baba), Okinawa Prefectural Chubu Hospital (Dr. Masanori Gushimiyagi), Department of Surgery-University of Ryukyu (Dr. Hideaki Shimozi).

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Authors and Affiliations

  1. Department of Surgical Oncology and Digestive Surgery, Kagoshima University Graduate School of Medicine, Mail Stop 8-35-1, Sakuragaoka, Kagoshima, 890-8520, Japan

    Akihiro Nakajo, Shuichi Hokita, Sumiya Ishigami, Futoshi Miyazono, Shoji Natsugoe & Takashi Aikou

  2. First Department of Surgery, Miyazaki University, Miyazaki, Japan

    Tadaaki Etoh

  3. Kagoshima Kouseiren Hospital, Kagoshima, Japan

    Masahiro Hamanoue & Shigeho Maenohara

  4. Kitakyushu Medical Center, Fukuoka, Japan

    Toshimitsu Iwashita

  5. Sasebo City General Hospital, Nagasaki, Japan

    Hideaki Komatsu

  6. Department of Digestive Surgery, Saga University, Saga, Japan

    Kiyoharu Satoh

  7. Saiseikai Sendai Hospital, Kagoshima, Japan

    Kuniaki Aridome

  8. Health and Community Medicine Program, Nagoya University Graduate School of Medicine, Nagoya, Japan

    Satoshi Morita & Junichi Sakamoto

  9. Second Department of Internal Medicine, Osaka Medical College, Osaka, Japan

    Hiroya Takiuchi

  10. First Department of Internal Medicine and Department of Biosystemic Science of Medicine, Kyushu University Graduate School of Medicine, Fukuoka, Japan

    Shyuji Nakano

  11. Department of Surgery and Science, Kyushu University Graduate School of Medicine, Fukuoka, Japan

    Yoshihiko Maehara

Authors
  1. Akihiro Nakajo
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  2. Shuichi Hokita
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  3. Sumiya Ishigami
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  4. Futoshi Miyazono
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  5. Tadaaki Etoh
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  6. Masahiro Hamanoue
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  7. Shigeho Maenohara
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  8. Toshimitsu Iwashita
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  9. Hideaki Komatsu
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  10. Kiyoharu Satoh
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  11. Kuniaki Aridome
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  12. Satoshi Morita
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  13. Shoji Natsugoe
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  14. Hiroya Takiuchi
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  15. Shyuji Nakano
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  16. Yoshihiko Maehara
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  17. Junichi Sakamoto
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  18. Takashi Aikou
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Consortia

Kyushu Taxol, TS-1, Study Group (KTT-SG)

Corresponding author

Correspondence to Akihiro Nakajo.

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Nakajo, A., Hokita, S., Ishigami, S. et al. A multicenter phase II study of biweekly paclitaxel and S-1 combination chemotherapy for unresectable or recurrent gastric cancer. Cancer Chemother Pharmacol 62, 1103–1109 (2008). https://doi.org/10.1007/s00280-008-0693-y

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  • DOI: https://doi.org/10.1007/s00280-008-0693-y

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