Phase II study of docetaxel and S-1 (DS) as neoadjuvant chemotherapy for clinical stage III resectable gastric cancer

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

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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.

Original languageEnglish
Pages (from-to)2340-2346
Number of pages7
JournalAnnals of Surgical Oncology
Volume21
Issue number7
DOIs
Publication statusPublished - Jul 2014

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docetaxel
Stomach Neoplasms
Drug Therapy
Febrile Neutropenia
Anorexia
Gastrectomy
Clinical Protocols
Neutropenia
Lymph Node Excision
Fatigue
Oral Administration
Registries

All Science Journal Classification (ASJC) codes

  • Surgery
  • Oncology

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Phase II study of docetaxel and S-1 (DS) as neoadjuvant chemotherapy for clinical stage III resectable gastric cancer. / Oki, Eiji; Emi, Yasunori; Kusumoto, Tetsuya; Sakaguchi, Yoshihisa; Yamamoto, Manabu; Sadanaga, Noriaki; Shimokawa, Mototsugu; Yamanaka, Takeharu; Saeki, Hiroshi; Morita, Masaru; Takahashi, Ikuo; Hirabayashi, Naoki; Sakai, Kenji; Orita, Hiroyuki; Aishima, Shinichi; Kakeji, Yoshihiro; Yamaguchi, Kazuya; Yoshida, Kazuhiro; Baba, Hideo; Maehara, Yoshihiko.

In: Annals of Surgical Oncology, Vol. 21, No. 7, 07.2014, p. 2340-2346.

Research output: Contribution to journalArticle

Oki, E, Emi, Y, Kusumoto, T, Sakaguchi, Y, Yamamoto, M, Sadanaga, N, Shimokawa, M, Yamanaka, T, Saeki, H, Morita, M, Takahashi, I, Hirabayashi, N, Sakai, K, Orita, H, Aishima, S, Kakeji, Y, Yamaguchi, K, Yoshida, K, Baba, H & Maehara, Y 2014, 'Phase II study of docetaxel and S-1 (DS) as neoadjuvant chemotherapy for clinical stage III resectable gastric cancer', Annals of Surgical Oncology, vol. 21, no. 7, pp. 2340-2346. https://doi.org/10.1245/s10434-014-3594-9
Oki, Eiji ; Emi, Yasunori ; Kusumoto, Tetsuya ; Sakaguchi, Yoshihisa ; Yamamoto, Manabu ; Sadanaga, Noriaki ; Shimokawa, Mototsugu ; Yamanaka, Takeharu ; Saeki, Hiroshi ; Morita, Masaru ; Takahashi, Ikuo ; Hirabayashi, Naoki ; Sakai, Kenji ; Orita, Hiroyuki ; Aishima, Shinichi ; Kakeji, Yoshihiro ; Yamaguchi, Kazuya ; Yoshida, Kazuhiro ; Baba, Hideo ; Maehara, Yoshihiko. / Phase II study of docetaxel and S-1 (DS) as neoadjuvant chemotherapy for clinical stage III resectable gastric cancer. In: Annals of Surgical Oncology. 2014 ; Vol. 21, No. 7. pp. 2340-2346.
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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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T1 - Phase II study of docetaxel and S-1 (DS) as neoadjuvant chemotherapy for clinical stage III resectable gastric cancer

AU - Oki, Eiji

AU - Emi, Yasunori

AU - Kusumoto, Tetsuya

AU - Sakaguchi, Yoshihisa

AU - Yamamoto, Manabu

AU - Sadanaga, Noriaki

AU - Shimokawa, Mototsugu

AU - Yamanaka, Takeharu

AU - Saeki, Hiroshi

AU - Morita, Masaru

AU - Takahashi, Ikuo

AU - Hirabayashi, Naoki

AU - Sakai, Kenji

AU - Orita, Hiroyuki

AU - Aishima, Shinichi

AU - Kakeji, Yoshihiro

AU - Yamaguchi, Kazuya

AU - Yoshida, Kazuhiro

AU - Baba, Hideo

AU - Maehara, Yoshihiko

PY - 2014/7

Y1 - 2014/7

N2 - 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.

AB - 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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