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Cyramza ® (ramucirumab)
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A global, randomized, double-blind, placebo-controlled study compared ramucirumab plus BSC and placebo plus BSC in patients with advanced HCC and elevated baseline AFP following first-line sorafenib.1
Patients were stratified by
geographic region (Americas, Europe, Israel, and Australia vs Asia [except Japan] vs Japan)
baseline ECOG PS (0 vs 1), and
macrovascular invasion (yes vs no).1
Patients were randomly assigned (2:1) to receive ramucirumab 8 mg/kg plus BSC (n=197) or placebo plus BSC (n=95) every 14 days until disease progression or unacceptable toxicity, or until discontinuation criteria were met.1
Treatment Duration
The median duration of therapy was 12 weeks for the ramucirumab arm (with a median of 6 cycles received, each cycle being 14 days) compared to 8 weeks for the placebo arm (with a median of 4 cycles received).1,2 Additional details on treatment duration are summarized in Table 1.
Table 1. Duration of Treatment2
|
RAM
+ BSC |
BSC
+ PBO |
Duration of therapy (weeks) |
||
Mean (SD) |
20.05 (19.93) |
10.45 (7.69) |
Median (min-max) |
12.00 (2.00-107.29) |
8.00 (2.00-43.00) |
Cycles received per patient (%)a |
||
Mean (SD) |
9.49 (9.50) |
5.07 (3.61) |
Median (min-max) |
6.00 (1.00-51.00) |
4.00 (1.00-20.00) |
Abbreviations: BSC = best supportive care; max = maximum; min = minimum; PBO = placebo; RAM = ramucirumab.
a Subject is considered to have received a treatment cycle after receiving at least 1 dose of study drug.
1. Zhu AX, Kang YK, Yen CJ, et al. REACH-2: A randomized, double-blind, placebo-controlled phase 3 study of ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein (AFP) following first-line sorafenib. Presented as an oral presentation at: 54th Annual Meeting of the American Society of Clinical Oncology (ASCO); June 1-5, 2018; Chicago, IL. Abstract #4003. https://meetinglibrary.asco.org/record/159169/abstract
2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
AFP = alpha-fetoprotein
BSC = best supportive care
ECOG = Eastern Cooperative Oncology Group
HCC = hepatocellular carcinoma
PS = performance status
Datum fӧr senaste ӧversyn 2018 M10 01