Phase II Study of Docetaxel and S-1 (DS) as Neoadjuvant Chemotherapy for Clinical Stage III Resectable Gastric Cancer
详细信息 查看全文
- 作者：Eiji Oki MD ; PhD ; FACS (1)
Yasunori Emi MD ; PhD (2)
Tetsuya Kusumoto MD ; PhD (3)
Yoshihisa Sakaguchi MD ; PhD (3)
Manabu Yamamoto MD ; PhD (4)
Noriaki Sadanaga MD ; PhD (2)
Mototsugu Shimokawa PhD (5)
Takeharu Yamanaka PhD (5)
Hiroshi Saeki MD ; PhD (1)
Masaru Morita MD ; PhD (1)
Ikuo Takahashi MD ; PhD (6)
Naoki Hirabayashi MD (7)
Kenji Sakai MD (8)
Hiroyuki Orita MD ; PhD (9)
Shinichi Aishima MD ; PhD (10)
Yoshihiro Kakeji MD ; PhD ; FACS (11)
Kazuya Yamaguchi MD ; PhD (12)
Kazuhiro Yoshida MD ; PhD (12)
Hideo Baba MD ; PhD ; FACS (13)
Yoshihiko Maehara MD ; PhD ; FACS (1) - 刊名：Annals of Surgical Oncology
- 出版年：2014
- 出版时间：July 2014
- 年：2014
- 卷：21
- 期：7
- 页码：2340-2346
- 全文大小：
- 参考文献：1. Pisani P, Parkin DM, Bray F, Ferlay J. Estimates of the worldwide mortality from 25 cancers in 1990. / Int J Cancer. 1999;83:18-9. 10.1002/(SICI)1097-0215(19990924)83:1<18::AID-IJC5>3.0.CO;2-M" target="_blank" title="It opens in new window">CrossRef
2. Yoshikawa T, Sasako M. Gastrointestinal cancer: adjuvant chemotherapy after D2 gastrectomy for gastric cancer. / Nat Rev Clin Oncol. 2012;9:192-4. 10.1038/nrclinonc.2012.23" target="_blank" title="It opens in new window">CrossRef
3. Songun I, Putter H, Kranenbarg EM, Sasako M, van de Velde CJ. Surgical treatment of gastric cancer: 15-year follow-up results of the randomised nationwide Dutch D1D2 trial. / Lancet Oncol. 2010;11:439-9. 10.1016/S1470-2045(10)70070-X" target="_blank" title="It opens in new window">CrossRef
4. Sasako M, Sano T, Yamamoto S, Kurokawa Y, Nashimoto A, Kurita A et al. D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer. / N Engl J Med. 2008;359:453-2. 10.1056/NEJMoa0707035" target="_blank" title="It opens in new window">CrossRef
5. Sasako M, Sakuramoto S, Katai H, Kinoshita T, Furukawa H, Yamaguchi T, et al. Five-year outcomes of a randomized phase III trial comparing adjuvant chemotherapy with S-1 versus surgery alone in stage II or III gastric cancer. / J Clin Oncol. 2011;29:4387-3. 10.1200/JCO.2011.36.5908" target="_blank" title="It opens in new window">CrossRef
6. Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, et al. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. / N Engl J Med. 2007;357:1810-0. 10.1056/NEJMoa072252" target="_blank" title="It opens in new window">CrossRef
7. Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, et al. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. / Lancet. 2012;379:315-1. 10.1016/S0140-6736(11)61873-4" target="_blank" title="It opens in new window">CrossRef
8. Maehara Y. S-1 in gastric cancer: a comprehensive review. / Gastric Cancer. 2003;6:2-. 10.1007/s10120-003-0232-9" target="_blank" title="It opens in new window">CrossRef
9. Boku N, Yamamoto S, Fukuda H, Shirao K, Doi T, Sawaki A, et al. Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomised phase 3 study. / Lancet Oncol. 2009;10:1063-069. 10.1016/S1470-2045(09)70259-1" target="_blank" title="It opens in new window">CrossRef
10. Takahashi I, Emi Y, Kakeji Y, Tokunaga E, Ushiro S, Oki E, et al. Phase I study of S-1 and biweekly docetaxel combination chemotherapy for advanced and recurrent gastric cancer. / Oncol Rep. 2006;15:849-4.
