TACE is commonly used in patients (pts) with unresectable HCC (uHCC). However, there is no global consensus on appropriate TACE use. Evaluating the risks associated with TACE is critical to ensure pt eligibility for subsequent effective therapies.
OPTIMIS is an international, prospective, non-interventional study of uHCC pts for whom the decision to treat with TACE was made prior to enrollment. Here we report practice patterns, subsequent treatments, and liver deterioration data from Europe and Canada (Eur/Can) and the global population. TACE ineligibility was defined using international and regional guidelines.
Overall, 1650 enrolled pts received TACE including 497 from Eur/Can (n = 447 Eur, n = 50 Can). Of those, 40% of pts in Eur/Can and 39% globally were TACE ineligible according to guidelines (Table). After exclusion of pts with prior sorafenib use, 35% of pts in Eur/Can and 31% globally became TACE ineligible during the study (to be assessed for primary endpoint). Of those, 8% in Eur/Can and 9% globally received sorafenib immediately after TACE ineligibility. At inclusion, most pts were BCLC stage B, and the presence of extrahepatic spread and portal vein thrombosis was lower in Eur/Can vs globally (Table). In pts with available laboratory values, chronic liver function deterioration (worsening in CTCAE grade 30–90 days post TACE) after first TACE was noted in Eur/Can and the global population: ALT 19% and 19%, albumin 30% and 29%, AST 25% and 24%, bilirubin 9% and 11%, and INR 15% and 14%, respectively.Table: 710P Table. Disease characteristics and TACE ineligibility at inclusion.
|n (%)||Europe/Canada (n = 497)||Global total (Europe/Canada, Central/South America, Asia) (N = 1650)|
|Disease status Extrahepatic spread Portal vein thrombosis||19 (4) 15 (3)||118 (7) 123 (7)|
|BCLC stage B C D Missing||298 (60) 149 (30) 2 (<1) 48 (10)||1034 (63) 529 (32) 19 (1) 68 (4)|
|Ineligible for TACE||201 (40)||636 (39)|
Adherence to TACE eligibility guidelines appear to be similar in Eur/Can and the global population. In the Eur/Can subgroup, chronic deterioration of liver function was observed. These results also suggest that systemic therapies are not commonly used after TACE ineligibility in Eur/Can clinical practice.
Clinical trial identification
Legal entity responsible for the study
Editorial assistance in the preparation of this abstract was provided by Luke Burke of SuccinctChoice Medical Communications (London, UK), with financial support from Bayer.
J-L. Raoul: Grants, Research support: Celgene; Advisory board: Genoscience Pharma, Bayer Schering Pharma AG, BTG plc, Bristol-Myers Squibb; Honoraria: Bayer, Merck Serono. T. Decaens: Grants, Research support: ArQule, Genoscience pharma; Advisory board: Bayer, Bristol-Myers Squibb, Ipsen; Consulting: Bayer, Bristol-Myers Squibb. K. Burak: Grants, Research support: Bayer, Lupin. J. Koskinas: Grants, Research support: Gilead Sciences, Novartis, Roche, Merck Sharp & Dohme, Bayer, Bristol-Myers Squibb, AbbVie, Janssen; Clinical trials talks: Novartis, Roche, Merck Sharp & Dohme, Bayer, Gilead Sciences, Janssen, AbbVie, Bristol-Myers Squibb. I. Bayh: Advisory board: Fresenius Medical Care Deutschland GmbH; Stock ownership, Consulting: Fresenius Medical Care Deutschland GmbH; Full-time employee: Bayer. A-L. Cheng: Advisory board: Bayer Schering Pharma, Bristol-Myers Squibb, Eisai, Merck Serono, Novartis, Ono Pharmaceutical, Onxeo; Honoraria: Bayer, Eisai, Merck Sharp & Dohme; Consulting: Novartis. M. Kudo: Grants, Research support: AbbVie, Bayer, Chugai Pharma, Daiichi Sankyo, Eisai, Merck Sharp & Dohme, Otsuka, Sumitomo Dainippon Pharma, Taiho Pharmaceutical, Takeda; Advisory board: Bayer, Bristol-Myers Squibb, Chugai Pharma, Kowa, Merck Sharp & Dohme, Taiho Pharmaceutical; Honoraria: Ajinomoto, Bayer, Eisai, Merck Sharp, Dohme. H.C. Lee: Grants, Research support: Sillajen, Bayer, Ono Pharmaceutical Co; Advisory board: Bayer. K. Nakajima: Stock ownership, Employee: Bayer. M. Peck-Radosavljevic: Grants, Research support: AbbVie, ArQule, Daiichi Sankyo, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, ImClone Systems, Lilly, Merck Sharp & Dohme, Novartis, Roche; Advisory board: AbbVie, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Eisai, Ipsen, Lilly, Merck Sharp & Dohme, Roche; Honoraria, Consulting: Bayer. All other authors have declared no conflicts of interest.