Rationale and design of the Pan Australasian chemotherapy-induced emesis burden of illness study
Abstract
Background
Preventing
and managing chemotherapy-induced nausea and vomiting (CINV) remain
important goals. The objective of the Pan Australasian
chemotherapy-induced emesis burden of illness (PrACTICE) study was to
describe the incidence of CINV after highly or moderately emetogenic
chemotherapy (HEC or MEC) for cancer in current clinical practice in
Australia and five Asian countries (China, India, Singapore, South
Korea, and Taiwan).
Study design
This
prospective, observational study of CINV was conducted at 31 sites in
these six countries from August 2011 through September 2012 and enrolled
male and female adult patients (≥18 years of age) naïve to HEC and MEC
who were scheduled to receive at least two cycles of single-day
chemotherapy. The primary effectiveness endpoint was complete response,
defined as no vomiting or use of rescue therapy, during chemotherapy
cycle 1 in the overall phase (0–120 h), acute phase (0–24 h), and
delayed phase (>24–120 h). Study outcomes were analyzed
descriptively. Primary outcomes, CINV incidence, and treatment patterns
(chemotherapy, CINV prophylaxis, rescue medication prescription, and
rescue medication use) were assessed by phase (overall, acute, delayed),
by cycle (as appropriate), within and across countries, and by level of
chemotherapy emetogenicity (HEC vs MEC). The impact of CINV in cycle 1
on CINV in cycle 2 was analyzed for all patients with evaluable data for
cycle 2. No site-specific analyses were performed.
Summary
The remainder of this special series of papers reports on the results of this study.
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