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Article

Phase I Radiation Dose-Escalation Study to Investigate the Dose-Limiting Toxicity of Concurrent Intra-Arterial Chemotherapy for Unresectable Hepatocellular Carcinoma

1
Department of Radiation Oncology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Korea
2
Department of Internal Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin 16995, Korea
3
Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Korea
4
Department of Radiology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Korea
5
Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Korea
*
Authors to whom correspondence should be addressed.
Cancers 2020, 12(6), 1612; https://doi.org/10.3390/cancers12061612
Received: 11 May 2020 / Revised: 9 June 2020 / Accepted: 15 June 2020 / Published: 18 June 2020
(This article belongs to the Special Issue Radiotherapy for Hepatocellular Carcinoma)
Concurrent intra-arterial chemotherapy and radiotherapy (iA-CCRT) can increase the response rate in hepatocellular carcinoma (HCC), but may cause a higher toxicity. We conducted this Phase I study to investigate the dose-limiting toxicity of iA-CCRT for HCC. In total, 52.5 Gy in 25 fractions was prescribed as planning target volume (PTV) 1 at dose level 1. The dose escalation was 0.2 Gy per fraction and up to 2.5 Gy, with 62.5 Gy at level 3. Concurrent intra-arterial 5-fluorouracil was administered during the first and fifth weeks of radiotherapy (RT). Toxicities were graded using the Common Toxicity Criteria for Adverse Events, version 4.0. Results: Seventeen patients with HCC were analyzed: four at dose level 1, 6 at level 2, and 7 at level 3. The mean irradiated dose administered to the uninvolved liver at each dose level was 21.3, 21.6, and 18.2 Gy, respectively. There was no grade ≥3 gastrointestinal toxicity; two patients experienced grade 3 hyperbilirubinemia. All patients had Child-Pugh class A disease, but 3 patients developed class B disease after iA-CCRT. During a median follow-up of 13 months, the median progression-free survival (PFS) and overall survival (OS) were 10 and 22 months, respectively. Patients treated at dose level 3 showed improved PFS and OS. Conclusions: Radiation dose escalation of iA-CCRT did not cause any significant toxicities in patients with advanced HCC. Further large-scale studies with long-term follow-up are needed to determine the efficacy and feasibility of higher doses of iA-CCRT. View Full-Text
Keywords: Hepatocellular carcinoma; radiotherapy; chemoradiotherapy; toxicity Hepatocellular carcinoma; radiotherapy; chemoradiotherapy; toxicity
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MDPI and ACS Style

Cho, Y.; Kim, J.W.; Kim, J.K.; Lee, K.S.; Lee, J.I.; Lee, H.W.; Lee, K.-H.; Joo, S.-M.; Lim, J.H.; Lee, I.J. Phase I Radiation Dose-Escalation Study to Investigate the Dose-Limiting Toxicity of Concurrent Intra-Arterial Chemotherapy for Unresectable Hepatocellular Carcinoma. Cancers 2020, 12, 1612. https://doi.org/10.3390/cancers12061612

AMA Style

Cho Y, Kim JW, Kim JK, Lee KS, Lee JI, Lee HW, Lee K-H, Joo S-M, Lim JH, Lee IJ. Phase I Radiation Dose-Escalation Study to Investigate the Dose-Limiting Toxicity of Concurrent Intra-Arterial Chemotherapy for Unresectable Hepatocellular Carcinoma. Cancers. 2020; 12(6):1612. https://doi.org/10.3390/cancers12061612

Chicago/Turabian Style

Cho, Yeona, Jun W. Kim, Ja K. Kim, Kwan S. Lee, Jung I. Lee, Hyun W. Lee, Kwang-Hun Lee, Seung-Moon Joo, Jin H. Lim, and Ik J. Lee 2020. "Phase I Radiation Dose-Escalation Study to Investigate the Dose-Limiting Toxicity of Concurrent Intra-Arterial Chemotherapy for Unresectable Hepatocellular Carcinoma" Cancers 12, no. 6: 1612. https://doi.org/10.3390/cancers12061612

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