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Phase II Study of Radiation Therapy Combined With Weekly Low-Dose Gemcitabine for Locally Advanced, Unresectable Pancreatic Cancer

Shibuya, Keiko, MD*; Oya, Natsuo, MD; Fujii, Takashi, MD; Doi, Ryuichiro, MD§; Nakamura, Akira, MD*; Matsuo, Yukinori, MD*; Mitsumori, Michihide, MD*; Hiraoka, Masahiro, MD*

American Journal of Clinical Oncology: April 2011 - Volume 34 - Issue 2 - p 115-119
doi: 10.1097/COC.0b013e3181c4c7a8
Original Articles: Gastrointestinal
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Background: Through 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/m2 in combination with radiation therapy for patients with unresectable pancreatic cancer.

Objective: The purpose of this phase-II study was to evaluate the safety and efficacy of the regimen which was established in the phase I study.

Methods: In 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/m2.

Results: Between 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.

Conclusion: Treatment 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.

From the *Department of Radiation Oncology and Image-Applied Therapy, Kyoto University Graduate School of Medicine, Kyoto, Japan; †Department of Radiation Oncology, Kumamoto University Graduate School of Medical Sciences, Kumamoto, Japan; ‡Department of Radiation Oncology, Ehime University Graduate School of Medicine, Ehime, Japan; and §Department of Hepatobiliary Pancreatic Surgery and Transplantation, Kyoto University Graduate School of Medicine, Kyoto, Japan.

Reprints: Keiko Shibuya, MD, Department of Radiation Oncology and Image-applied Therapy, Kyoto University Graduate School of Medicine, 54 Shogoin Kawaharacho Sakyo-ku, Kyoto, 606–8507, Japan. E-mail: kei@kuhp.kyoto-u.ac.jp.

© 2011 Lippincott Williams & Wilkins, Inc.