A randomized phase III study evaluating the efficacy and safety of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy.

BACKGROUND: Antiemetic guidelines recommend co-administration of agents that target multiple molecular pathways involved in emesis to maximize prevention and control of chemotherapy-induced nausea and vomiting (CINV). NEPA is a new oral fixed-dose combination of 300 mg netupitant, a highly selective NK1 receptor antagonist (RA) and 0.50 mg palonosetron (PALO), a pharmacologically and clinically distinct 5-HT3 RA, which targets dual antiemetic pathways. PATIENTS AND METHODS: This multinational, randomized, double-blind, parallel group phase III study (NCT01339260) in 1455 chemotherapy-naïve patients receiving moderately emetogenic (anthracycline-cyclophosphamide) chemotherapy evaluated the efficacy and safety of a single oral dose of NEPA versus a single oral dose (0.50 mg) of PALO. All patients also received oral dexamethasone (DEX) on day 1 only (12 mg in the NEPA arm and 20 mg in the PALO arm). The primary efficacy end point was complete response (CR: no emesis, no rescue medication) during the delayed (25-120 h) phase in cycle 1. RESULTS: The percentage of patients with CR during the delayed phase was significantly higher in the NEPA group compared with the PALO group (76.9% versus 69.5%; P = 0.001), as were the percentages in the overall (0-120 h) (74.3% versus 66.6%; P = 0.001) and acute (0-24 h) (88.4% versus 85.0%; P = 0.047) phases. NEPA was also superior to PALO during the delayed and overall phases for all secondary efficacy end points of no emesis, no significant nausea and complete protection (CR plus no significant nausea). NEPA was well tolerated with a similar safety profile as PALO. CONCLUSIONS: NEPA plus a single dose of DEX was superior to PALO plus DEX in preventing CINV following moderately emetogenic chemotherapy in acute, delayed and overall phases of observation. As a fixed-dose antiemetic drug combination, NEPA along with a single dose of DEX on day 1 offers guideline-based prophylaxis with a convenient, single-day treatment.

STUDY ON HEALTH PROFESSIONALS' PERCEPTION OF QUALITY OF HEALTHCARE PROVIDED TO PATIENTS.

UNLABELLED: The quality of the health care system is an essential condition for in improving the quality of health services and satisfying both the patients and healthcare professionals. RESEARCH OBJECTIVES: To identify the characteristics of medical profession, the factors of professional satisfaction or dissatisfaction and health care team-related factors that influence the quality of care. MATERIAL AND METHODS: Qualitative study using a SurveyMonkey online questionnaire consisting of 14 open-ended questions. The respondents were 1013 health professionals in university and non-university hospitals with various unit profiles. RESULTS: According to healthcare professionals, medical profession is defined by: humanism and personal sacrifice (33.37%) and also high professional competence (33.07%). Satisfaction factors are: patient health (40.57%), high social status (36.33) and saved lives (33.07%). Dissatisfaction may be due to: low salary (39.98%), disorganization (38.10%) and lack of procedures (33.96%). Performance may decrease as a result of: stressful working conditions, lack of adequate medical supplies, lack of recognition at work, routine, and strained relations with superiors. CONCLUSIONS: The study shows the need for correlating the medical education system and health systems, and for an integrated analysis of both systems by determining the required skills and modeling the medical team behavior in accordance with the performance variables which take into account satisfaction among both patients and health care professionals.