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Annals of Surgical Oncology
Published in: Annals of Surgical Oncology 9/2017

01-09-2017 | Pancreatic Tumors

A Prospective Phase II Trial of Neoadjuvant S-1 with Concurrent Hypofractionated Radiotherapy in Patients with Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma

Authors: Keiichi Okano, MD, PhD, FACS, Hironobu Suto, MD, Minoru Oshima, MD, PhD, Eri Maeda, MD, Naoki Yamamoto, MD, PhD, Keitaro Kakinoki, MD, PhD, Hideki Kamada, MD, PhD, Tsutomu Masaki, MD, PhD, Shigeo Takahashi, MD, Toru Shibata, MD, PhD, Yasuyuki Suzuki, MD, PhD

Published in: Annals of Surgical Oncology | Issue 9/2017

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Abstract

Background

The ideal neoadjuvant treatment protocol for patients with pancreatic cancer (PDAC) remains unclear. We evaluated the efficacy and safety of neoadjuvant hypofractionated chemoradiotherapy with S-1 for patients with resectable (R) and borderline resectable (BR) PDAC.

Methods

Eligibility criteria included patients with R and BR PDAC, performance status 0–1, and age 20–85 years. Hypofractionated external-beam radiotherapy (30 Gy in 10 fractions) with concurrent S-1 (60 mg/m2) was delivered 5 days/week for 2 weeks prior to pancreatectomy.

Results

Fifty-seven patients were enrolled in this study, including 33 R and 24 BR [19 BR tumors with portal vein contact (BR-PV) and 5 BR tumors with arterial contact (BR-A)]. The total rates of protocol treatment completion and resection were 91% (50/57) and 96% (55/57), respectively. Seven patients failed to complete S-1 due to cholangitis (n = 5) or neutropenia (n = 2). The most common grade 3 toxicities [Common Terminology Criteria for Adverse Events (CTCAE) version 4.0] were anorexia (7%), nausea (5%), neutropenia (4%), and leukopenia (4%). No patient experienced grade 4 toxicity. Pathologically negative margins (R0) were achieved in 54 of 55 patients (98%) who underwent pancreatectomy. Pathological response was classified as Evans grade I in 8 patients (15%), IIa in 31 patients (56%), IIb in 14 patients (25%), III in 1 patient (2%), and IV in 1 patient (2%), and operative morbidity (Clavien-Dindo grade IIIb or less) was observed in 4 patients (8%). The 1- and 2-year overall survival (OS) rates were 91 and 83% in R patients, respectively, and 77 and 58% in BR patients, respectively (p = 0.03).

Conclusion

Neoadjuvant S-1 with concurrent hypofractionated radiotherapy is tolerable and appears promising for patients with R and BR PDAC.
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Metadata
Title
A Prospective Phase II Trial of Neoadjuvant S-1 with Concurrent Hypofractionated Radiotherapy in Patients with Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma
Authors
Keiichi Okano, MD, PhD, FACS
Hironobu Suto, MD
Minoru Oshima, MD, PhD
Eri Maeda, MD
Naoki Yamamoto, MD, PhD
Keitaro Kakinoki, MD, PhD
Hideki Kamada, MD, PhD
Tsutomu Masaki, MD, PhD
Shigeo Takahashi, MD
Toru Shibata, MD, PhD
Yasuyuki Suzuki, MD, PhD
Publication date
01-09-2017
Publisher
Springer International Publishing
Published in
Annals of Surgical Oncology / Issue 9/2017
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-017-5921-4

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