- Email: [email protected]
266 COMBINED PERCUTANEOUS MICROWAVE ABLATION (MWA) AND TRANSARTERIAL CHEMOEMBOLIZATION (TACE) FOR HEPATOCELLULAR CARCINOMA
POSTERS review results using a random-effects model. Costs were assessed from the perspective of the health care providers. A Monte Carlo probabilistic sensitivity analysis was used to estimate outcomes with distribution samples of 1,000 patients for each treatment arm. Findings: Two randomized controlled trials and fifteen observational studies fulfilled the inclusion criteria; 8,420 patients were included: 3,996 patients underwent resection and 4,424 underwent RFA for early HCC. In a 10 year perspective, for very early HCC (single nodule <2cm) in Child–Pugh class A patients, RFA provided similar life-expectancy and quality-adjusted lifeexpectancy at a lower cost than resection and was the most costeffective therapeutic strategy. For single HCCs, 1–3 cm and 3–5 cm in diameter, resection provided better life-expectancy and was more cost-effective than RFA, at a willingness-to-pay above €4,200 per quality-adjusted life-year for nodules 3–5 cm. In the presence of two or three nodules ≤3 cm, life-expectancy and quality-adjusted life-expectancy were very similar between the two treatments, but cost-effectiveness was again in favour of RFA, given its lower costs. Interpretation: For very early HCC and in the presence of two or three nodules ≤3 cm, RFA is more cost-effective than surgical resection; conversely, for single larger early stage HCCs, surgical resection remains the best strategy to adopt as a result of better survival rates at an acceptable increase in cost. 266 COMBINED PERCUTANEOUS MICROWAVE ABLATION (MWA) AND TRANSARTERIAL CHEMOEMBOLIZATION (TACE) FOR HEPATOCELLULAR CARCINOMA G. Poggi1 , B. Montagna1 , P. Di Cesare2 , F. Melchiorre3 , G. Riva4 . 1 U.O. Oncology, Istituto Clinico Citt` a di Pavia, 2 UO Oncology, Maugeri Foundation, Pavia, 3 Interventional Radiology, Ospedale San Paolo, Milan, 4 Institute of Oncology, University of Pavia, Pavia, Italy E-mail: [email protected] Background and Aims: Locoregional therapies are useful for the treatment of unresectable hepatocellular carcinoma (HCC). Radiofrequency thermal ablation (RFA) is considered the standard of care for patients with lesions smaller than 3 cm in diameter not suitable for surgery. However the likelihood of complete ablation using RFA declines rapidly as tumor diameter is greater than 3 cm. The combination of RFA and transarterial chemoembolization (TACE) has resulted in higher percentage of complete necrosis of the HCCs over 3 cm. Microwaves ablation (MWA) has recently emerged as a new technique promising larger and faster ablation areas without some of the RFA limitations. There is only one report in literature regarding the use of MWA in association with TACE in the treatment of liver lesions; herein we report our preliminary results on feasibility and effectiveness of the combination of thermal ablation with a new 2.45-MHz generator of microwave and TACE in unresectable HCCs larger than 3 cm. Methods: Thirty-six nodules (size 3–11 cm, mean 4.78 cm, DS=2.09) of HCC were treated with a combination of percutaneous US-guided MWA and TACE (one treatment of ablation and one session of TACE for each lesion). Abdominal contrast enhanced CT scan was carried out 1 month after treatments, and then every three months to assess efficacy. “Technique effectiveness” was defined as complete absence of contrast enhancement with homogeneous hypodensity in treated area. Results: Technique effectiveness was achieved in 83.3% of the lesions; intermediate-sized HCCs obtained 100% of complete necrosis. Local tumor progressions were found in 3 treated lesions (8%) a median of 9 months after the procedures (range 7–19). Treatments were followed by few adverse effects (AEs), without G4 AEs, according to CTCAE 4.0; particularly, we found hypertransaminasemia G3 in two cases (5%), without any worsening
of liver function according to Child–Pugh Score. No deaths, or other major complications occurred. Conclusion: Our preliminary data showed that the combination of MWA and TACE for the treatment of intermediate and large-sized HCCs is a feasible and safe method, not burdened by an increase of toxicity, with encouraging results in terms of efficacy. 267 DERMATOLOGIC ADVERSE EVENTS WITHIN THE FIRST 60 DAYS OF SORAFENIB TREATMENT ARE ASSOCIATED WITH BETTER OVERALL SURVIVAL (OS) IN PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) M. Reig1 , C. Rodriguez de Lope1 , N. Llarch1 , A. Forner1 , F. Torres2 , J. Rios2 , L. Boix1 , J. Rimola3 , A. Darnell3 , C. Ayuso3 , J. Bruix1 . 