HOPS-R01 phase II trial evaluating neoadjuvant S-1 therapy for resectable pancreatic adenocarcinoma.
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
15 06 2022
15 06 2022
Historique:
received:
07
12
2021
accepted:
01
06
2022
entrez:
15
6
2022
pubmed:
16
6
2022
medline:
18
6
2022
Statut:
epublish
Résumé
Although neoadjuvant therapy (Nac) is recommended for high-risk resectable pancreatic cancer (R-PDAC), evidence regarding specific regimes is scarce. This report aimed to investigate the efficacy of S-1 Nac for R-PDAC. In a multicenter phase II trial, we investigated the efficacy of Nac S-1 (an oral fluoropyrimidine agent containing tegafur, gimeracil, and oteracil potassium) in R-PDAC patients. The protocol involved two cycles of preoperative S-1 chemotherapy, followed by surgery, and four cycles of postoperative S-1 chemotherapy. Two-year progression-free survival (PFS) rates were the primary endpoint. Overall survival (OS) rates and median survival time (MST) were secondary endpoints. Forty-nine patients were eligible, and 31 patients underwent resection following Nac, as per protocol (31/49; 63.3%). Per-protocol analysis included data from 31 patients, yielding the 2-year PFS rate of 58.1%, and 2-, 3-, and 5-year OS rates of 96.8%, 54.8%, and 44.0%, respectively. MST was 49.2 months. Intention-to-treat analysis involved 49 patients, yielding the 2-year PFS rate of 40.8%, and the 2-, 3-, and 5-year OS rates of 87.8%, 46.9%, and 33.9%, respectively. MST was 35.5 months. S-1 single regimen might be an option for Nac in R-PDAC; however, the high drop-out rate (36.7%) was a limitation of this study.
Identifiants
pubmed: 35705607
doi: 10.1038/s41598-022-14094-0
pii: 10.1038/s41598-022-14094-0
pmc: PMC9200853
doi:
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
9966Investigateurs
Toru Nakamura
(T)
Tsuyoshi Hayashi
(T)
Yasutoshi Kimura
(Y)
Hiroshi Kawakami
(H)
Kuniyuki Takahashi
(K)
Hirotoshi Ishiwatari
(H)
Takuma Goto
(T)
Masayo Motoya
(M)
Keisuke Yamakita
(K)
Yusuke Sakuhara
(Y)
Michihiro Ono
(M)
Eiichi Tanaka
(E)
Makoto Omi
(M)
Katsuhiko Murakawa
(K)
Tomoya Iida
(T)
Tamaki Sakurai
(T)
Shin Haba
(S)
Takehiro Abiko
(T)
Yoichi M Ito
(YM)
Hiroyuki Maguchi
(H)
Satoshi Hirano
(S)
Junpei Sasajima
(J)
Yohei Kitano
(Y)
Nobuyuki Yanagawa
(N)
Kakuya Matsumoto
(K)
Satoshi Tanno
(S)
Masafumi Imamura
(M)
Masahiro Shitani
(M)
Minoru Takahashi
(M)
Hiroyuki Miyakawa
(H)
Fumitaka Nakamura
(F)
Yoshiyasu Ambo
(Y)
Hirofumi Kamachi
(H)
Akinobu Taketomi
(A)
Informations de copyright
© 2022. The Author(s).
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