11. Takahashi I, Emi Y, Kakeji Y, Uchida J, Fukushima M, Maehara Y. Increased antitumor activity in combined treatment TS-1 and docetaxel. A preclinical study using gastric cancer xenografts. / Oncology. 2005;68:130-7. 10.1159/000086767" target="_blank" title="It opens in new window">CrossRef
12. Kakeji Y, Oki E, Egashira A, Sadanaga N, Takahashi I, Morita M, et al. Phase II study of biweekly docetaxel and S-1 combination therapy for advanced or recurrent gastric cancer. / Oncology. 2009;77:49-2. 10.1159/000226111" target="_blank" title="It opens in new window">CrossRef
13. Kunisaki C, Takahashi M, Makino H, Oshima T, Fujii S, Takagawa R, et al. Phase II study of biweekly docetaxel and S-1 combination chemotherapy as first-line treatment for advanced gastric cancer. / Cancer Chemother Pharmacol. 2011;67:1363-. 10.1007/s00280-010-1433-7" target="_blank" title="It opens in new window">CrossRef
14. Yoshida K, Ninomiya M, Takakura N, Hirabayashi N, Takiyama W, Sato Y, et al. Phase II study of docetaxel and S-1 combination therapy for advanced or recurrent gastric cancer. / Clin Cancer Res. 2006;12:3402-. 10.1158/1078-0432.CCR-05-2425" target="_blank" title="It opens in new window">CrossRef
15. Tsuburaya A, Nagata N, Cho H, Hirabayashi N, Kobayashi M, Kojima H, et al. Phase II trial of paclitaxel and cisplatin as neoadjuvant chemotherapy for locally advanced gastric cancer. / Cancer Chemother Pharmacol. 2013;71:1309-4. 10.1007/s00280-013-2130-0" target="_blank" title="It opens in new window">CrossRef
16. Yoshikawa T, Taguri M, Sakuramoto S, Kunisaki C, Fukunaga T, Ito S, et al. A comparison of multimodality treatment: two and four courses of neoadjuvant chemotherapy using S-1/CDDP or S-1/CDDP/docetaxel followed by surgery and S-1 adjuvant chemotherapy for macroscopically resectable serosa-positive gastric cancer: a randomized phase II trial (COMPASS-D trial). / Jpn J Clin Oncol. 2012;42:74-. 10.1093/jjco/hyr166" target="_blank" title="It opens in new window">CrossRef
17. Yoshikawa T, Sasako M, Yamamoto S, Sano T, Imamura H, Fujitani K, et al. Phase II study of neoadjuvant chemotherapy and extended surgery for locally advanced gastric cancer. / Br J Surg. 2009;96:1015-2. 10.1002/bjs.6665" target="_blank" title="It opens in new window">CrossRef
18. Kochi M, Fujii M, Kanamori N, Kaiga T, Takahashi T, Kobayashi M, et al. Neoadjuvant chemotherapy with S-1 and CDDP in advanced gastric cancer. / J Cancer Res Clin Oncol. 2006;132:781-. 10.1007/s00432-006-0126-4" target="_blank" title="It opens in new window">CrossRef
19. Japanese Gastric Cancer Association. Japanese classification of gastric carcinoma-nd English edition–response assessment of chemotherapy and radiotherapy for gastric carcinoma: clinical criteria. / Gastric Cancer. 2001;4:1-. 10.1007/s101200100009" target="_blank" title="It opens in new window">CrossRef
20. Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2010 (ver. 3). / Gastric Cancer. 2011;14:113-3.
21. Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, et al. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. / N Engl J Med. 2006;355:11-0. 10.1056/NEJMoa055531" target="_blank" title="It opens in new window">CrossRef
22. Ychou M, Boige V, Pignon JP, Conroy T, Bouche O, Lebreton G, et al. Perioperative chemotherapy compared with surgery alone for resectable gastroesophageal adenocarcinoma: an FNCLCC and FFCD multicenter phase III trial. / J Clin Oncol. 2011;29:1715-1. 10.1200/JCO.2010.33.0597" target="_blank" title="It opens in new window">CrossRef
23. Yamaguchi K, Shimamura T, Hyodo I, Koizumi W, Doi T, Narahara H, et al. Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer. / Br J Cancer. 2006;94:1803-. 10.1038/sj.bjc.6603196" target="_blank" title="It opens in new window">CrossRef
24. Kurokawa Y, Sasako M, Ando N, Sano T, Igaki H, Iwasaki Y, et al. Validity of response criteria in neoadjuvant chemotherapy against gastric and esophageal cancer: Correlative analyses of multicenter JCOG trial. In: Gastrointestinal Cancers Symposium. Orlando: 2009. p. Abst. 11.
25. Fujitani K, Sasako M, Iwasaki Y, Yoshimura K, Sano T, Nashimoto A et al. A phase II study of preoperative chemotherapy (CX) with S-1 and cisplatin followed by gastrectomy for clinically resectable type 4 and large type 3 gastric cancer: JCOG 0210. In ASCO Annual Meeting. Chicago: 2007; 4609. - 作者单位：Eiji Oki MD, PhD, FACS (1)
Yasunori Emi MD, PhD (2)
Tetsuya Kusumoto MD, PhD (3)
Yoshihisa Sakaguchi MD, PhD (3)
Manabu Yamamoto MD, PhD (4)
Noriaki Sadanaga MD, PhD (2)
Mototsugu Shimokawa PhD (5)
Takeharu Yamanaka PhD (5)
Hiroshi Saeki MD, PhD (1)
Masaru Morita MD, PhD (1)
Ikuo Takahashi MD, PhD (6)
Naoki Hirabayashi MD (7)
Kenji Sakai MD (8)
Hiroyuki Orita MD, PhD (9)
Shinichi Aishima MD, PhD (10)
Yoshihiro Kakeji MD, PhD, FACS (11)
Kazuya Yamaguchi MD, PhD (12)
Kazuhiro Yoshida MD, PhD (12)
Hideo Baba MD, PhD, FACS (13)
Yoshihiko Maehara MD, PhD, FACS (1)
1. Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan
2. Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan
3. Department of Gastroenterological Surgery, Kyushu National Medical Center, Fukuoka, Japan
4. Department of Gastroenterological Surgery, National Kyushu Cancer Center Hospital, Fukuoka, Japan
5. Center of Clinical Research, National Kyushu Cancer Center Hospital, Fukuoka, Japan
6. Department of Surgery, Matsuyama Red Cross Hospital, Matsuyama, Japan
7. Department of Surgery, Hiroshima City Asa Hospital, Hiroshima, Japan
8. Department of Clinical Oncology, Saiseikai Kumamoto Hospital, Kumamoto, Japan
9. Department of Surgery, National Beppu Medical Center, Beppu, Japan
10. Department of Anatomic Pathology, Pathological Sciences, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
11. Department of Gastrointestinal Surgery, Kobe University, Kobe, Japan
12. Department of Surgical Oncology, Gifu University, Gifu, Japan
13. Department of Gastroenterological Surgery, Kumamoto University, Kumamoto, Japan - ISSN：1534-4681
文摘
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 1-4 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), 34-0?%; 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.