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WorksheetsECOG
Total questions: 16
Worksheet time: 16mins
1. The updated indication wording in our SmPC states the following:
“IMBRUVICA as a single agent or in combination with rituximab or obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) .”
True
False
The study design of ECOG1912 is
Multicenter, Randomised (2:2), Phase III, Controlled and Open label trial
Multicenter, Randomised (2:1), Phase III, Controlled and Open label trial
Multicenter, Randomised (2:1), Phase II, Controlled and Open label trial
Multicenter, Randomised (2:2), Phase II, Controlled and closed label trial
1. The ECOG trial evaluated the superiority of Ibrutinib in combination with Rituximab to Chemo-immunotherapy (FCR) , the eligibility criteria is
Young CLL patient with age less than or equals 70 years who are able to tolerate FCR , High risk patients excluding 17p deletion
Young CLL patient with age less than or equals 65 years, High risk patients excluding 17p deletion
Young CLL patient with age less than or equals 70 years who are able to tolerate FCR , High risk patients including 17p deletion
The primary endpoint of the ECOG1912 is
PFS
OS
Safety
The secondary endpoint of the ECOG is
Overall Survival Only
Overall Survival and Safety
Safety Only
Rituximab was added to the ibrutinib arm starting from
Cycle 1
Cycle 2
In the Ibrutinib based arm, Ibrutinib were administered on a dose of 420 mg , until disease progression or unacceptable toxicity
True
False
ECOG 1st followup was published in
New England Journal of Medicine
Blood Journal
Hematologica Journal
On ASH 2019, ECOG1912 followup was upto
48months
33.6months
38months
60months
At 48 months FU, the PFS rate at 3 years with ibrutinib in combination with rituximab is
89%
91%
79%
80%
At median 48 months, the PFS rate at 3 years with the CIT arm, FCR is
89%
91%
71%
80%
At median of 48 months in the ECOG, the Hazard Ratio forintent to treat population progression free survival of IR versus FCR is
0.39
0.35
0.42
0.28
In the ECOG trial, at median follow-up 48months the relative risk reduction of progression or death in uIGHV with IR versus FCR is
72%(HR:0.28)
58%(0.42)
66% (0.34)
61% (0.39)
In the ECOG trial, at median follow-up 48months the relative risk reduction of progression or death in mIGHV with IR versus FCR is
72%(HR:0.28)
58%(0.42)
66% (0.34)
61% (0.39)
At median followup of 48 months, the 3 years overall survival rates for the IR vs FCR is
99%, 91%
91%,99%
90%,99%
98%, 91%
Why was a statistically significant PFS benefit seen in the uIGHV sub-group but not the mIGHV sub-group given both have HR <0.5?
Lack of statistical significance for the mIGHV subgroup may be due to the large sample size and limited follow-up
Not true, the statistical significance was seen in both subgroups
The HR for patients with mIGHV had 95% confidence intervals that included 1
