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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
Inclusion Criteria
Patients were eligible for participation if they had
received prior sorafenib treatment as the only systemic therapeutic intervention for advanced HCC for at least 14 days, and
had discontinued sorafenib treatment ≥14 days prior to randomization.
The patient must also have either
experienced radiographically confirmed disease progression during or after discontinuation of sorafenib therapy, or
discontinued sorafenib treatment because of intolerance despite appropriate sorafenib management and supportive care.2
Baseline Patient Characteristics
The median duration of prior sorafenib was 4.11 months in both treatment arms. Additional details about prior sorafenib use are summarized in Table 1.
Table 1. Prior Sorafenib Treatment2
|
Parameter |
Ramucirumab
+ BSC |
Placebo
+ BSC |
Total |
|
Reason for discontinuation of sorafenib |
|||
|
Progressive disease |
166 (84.3) |
76 (80.0) |
242 (82.9) |
|
Intolerance |
31 (15.7) |
19 (20.0) |
50 (17.1) |
|
Duration of prior sorafenib treatment |
|||
|
<5 months |
110 (55.8) |
57 (60.0) |
167 (57.2) |
|
≥5 months |
87 (44.2) |
38 (40.0) |
125 (42.8) |
|
Time from last sorafenib treatment to randomization |
|||
|
<1 months |
102 (51.8) |
54 (56.8) |
156 (53.4) |
|
≥1 months |
95 (48.2) |
41 (43.2) |
136 (46.6) |
Abbreviation: BSC = best supportive care.
Efficacy Results
Efficacy results according to the reason for discontinuation of prior sorafenib are summarized in Table 2.
Table 2. Efficacy Results According to Reason for Prior Sorafenib Discontinuation2
|
|
RAM
+ BSC |
PBO
+ BSC |
RAM
+ BSC |
PBO
+ BSC |
|
Sorafenib Intolerance |
Progressive Disease on Sorafenib |
|||
|
Median OSa, mo (95% CI) |
10.18 (6.44-15.97) |
8.51 (5.03-14.23) |
8.28 (6.57-9.99) |
7.29 (5.22-9.00) |
|
HRb (95% CI) |
0.633 (0.318-1.260); p=.1898 |
0.763 (0.559-1.041); p=.0882 |
||
|
Interaction p valuec |
p=NS |
|||
|
Median PFSa, mo (95% CI) |
4.11 (2.79-5.55) |
1.43 (1.35-2.79) |
2.83 (2.60-3.75) |
1.61 (1.45-2.73) |
|
HRb (95% CI); p valued |
0.375 (0.200-0.704); p=.0017 |
0.495 (0.365-0.671); p<.0001 |
||
|
Interaction p valuec |
p=NS |
|||
Abbreviations: BSC = best supportive care; HR = hazard ratio; mo = month; NS = not significant; OS = overall survival; PBO = placebo; PFS = progression-free survival; RAM = ramucirumab.
a Estimated using the Kaplan-Meier method.
b Hazard ratio and 95% CI (Wald) were estimated from unstratified Cox model.
c Wald test of treatment-by-subgroup interaction from unstratified Cox model.
d Two-sided p value from unstratified log-rank test.
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 M07 01