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- Title
Clinical evaluation of Elecsys PIVKA-II for patients with advanced hepatocellular carcinoma.
- Authors
Kaneko, Shun; Kurosaki, Masayuki; Tsuchiya, Kaoru; Yasui, Yutaka; Hayakawa, Yuka; Inada, Kento; Tanaka, Yuki; Ishido, Shun; Kirino, Sakura; Yamashita, Koji; Nobusawa, Tsubasa; Matsumoto, Hiroaki; Kakegawa, Tatsuya; Higuchi, Mayu; Takaura, Kenta; Tanaka, Shohei; Maeyashiki, Chiaki; Tamaki, Nobuharu; Takahashi, Yuka; Nakanishi, Hiroyuki
- Abstract
Background: Prothrombin induced by vitamin K absence-II (PIVKA-II) was reported as a diagnosis and prognosis marker for hepatocellular carcinoma (HCC). Although the development of systemic therapies for advanced HCC has been remarkable, the role of PIVKA-II is unclear. This prospective study aimed to verify Elecsys PIVKA-II compared with Lumipulse PIVKA-II in a cohort with advanced HCC undergoing systemic therapy. Methods: A total of 62 HCC patients who were treated with atezolizumab and bevacizumab (ATZ+BEV) and molecular targeted agents (MTAs) were prospectively enrolled at Musashino Red Cross Hospital from January 2020 to December 2020. A total of 208 serum samples from 52 patients were tested using Elecsys PIVKA-II and Lumipulse PIVKA-II assays. Furthermore, the relationship of Elecsys PIVKA-II and progression-free survival (PFS) was investigated with 48 patients (24 ATZ+BEV and 24 MTAs) whose Lumipulse PIVKA-II levels were >40 mAU/mL. Results: In the test accuracy analysis, the Elecsys assay has a correlation coefficient (R) of 0.92 compared with that of the Lumipulse assay (ATZ+BEV, 0.95; MTAs, 0.91). In the PFS analysis, the number of patients who received ATZ+BEV and MTAs as first- and late-line therapy were 9 and 13, and 15 and 11, respectively. The PIVKA-II response was defined for patients who had a reduction in the Elecsys PIVKA-II level on the first month of treatment evaluation. The PFS of patients with Elecsys PIVKA-II response was significantly longer than that of nonresponse patients (5.8 months vs 3.8 months, p = 0.0205). Conclusion: The Elecsys PIVKA-II was not only as useful as the Lumipulse PIVKA-II but also for stratifying the PFS of patients with advanced HCC.
- Subjects
HEPATOCELLULAR carcinoma; BEVACIZUMAB; VITAMIN K; CANCER prognosis; PROGRESSION-free survival
- Publication
PLoS ONE, 2022, Vol 17, Issue 3, p1
- ISSN
1932-6203
- Publication type
Article
- DOI
10.1371/journal.pone.0265235