Alpha-fetoprotein kinetics in patients with hepatocellular carcinoma receiving ramucirumab or placebo

An analysis of the phase 3 REACH study

Ian Chau, Joon Oh Park, Baek Yeol Ryoo, Chia Jui Yen, Ronnie Poon, Davide Pastorelli, Jean Frédéric Blanc, Masatoshi Kudo, Tulio Pfiffer, Etsuro Hatano, Hyuncheol Chung, Katerina Kopeckova, Jean Marc Phelip, Giovanni Brandi, Shinichi Ohkawa, Chung Pin Li, Takuji Okusaka, Yanzhi Hsu, Paolo B. Abada, Andrew X. Zhu

Research output: Contribution to journalArticle

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Abstract

Background: Post-hoc analyses of AFP response and progression and their relationship with objective measures of response and survival were performed in patients from REACH. Methods: Serum AFP was measured at baseline and every 3 cycles (2 weeks/cycle). Associations between AFP and radiographic progression and efficacy end points were analysed. Results: Median percent AFP increase from baseline was smaller in the ramucirumab than in the placebo arm throughout treatment. Time to AFP progression (HR 0.621; P < 0.0001) and to radiographic progression (HR 0.613; P < 0.0001) favoured ramucirumab. Association between AFP and radiographic progression was shown at 6 (OR 6.44, 95% CI 4.03, 10.29; P < 0.0001) and 12 weeks (OR 2.28, 95% CI 1.47, 3.53; P = 0.0002). AFP response was higher with ramucirumab compared with placebo (P < 0.0001). More patients in the ramucirumab arm experienced tumour shrinkage and AFP response compared with placebo. Survival was longer in patients with AFP response (13.6 months) than in patients without (6.2 months), irrespective of treatment (HR 0.457, P < 0.0001). Conclusions: Treatment with ramucirumab prolonged time to AFP progression, slowed AFP increase and was more likely to induce AFP response. Similar benefits in radiographic progression and response correlated with AFP changes.

Original languageEnglish
Pages (from-to)19-26
Number of pages8
JournalBritish journal of cancer
Volume119
Issue number1
DOIs
Publication statusPublished - 2018 Jul 3

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alpha-Fetoproteins
Hepatocellular Carcinoma
Placebos
Survival
Therapeutics
ramucirumab
Serum
Neoplasms

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Chau, Ian ; Park, Joon Oh ; Ryoo, Baek Yeol ; Yen, Chia Jui ; Poon, Ronnie ; Pastorelli, Davide ; Blanc, Jean Frédéric ; Kudo, Masatoshi ; Pfiffer, Tulio ; Hatano, Etsuro ; Chung, Hyuncheol ; Kopeckova, Katerina ; Phelip, Jean Marc ; Brandi, Giovanni ; Ohkawa, Shinichi ; Li, Chung Pin ; Okusaka, Takuji ; Hsu, Yanzhi ; Abada, Paolo B. ; Zhu, Andrew X. / Alpha-fetoprotein kinetics in patients with hepatocellular carcinoma receiving ramucirumab or placebo : An analysis of the phase 3 REACH study. In: British journal of cancer. 2018 ; Vol. 119, No. 1. pp. 19-26.
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abstract = "Background: Post-hoc analyses of AFP response and progression and their relationship with objective measures of response and survival were performed in patients from REACH. Methods: Serum AFP was measured at baseline and every 3 cycles (2 weeks/cycle). Associations between AFP and radiographic progression and efficacy end points were analysed. Results: Median percent AFP increase from baseline was smaller in the ramucirumab than in the placebo arm throughout treatment. Time to AFP progression (HR 0.621; P < 0.0001) and to radiographic progression (HR 0.613; P < 0.0001) favoured ramucirumab. Association between AFP and radiographic progression was shown at 6 (OR 6.44, 95{\%} CI 4.03, 10.29; P < 0.0001) and 12 weeks (OR 2.28, 95{\%} CI 1.47, 3.53; P = 0.0002). AFP response was higher with ramucirumab compared with placebo (P < 0.0001). More patients in the ramucirumab arm experienced tumour shrinkage and AFP response compared with placebo. Survival was longer in patients with AFP response (13.6 months) than in patients without (6.2 months), irrespective of treatment (HR 0.457, P < 0.0001). Conclusions: Treatment with ramucirumab prolonged time to AFP progression, slowed AFP increase and was more likely to induce AFP response. Similar benefits in radiographic progression and response correlated with AFP changes.",
author = "Ian Chau and Park, {Joon Oh} and Ryoo, {Baek Yeol} and Yen, {Chia Jui} and Ronnie Poon and Davide Pastorelli and Blanc, {Jean Fr{\'e}d{\'e}ric} and Masatoshi Kudo and Tulio Pfiffer and Etsuro Hatano and Hyuncheol Chung and Katerina Kopeckova and Phelip, {Jean Marc} and Giovanni Brandi and Shinichi Ohkawa and Li, {Chung Pin} and Takuji Okusaka and Yanzhi Hsu and Abada, {Paolo B.} and Zhu, {Andrew X.}",
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Chau, I, Park, JO, Ryoo, BY, Yen, CJ, Poon, R, Pastorelli, D, Blanc, JF, Kudo, M, Pfiffer, T, Hatano, E, Chung, H, Kopeckova, K, Phelip, JM, Brandi, G, Ohkawa, S, Li, CP, Okusaka, T, Hsu, Y, Abada, PB & Zhu, AX 2018, 'Alpha-fetoprotein kinetics in patients with hepatocellular carcinoma receiving ramucirumab or placebo: An analysis of the phase 3 REACH study', British journal of cancer, vol. 119, no. 1, pp. 19-26. https://doi.org/10.1038/s41416-018-0103-0

