Long-term results of a randomized controlled trial comparing neoadjuvant Adriamycin, cisplatin, and 5-fluorouracil vs docetaxel, cisplatin, and 5-fluorouracil followed by surgery for esophageal cancer (OGSG1003)

Sugimura, Keijiro; Yamasaki, Makoto; Yasuda, Takushi; Yano, Masahiko; Hirao, Motohiro; Fujitani, Kazumasa; Kimura, Yutaka; Miyata, Hiroshi; Motoori, Masaaki; Takeno, Atsushi; Shiraishi, Osamu; Makino, Tomoki; Kii, Takayuki; Tanaka, Koji; Satoh, Taro; Mori, Masaki; Doki, Yuichiro

doi:https://doi.org/10.1002/ags3.12388

Long-term results of a randomized controlled trial comparing neoadjuvant Adriamycin, cisplatin, and 5-fluorouracil vs docetaxel, cisplatin, and 5-fluorouracil followed by surgery for esophageal cancer (OGSG1003)

Sugimura, Keijiro; Yamasaki, Makoto; Yasuda, Takushi et al.

Annals of Gastroenterological Surgery, 2020, 5(1), 75-82

Number of Access:2,370（2025-07-18 17:11 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/78301

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Title	Long-term results of a randomized controlled trial comparing neoadjuvant Adriamycin, cisplatin, and 5-fluorouracil vs docetaxel, cisplatin, and 5-fluorouracil followed by surgery for esophageal cancer (OGSG1003)
Creator	NRID 1000000571374 1000000571374 CreatorName Sugimura, Keijiro
	NRID 1000050444518 1000050444518 CreatorName Yamasaki, Makoto
	NRID 1000010324782 1000010324782 CreatorName Yasuda, Takushi
	NRID 1000070273646 1000070273646 CreatorName Yano, Masahiko
	CreatorName Hirao, Motohiro
	CreatorName Fujitani, Kazumasa
	NRID 1000080716994 1000080716994 CreatorName Kimura, Yutaka
	NRID 1000080362713 1000080362713 CreatorName Miyata, Hiroshi
	CreatorName Motoori, Masaaki
	CreatorName Takeno, Atsushi
	NRID 1000070388536 1000070388536 CreatorName Shiraishi, Osamu
	NRID 1000080528620 1000080528620 researchmap permalink _-_-_- _-_-_- Scopus Author ID 56339970700 56339970700 CreatorName Makino, Tomoki
	CreatorName Kii, Takayuki
	NRID 1000070621019 1000070621019 ORCID 0000-0001-5178-9388 0000-0001-5178-9388 researchmap permalink koji_tanaka koji_tanaka Scopus Author ID 55628548952 55628548952 CreatorName Tanaka, Koji
	CreatorName Satoh, Taro
	NRID 1000070190999 1000070190999 CreatorName Mori, Masaki
	NRID 1000020291445 1000020291445 researchmap permalink ydoki3251 ydoki3251 Scopus Author ID 7006390687 7006390687 CreatorName Doki, Yuichiro
Subject	esophageal cancer
	neoadjuvant chemotherapy
	squamous cell carcinoma
Description	Sugimura, K, Yamasaki, M, Yasuda, T, et al. Long‐term results of a randomized controlled trial comparing neoadjuvant Adriamycin, cisplatin, and 5‐fluorouracil vs docetaxel, cisplatin, and 5‐fluorouracil followed by surgery for esophageal cancer (OGSG1003). Ann. Gastroenterol. Surg. 2020; 00: 1– 8. https://doi.org/10.1002/ags3.12388.
Abstract	Aim: The aim is to report the long-term outcomes of preoperative cisplatin and fluorouracil plus docetaxel (DCF) vs Adriamycin (ACF) for resectable esophageal squamous cell carcinoma (ESCC). Previously, this trial showed that DCF is associated with prolonged recurrence-free survival (RFS). Methods: Patients were randomly assigned to two cycles of ACF (35 mg/m2 of Adriamycin, 70 mg/m2 of cisplatin intravenously on day 1, and 700 mg/m2 of fluorouracil infusion for 7 days) every 4 weeks or DCF (70 mg/m2 of docetaxel, 70 mg/m2 of cisplatin intravenously on day 1, and 700 mg/m2 of fluorouracil infusion for 5 days) every 3 weeks, followed by surgery. The primary endpoint was RFS. The secondary endpoint was overall survival (OS). Results: Between October 2011 and October 2013, 162 patients at 10 institutions were enrolled in the study, 162 of whom were eligible and randomly assigned to the two groups. The median follow-up for surviving patients was 69.8 months. The 5-year RFS was significantly better in the DCF group than in the ACF group (59.9% vs 40.7%, hazard ratio [HR] 0.55; 95% confidence interval [CI], 0.35-0.86; P =.009) and the 5-year OS was significantly better in the DCF group than in the ACF group (63.5% vs 49.4%, HR, 0.61; 95% CI, 0.38-0.96; P =.03). The benefit of DCF chemotherapy on survival was significantly greater in the subgroups with more advanced clinical T and N stage. Conclusions: Cisplatin and fluorouracil plus docetaxel are associated with better RFS and OS than ACF in resectable ESCC patients.
Publisher	John Wiley & Sons
Source Title	Annals of Gastroenterological Surgery
Volume (Issue)	5(1)
Page	75-82
Date of Issued	2020-11-28
Language	English
Handle URL	https://hdl.handle.net/11094/78301
eISSN	24750328
Relation.isIdenticalTo	DOI (Publisher Version) https://doi.org/10.1002/ags3.12388
Access Rights	open access
CopyRight	© 2020 The Authors. This article is licensed under a Creative Commons Attribution 4.0 International License.
oaire:version	Version of Record
Category	学術雑誌論文 Journal Article

