Author(s)
Brück P1, Kisro J2, Cohn AL3, Yoshino T4, Van Cutsem E5, Hegewisch-Becker S6, Kullmann F7, Liepa AM8, Yang L9, Nasroulah F9, Tabernero J10
1Lilly Deutschland GmbH, Bad Homburg, Germany, 2Onkologisches Zentrum Lübeck e.V, Lübeck, Germany, 3Rocky Mountain Cancer Center/US Oncology, Denver, CO, USA, 4National Cancer Center Hospital East, Chiba, Japan, 5University Hospitals Gasthuisberg, Leuven, Belgium, 6Hematological/Oncological Practice, Hamburg, Germany, 7Klinikum Weiden, Weiden, Germany, 8Eli Lilly and Company, Indianapolis, IN, USA, 9Eli Lilly and Company, Bridgewater, NJ, USA, 10Vall d'Hebron University Hospital, Barcelona, Spain
OBJECTIVES:: To present secondary resource utilization data from the RAISE study. METHODS:: Eligible patients with mCRC were randomized 1:1 to receive 8 mg/kg ramucirumab+FOLFIRI or placebo+FOLFIRI every 2 weeks until disease progression (PD), unacceptable toxicity, or death. Adverse events (AEs) and resource utilization data were collected at each cycle until 30 days after treatment discontinuation. These data were evaluated for all patients who received at least 1 dose of study treatment. Exploratory p-values were calculated using Fisher’s exact test for categorical variables and Wilcoxon rank sum tests for continuous variables. RESULTS:: Of 1072 patients, 1057 were eligible for safety and resource utilization analyses (ramucirumab 529, placebo 528). Most of the common (≥5% patients) ≥grade 3 AEs occurred at higher frequencies with ramucirumab than with placebo: neutropenia (38.4% vs 23.3% [≥grade 3 febrile neutropenia similar at 3.4% vs 2.5%]), hypertension (10.8% vs 2.8%), diarrhea (10.8% vs 9.7%), and fatigue (11.5% vs 7.8%). In the ramucirumab arm, 20% of patients required ≥1 hospitalization due to study drug–related AEs (placebo 14%). In both arms, the mean number of hospitalization days and the proportion of patients requiring transfusions were similar. Diarrhea, febrile neutropenia, and vomiting were the most common drug-related AEs leading to hospitalization in both arms. More patients in the ramucirumab arm required antibiotics and colony-stimulating factors, but there were few needs for other additional concomitant medications compared with placebo. CONCLUSIONS:: The addition of ramucirumab to FOLFIRI second-line treatment for mCRC, although associated with increased rates of ≥grade 3 AEs such as neutropenia or hypertension, was associated with few additional medical resource requirements. DISCLOSURES: This study was supported/conducted by Eli Lilly and Company, Indianapolis, IN, USA. This is an encore of an abstract presented at the European Society for Medical Oncology – 18th World Congress on Gastrointestinal Cancer, June 29 – July 2, 2016; Barcelona, Spain.
Conference/Value in Health Info
2017-09, ISPOR Latin America 2017, Sao Paulo, Brazil
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PCN1
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Oncology