Mohamed M A Zaitoun1,2, Saeed B Elsayed1, Nahla A Zaitoun3, Radwa K Soliman4, Ali H Elmokadem5, Alaa A Farag6, Mahmoud Amer6, Ali M Hendi7, Nader E M Mahmoud1, Dalia Salah El Deen1, Ahmed M Alsowey1, Shahenda Shahin1, Mohammad Abd Alkhalik Basha1. 1. Diagnostic Radiology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt. 2. Diagnostic Radiology Department, King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia. 3. Family Medicine Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt. 4. Diagnostic Radiology Department, Faculty of Medicine, Assiut University, Assiut, Egypt. 5. Diagnostic Radiology Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt. 6. Internal medicine Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt. 7. Diagnostic Radiology Department, Faculty of Medicine, Jazan University, Jazan, Saudi Arabia.
Abstract
PURPOSE: To compare safety and efficacy of combined therapy with conventional transarterial chemoembolization (cTACE)+microwave ablation (MWA) versus only TACE or MWA for treatment of hepatocellular carcinoma (HCC) >3-<5 cm. METHODS: This randomized controlled trial (NCT04721470) screened 278 patients with HCC >3-<5 cm. Patients were randomized into three groups: 90 underwent TACE (Group 1); 95 underwent MWA (Group 2); and 93 underwent combined therapy (Group 3). Patients were followed-up with contrast-enhanced CT or MRI. Images were evaluated and compared for treatment response and adverse events based on modified response evaluation criteria in solid tumor. Serum alpha-fetoprotein (AFP) concentration was measured at baseline and during every follow-up visit. RESULTS: Final analysis included 265 patients (154 men, 111 women; mean age = 54.5 ± 11.8 years; range = 38-76 years). Complete response was achieved by 86.5% of patients who received combined therapy compared with 54.8% with only TACE and 56.5% with only MWA (p = 0.0002). The recurrence rate after 12 months was significantly lower in Group 3 (22.47%) than Groups 1 (60.7%) and 2 (51.1%) (p = 0.0001). The overall survival rate (three years after therapy) was significantly higher in Group 3 (69.6%) than Groups 1 (54.7%) and 2 (54.3%) (p = 0.02). The mean progression-free survival was significantly higher in Group 3 than groups 1 and 2 (p < 0.001). A decrease in AFP concentration was seen in 75%, 63%, and 48% patients of Group 3, 2, and 1, respectively. CONCLUSIONS: Combined therapy with cTACE + MWA is safe, well-tolerated, and more effective than TACE or MWA alone for treatment of HCC >3-<5 cm.
RCT Entities:
PURPOSE: To compare safety and efficacy of combined therapy with conventional transarterial chemoembolization (cTACE)+microwave ablation (MWA) versus only TACE or MWA for treatment of hepatocellular carcinoma (HCC) >3-<5 cm. METHODS: This randomized controlled trial (NCT04721470) screened 278 patients with HCC >3-<5 cm. Patients were randomized into three groups: 90 underwent TACE (Group 1); 95 underwent MWA (Group 2); and 93 underwent combined therapy (Group 3). Patients were followed-up with contrast-enhanced CT or MRI. Images were evaluated and compared for treatment response and adverse events based on modified response evaluation criteria in solid tumor. Serum alpha-fetoprotein (AFP) concentration was measured at baseline and during every follow-up visit. RESULTS: Final analysis included 265 patients (154 men, 111 women; mean age = 54.5 ± 11.8 years; range = 38-76 years). Complete response was achieved by 86.5% of patients who received combined therapy compared with 54.8% with only TACE and 56.5% with only MWA (p = 0.0002). The recurrence rate after 12 months was significantly lower in Group 3 (22.47%) than Groups 1 (60.7%) and 2 (51.1%) (p = 0.0001). The overall survival rate (three years after therapy) was significantly higher in Group 3 (69.6%) than Groups 1 (54.7%) and 2 (54.3%) (p = 0.02). The mean progression-free survival was significantly higher in Group 3 than groups 1 and 2 (p < 0.001). A decrease in AFP concentration was seen in 75%, 63%, and 48% patients of Group 3, 2, and 1, respectively. CONCLUSIONS: Combined therapy with cTACE + MWA is safe, well-tolerated, and more effective than TACE or MWA alone for treatment of HCC >3-<5 cm.