TY - JOUR
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
N1 - Funding Information:
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: Kuma-moto 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.
Funding Information:
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.
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.
UR - http://www.scopus.com/inward/record.url?scp=84902188520&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84902188520&partnerID=8YFLogxK
U2 - 10.1245/s10434-014-3594-9
DO - 10.1245/s10434-014-3594-9
M3 - Article
C2 - 24604583
AN - SCOPUS:84902188520
SN - 1068-9265
VL - 21
SP - 2340
EP - 2346
JO - Annals of Surgical Oncology
JF - Annals of Surgical Oncology
IS - 7
ER -
