PLoS ONE (Jan 2022)

Clinical evaluation of Elecsys PIVKA-II for patients with advanced hepatocellular carcinoma

  • Shun Kaneko,
  • Masayuki Kurosaki,
  • Kaoru Tsuchiya,
  • Yutaka Yasui,
  • Yuka Hayakawa,
  • Kento Inada,
  • Yuki Tanaka,
  • Shun Ishido,
  • Sakura Kirino,
  • Koji Yamashita,
  • Tsubasa Nobusawa,
  • Hiroaki Matsumoto,
  • Tatsuya Kakegawa,
  • Mayu Higuchi,
  • Kenta Takaura,
  • Shohei Tanaka,
  • Chiaki Maeyashiki,
  • Nobuharu Tamaki,
  • Yuka Takahashi,
  • Hiroyuki Nakanishi,
  • Namiki Izumi

Journal volume & issue
Vol. 17, no. 3

Abstract

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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.