Cancer Res Treat.  2015 Jan;47(1):34-45. 10.4143/crt.2013.218.

Phase I Dose-Escalation Study of Proton Beam Therapy for Inoperable Hepatocellular Carcinoma

• Kim TH
• Park JW
• Kim YJ
• Kim BH
• Woo SM
• Moon SH
• Kim SS
• Koh YH
• Lee WJ
• Park SJ
• Kim JY
• Kim DY
• Kim CM

• KMID: 2380388
• DOI: http://doi.org/10.4143/crt.2013.218

Abstract

PURPOSE
The purpose of this study is to determine the optimal dose of proton beam therapy (PBT) in hepatocellular carcinoma (HCC) patients.
MATERIALS AND METHODS
Inoperable HCC patients who had naive, recurrent, or residual tumor to treatment were considered eligible for PBT. Patients received PBT with 60 GyE in 20 fractions (dose level 1; equivalent dose in 2 Gy fractions [EQD2], 65 GyE10); 66 GyE in 22 fractions (dose level 2; EQD2, 71.5 GyE10); or 72 GyE in 24 fractions (dose level 3; EQD2, 78 GyE10). Dose-limiting toxicity was determined by grade > or = 3 acute toxicity.
RESULTS
Twenty-seven patients were enrolled; eight, seven, and 12 patients were treated with dose levels 1, 2, and 3, respectively. Overall, treatment was well tolerated, with no dose-limiting toxicities. The complete response (CR) rates of primary tumors after PBT for dose levels 1, 2, and 3 were 62.5% (5/8), 57.1% (4/7), and 100% (12/12), respectively (p=0.039). The 3-and 5-year local progression-free survival (LPFS) rates among 26 patients, excluding one patient who underwent liver transplantation after PBT due to its probable significant effect on disease control, were 79.9% and 63.9%, respectively, and the 3-and 5-year overall survival rates were 56.4% and 42.3%, respectively. The 3-year LPFS rate was significantly higher in patients who achieved CR than in those who did not (90% vs. 40%, p=0.003).
CONCLUSION
PBT is safe and effective and an EQD2 > or = 78 GyE10 should be delivered for achievement of local tumor control.

Keyword

Hepatocellular carcinoma; Proton therapy; Radiotherapy

MeSH Terms

Carcinoma, Hepatocellular*
Disease-Free Survival
Humans
Liver Transplantation
Neoplasm, Residual
Proton Therapy*
Radiotherapy
Survival Rate

Figure

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  Fig. 1. Complete response of a primary tumor to proton beam therapy (PBT). (A) Pretreatment computed tomography (CT) scan showed the primary tumor (arrow). (B) The patient underwent PBT. (C) CT scan three months after PBT showed complete remission of the primary tumor (arrow).

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  Fig. 2. Local progression-free survival (LPFS) (A and D), disease-free survival (DFS) (B and E), and overall survival (OS) (C and F) curves relative to the three radiation dose levels (DLs) and tumor response (complete response [CR] vs. non-CR). CI, confidence interval; NR, not reached. a)Log-rank test.

Reference

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