Results of a Randomized Clinical Study of Gemcitabine Plus Nab-Paclitaxel Versus Gemcitabine Plus S-1 as Neoadjuvant Chemotherapy for Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma (RCT, CSGO-HBP-015)

Yamada, Daisaku; Kobayashi, Shogo; Takahashi, Hidenori; Iwagami, Yoshifumi; Akita, Hirofumi; Asukai, Kei; Shimizu, Junzo; Yamada, Terumasa; Tanemura, Masahiro; Yokoyama, Shigekazu; Tsujie, Masanori; Asaoka, Tadafumi; Takeda, Yutaka; Morimoto, Osakuni; Tomokuni, Akira; Doki, Yuichiro; Eguchi, Hidetoshi

doi:https://doi.org/10.1245/s10434-024-15199-8

Results of a Randomized Clinical Study of Gemcitabine Plus Nab-Paclitaxel Versus Gemcitabine Plus S-1 as Neoadjuvant Chemotherapy for Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma (RCT, CSGO-HBP-015)

Yamada, Daisaku; Kobayashi, Shogo; Takahashi, Hidenori et al.

Annals of Surgical Oncology, 2024, 31, 4621-4633

Number of Access:2,322（2025-07-19 21:02 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/95727

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Title	Results of a Randomized Clinical Study of Gemcitabine Plus Nab-Paclitaxel Versus Gemcitabine Plus S-1 as Neoadjuvant Chemotherapy for Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma (RCT, CSGO-HBP-015)
Creator	NRID 1000060571396 1000060571396 ORCID 0000-0002-6702-3800 0000-0002-6702-3800 researchmap permalink dyamada79222 dyamada79222 Scopus Author ID 37008067700 37008067700 CreatorName Yamada, Daisaku
	NRID 1000030452436 1000030452436 researchmap permalink 30452436 30452436 Scopus Author ID 7405376089 7405376089 ORCID 0000-0002-8828-1067 0000-0002-8828-1067 CreatorName Kobayashi, Shogo
	NRID 1000090601120 1000090601120 ORCID 0000-0003-4801-3540 0000-0003-4801-3540 researchmap permalink hdnr_tkhs hdnr_tkhs Scopus Author ID 7405468781 7405468781 CreatorName Takahashi, Hidenori
	NRID 1000060597441 1000060597441 researchmap permalink yiwagami yiwagami Scopus Author ID 35074034100 35074034100 CreatorName Iwagami, Yoshifumi
	NRID 1000070528463 1000070528463 researchmap permalink hirofumi_akita hirofumi_akita CreatorName Akita, Hirofumi
	CreatorName Asukai, Kei
	CreatorName Shimizu, Junzo
	CreatorName Yamada, Terumasa
	NRID 1000030379250 1000030379250 researchmap permalink read0118541 read0118541 CreatorName Tanemura, Masahiro
	CreatorName Yokoyama, Shigekazu
	CreatorName Tsujie, Masanori
	NRID 1000060528470 1000060528470 CreatorName Asaoka, Tadafumi
	CreatorName Takeda, Yutaka
	CreatorName Morimoto, Osakuni
	CreatorName Tomokuni, Akira
	NRID 1000020291445 1000020291445 researchmap permalink ydoki3251 ydoki3251 Scopus Author ID 7006390687 7006390687 CreatorName Doki, Yuichiro
	NRID 1000090542118 1000090542118 researchmap permalink abcdabcdabcd abcdabcdabcd Scopus Author ID 7101627772 7101627772 CreatorName Eguchi, Hidetoshi
Subject	GEM+nPTX
	GEM+S-1
	NAC
	R-PDAC
	R/BR-PDAC
Description	The version of record of this article, first published in Annals of Surgical Oncology, is available online at Publisher’s website: https://doi.org/10.1245/s10434-024-15199-8.
Abstract	Background: The optimal neoadjuvant chemotherapy (NAC) regimen for patients with localized pancreatic ductal adenocarcinoma (PDAC) remains uncertain. This trial aimed to evaluate the efficacy and safety of two neoadjuvant chemotherapy (NAC) regimens, gemcitabine plus nab-paclitaxel (GA) and gemcitabine plus S-1 (GS), in patients with resectable/borderline-resectable (R/BR) PDAC. Patients and Methods: Treatment-naïve patients with R/BR-PDAC were enrolled and randomly allocated. They received two cycles (2 months) of each standard protocol, followed by radical surgery for those without tumor progression in general hospitals belonging to our intergroup. The primary endpoint was to determine the superior regimen on the basis of achieving a 10% increase in the rate of patients with progression-free survival (PFS) at 2 years from allocation. Results: A total of 100 patients were enrolled, with 94 patients randomly assigned to the GS arm (N = 46) or GA arm (N = 48). The 2-year PFS rates did not show the stipulated difference [GA, 31% (24–38%)/GS, 26% (18–33%)], but the Kaplan–Myer analysis showed significance (median PFS, GA/GS 14 months/9 months, P = 0.048; HR 0.71). Secondary endpoint comparisons yielded the following results (GA/GS arm, P-value): rates of severe adverse events during NAC, 73%/78%, P = 0.55; completion rates of the stipulated NAC, 92%/83%, P = 0.71; resection rates, 85%/72%, P = 0.10; average tumor marker (CA19-9) reduction rates, −50%/−21%, P = 0.01; average numbers of lymph node metastasis, 1.7/3.2, P = 0.04; and median overall survival times, 42/22 months, P = 0.26. Conclusions: This study found that GA and GS are viable neoadjuvant treatment regimens in R/BR-PDAC. Although the GA group exhibited a favorable PFS outcome, the primary endpoint was not achieved.
