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

• Published in: Supportive care in cancer 2015, Vol.23 (1), p.253-261
• Main Authors: Keefe, Dorothy M. K., Chan, Alexandre, Kim, Hoon-Kyo, Hsieh, Ruey Kuen, Yu, Shiying, Wang, Yachuan, Nicholls, Rebecca J., Burke, Thomas A.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Analysis; Antiemetics - therapeutic use; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Australia - epidemiology; Cancer; Chemotherapy; China - epidemiology; Cost of Illness; Female; Humans; Incidence; India - epidemiology; Induction Chemotherapy; Male; Medical research; Medicine; Medicine & Public Health; Medicine, Experimental; Middle Aged; Nausea; Nausea - chemically induced; Nausea - drug therapy; Nausea - epidemiology; Neoplasms - drug therapy; Nursing; Nursing Research; Oncology; Pain Medicine; Preventive medicine; Prospective Studies; Rehabilitation Medicine; Republic of Korea - epidemiology; Special Article; Surveys and Questionnaires; Vomiting; Vomiting - chemically induced; Vomiting - drug therapy; Vomiting - epidemiology
• ISSN: 0941-4355; 1433-7339
• DOI: 10.1007/s00520-014-2374-1

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.