1 BCLC Group, Liver Unit, Barcelona University, CIBERehd, IDIBAPS, Hospital Clinic, 2 Plataforma de Bioestad´ıstica y Gesti´ on de Datos, IDIBAPS, Hospital Cl´ınic Barcelona, Unidad de Bioestad´ıstica, Facultat de Medicina, Universitat Aut` onoma de Barcelona, 3 BCLC Group, Radiology Department, Barcelona University, CIBERehd, IDIBAPS, Hospital Clinic, Barcelona, Spain E-mail: [email protected] Background: Sorafenib [Sor] improves the OS of patients with advanced HCC. Currently, there are no clinical data or markers to predict better survival. The majority of Sor adverse events (AEs) [dermatologic, gastrointestinal or cardiovascular], appear within the first 60 days of treatment and they may influence patients management and outcome. Aim: To analyze in a cohort of HCC patients treated with Sor the association of dermatologic AEs emerging within the first 60 days (AED60) with the outcome in terms of time to progression (TTP) and OS. Methods: We prospectively included patients Child–Pugh A/B7 without ascites/encephalopathy, PS 0–1, and without contraindication or risk for Sor. Follow-up included monthly clinical and laboratory monitoring and tumor staging at week 4 and every 8 weeks. Results: We included 147 patients [Oct. 2007-Jul. 2011] (97% cirrhotic, 46% HCV+, 64yrs, 82% Child–Pugh A, PS 0 84%, BCLC-B 78, BCLC-C 69. With a median follow up of 11.6 months and a treatment duration (mTD) of 6.7 months, TTP and OS were 5.1 months and 12.7 months, respectively. 79 patients presented AED60 and 37 patients needed Sor dose modification due to AED60. Median TTP (6.3 vs. 2.7; p = 0.02) and OS (18.2 vs. 9.9; p < 0.001) were significantly better in patients with AED60, while mTD was similar [EAD60: 7.6 vs. noEAD60: 5.5; p=NS]. However, patients with EAD60 presented more dose modifications [3 vs. 2 (p = 0.006)]. Results were similar when excluding the 8 patients that died during the first 60 days. Other early AEs categories did not have an impact in outcome. Baseline PS (p < 0.001), BCLC (p = 0.009) and EAD60 of any grade (p = 0.04) were associated with better OS in the multivariate analysis of the whole cohort. Nevertheless, when excluding early deaths, the predictive value was restricted to EAD60 > grade I which determines Sor dose modification (p = 0.03). Conclusion: Development of dermatologic adverse events within 60 days of sorafenib initiation is associated with better survival. Therefore, this should not to be taken as a negative event and discourage treatment maintenance. Likewise, 2nd line clinical trials should be designed and/or evaluated considering this information to avoid significant bias.
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of liver function according to Child–Pugh Score. No deaths, or other major complications occurred. Conclusion: Our preliminary data showed that the combination of MWA and TACE for the treatment of intermediate and large-sized HCCs is a feasible and safe method, not burdened by an increase of toxicity, with encouraging results in terms of efficacy. 267 DERMATOLOGIC ADVERSE EVENTS WITHIN THE FIRST 60 DAYS OF SORAFENIB TREATMENT ARE ASSOCIATED WITH BETTER OVERALL SURVIVAL (OS) IN PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) M. Reig1 , C. Rodriguez de Lope1 , N. Llarch1 , A. Forner1 , F. Torres2 , J. Rios2 , L. Boix1 , J. Rimola3 , A. Darnell3 , C. Ayuso3 , J. Bruix1 . 1 BCLC Group, Liver Unit, Barcelona University, CIBERehd, IDIBAPS, Hospital Clinic, 2 Plataforma de Bioestad´ıstica y Gesti´ on de Datos, IDIBAPS, Hospital Cl´ınic Barcelona, Unidad de Bioestad´ıstica, Facultat de Medicina, Universitat Aut` onoma de Barcelona, 3 BCLC Group, Radiology Department, Barcelona University, CIBERehd, IDIBAPS, Hospital Clinic, Barcelona, Spain E-mail: [email protected] Background: Sorafenib [Sor] improves the OS of patients with advanced HCC. Currently, there are no clinical data or markers to predict better survival. The majority of Sor adverse events (AEs) [dermatologic, gastrointestinal or cardiovascular], appear within the first 60 days of treatment and they may influence patients management and outcome. Aim: To analyze in a cohort of HCC patients treated with Sor the association of dermatologic AEs emerging within the first 60 days (AED60) with the outcome in terms of time to progression (TTP) and OS. Methods: We prospectively included patients Child–Pugh A/B7 without ascites/encephalopathy, PS 0–1, and without contraindication or risk for Sor. Follow-up included monthly clinical and laboratory monitoring and tumor staging at week 4 and every 8 weeks. Results: We included 147 patients [Oct. 2007-Jul. 2011] (97% cirrhotic, 46% HCV+, 64yrs, 82% Child–Pugh A, PS 0 84%, BCLC-B 78, BCLC-C 69. With a median follow up of 11.6 months and a treatment duration (mTD) of 6.7 months, TTP and OS were 5.1 months and 12.7 months, respectively. 79 patients presented AED60 and 37 patients needed Sor dose modification due to AED60. Median TTP (6.3 vs. 2.7; p = 0.02) and OS (18.2 vs. 9.9; p < 0.001) were significantly better in patients with AED60, while mTD was similar [EAD60: 7.6 vs. noEAD60: 5.5; p=NS]. However, patients with EAD60 presented more dose modifications [3 vs. 2 (p = 0.006)]. Results were similar when excluding the 8 patients that died during the first 60 days. Other early AEs categories did not have an impact in outcome. Baseline PS (p < 0.001), BCLC (p = 0.009) and EAD60 of any grade (p = 0.04) were associated with better OS in the multivariate analysis of the whole cohort. Nevertheless, when excluding early deaths, the predictive value was restricted to EAD60 > grade I which determines Sor dose modification (p = 0.03). Conclusion: Development of dermatologic adverse events within 60 days of sorafenib initiation is associated with better survival. Therefore, this should not to be taken as a negative event and discourage treatment maintenance. Likewise, 2nd line clinical trials should be designed and/or evaluated considering this information to avoid significant bias.
Journal of Hepatology 2013 vol. 58 | S63–S227
S113