A phase I/II study of fixed-dose-rate gemcitabine and S-1 with concurrent radiotherapy for locally advanced pancreatic cancer

Purpose: This study was conducted to identify the maximum-tolerated dose (MTD) of fixed-dose-rate gemcitabine (FDR-gem) administered concurrently with S-1 and radical radiation for locally advanced pancreatic cancer (LAPC) and to provide efficacy and safety data.
Methods: Patients with unresectable pancreatic cancer confined to the pancreatic region were treated with FDR-gem (300-400mg/m2, 5mg/m2/min) on days 1, 8, 22, 29 and 60mg/m2 of S-1 orally on days 1-14, 22-35. A total radiation dose of 50.4 Gy (1.8 Gy/day, 28fractions) was delivered concurrently.
Results: Twenty-five patients were enrolled; all were evaluable for toxicity assessment. In phase I, eight patients were treated in sequential cohorts of three to five patients per dose level. The MTD was reached at level 2, and dose-limiting toxicities were neutropenia and thrombocytopenia. The recommended doses were 300mg/m2 of gemcitabine and 60mg/m2 of S-1 daily. The overall response rate was 25% and disease control rate (partial response plus stable disease) was 92%. The progression-free survival was 11.0 months. The median overall survival and 1-year survival rate were 16.0 months and 73%, respectively.
Conclusion: The combination of FDR-gem and S-1 with radiation is a feasible regimen that shows favorable antitumor activity with an acceptable safety profile in patients with LAPC.

内容要旨・審査要旨・論文本文の公開：
内容要旨・審査要旨：LID201704141008.pdf
論文本文：k3028_fulltext.pdf
本論文は, 著者Takahiro Gojiの学位論文として提出され, 学位審査・授与の対象となっている。
The final publication is available at link.springer.com.