Department of Medicine, Royal Marsden Hospital, Sutton, Surrey, SM2 5PT, UK. Ian.Chau@rmh.nhs.uk.
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 135-710, Korea.
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, 05505, Korea.
Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, 701, Taiwan.
Departmentof Surgery, The University of Hong Kong, Pokfulam, Hong Kong.
Department of Oncology, Santa Maria del Prato Hospital, Feltre (Belluno), 32032, Italy.
Department of Hepato-Gastroenterology and Medical Oncology, CHU de Bordeaux, Hôpital Haut-Lévêque, 33604, Pessac, France.
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, 589-8511, Japan.
Department of Medical Oncology, Instituto do Câncer do Estado de São Paulo, São Paulo, 01246-000, Brazil.
Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, 606-8507, Japan.
Department of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, 03722, Korea.
Department of Oncology, University Hospital Motol, 2nd Faculty of Medicine of Charles University, 150 00, Praha, Czech Republic.
Department of Gastroenterology and Digestive Oncology, University Hospital of St Etienne, 42100, Saint Etienne, France.
Department of Experimental, Diagnostic and Specialty Medicine, University Hospital S. Orsola, 40138, Bologna, Italy.
Division of Hepatobiliary and Pancreatic Oncology, Kanagawa Cancer Center, Yokohama, 241-0815, Japan.
Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, 112, Taiwan.
National Yang-Ming University School of Medicine, Taipei, 112, Taiwan.
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, 104-0045, Japan.
Eli Lilly and Company, New York, NY, 10016, USA.
Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Department of Medicine, Harvard Medical School, Massachusetts General Hospital, Boston, MA, 02114, USA.
Post-hoc analyses of AFP response and progression and their relationship with objective measures of response and survival were performed in patients from REACH.
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.
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).
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.