|Author||Brade, Anthony M. ♦ Ng, Sylvia ♦ Brierley, James ♦ Kim, John ♦ Dinniwell, Robert ♦ Ringash, Jolie ♦ Wong, Rebecca R. ♦ Cho, Charles ♦ Knox, Jennifer ♦ Dawson, Laura A.|
|Source||United States Department of Energy Office of Scientific and Technical Information|
|Subject Keyword||RADIOLOGY AND NUCLEAR MEDICINE ♦ CLINICAL TRIALS ♦ GY RANGE 10-100 ♦ LIVER ♦ NEOPLASMS ♦ PATIENTS ♦ RADIATION DOSES ♦ RADIOTHERAPY ♦ TOXICITY|
|Abstract||Purpose: To determine the maximally tolerated dose of sorafenib delivered before, during, and after stereotactic body radiation therapy (SBRT) in hepatocellular carinoma (HCC). Methods and Materials: Eligible patients had locally advanced Child-Pugh class A HCC, showed Eastern Cooperative Oncology Group performance status 0-1, and were ineligible for standard local-regional therapies. Sorafenib was dose escalated in 2 strata: (1) low effective irradiated liver volume (veff) < 30% and (2) high veff 30%to 60%. Sorafenib (400 mg daily = dose level 1) was administered for 12 weeks, with 6 fractions SBRT delivered weeks 2 and 3, and escalation to full dose (400 mg twice daily) after 12 weeks as tolerated. Standard 3 + 3 cohorts with dose escalation of sorafenib were planned. Results: Sixteen patients (4 low veff, median dose 51 Gy; 12 high veff, median dose 33 Gy) were treated at 2 sorafenib dose levels. Of those patients 75% were had Barcelona Clinic Liver Cancer stage C, and 63% had main branch portal vein invasion. In the low veff stratum, no dose-limiting toxicities (DLTs) were observed in 4 patients treated with SBRT and sorafenib 400 mg. Inb the high veff stratum: 2 of 3 evaluable patients treated with sorafenib 400 mg experienced DLT (grade 3 large bowel bleed and grade 4 bowel obstruction 51 and 27 days, respectively, after SBRT). One of 6 evaluable patients at dose level −1 (200 mg once daily) experienced a grade 3 tumor rupture at week 5. Median overall survival and in-field local progression have not been reached. Worsening of Child-Pugh liver function class was seen in 6 of 12 patients in the high veff stratum. Conclusions: Significant toxicity was observed in the high veff stratum, and concurrent SBRT with sorafenib is not recommended outside a clinical trial.|
|Learning Resource Type||Article|
|Publisher Place||United States|
|Journal||International Journal of Radiation Oncology, Biology and Physics|
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