Alpha-fetoprotein kinetics in patients with hepatocellular carcinoma receiving ramucirumab or placebo : An analysis of the phase 3 REACH study. / Chau, Ian; Park, Joon Oh; Ryoo, Baek Yeol; Yen, Chia Jui; Poon, Ronnie; Pastorelli, Davide; Blanc, Jean Frédéric; Kudo, Masatoshi; Pfiffer, Tulio; Hatano, Etsuro; Chung, Hyuncheol; Kopeckova, Katerina; Phelip, Jean Marc; Brandi, Giovanni; Ohkawa, Shinichi; Li, Chung Pin; Okusaka, Takuji; Hsu, Yanzhi; Abada, Paolo B.; Zhu, Andrew X.

In: British journal of cancer, Vol. 119, No. 1, 03.07.2018, p. 19-26.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Alpha-fetoprotein kinetics in patients with hepatocellular carcinoma receiving ramucirumab or placebo

T2 - An analysis of the phase 3 REACH study

AU - Chau, Ian

AU - Park, Joon Oh

AU - Ryoo, Baek Yeol

AU - Yen, Chia Jui

AU - Poon, Ronnie

AU - Pastorelli, Davide

AU - Blanc, Jean Frédéric

AU - Kudo, Masatoshi

AU - Pfiffer, Tulio

AU - Hatano, Etsuro

AU - Chung, Hyuncheol

AU - Kopeckova, Katerina

AU - Phelip, Jean Marc

AU - Brandi, Giovanni

AU - Ohkawa, Shinichi

AU - Li, Chung Pin

AU - Okusaka, Takuji

AU - Hsu, Yanzhi

AU - Abada, Paolo B.

AU - Zhu, Andrew X.

PY - 2018/7/3

Y1 - 2018/7/3

N2 - Background: Post-hoc analyses of AFP response and progression and their relationship with objective measures of response and survival were performed in patients from REACH. Methods: Serum AFP was measured at baseline and every 3 cycles (2 weeks/cycle). Associations between AFP and radiographic progression and efficacy end points were analysed. Results: Median percent AFP increase from baseline was smaller in the ramucirumab than in the placebo arm throughout treatment. Time to AFP progression (HR 0.621; P < 0.0001) and to radiographic progression (HR 0.613; P < 0.0001) favoured ramucirumab. Association between AFP and radiographic progression was shown at 6 (OR 6.44, 95% CI 4.03, 10.29; P < 0.0001) and 12 weeks (OR 2.28, 95% CI 1.47, 3.53; P = 0.0002). AFP response was higher with ramucirumab compared with placebo (P < 0.0001). More patients in the ramucirumab arm experienced tumour shrinkage and AFP response compared with placebo. Survival was longer in patients with AFP response (13.6 months) than in patients without (6.2 months), irrespective of treatment (HR 0.457, P < 0.0001). Conclusions: Treatment with ramucirumab prolonged time to AFP progression, slowed AFP increase and was more likely to induce AFP response. Similar benefits in radiographic progression and response correlated with AFP changes.

AB - Background: Post-hoc analyses of AFP response and progression and their relationship with objective measures of response and survival were performed in patients from REACH. Methods: Serum AFP was measured at baseline and every 3 cycles (2 weeks/cycle). Associations between AFP and radiographic progression and efficacy end points were analysed. Results: Median percent AFP increase from baseline was smaller in the ramucirumab than in the placebo arm throughout treatment. Time to AFP progression (HR 0.621; P < 0.0001) and to radiographic progression (HR 0.613; P < 0.0001) favoured ramucirumab. Association between AFP and radiographic progression was shown at 6 (OR 6.44, 95% CI 4.03, 10.29; P < 0.0001) and 12 weeks (OR 2.28, 95% CI 1.47, 3.53; P = 0.0002). AFP response was higher with ramucirumab compared with placebo (P < 0.0001). More patients in the ramucirumab arm experienced tumour shrinkage and AFP response compared with placebo. Survival was longer in patients with AFP response (13.6 months) than in patients without (6.2 months), irrespective of treatment (HR 0.457, P < 0.0001). Conclusions: Treatment with ramucirumab prolonged time to AFP progression, slowed AFP increase and was more likely to induce AFP response. Similar benefits in radiographic progression and response correlated with AFP changes.

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