Publisher	Springer
Source Title	Annals of Surgical Oncology
Volume (Issue)	31
Page	4621-4633
Date of Issued	2024-03-28
Language	English
Handle URL	https://hdl.handle.net/11094/95727
PISSN	10689265
eISSN	15344681
Relation.isIdenticalTo	DOI (Publisher Version) https://doi.org/10.1245/s10434-024-15199-8
Access Rights	open access
CopyRight	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 Surgical Oncology. 2024, 31, p. 4621-4633
DC.title	Results of a Randomized Clinical Study of Gemcitabine Plus Nab-Paclitaxel Versus Gemcitabine Plus S-1 as Neoadjuvant Chemotherapy for Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma (RCT, CSGO-HBP-015)
DC.creator	Yamada, Daisaku
	Kobayashi, Shogo
	Takahashi, Hidenori
	Iwagami, Yoshifumi
	Akita, Hirofumi
	Asukai, Kei
	Shimizu, Junzo
	Yamada, Terumasa
	Tanemura, Masahiro
	Yokoyama, Shigekazu
	Tsujie, Masanori
	Asaoka, Tadafumi
	Takeda, Yutaka
	Morimoto, Osakuni
	Tomokuni, Akira
	Doki, Yuichiro
	Eguchi, Hidetoshi
DC.publisher	Springer
DC.language' scheme='DCTERMS.RFC1766	English
DC.type' scheme='DCTERMS.DCMIType	Text
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2024-03-28
DC.identifier	https://doi.org/10.1245/s10434-024-15199-8
DC.subject	GEM+nPTX
	GEM+S-1
	NAC
	R-PDAC
	R/BR-PDAC
DC.description	The version of record of this article, first published in Annals of Surgical Oncology, is available online at Publisher’s website: https://doi.org/10.1245/s10434-024-15199-8.
DCTERMS.abstract	Background: The optimal neoadjuvant chemotherapy (NAC) regimen for patients with localized pancreatic ductal adenocarcinoma (PDAC) remains uncertain. This trial aimed to evaluate the efficacy and safety of two neoadjuvant chemotherapy (NAC) regimens, gemcitabine plus nab-paclitaxel (GA) and gemcitabine plus S-1 (GS), in patients with resectable/borderline-resectable (R/BR) PDAC. Patients and Methods: Treatment-naïve patients with R/BR-PDAC were enrolled and randomly allocated. They received two cycles (2 months) of each standard protocol, followed by radical surgery for those without tumor progression in general hospitals belonging to our intergroup. The primary endpoint was to determine the superior regimen on the basis of achieving a 10% increase in the rate of patients with progression-free survival (PFS) at 2 years from allocation. Results: A total of 100 patients were enrolled, with 94 patients randomly assigned to the GS arm (N = 46) or GA arm (N = 48). The 2-year PFS rates did not show the stipulated difference [GA, 31% (24–38%)/GS, 26% (18–33%)], but the Kaplan–Myer analysis showed significance (median PFS, GA/GS 14 months/9 months, P = 0.048; HR 0.71). Secondary endpoint comparisons yielded the following results (GA/GS arm, P-value): rates of severe adverse events during NAC, 73%/78%, P = 0.55; completion rates of the stipulated NAC, 92%/83%, P = 0.71; resection rates, 85%/72%, P = 0.10; average tumor marker (CA19-9) reduction rates, −50%/−21%, P = 0.01; average numbers of lymph node metastasis, 1.7/3.2, P = 0.04; and median overall survival times, 42/22 months, P = 0.26. Conclusions: This study found that GA and GS are viable neoadjuvant treatment regimens in R/BR-PDAC. Although the GA group exhibited a favorable PFS outcome, the primary endpoint was not achieved.
DC.rights	This article is licensed under a Creative Commons Attribution 4.0 International License.
DC.format	95727
citation_title	Results of a Randomized Clinical Study of Gemcitabine Plus Nab-Paclitaxel Versus Gemcitabine Plus S-1 as Neoadjuvant Chemotherapy for Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma (RCT, CSGO-HBP-015)
citation_author	Yamada, Daisaku
	Kobayashi, Shogo
	Takahashi, Hidenori
	Iwagami, Yoshifumi
	Akita, Hirofumi
	Asukai, Kei
	Shimizu, Junzo
	Yamada, Terumasa
	Tanemura, Masahiro
	Yokoyama, Shigekazu
	Tsujie, Masanori
	Asaoka, Tadafumi
	Takeda, Yutaka
	Morimoto, Osakuni
	Tomokuni, Akira
	Doki, Yuichiro
	Eguchi, Hidetoshi
citation_publisher	Springer
citation_language	English
citation_date	2024-03-28
citation_journal_title	Annals of Surgical Oncology
citation_volume	31
citation_firstpage	4621
citation_lastpage	4633
citation_doi	https://doi.org/10.1245/s10434-024-15199-8
citation_public_url	https://hdl.handle.net/11094/95727

Results of a Randomized Clinical Study of Gemcitabine Plus Nab-Paclitaxel Versus Gemcitabine Plus S-1 as Neoadjuvant Chemotherapy for Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma (RCT, CSGO-HBP-015)

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