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01.02.2014 | Original Article

A phase I trial of combination therapy using gemcitabine and S-1 concurrent with full-dose radiation for resectable pancreatic cancer

verfasst von: Hidetoshi Eguchi, Hiroaki Nagano, Shogo Kobayashi, Koichi Kawamoto, Hiroshi Wada, Naoki Hama, Yoshito Tomimaru, Hirofumi Akita, Daisuke Sakai, Taroh Satoh, Toshihiro Kudo, Fumiaki Isohashi, Masaki Mori, Yuichiro Doki

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 2/2014

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Abstract

Purpose

Use of the fourth-generation oral fluoropyrimidine S-1 together with gemcitabine has shown striking anticancer effects. In this single-arm phase I trial of preoperative combination therapy using gemcitabine and S-1 concurrently with radiotherapy, we verified the safety and feasibility and determined the maximum-tolerated dose of each drug in patients with resectable pancreatic cancer.

Methods

A standard 3+3 dose escalation scheme was used. Patients with cytologically or histologically proven resectable pancreatic ductal adenocarcinoma were administered 30-min intravenous gemcitabine infusions on days 1, 8, 22, and 29 and S-1 orally on days 1–5, 8–12, 22–26, and 29–33. A total radiation dose of 50.4 Gy (1.8 Gy/day, 5 times per week, 28 fractions) was concurrently delivered. Surgical exploration was scheduled 4–7 weeks after the final radiation fraction.

Results

Twenty-one patients were enrolled. No treatment-related deaths occurred during this study. Recommended doses were determined to be 80 mg/m² of S-1 daily and 1,000 mg/m² of gemcitabine. CA19-9 was reduced to <50 % of baseline values in 12 (75 %) of 16 measurable patients. Nineteen of 21 enrolled patients successfully underwent surgical resection.

Conclusions

Preoperative chemoradiotherapy consisting of gemcitabine and S-1 concurrent with full-dose radiation is feasible and well tolerated.

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Titel: A phase I trial of combination therapy using gemcitabine and S-1 concurrent with full-dose radiation for resectable pancreatic cancer
verfasst von: Hidetoshi Eguchi
Hiroaki Nagano
Shogo Kobayashi
Koichi Kawamoto
Hiroshi Wada
Naoki Hama
Yoshito Tomimaru
Hirofumi Akita
Daisuke Sakai
Taroh Satoh
Toshihiro Kudo
Fumiaki Isohashi
Masaki Mori
Yuichiro Doki
Publikationsdatum: 01.02.2014
Verlag: Springer Berlin Heidelberg
Erschienen in: Cancer Chemotherapy and Pharmacology / Ausgabe 2/2014
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-013-2357-9

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A phase I trial of combination therapy using gemcitabine and S-1 concurrent with full-dose radiation for resectable pancreatic cancer

Abstract

Purpose

Methods

Results

Conclusions

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Springer Medizin

Abstract

Purpose

Methods

Results

Conclusions

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