摘要
AIM: To investigate the clinical significance of KL-6 as a tumor marker of HCC in two different ethnic groups with chronic liver disease consecutively encountered at outpatient clinics.METHODS: Serum KL-6 was measured by the sandwich enzyme immunoassay method using the KL-6 antibody (Ab) as both the capture and tracerAb according to the manufacturer's instructions (Eisai, Tokyo, Japan).Assessment of alpha fetoprotein (AFP) and protein induced vitamin K deficiency or absence (PIVKA-Ⅱ) was performed in both groups using commercially available kits.RESULTS: A significantly higher mean serum KL-6(556±467 U/L) was found in HCC in comparison with non-HCC groups either with (391±176 U/L; P＜0.001)or without (361±161 U/L; P＜0.001) liver cirrhosis (LC).Serum KL-6 level did not correlate with either AFP or PIVKA-Ⅱ serU/Levels. Using receiver operating curve analysis for KL-6 as a predictor for HCC showed that the area under the curve was 0.574 (95%CI = 0.50-0.64)and the KL-6 level that gave the best sensitivity (61%) was found to be 334 U/L but according to the manufacturer's instructions; a cut-off point of 500 U/Lwas used that showed the highest specificity (80%)in comparison with AFP and PIVKA-Ⅱ (78% vs 72%respectively). Combining the values of the three markers improved specificity of AFP for HCC diagnosis from 78%for AFP alone; 93% for AFP plus PIVKA-Ⅱ to 99% for both plus KL-6 value (P＜0.001). Mean serum alkaline phosphatase level was significantly higher in KL-6positive (564±475) in comparison with KL-6 negative (505±469) HCC patients (P = 0.021), but such a difference was not found among non-HCC corresponding groups.CONCLUSION: KL-6 is suggested as a tumor for HCC.Its positivity may reflect HCC-associated cholestasis and/or local tumor invasion.
AIM： To investigate the clinical significance of KL-6 as a tumor marker of HCC in two different ethnic groups with chronic liver disease consecutively encountered at outpatient clinics. METHODS： Serum KL-6 was measured by the sandwich enzyme immunoassay method using the KL-6 antibody （Ab） as both the capture and tracer Ab according to the manufacturer＇s instructions （Eisai, Tokyo, Japan）. Assessment of alpha fetoprotein （AFP） and protein induced vitamin K deficiency or absence （PIVKA-II） was performed in both groups using commercially available kits. RESULTS： A significantly higher mean serum KL-6 （556±467 U/L） was found in HCC in comparison with non-HCC groups either with （391±176 U/L; P〈0.001） or without （361±161 U/L; P〈0.001） liver cirrhosis （LC）. Serum KL-6 level did not correlate with either AFP or PIVKA-II serU/Levels. Using rec：eiver operating curve analysis for KL-6 as a predictor for HCC showed that the area under the curve was 0.574 （95%CI = 0.50-0.64） and the KL-6 level that gave the best sensitivity （61%） was found to be 334 U/L but according to the manufacturer＇s instructions; a cut-off point of 500 U/L was used that showed the highest specificity （80%） in comparison with AFP and PIVKA-II （78% vs 72% respectively）. Combining the values of the three markersimproved specificity of AFP for HCC diagnosis from 78% for AFP alone; 93% for AFP plus PIVKA-II to 99% for both plus KL-6 value （P〈0.001）. Mean serum alkaline phosphatase level was significantly higher in KL-6 positive （564＋475） in comparison with KL-6 negative （505＋469） HCC patients （P = 0.021）, but such a difference was not found among non-HCC corresponding groups. CONCLUSION： KL-6 is suggested as a tumor for HCC. Its positivity may reflect HCC-associated cholestasis and/ or local tumor invasion.
基金
Supported by the Takeda Foundation, Osaka, Japan
