Author(s)
Maria Soledad García Pulgar, BSc, Pharmacoeconomic Specialist1, Manuel Constenla, MD, Oncologist2, Alvaro Montaño, MD, Oncologist3, