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Phase II Study of Docetaxel and S-1 (DS) as Neoadjuvant Chemotherapy for Clinical Stage III Resectable Gastric Cancer

  • Gastrointestinal Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

We conducted a phase II trial to evaluate the efficacy and safety of preoperative chemotherapy with docetaxel (DTX) plus S-1 for resectable advanced gastric cancer.

Patients and Methods

A total of 47 patients from 14 centers were centrally registered. Patients received DTX (35 mg/m2) on days 1 and 15, and daily oral administration of S-1 (80 mg/m2/day) for days 1–14 every 4 weeks for two courses, followed by gastrectomy with D2 lymphadenectomy. The primary endpoint was pathological response rate (pRR). This study was registered in the UMIN clinical trial registry (UMIN000000875).

Results

The primary endpoint pRR was 47 % (90 % confidence interval (CI), 34–60 %; p < 0.0001). The response rate to preoperative chemotherapy using Response Evaluation Criteria in Solid Tumors (RECIST) was 34 %. Forty-six patients (98 %) underwent surgery, and curative resection was performed in 44 patients. Thirty-seven patients completed the protocol treatment. The most common toxicities of neoadjuvant chemotherapy were grade 3/4 neutropenia (42 %), febrile neutropenia (4 %), grade 2 anorexia (21 %), and fatigue (15 %). Treatment-related death and operative mortality was not observed in this study.

Conclusions

The combination of docetaxel and S-1 was well tolerated. This is promising as a preoperative chemotherapy regimen for patients with potentially resectable advanced gastric cancer.

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Acknowledgment

We thank all the patients and families who participated in this trial. We are indebted to the physicians and all the clinical study teams at the participating institutions. The following 14 surgical departments participated in the trial: Kumamoto University, National Kyushu Cancer Center, Saiseikai Fukuoka General Hospital, Kyushu University, Hiroshima Red Cross Atomic-bomb Survivors Hospital, Hiroshima City Asa Hospital, Gifu University, Saiseikai Yahata General Hospital, National Kyushu Medical Center, Kyushu Central Hospital, Fukuoka City Hospital, Matsuyama Red Cross Hospital, Oita Red Cross Hospital, and Saiseikai Kumamoto Hospital. We also thank Ms. Satomi Abe for her excellent secretarial assistance at the data center of Kyushu University. This work was supported in part by a Grant-in-Aid from the Ministry of Education, Culture, Sports, Science and Technology of Japan.

Conflict of interest

Yoshihiko Maehara is partly supported by research funding from Sanofi-Aventis and Taiho Pharmaceutical Company. All remaining authors have no conflicts of interest to declare.

Author information

Authors and Affiliations

  1. Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan

    Eiji Oki MD, PhD, FACS, Hiroshi Saeki MD, PhD, Masaru Morita MD, PhD & Yoshihiko Maehara MD, PhD, FACS

  2. Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan

    Yasunori Emi MD, PhD & Noriaki Sadanaga MD, PhD

  3. Department of Gastroenterological Surgery, Kyushu National Medical Center, Fukuoka, Japan

    Tetsuya Kusumoto MD, PhD & Yoshihisa Sakaguchi MD, PhD

  4. Department of Gastroenterological Surgery, National Kyushu Cancer Center Hospital, Fukuoka, Japan

    Manabu Yamamoto MD, PhD

  5. Center of Clinical Research, National Kyushu Cancer Center Hospital, Fukuoka, Japan

    Mototsugu Shimokawa PhD & Takeharu Yamanaka PhD

  6. Department of Surgery, Matsuyama Red Cross Hospital, Matsuyama, Japan

    Ikuo Takahashi MD, PhD

  7. Department of Surgery, Hiroshima City Asa Hospital, Hiroshima, Japan

    Naoki Hirabayashi MD

  8. Department of Clinical Oncology, Saiseikai Kumamoto Hospital, Kumamoto, Japan

    Kenji Sakai MD

  9. Department of Surgery, National Beppu Medical Center, Beppu, Japan

    Hiroyuki Orita MD, PhD

  10. Department of Anatomic Pathology, Pathological Sciences, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan

    Shinichi Aishima MD, PhD

  11. Department of Gastrointestinal Surgery, Kobe University, Kobe, Japan

    Yoshihiro Kakeji MD, PhD, FACS

  12. Department of Surgical Oncology, Gifu University, Gifu, Japan

    Kazuya Yamaguchi MD, PhD & Kazuhiro Yoshida MD, PhD

  13. Department of Gastroenterological Surgery, Kumamoto University, Kumamoto, Japan

    Hideo Baba MD, PhD, FACS

Authors
  1. Eiji Oki MD, PhD, FACS
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  2. Yasunori Emi MD, PhD
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  3. Tetsuya Kusumoto MD, PhD
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  4. Yoshihisa Sakaguchi MD, PhD
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  5. Manabu Yamamoto MD, PhD
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  6. Noriaki Sadanaga MD, PhD
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  7. Mototsugu Shimokawa PhD
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  8. Takeharu Yamanaka PhD
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  9. Hiroshi Saeki MD, PhD
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  10. Masaru Morita MD, PhD
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  11. Ikuo Takahashi MD, PhD
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  12. Naoki Hirabayashi MD
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  13. Kenji Sakai MD
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  14. Hiroyuki Orita MD, PhD
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  15. Shinichi Aishima MD, PhD
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  16. Yoshihiro Kakeji MD, PhD, FACS
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  17. Kazuya Yamaguchi MD, PhD
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  18. Kazuhiro Yoshida MD, PhD
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  19. Hideo Baba MD, PhD, FACS
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  20. Yoshihiko Maehara MD, PhD, FACS
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Corresponding author

Correspondence to Eiji Oki MD, PhD, FACS.

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Oki, E., Emi, Y., Kusumoto, T. et al. Phase II Study of Docetaxel and S-1 (DS) as Neoadjuvant Chemotherapy for Clinical Stage III Resectable Gastric Cancer. Ann Surg Oncol 21, 2340–2346 (2014). https://doi.org/10.1245/s10434-014-3594-9

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  • DOI: https://doi.org/10.1245/s10434-014-3594-9

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