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 Abstract

PURPOSE:

To evaluate the efficacy and safety of high-dose, hypofractionated proton beam therapy for hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC).

MATERIALS AND METHODS:

In this single-arm, phase II, multi-institutional study, 92 patients with biopsy-confirmed HCC or ICC, determined to be unresectable by multidisciplinary review, with a Child-Turcotte-Pugh score (CTP) of A or B, ECOG performance status of 0 to 2, no extrahepatic disease, and no prior radiation received 15 fractions of proton therapy to a maximum total dose of 67.5 Gy equivalent. Sample size was calculated to demonstrate > 80% local control (LC) defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria at 2 years for HCC patients, with the parallel goal of obtaining acceptable precision for estimating outcomes for ICC.

RESULTS:

Eighty-three patients were evaluable: 44 with HCC, 37 with ICC, and two with mixed HCC/ICC. The CTP score was A for 79.5% of patients and B for 15.7%; 4.8% of patients had no cirrhosis. Prior treatment had been given to 31.8% of HCC patients and 61.5% of ICC patients. The median maximum dimension was 5.0 cm (range, 1.9 to 12.0 cm) for HCC patients and 6.0 cm (range, 2.2 to 10.9 cm) for ICC patients. Multiple tumors were present in 27.3% of HCC patients and in 12.8% of ICC patients. Tumor vascular thrombosis was present in 29.5% of HCC patients and in 28.2% of ICC patients. The median dose delivered to both HCC and ICC patients was 58.0 Gy. With a median follow-up among survivors of 19.5 months, the LC rate at 2 years was 94.8% for HCC and 94.1% for ICC. The overall survival rate at 2 years was 63.2% for HCC and 46.5% ICC.

CONCLUSION:

High-dose hypofractionated proton therapy demonstrated high LC rates for HCC and ICC safely, supporting ongoing phase III trials of radiation in HCC and ICC. 

Author information

Hong TS1, Wo JY2, Yeap BY2, Ben-Josef E2, McDonnell EI2, Blaszkowsky LS2, Kwak EL2, Allen JN2, Clark JW2, Goyal L2, Murphy JE2, Javle MM2, Wolfgang JA2, Drapek LC2, Arellano RS2, Mamon HJ2, Mullen JT2, Yoon SS2, Tanabe KK2, Ferrone CR2, Ryan DP2, DeLaney TF2, Crane CH2, Zhu AX2.​

1Theodore S. Hong, Jennifer Y. Wo, Beow Y. Yeap, Erin I. McDonnell, Lawrence S. Blaszkowsky, Eunice L. Kwak, Jill N. Allen, Jeffrey W. Clark, Lipika Goyal, Janet E. Murphy, John A. Wolfgang, Lorraine C. Drapek, Ronald S. Arellano, John T. Mullen, Sam S. Yoon, Kenneth K. Tanabe, Cristina R. Ferrone, David P. Ryan, Thomas F. DeLaney, and Andrew X. Zhu, Massachusetts General Hospital, Harvard Medical School; Harvey J. Mamon, Brigham and Women's Hospital/Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Edgar Ben-Josef, University of Pennsylvania Hospital, Philadelphia, PA; and Milind M. Javle and Christopher H. Crane, University of Texas MD Anderson Cancer Center, Houston, TX. tshong1@partners.org.

2Theodore S. Hong, Jennifer Y. Wo, Beow Y. Yeap, Erin I. McDonnell, Lawrence S. Blaszkowsky, Eunice L. Kwak, Jill N. Allen, Jeffrey W. Clark, Lipika Goyal, Janet E. Murphy, John A. Wolfgang, Lorraine C. Drapek, Ronald S. Arellano, John T. Mullen, Sam S. Yoon, Kenneth K. Tanabe, Cristina R. Ferrone, David P. Ryan, Thomas F. DeLaney, and Andrew X. Zhu, Massachusetts General Hospital, Harvard Medical School; Harvey J. Mamon, Brigham and Women's Hospital/Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Edgar Ben-Josef, University of Pennsylvania Hospital, Philadelphia, PA; and Milind M. Javle and Christopher H. Crane, University of Texas MD Anderson Cancer Center, Houston, TX.