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Article: Serum alpha-fetoprotein levels and clinical outcome in the phase 3 CELESTIAL study of cabozantinib versus placebo in patients with advanced hepatocellular carcinoma

TitleSerum alpha-fetoprotein levels and clinical outcome in the phase 3 CELESTIAL study of cabozantinib versus placebo in patients with advanced hepatocellular carcinoma
Authors
Issue Date2020
PublisherAmerican Association for Cancer Research. The Journal's web site is located at http://clincancerres.aacrjournals.org/
Citation
Clinical Cancer Research, 2020, Epub 2020-07-07 How to Cite?
AbstractPurpose The phase 3 CELESTIAL study demonstrated improved overall survival (OS) and progression-free survival (PFS) with cabozantinib versus placebo in patients with previously treated, advanced hepatocellular carcinoma (HCC). We analyzed outcomes by baseline alpha-fetoprotein (AFP) and on-treatment AFP changes. Experimental design Serum AFP was measured every 8 weeks by blinded, centralized testing. Outcomes were analyzed by baseline AFP bifurcated at 400 ng/mL and by on-treatment AFP response (≥20% decrease from baseline at Week 8). The optimal cutoff for change in AFP at Week 8 was evaluated using maximally selected rank statistics. Results Median OS for cabozantinib versus placebo was 13.9 versus 10.3 months (HR, 0.81; 95% CI, 0.62-1.04) for patients with baseline AFP <400 ng/mL, and 8.5 versus 5.2 months (HR, 0.71; 95% CI, 0.54-0.94) for patients with baseline AFP ≥400 ng/mL. Week 8 AFP response rate was 50% for cabozantinib versus 13% for placebo. In the cabozantinib arm, median OS for patients with and without AFP response was 16.1 versus 9.1 months (HR, 0.61; 95% CI, 0.45-0.84). AFP response was independently associated with longer OS. The optimal cutoff for association with OS in the cabozantinib arm was ≤0% change in AFP at Week 8 (AFP control; HR 0.50 [95% CI, 0.35-0.71]). HRs for PFS were consistent with those for OS. Conclusions Cabozantinib improved outcomes versus placebo across a range of baseline AFP levels. On-treatment AFP response and control rates were higher with cabozantinib than placebo, and were associated with longer OS and PFS with cabozantinib.
Persistent Identifierhttp://hdl.handle.net/10722/284100
ISSN
2019 Impact Factor: 10.107
2015 SCImago Journal Rankings: 5.314

 

DC FieldValueLanguage
dc.contributor.authorKelley, RK-
dc.contributor.authorMeyer, T-
dc.contributor.authorRimassa, L-
dc.contributor.authorMerle, P-
dc.contributor.authorPark, JW-
dc.contributor.authorYau, T-
dc.contributor.authorChan, SL-
dc.contributor.authorBlanc, JF-
dc.contributor.authorTam, VC-
dc.contributor.authorTran, A-
dc.contributor.authorDadduzio, V-
dc.contributor.authorMarkby, DW-
dc.contributor.authorKaldate, R-
dc.contributor.authorCheng, AL-
dc.contributor.authorEl-Khoueiry, AB-
dc.contributor.authorAbou-Alfa, GK-
dc.date.accessioned2020-07-20T05:56:05Z-
dc.date.available2020-07-20T05:56:05Z-
dc.date.issued2020-
dc.identifier.citationClinical Cancer Research, 2020, Epub 2020-07-07-
dc.identifier.issn1078-0432-
dc.identifier.urihttp://hdl.handle.net/10722/284100-
dc.description.abstractPurpose The phase 3 CELESTIAL study demonstrated improved overall survival (OS) and progression-free survival (PFS) with cabozantinib versus placebo in patients with previously treated, advanced hepatocellular carcinoma (HCC). We analyzed outcomes by baseline alpha-fetoprotein (AFP) and on-treatment AFP changes. Experimental design Serum AFP was measured every 8 weeks by blinded, centralized testing. Outcomes were analyzed by baseline AFP bifurcated at 400 ng/mL and by on-treatment AFP response (≥20% decrease from baseline at Week 8). The optimal cutoff for change in AFP at Week 8 was evaluated using maximally selected rank statistics. Results Median OS for cabozantinib versus placebo was 13.9 versus 10.3 months (HR, 0.81; 95% CI, 0.62-1.04) for patients with baseline AFP <400 ng/mL, and 8.5 versus 5.2 months (HR, 0.71; 95% CI, 0.54-0.94) for patients with baseline AFP ≥400 ng/mL. Week 8 AFP response rate was 50% for cabozantinib versus 13% for placebo. In the cabozantinib arm, median OS for patients with and without AFP response was 16.1 versus 9.1 months (HR, 0.61; 95% CI, 0.45-0.84). AFP response was independently associated with longer OS. The optimal cutoff for association with OS in the cabozantinib arm was ≤0% change in AFP at Week 8 (AFP control; HR 0.50 [95% CI, 0.35-0.71]). HRs for PFS were consistent with those for OS. Conclusions Cabozantinib improved outcomes versus placebo across a range of baseline AFP levels. On-treatment AFP response and control rates were higher with cabozantinib than placebo, and were associated with longer OS and PFS with cabozantinib.-
dc.languageeng-
dc.publisherAmerican Association for Cancer Research. The Journal's web site is located at http://clincancerres.aacrjournals.org/-
dc.relation.ispartofClinical Cancer Research-
dc.titleSerum alpha-fetoprotein levels and clinical outcome in the phase 3 CELESTIAL study of cabozantinib versus placebo in patients with advanced hepatocellular carcinoma-
dc.typeArticle-
dc.identifier.emailYau, T: tyaucc@hku.hk-
dc.identifier.authorityYau, T=rp01466-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1158/1078-0432.CCR-19-3884-
dc.identifier.hkuros311475-
dc.identifier.volumeEpub 2020-07-07-
dc.publisher.placeUnited States-

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