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Background <p>Achieving complete response (CR) is a desirable goal in early-to-intermediate-stage hepatocellular carcinoma (HCC). While systemic and locoregional therapies show promise, optimal drug discontinuation criteria remain unclear. This study aims to investigate drug-off criteria for atezolizumab plus bevacizumab as a proof-of-concept study.</p> Methods <p>This retrospective multicenter study included child–pugh class A patients with unresectable HCC without extrahepatic spread or macrovascular invasion who received atezolizumab plus bevacizumab as first-line therapy. Modified clinical CR (mCCR) was defined as CR per mRECIST with sustained normal alpha-fetoprotein (AFP) levels (&lt; 10.0&#xa0;ng/dl). Recurrence-free survival (RFS) and overall survival (OS) were analyzed based on the “drug-off” criteria defined by following: (1) mRECIST CR with locoregional therapies, (2) sustained normalization of AFP/AFP-L3/ des-gamma-carboxy prothrombin (DCP) for 12–24&#xa0;weeks, and (3) complete tumor vascularity disappearance by contrast-enhanced ultrasonography (CEUS) or pathological curative resection.</p> Results <p>The median follow-up was 16.5&#xa0;months (95% CI 15.2–17.8). Among 51 patients achieving mCCR, 11 underwent surgery, with pathological CR in three cases. In contrast, viable lesions were observed in 7 of 40 cases assessed using CEUS. All patients meeting the drug-off criteria (<i>n</i> = 9) showed no recurrence and none of them experienced mortality, while 45.2% (19/42) of those not meeting the criteria experienced recurrence (median RFS: 12.8&#xa0;months, <i>p</i> = 0.007). The median OS was not reached in dug-off criteria met patients (<i>n</i> = 9), 37.7&#xa0;months (95% CI: NA) in non-criteria met patients (<i>n</i> = 42), and 27.1&#xa0;months (95% CI 16.7–37.6) in non-mCCR patients (<i>n</i> = 184) (<i>p</i> &lt; 0.001).</p> Conclusion <p>In patients with unresectable and TACE-unsuitable early-to-intermediate-stage HCC who met the drug-off criteria, significantly improved RFS and OS were observed compared those who did not meet the criteria. However, further validation studies are required to confirm the utility of the criteria.</p>

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Proposal of discontinuation criteria of atezolizumab plus bevacizumab after curative conversion therapy for unresectable early-to-intermediate-stage hepatocellular carcinoma: a multicenter proof-of-concept study

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  • 发表日期：

    2025年3月7日

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  • Tomoko Aoki,
  • Masatoshi Kudo,
  • Naoshi Nishida,
  • Kazuomi Ueshima,
  • Kaoru Tsuchiya,
  • Toshifumi Tada,
  • Masahiro Morita,
  • Hirokazu Chishina,
  • Masahiro Takita,
  • Satoru Hagiwara,
  • Hiroshi Ida,
  • Yasunori Minami,
  • Hidekatsu Kuroda,
  • Noriaki Nakamura,
  • Atsushi Hiraoka,
  • Tetsu Tomonari,
  • Joji Tani,
  • Atsushi Naganuma,
  • Satoru Kakizaki,
  • Chikara Ogawa,
  • Takeshi Hatanaka,
  • Toru Ishikawa,
  • Kazuhito Kawata,
  • Atsushi Takebe,
  • Ippei Matsumoto,
  • Masaaki Hidaka,
  • Masayuki Kurosaki,
  • Takashi Kumada,
  • Namiki Izumi

摘要

Background

Achieving complete response (CR) is a desirable goal in early-to-intermediate-stage hepatocellular carcinoma (HCC). While systemic and locoregional therapies show promise, optimal drug discontinuation criteria remain unclear. This study aims to investigate drug-off criteria for atezolizumab plus bevacizumab as a proof-of-concept study.

Methods

This retrospective multicenter study included child–pugh class A patients with unresectable HCC without extrahepatic spread or macrovascular invasion who received atezolizumab plus bevacizumab as first-line therapy. Modified clinical CR (mCCR) was defined as CR per mRECIST with sustained normal alpha-fetoprotein (AFP) levels (< 10.0 ng/dl). Recurrence-free survival (RFS) and overall survival (OS) were analyzed based on the “drug-off” criteria defined by following: (1) mRECIST CR with locoregional therapies, (2) sustained normalization of AFP/AFP-L3/ des-gamma-carboxy prothrombin (DCP) for 12–24 weeks, and (3) complete tumor vascularity disappearance by contrast-enhanced ultrasonography (CEUS) or pathological curative resection.

Results

The median follow-up was 16.5 months (95% CI 15.2–17.8). Among 51 patients achieving mCCR, 11 underwent surgery, with pathological CR in three cases. In contrast, viable lesions were observed in 7 of 40 cases assessed using CEUS. All patients meeting the drug-off criteria (n = 9) showed no recurrence and none of them experienced mortality, while 45.2% (19/42) of those not meeting the criteria experienced recurrence (median RFS: 12.8 months, p = 0.007). The median OS was not reached in dug-off criteria met patients (n = 9), 37.7 months (95% CI: NA) in non-criteria met patients (n = 42), and 27.1 months (95% CI 16.7–37.6) in non-mCCR patients (n = 184) (p < 0.001).

Conclusion

In patients with unresectable and TACE-unsuitable early-to-intermediate-stage HCC who met the drug-off criteria, significantly improved RFS and OS were observed compared those who did not meet the criteria. However, further validation studies are required to confirm the utility of the criteria.