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01-07-2014 | Gastrointestinal Oncology

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

Authors: Eiji Oki, MD, PhD, FACS, Yasunori Emi, MD, PhD, Tetsuya Kusumoto, MD, PhD, Yoshihisa Sakaguchi, MD, PhD, Manabu Yamamoto, MD, PhD, Noriaki Sadanaga, MD, PhD, Mototsugu Shimokawa, PhD, Takeharu Yamanaka, PhD, Hiroshi Saeki, MD, PhD, Masaru Morita, MD, PhD, Ikuo Takahashi, MD, PhD, Naoki Hirabayashi, MD, Kenji Sakai, MD, Hiroyuki Orita, MD, PhD, Shinichi Aishima, MD, PhD, Yoshihiro Kakeji, MD, PhD, FACS, Kazuya Yamaguchi, MD, PhD, Kazuhiro Yoshida, MD, PhD, Hideo Baba, MD, PhD, FACS, Yoshihiko Maehara, MD, PhD, FACS

Published in: Annals of Surgical Oncology | Issue 7/2014

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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Title: Phase II Study of Docetaxel and S-1 (DS) as Neoadjuvant Chemotherapy for Clinical Stage III Resectable Gastric Cancer
Authors: Eiji Oki, MD, PhD, FACS
Yasunori Emi, MD, PhD
Tetsuya Kusumoto, MD, PhD
Yoshihisa Sakaguchi, MD, PhD
Manabu Yamamoto, MD, PhD
Noriaki Sadanaga, MD, PhD
Mototsugu Shimokawa, PhD
Takeharu Yamanaka, PhD
Hiroshi Saeki, MD, PhD
Masaru Morita, MD, PhD
Ikuo Takahashi, MD, PhD
Naoki Hirabayashi, MD
Kenji Sakai, MD
Hiroyuki Orita, MD, PhD
Shinichi Aishima, MD, PhD
Yoshihiro Kakeji, MD, PhD, FACS
Kazuya Yamaguchi, MD, PhD
Kazuhiro Yoshida, MD, PhD
Hideo Baba, MD, PhD, FACS
Yoshihiko Maehara, MD, PhD, FACS
Publication date: 01-07-2014
Publisher: Springer US
Published in: Annals of Surgical Oncology / Issue 7/2014
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI: https://doi.org/10.1245/s10434-014-3594-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Patients and Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Patients and Methods

Results

Conclusions

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