Resource Type	journal article
Local Type	Journal Article
DCMI Type	Text
DCTERMS.bibliographicCitation	Annals of Gastroenterological Surgery. 2020, 5(1), p. 75-82
DC.title	Long-term results of a randomized controlled trial comparing neoadjuvant Adriamycin, cisplatin, and 5-fluorouracil vs docetaxel, cisplatin, and 5-fluorouracil followed by surgery for esophageal cancer (OGSG1003)
DC.creator	Sugimura, Keijiro
	Yamasaki, Makoto
	Yasuda, Takushi
	Yano, Masahiko
	Hirao, Motohiro
	Fujitani, Kazumasa
	Kimura, Yutaka
	Miyata, Hiroshi
	Motoori, Masaaki
	Takeno, Atsushi
	Shiraishi, Osamu
	Makino, Tomoki
	Kii, Takayuki
	Tanaka, Koji
	Satoh, Taro
	Mori, Masaki
	Doki, Yuichiro
DC.publisher	John Wiley & Sons
DC.language' scheme='DCTERMS.RFC1766	English
DC.type' scheme='DCTERMS.DCMIType	Text
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2020-11-28
DC.identifier	https://doi.org/10.1002/ags3.12388
DC.subject	esophageal cancer
	neoadjuvant chemotherapy
	squamous cell carcinoma
DC.description	Sugimura, K, Yamasaki, M, Yasuda, T, et al. Long‐term results of a randomized controlled trial comparing neoadjuvant Adriamycin, cisplatin, and 5‐fluorouracil vs docetaxel, cisplatin, and 5‐fluorouracil followed by surgery for esophageal cancer (OGSG1003). Ann. Gastroenterol. Surg. 2020; 00: 1– 8. https://doi.org/10.1002/ags3.12388.
DCTERMS.abstract	Aim: The aim is to report the long-term outcomes of preoperative cisplatin and fluorouracil plus docetaxel (DCF) vs Adriamycin (ACF) for resectable esophageal squamous cell carcinoma (ESCC). Previously, this trial showed that DCF is associated with prolonged recurrence-free survival (RFS). Methods: Patients were randomly assigned to two cycles of ACF (35 mg/m2 of Adriamycin, 70 mg/m2 of cisplatin intravenously on day 1, and 700 mg/m2 of fluorouracil infusion for 7 days) every 4 weeks or DCF (70 mg/m2 of docetaxel, 70 mg/m2 of cisplatin intravenously on day 1, and 700 mg/m2 of fluorouracil infusion for 5 days) every 3 weeks, followed by surgery. The primary endpoint was RFS. The secondary endpoint was overall survival (OS). Results: Between October 2011 and October 2013, 162 patients at 10 institutions were enrolled in the study, 162 of whom were eligible and randomly assigned to the two groups. The median follow-up for surviving patients was 69.8 months. The 5-year RFS was significantly better in the DCF group than in the ACF group (59.9% vs 40.7%, hazard ratio [HR] 0.55; 95% confidence interval [CI], 0.35-0.86; P =.009) and the 5-year OS was significantly better in the DCF group than in the ACF group (63.5% vs 49.4%, HR, 0.61; 95% CI, 0.38-0.96; P =.03). The benefit of DCF chemotherapy on survival was significantly greater in the subgroups with more advanced clinical T and N stage. Conclusions: Cisplatin and fluorouracil plus docetaxel are associated with better RFS and OS than ACF in resectable ESCC patients.
DC.rights	© 2020 The Authors. This article is licensed under a Creative Commons Attribution 4.0 International License.
DC.format	78301
citation_title	Long-term results of a randomized controlled trial comparing neoadjuvant Adriamycin, cisplatin, and 5-fluorouracil vs docetaxel, cisplatin, and 5-fluorouracil followed by surgery for esophageal cancer (OGSG1003)
citation_author	Sugimura, Keijiro
	Yamasaki, Makoto
	Yasuda, Takushi
	Yano, Masahiko
	Hirao, Motohiro
	Fujitani, Kazumasa
	Kimura, Yutaka
	Miyata, Hiroshi
	Motoori, Masaaki
	Takeno, Atsushi
	Shiraishi, Osamu
	Makino, Tomoki
	Kii, Takayuki
	Tanaka, Koji
	Satoh, Taro
	Mori, Masaki
	Doki, Yuichiro
citation_publisher	John Wiley & Sons
citation_language	English
citation_date	2020-11-28
citation_journal_title	Annals of Gastroenterological Surgery
citation_volume	5
citation_issue	1
citation_firstpage	75
citation_lastpage	82
citation_doi	https://doi.org/10.1002/ags3.12388
citation_public_url	https://hdl.handle.net/11094/78301

Long-term results of a randomized controlled trial comparing neoadjuvant Adriamycin, cisplatin, and 5-fluorouracil vs docetaxel, cisplatin, and 5-fluorouracil followed by surgery for esophageal cancer (OGSG1003)

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