eUpdate: Hepatocellular Carcinoma Treatment Recommendations

eUpdate – Hepatocellular Carcinoma Treatment Recommendations

Published: 23 September 2019. Authors: ESMO Guidelines Committee

Note: Other eUpdates may have been published for these guidelines. All currently valid eUpdates can be accessed from the page displaying the  full guidelines on this topic

Clinical Practice Guidelines

This eUpdate refers to Hepatocellular carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Vogel A, Cervantes A, Chau I et al. Ann Oncol 2018; 29 (Suppl 4): iv238–iv255.

Section

Management of early and intermediate HCC, Selective internal radiotherapy

Text update

Thus, in exceptional circumstances, for patients with liver-confined disease and preserved liver function in whom neither TACE nor systemic therapy is possible, SIRT may be considered.

Is replaced with:

Thus, in exceptional circumstances, for patients with liver-confined disease and preserved liver function in whom neither TACE nor systemic therapy is possible, SIRT may be considered [III, C].

Section

Table 4. BCLC staging and treatment options according to level of evidence and approval status

Text update

Under ‘Alternative treatment’:
BCLC stage B
SIRT (after TACE failure/ refractoriness) 

Is replaced with:
SIRT (liver-confined, good liver function, no systemic therapy feasible)

BCLC stage C
Nivolumab (second-line) [III, B]
Pembrolizumab (second-line) [III, B]
SIRT (liver confined, good liver function, no systemic therapy feasible) [III, C] 

Is replaced with:
SIRT (liver-confined, good liver function, no systemic therapy feasible)

Under ‘Treatment (standard of care)’:
Sorafenib (first-line) [I, A]
Regorafenib (second-line) [I, A; MCBS 4]
Lenvatinib (first-line) [I, A; MCBS 4]
Cabozantinib (second-line) [I, A; MCBS 3]

Is replaced with:
Sorafenib (first-line) [I, A]
Regorafenib (second-line) [I, A; MCBS 4]
Lenvatinib (first-line) [I, A; MCBS 4]
Cabozantinib (second-line) [I, A; MCBS 3]
Ramucirumab (AFPhigh, second-line)

The heading ‘Alternative treatment; Not yet EMA-approved’ is removed.

Section

Management of advanced disease, Systemic therapies for advanced HCC, Targeted second-line therapies

Text update

Ramucirumab (RAM) can be considered for patients in second-line treatment with baseline AFP 400 ng/mL, well-preserved liver function and ECOG PS 0–1 [I, A]. It received EMA approval in August 2019.

Section

Immunotherapies

Text update

Immunotherapy with nivolumab and pembrolizumab can be considered in patients who are intolerant to, or have progressed under, approved tyrosine kinase inhibitors, pending EMA approval [III, B]. For a definitive recommendation, it is necessary to wait for the results of randomised trials.

Is replaced with:

Immunotherapy with nivolumab and pembrolizumab have been evaluated for patients who are intolerant to or have progressed under approved tyrosine kinase inhibitors. The first-line phase III CheckMate 459 trial, comparing sorafenib with nivolumab as a first-line treatment option failed to meet the primary endpoint of overall survival (OS). The second-line phase III KEYNOTE-240 trial of pembrolizumab also failed to meet its co-primary endpoints of OS and progression-free survival (PFS), compared with placebo plus best supportive care. For a definitive recommendation, it is necessary to wait for the final results of the randomised trials.

Section

Table 6. Summary of Recommendations, Management of advanced disease

Text update

  • Ramucirumab can be considered for patients in second-line patients with baseline AFP ≥400 ng/mL, well-preserved liver function and ECOG PS 0–1, pending EMA approval [I, A].

Is replaced with:

  • Ramucirumab can be considered as second-line treatment for patients with baseline AFP ≥400 ng/mL, well-preserved liver function and ECOG PS 0–1, and is now EMA-approved [I, A].

 

  • Immunotherapy with nivolumab and pembrolizumab can be considered in patients who are intolerant to, or have progressed under, approved tyrosine kinase inhibitors, pending EMA approval [III, B]. For a definitive recommendation, it is necessary to wait for the results of randomised trials. 

Is replaced with:

  • Immunotherapy with nivolumab and pembrolizumab have been evaluated for patients who are intolerant to, or have progressed under approved TKIs [III, B], but further studies are needed.