Radiology · 2007
Inoperable hepatocellular carcinoma: transarterial 188Re HDD-labeled iodized oil for treatment--prospective multicenter clinical trial.
Клиническое исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Kumar Ajay, Srivastava Deep Narayan, Chau Trinh Thi Minh, Long Huynh Duc, Bal Chandrasekhar, Chandra Prem, Chien Le Truong, Hoa Nguyen Van, Thulkar Sanjay, Sharma Sanjay, Tam Le Huu, Xuan Truong Quang, Canh Nguyen Xuan, Pant Gauri Shankar, Bandopadhyaya Guru Pad
Аннотация
PURPOSE: To prospectively evaluate, in a multicenter clinical trial, dosimetry-guided transarterial radionuclide therapy (TART) with rhenium 188 ((188)Re) 4-hexadecyl 1,2,9,9-tetramethyl-4,7-diaza-1,10-decanethiol (HDD)-labeled iodized oil in inoperable hepatocellular carcinoma (HCC).
MATERIALS AND METHODS: Ninety-three patients were recruited from 2000 to 2005 for this ethics committee-approved study. Informed written consent was obtained. After complete clinical evaluation (including assessment of liver status, serum alpha-fetoprotein [AFP] level, tumor size, portal vein status, Child-Pugh classification, Okuda staging), radiation absorbed dose (RAD) to various organs, including tumor, was calculated after injecting 185 MBq of (188)Re HDD iodized oil via the hepatic artery. From this value, the maximum tolerable activity of (188)Re, defined as the amount of radioactivity delivering no more than 12 Gy of RAD to lungs, 30 Gy to normal liver, or 1.5 Gy to bone marrow, was calculated and injected.
RESULTS: Mean patient age was 53 years (80 men and 13 women). Sixty-eight percent of patients had serologic evidence of hepatitis B and/or C; 40% had clinicoradiologic evidence of cirrhosis. Mean tumor diameter was 10.3 cm +/- 4.4, with 40% of patients having more than three lesions; in 50% of patients, tumor was either unilateral, occupying 50% or more of the liver, or bilateral. AFP was elevated in 68% of patients and was elevated to more than 300 ng/mL in 44% of patients. There was portal vein thrombosis in 38% of patients, Child-Pugh status B disease in 37% of patients, and Okuda stage II or III disease in 50% of patients. Mean first administered activity was 5.3 GBq +/- 1.6, which delivered 88 Gy of RAD to the tumor. Treatment was tolerated well. Of 66 patients in whom complete tumor response occurred, five (8%) had complete tumor mass ablation, 17 (26%) had a partial response (>50% tumor reduction), and 23 (35%) had stable disease. Only RAD to the tumors was found to be significantly (P = .001) associated with tumor and/or AFP response. Survival rates at 6, 9, 12, 24, and 36 months among patients with objective tumor response were 100%, 95%, 90%, 58%, and 30%, respectively, with a median survival of 980 days.
CONCLUSION: TART appears to be a safe, effective, and promising therapeutic option in patients with inoperable HCC.
MATERIALS AND METHODS: Ninety-three patients were recruited from 2000 to 2005 for this ethics committee-approved study. Informed written consent was obtained. After complete clinical evaluation (including assessment of liver status, serum alpha-fetoprotein [AFP] level, tumor size, portal vein status, Child-Pugh classification, Okuda staging), radiation absorbed dose (RAD) to various organs, including tumor, was calculated after injecting 185 MBq of (188)Re HDD iodized oil via the hepatic artery. From this value, the maximum tolerable activity of (188)Re, defined as the amount of radioactivity delivering no more than 12 Gy of RAD to lungs, 30 Gy to normal liver, or 1.5 Gy to bone marrow, was calculated and injected.
RESULTS: Mean patient age was 53 years (80 men and 13 women). Sixty-eight percent of patients had serologic evidence of hepatitis B and/or C; 40% had clinicoradiologic evidence of cirrhosis. Mean tumor diameter was 10.3 cm +/- 4.4, with 40% of patients having more than three lesions; in 50% of patients, tumor was either unilateral, occupying 50% or more of the liver, or bilateral. AFP was elevated in 68% of patients and was elevated to more than 300 ng/mL in 44% of patients. There was portal vein thrombosis in 38% of patients, Child-Pugh status B disease in 37% of patients, and Okuda stage II or III disease in 50% of patients. Mean first administered activity was 5.3 GBq +/- 1.6, which delivered 88 Gy of RAD to the tumor. Treatment was tolerated well. Of 66 patients in whom complete tumor response occurred, five (8%) had complete tumor mass ablation, 17 (26%) had a partial response (>50% tumor reduction), and 23 (35%) had stable disease. Only RAD to the tumors was found to be significantly (P = .001) associated with tumor and/or AFP response. Survival rates at 6, 9, 12, 24, and 36 months among patients with objective tumor response were 100%, 95%, 90%, 58%, and 30%, respectively, with a median survival of 980 days.
CONCLUSION: TART appears to be a safe, effective, and promising therapeutic option in patients with inoperable HCC.