ASH Clinical News Advances in Hematology Research & Patient Care: Hi | Page 20
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TABLE 5. 6MP Intake by Self-Report Versus MEMS
Study
Month
Patients
(N)
Self-report, days
(mean, SD)
MEMS, days
(mean, SD)
Correlation
p Value
1
275
26.1 (4.5)
25.4 (4.5)
0.58
<0.0433
2
370
26.1 (4.3)
22.8 (6.4)
0.44
<0.0001
3
355
25.9 (4.9)
23.7 (6.3)
0.36
<0.0001
4
344
25.8 (5.3)
23.2 (6.7)
0.43
<0.0001
Odds Ratio
95% CI
p Value
Age ≥12 (per year)
1.07
1.0-1.1
0.04
Hispanic
2.4
1.2-5.0
0.02
Asian
3.1
1.2-8.3
African-American
5.3
2.2-12.5
Paternal education lower than
college-level
2.1
1.1-4.1
6MP non-adherence <95%
8.6
4.7-15.9
investigators compared self-reported oral 6MP intake (subjective
record group) with electronically monitored intake (objective record
group) in 416 young patients with ALL.
In the subjective record group, the patient (or the patient’s
parent, if the patient was younger than 12 years old) self-reported the
number of days that the 6MP had been taken over the past month
at the end of each of the four study months. In the objective record
group, 6MP was measured electronically using the Medication Event
Management System (MEMS) tracking cap, which recorded the dates
and times whenever the 6MP bottle was opened, continuing for four
study months per patient.
All patients included in the study (median age = 6 years; age
range = 2-20 years) were in first remission and receiving 75 mg/
m2 once-daily 6MP as maintenance therapy. Thirty-nine percent of
patients had high-risk disease and 36 percent were Caucasian.
At the end of the study period, the data from the MEMS cap
were compared with the self-report records. Patients were then
categorized as either:
• perfect reporters: objective and subjective records matched
• over-reporters: 6MP intakes was greater on self-report than
MEMS for 5 or more days for more than half of the study months
• others: 6MP intake was different on self-report than MEMS for
less than 5 days or less than half of the study months
Only 50 patients (12%) were identified as “perfect reporters,” Dr. Landier and colleagues wrote, while 98 (23.6%) were identified as “over-reporters.” The remaining 64.4 percent were classified as “others.”
A total of 1,344 patient-months of self-report and MEMS data
were evaluated. As seen in TABLE 5, mean days of reported 6MP intake
per month were higher in the subjective record group (ranging from
25.8-26.1 days) than in the objective record group (22.8-25.4 days).
Eighty-eight percent of patients/parents over-reported the num2015 ASH Annual Meeting
• <0 days in 2 patients (<1%)
• 0 days in 50 patients (12%)
• 1-4 days in 266 patients (64%)
TABLE 6. Predictors of Over-Reporting of 6MP Intake
18
ber of days 6MP was taken, with most
over-reporting by one to four days. The
difference between objective and subjective records due to over-reporting was:
• ≥5 days in 98 patients (24%)
The authors identified the following as
independent predictors of over-reporting:
<0.001
older age, non-white race, a household in
which fathers did not attend college, and
0.02
6MP non-adherence (TABLE 6).
Overall, 40.4 percent of all patients
<0.001
were non-adherent to oral 6MP. Notably,
non-adherent patients were 8.6 times
more likely than adherent patients to over-report 6MP intake. “While
77 of 98 (78.6%) of over-reporters were non-adherent, only one of the
50 (2%) of the perfect reporters was non-adherent,” Dr. Landier and
colleagues concluded. “Subjective reporting of 6MP ingestion during
maintenance therapy for childhood ALL may be unreliable, particularly in non-adherent patients, and should be used with caution.”
0.02
Reference
Landier W, Chen Y, Hageman L, et al. 6-Mercaptopurine (6MP) intake during
maintenance for childhood ac ]H [\؛\