Rationale and design of the Pan Australasian chemotherapy-induced emesis burden of illness study

Abstract

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. The remainder of this special series of papers reports on the results of this study.

Clinical Practices and Outcomes on Chemotherapy-Induced Nausea and Vomiting Management in South Korea: Comparison with Asia-Pacific Data of the Pan Australasian Chemotherapy Induced Emesis Burden of Illness Study

“…The detailed study design has been previously published [18]. The study was conducted in accordance with the Declaration of Helsinki and local regulations.…”

“…The Pan Australasian Chemotherapy Induced Emesis burden of illness (PrACTICE) study evaluated the burden of CINV among patients receiving HEC or MEC in six countries across the Asia-Pacific (AP) region [14-18]. Data pertaining to the incidence of CINV in various chemotherapy cycles [14,16], the pattern of CINV prophylaxis in practice [15], predictors of anticipatory CINV [17], and the influence of CINV on modifications made to earlier cycles of chemotherapy regimens [16] have been previously published.…”

“…Although studies on CINV have been conducted in the AP region [19-22], differences in study design and location prevent broad generalizations. PrACTICE is the only study with a common study design evaluating the burden of CINV in six countries of the AP region [18]. …”

Antiemetic therapy in Asia Pacific countries for patients receiving moderately and highly emetogenic chemotherapy—a descriptive analysis of practice patterns, antiemetic quality of care, and use of antiemetic guidelines

“…The study was conducted at 31 sites in Australia and five Asia Pacific countries (China, India, Singapore, South Korea, Taiwan) from August 2011 to September 2012. Study methods have been described in detail in the first paper of this series [13]. In brief, we followed patients for at least one cycle, and up to three cycles, of HEC or MEC.…”

“…Instead, the NCCN guidelines recommend one of three options for an additional 2-3 days to prevent delayed CINV after MEC: either a 5HT3-RA, a corticosteroid, or an NK1-RA with or without corticosteroid [3]. This prospective observational study, the Pan Australasian Chemotherapy Induced Emesis burden of illness (PrACTICE) study, was designed to describe the incidence of CINV among chemotherapy-naïve adult patients initiating single-day HEC or MEC for cancer in the current clinical practice setting in five Asia Pacific countries and Australia [13].The second paper of this series describes the incidence of CINV in the PrACTICE study [14]. The purpose of this third paper is to report prescribing patterns of CINV prophylaxis both within and across countries according to HEC or MEC.…”