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, Hyun Cheol 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 journalArticlepeer-review

21 Citations (Scopus)

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

Bibliographical note

Funding Information:
This study was funded by Eli Lilly and Company. We thank the patients, their families and the study personnel across all sites for participating in this study. Yihuan Xu of Eli Lilly and Company (Bridgewater, NJ) provided statistical expertise. Nathalie Godinot of Eli Lilly and Company (Indianapolis, IN) provided writing assistance. I.C. would like to thank the National Health Service for funding to the National Institute for Health Research Biomedical Research Centre at the Royal Marsden NHS Foundation Trust and The Institute of Cancer Research.

Publisher Copyright:
© 2018 The Author(s).

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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