Serum Alpha-fetoprotein Levels and Clinical Outcomes in the Phase III CELESTIAL Study of Cabozantinib versus Placebo in Patients with Advanced Hepatocellular Carcinoma

Robin Kate Kelley; Tim Meyer; Lorenza Rimassa; Philippe Merle; Joong-Won Park; Thomas Yau; Stephen L Chan; Jean-Frederic Blanc; Vincent C Tam; Albert Tran; Vincenzo Dadduzio; David W Markby; Rajesh Kaldate; Ann-Lii Cheng; Anthony B El-Khoueiry; Ghassan K Abou-Alfa

doi:10.1158/1078-0432.CCR-19-3884

Serum Alpha-fetoprotein Levels and Clinical Outcomes in the Phase III CELESTIAL Study of Cabozantinib versus Placebo in Patients with Advanced Hepatocellular Carcinoma

Robin Kate Kelley, Tim Meyer, Lorenza Rimassa, Philippe Merle, Joong-Won Park, Thomas Yau, Stephen L Chan, Jean-Frederic Blanc, Vincent C Tam, Albert Tran, Vincenzo Dadduzio, David W Markby, Rajesh Kaldate, Ann-Lii Cheng, Anthony B El-Khoueiry, Ghassan K Abou-Alfa

Research output: Contribution to journal › Article › peer-review

Abstract

PURPOSE: The phase III 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.PATIENTS AND METHODS: 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% confidence interval (CI), 0.62-1.04] for patients with baseline AFP

Original language	English
Pages (from-to)	4795-4804
Number of pages	10
Journal	Clin. Cancer Res.
Volume	26
Issue number	18
DOIs	https://doi.org/10.1158/1078-0432.CCR-19-3884
Publication status	Published - Sep 15 2020

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Kelley, R. K., Meyer, T., Rimassa, L., Merle, P., Park, J-W., Yau, T., Chan, S. L., Blanc, J-F., Tam, V. C., Tran, A., Dadduzio, V., Markby, D. W., Kaldate, R., Cheng, A-L., El-Khoueiry, A. B., & Abou-Alfa, G. K. (2020). Serum Alpha-fetoprotein Levels and Clinical Outcomes in the Phase III CELESTIAL Study of Cabozantinib versus Placebo in Patients with Advanced Hepatocellular Carcinoma. Clin. Cancer Res., 26(18), 4795-4804. https://doi.org/10.1158/1078-0432.CCR-19-3884

Serum Alpha-fetoprotein Levels and Clinical Outcomes in the Phase III CELESTIAL Study of Cabozantinib versus Placebo in Patients with Advanced Hepatocellular Carcinoma. / Kelley, Robin Kate; Meyer, Tim; Rimassa, Lorenza; Merle, Philippe; Park, Joong-Won; Yau, Thomas; Chan, Stephen L; Blanc, Jean-Frederic; Tam, Vincent C; Tran, Albert; Dadduzio, Vincenzo; Markby, David W; Kaldate, Rajesh; Cheng, Ann-Lii; El-Khoueiry, Anthony B; Abou-Alfa, Ghassan K.

In: Clin. Cancer Res., Vol. 26, No. 18, 15.09.2020, p. 4795-4804.

Research output: Contribution to journal › Article › peer-review

Kelley, RK, Meyer, T, Rimassa, L, Merle, P, Park, J-W, Yau, T, Chan, SL, Blanc, J-F, Tam, VC, Tran, A, Dadduzio, V, Markby, DW, Kaldate, R, Cheng, A-L, El-Khoueiry, AB & Abou-Alfa, GK 2020, 'Serum Alpha-fetoprotein Levels and Clinical Outcomes in the Phase III CELESTIAL Study of Cabozantinib versus Placebo in Patients with Advanced Hepatocellular Carcinoma', Clin. Cancer Res., vol. 26, no. 18, pp. 4795-4804. https://doi.org/10.1158/1078-0432.CCR-19-3884

Kelley, Robin Kate ; Meyer, Tim ; Rimassa, Lorenza ; Merle, Philippe ; Park, Joong-Won ; Yau, Thomas ; Chan, Stephen L ; Blanc, Jean-Frederic ; Tam, Vincent C ; Tran, Albert ; Dadduzio, Vincenzo ; Markby, David W ; Kaldate, Rajesh ; Cheng, Ann-Lii ; El-Khoueiry, Anthony B ; Abou-Alfa, Ghassan K. / Serum Alpha-fetoprotein Levels and Clinical Outcomes in the Phase III CELESTIAL Study of Cabozantinib versus Placebo in Patients with Advanced Hepatocellular Carcinoma. In: Clin. Cancer Res. 2020 ; Vol. 26, No. 18. pp. 4795-4804.

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title = "Serum Alpha-fetoprotein Levels and Clinical Outcomes in the Phase III CELESTIAL Study of Cabozantinib versus Placebo in Patients with Advanced Hepatocellular Carcinoma",

abstract = "PURPOSE: The phase III 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.PATIENTS AND METHODS: 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% confidence interval (CI), 0.62-1.04] for patients with baseline AFP ",

author = "Kelley, {Robin Kate} and Tim Meyer and Lorenza Rimassa and Philippe Merle and Joong-Won Park and Thomas Yau and Chan, {Stephen L} and Jean-Frederic Blanc and Tam, {Vincent C} and Albert Tran and Vincenzo Dadduzio and Markby, {David W} and Rajesh Kaldate and Ann-Lii Cheng and El-Khoueiry, {Anthony B} and Abou-Alfa, {Ghassan K}",

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T1 - Serum Alpha-fetoprotein Levels and Clinical Outcomes in the Phase III CELESTIAL Study of Cabozantinib versus Placebo in Patients with Advanced Hepatocellular Carcinoma

AU - Kelley, Robin Kate

AU - Meyer, Tim

AU - Rimassa, Lorenza

AU - Merle, Philippe

AU - Park, Joong-Won

AU - Yau, Thomas

AU - Chan, Stephen L

AU - Blanc, Jean-Frederic

AU - Tam, Vincent C

AU - Tran, Albert

AU - Dadduzio, Vincenzo

AU - Markby, David W

AU - Kaldate, Rajesh

AU - Cheng, Ann-Lii

AU - El-Khoueiry, Anthony B

AU - Abou-Alfa, Ghassan K

PY - 2020/9/15

Y1 - 2020/9/15

N2 - PURPOSE: The phase III 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.PATIENTS AND METHODS: 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% confidence interval (CI), 0.62-1.04] for patients with baseline AFP

AB - PURPOSE: The phase III 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.PATIENTS AND METHODS: 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% confidence interval (CI), 0.62-1.04] for patients with baseline AFP

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