• Keiko Shibuya, Natsuo Oya, Takashi Fujii, Ryuichiro Doi, Akira Nakamura, Yukinori Matsuo, Michihide Mitsumori, and Masahiro Hiraoka.
• Department of Radiation Oncology and Image-Applied Therapy, Kyoto University Graduate School of Medicine, Kyoto, Japan. kei@kuhp.kyoto-u
• Am. J. Clin. Oncol. 2011 Apr 1; 34 (2): 115-9.

BackgroundThrough a phase I study with a fixed radiation dose of 54 Gy and escalating doses of weekly gemcitabine, we established a recommended dose of gemcitabine at 250 mg/m in combination with radiation therapy for patients with unresectable pancreatic cancer.ObjectiveThe purpose of this phase-II study was to evaluate the safety and efficacy of the regimen which was established in the phase I study.MethodsIn all patients with unresectable stage III and limited stage IV pancreatic cancer with no distant metastasis except for para-aortic lymph node involvement at a level as low as the left renal vein, a total dose of 54 Gy was delivered in 30 fractions of 1.8 Gy/d. Gemcitabine was given weekly at a dose of 250 mg/m.ResultsBetween December 2002 and March 2006, 22 patients were enrolled in this study and one withdrew after enrollment. Twenty of 21 patients (95%) completed the protocol therapy. Radiologic partial response was observed in 6 and stable disease was noted in 15. Normalization of the tumor marker (CA19-9) occurred in 61% of patients. The 1-year survival rate was 74% and the median survival time was 16.6 months. The major toxicity was leucopenia; grade 3 in 14 (67%), anorexia grade 3 in 2 (9.5%), and grade 3 gastric ulcer in 2 (10%) in National Cancer Institute's Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0). Neither grade 4 nor 5 was recognized.ConclusionTreatment with gemcitabine combined with radiation therapy according to the present schedule is well tolerated and can provide prolonged survival in patients with localized, unresectable pancreatic cancer.

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