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.
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.
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.
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.
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: email@example.com.