. 2023 May 3:41:100634.

doi: 10.1016/j.ctro.2023.100634. eCollection 2023 Jul.

Proton beam therapy for extrahepatic biliary tract cancer: Analysis with prospective multi-institutional patients' registration database, Proton-Net

Hideya Yamazaki¹, Kei Shibuya², Takuya Kimoto¹, Motohisa Suzuki³, Masao Murakami³, Kazuki Terashima⁴, Tomoaki Okimoto⁴, Takashi Iizumi⁵, Hideyuki Sakurai⁵, Masaru Wakatsuki⁶, Osamu Suzuki⁷, Norio Katoh⁸, Takeshi Arimura⁹, Takashi Ogino⁹, Masaru Takagi¹⁰, Masayuki Araya¹¹, Takahiro Waki¹², Sae Matsumoto¹³, Hiroyuki Ogino¹⁴, Takumi Fukumoto¹⁵, Masayuki Ohtsuka¹⁶

Affiliations

¹ Department of Radiology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
² Gunma University Heavy Ion Medical Center, Maebashi, Japan.
³ Department of Radiation Oncology, Southern TOHOKU Proton Therapy Center, Koriyama, Japan.
⁴ Department of Radiology, Hyogo Ion Beam Medical Center, Hyogo, Japan.
⁵ Department of Radiation Oncology, Proton Medical Research Center, University of Tsukuba Hospital, Tsukuba, Japan.
⁶ QST Hospital, National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan.
⁷ Osaka Heavy Ion Administration Company, Otemae, Chuo-ku, Osaka-city, Osaka, Japan.
⁸ Department of Radiation Oncology, Hokkaido University Faculty of Medicine, Sapporo, Hokkaido, Japan.
⁹ Medipolis Proton Therapy and Research Center, Ibusuki, Kagoshima, Japan.
¹⁰ Proton Therapy Center, Sapporo Teishinkai Hospital, Sapporo, Hokkaido, Japan.
¹¹ Proton Therapy Center, Aizawa Hospital, Matsumoto, Nagano, Japan.
¹² Department of Radiology, Tsuyama Chuo Hospital, Tsuyama, Okayama, Japan.
¹³ Proton Therapy Center, Fukui Prefectural Hospital, Fukui, Fukui, Japan.
¹⁴ Department of Radiation Oncology, Nagoya Proton Therapy Center, Nagoya City University West Medical Center, Nagoya, Japan.
¹⁵ Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.
¹⁶ Department of General Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.

PMID: 37234735
PMCID: PMC10206422
DOI: 10.1016/j.ctro.2023.100634

Proton beam therapy for extrahepatic biliary tract cancer: Analysis with prospective multi-institutional patients' registration database, Proton-Net

Hideya Yamazaki et al. Clin Transl Radiat Oncol. 2023.

. 2023 May 3:41:100634.

doi: 10.1016/j.ctro.2023.100634. eCollection 2023 Jul.

Authors

Affiliations

¹ Department of Radiology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
² Gunma University Heavy Ion Medical Center, Maebashi, Japan.
³ Department of Radiation Oncology, Southern TOHOKU Proton Therapy Center, Koriyama, Japan.
⁴ Department of Radiology, Hyogo Ion Beam Medical Center, Hyogo, Japan.
⁵ Department of Radiation Oncology, Proton Medical Research Center, University of Tsukuba Hospital, Tsukuba, Japan.
⁶ QST Hospital, National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan.
⁷ Osaka Heavy Ion Administration Company, Otemae, Chuo-ku, Osaka-city, Osaka, Japan.
⁸ Department of Radiation Oncology, Hokkaido University Faculty of Medicine, Sapporo, Hokkaido, Japan.
⁹ Medipolis Proton Therapy and Research Center, Ibusuki, Kagoshima, Japan.
¹⁰ Proton Therapy Center, Sapporo Teishinkai Hospital, Sapporo, Hokkaido, Japan.
¹¹ Proton Therapy Center, Aizawa Hospital, Matsumoto, Nagano, Japan.
¹² Department of Radiology, Tsuyama Chuo Hospital, Tsuyama, Okayama, Japan.
¹³ Proton Therapy Center, Fukui Prefectural Hospital, Fukui, Fukui, Japan.
¹⁴ Department of Radiation Oncology, Nagoya Proton Therapy Center, Nagoya City University West Medical Center, Nagoya, Japan.
¹⁵ Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.
¹⁶ Department of General Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.

PMID: 37234735
PMCID: PMC10206422
DOI: 10.1016/j.ctro.2023.100634

Abstract

Background and purpose: To examine the role of proton beam therapy (PBT) in the treatment of extrahepatic biliary tract cancer (EBC).

Methods and materials: We analyzed the data accumulated in the Proton-Net database, which prospectively registered all individual patient data treated with PBT in all Japanese proton institutions from May 2016 to June 2019. The primary endpoint was overall survival (OS), and the secondary endpoints were local control (LC), progression-free survival (PFS), and toxicity.

Results: Ninety-three patients with unresectable and/or recurrent EBC were treated with PBT using a median prescribed dose of 67.5 Gy (RBE) (range, 50-72.6 Gy) in 25 (22-30 fractions). With a median follow-up of 16.3 months, the median survival time was 20.1 months and the 2-year OS was 37.8%. Two-year PFS and LC rates were 20.6% and 66.5%, respectively. Poor liver function (Child-Pugh B, C), a narrower distance between the tumor and digestive tract (2 cm >), and a larger tumor diameter (2 cm <) were identified as poor prognostic factors for OS. PBT-related grade 3 ≤ acute and late adverse events occurred in 5.4% and 4.3% of patients, respectively, including one gastrointestinal late toxicity (duodenal ulcer).

Conclusions: This is the largest prospectively accumulated series of PBT for EBC, and PBT showed favorable outcomes with acceptable toxicity profiles.

Keywords: Extrahepatic bile duct cancer; Proton beam therapy.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

**Fig. 1**
Scheme of eligibility selection using inclusion or exclusion criteria.

**Fig. 2**
Survival analysis. Overall survival rate (OS), progression free survival rate (PFS) and local control (LC) in total population. OS according to liver function. OS according to tumor diameter. OS according to distance tumor from gastrointestinal tract (GI distance). OS according to tumor diameter and distance between tumor and gastrointestinal tract (GI distance). OS according to primary site of tumor.

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Proton beam therapy for extrahepatic biliary tract cancer: Analysis with prospective multi-institutional patients' registration database, Proton-Net

Affiliations

Proton beam therapy for extrahepatic biliary tract cancer: Analysis with prospective multi-institutional patients' registration database, Proton-Net

Authors

Affiliations

Abstract

Conflict of interest statement

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Abstract

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