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Neoadjuvant S-1 With Concurrent Radiotherapy Followed by Surgery for Borderline Resectable Pancreatic Cancer: A Phase II Open-label Multicenter Prospective Trial (JASPAC05)

Annals of Surgery, ISSN: 1528-1140, Vol: 276, Issue: 5, Page: E510-E517
2022
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Studies from National Cancer Center Hospital East in the Area of Pancreatic Cancer Reported [Neoadjuvant S-1 With Concurrent Radiotherapy Followed By Surgery for Borderline Resectable Pancreatic Cancer a Phase Ii Open-label Multicenter ...]

2022 NOV 16 (NewsRx) -- By a News Reporter-Staff News Editor at Japan Daily Report -- Research findings on Oncology - Pancreatic Cancer are discussed

Article Description

Objective: This study assessed whether neoadjuvant chemoradiotherapy (CRT) with S-1 increases the R0 resection rate in BRPC. Summary of Background Data: Although a multidisciplinary approach that includes neoadjuvant treatment has been shown to be a better strategy for BRPC than upfront resection, a standard treatment for BRPC has not been established. Methods: A multicenter, single-arm, phase II study was performed. Patients who fulfilled the criteria for BRPC received S-1 (40 mg/m2 bid) and concurrent radiotherapy (50.4 Gy in 28 fractions) before surgery. The primary endpoint was the R0 resection rate. At least 40 patients were required, with a 1-sided α = 0.05 and β = 0.05 and expected and threshold values for the primary endpoint of 30% and 10%, respectively. Results: Fifty-two patients were eligible, and 41 were confirmed to have definitive BRPC by a central review. CRT was completed in 50 (96%) patients and was well tolerated. The rate of grade 3/4 toxicity with CRT was 43%. The R0 resection rate was 52% among the 52 eligible patients and 63% among the 41 patients who were centrally confirmed to have BRPC. Postoperative grade III/IV adverse events according to the Clavien-Dindo classification were observed in 7.5%. Among the 41 centrally confirmed BRPC patients, the 2-year overall survival rate and median overall survival duration were 58% and 30.8 months, respectively. Conclusions: S-1 and concurrent radiotherapy seem to be feasible and effective at increasing the R0 resection rate and improving survival in patients with BRPC.

Bibliographic Details

Takahashi, Shinichiro; Ohno, Izumi; Ikeda, Masafumi; Konishi, Masaru; Kobayashi, Tatsushi; Akimoto, Tetsuo; Kojima, Motohiro; Morinaga, Soichiro; Toyama, Hirochika; Shimizu, Yasuhiro; Miyamoto, Atsushi; Tomikawa, Moriaki; Takakura, Norihisa; Takayama, Wataru; Hirano, Satoshi; Otsubo, Takehito; Nagino, Masato; Kimura, Wataru; Sugimachi, Keishi; Uesaka, Katsuhiko

Ovid Technologies (Wolters Kluwer Health)

Medicine

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