Carbon Ion Radiation Therapy With Concurrent Gemcitabine for Patients With Locally Advanced Pancreatic Cancer

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• 作者：Makoto Shinoto ; MD^&lowast ; ; ^&dagger ; ; ^&Dagger ; ; ^{shinoto@saga-himat.jp" class="auth_mail" title="E-mail the corresponding author} ; Shigeru Yamada ; MD ; PhD^&lowast ; ; Kotaro Terashima ; MD ; PhD^&Dagger ; ; Shigeo Yasuda ; MD ; PhD^&lowast ; ; Yoshiyuki Shioyama ; MD ; PhD^&dagger ; ; Hiroshi Honda ; MD ; PhD^&Dagger ; ; Tadashi Kamada ; MD ; PhD^&lowast ; ; Hirohiko Tsujii ; MD ; PhD^&lowast ; ; Hiromitsu Saisho ; MD ; PhD^§ ; ; the Working Group for Pancreas CancerTakehide Asano ; Taketo Yamaguchi ; Hodaka Amano ; Takeshi Ishihara ; Masayuki Otsuka ; Masamichi Matsuda ; Osamu Kainuma ; Akihiro Funakoshi ; Junji Furuse ; Toshio Nakagori ; Takuji Okusaka ; Hiroshi Ishii ; Tatsuya Nagakawa ; Shinichiro Takahashi ; Shoichi Hishinuma ; Masafumi Nakamura ; Hirofumi Saito ; Kiyoshi Ohara ; Shinichi Ohkawa ; Masahiro Hiraoka
• 刊名：International Journal of Radiation Oncology*Biology*Physics
• 出版年：2016
• 出版时间：1 May 2016
• 年：2016
• 卷：95
• 期：1
• 页码：498-504
• 全文大小：586 K

文摘

To determine, in the setting of locally advanced pancreatic cancer, the maximum tolerated dose of carbon ion radiation therapy (C-ion RT) and gemcitabine dose delivered concurrently and to estimate local effect and survival.

Methods and Materials

Eligibility included pathologic confirmation of pancreatic invasive ductal carcinomas and radiographically unresectable disease without metastasis. Concurrent gemcitabine was administered on days 1, 8, and 15, and the dose levels were escalated from 400 to 1000 mg/m² under the starting dose level (43.2 GyE) of C-ion RT. The dose levels of C-ion RT were escalated from 43.2 to 55.2 GyE at 12 fractions under the fixed recommended gemcitabine dose determined.

Results

Seventy-six patients were enrolled. Among the 72 treated patients, dose-limiting toxicity was observed in 3 patients: grade 3 infection in 1 patient and grade 4 neutropenia in 2 patients. Only 1 patient experienced a late grade 3 gastric ulcer and bleeding 10 months after C-ion RT. The recommended dose of gemcitabine with C-ion RT was found to be 1000 mg/m². The dose of C-ion RT with the full dose of gemcitabine (1000 mg/m²) was safely increased to 55.2 GyE. The freedom from local progression rate was 83% at 2 years using the Response Evaluation Criteria in Solid Tumors. The 2-year overall survival rates in all patients and in the high-dose group with stage III (≥45.6 GyE) were 35% and 48%, respectively.

Conclusions

Carbon ion RT with concurrent full-dose gemcitabine was well tolerated and effective in patients with unresectable locally advanced pancreatic cancer.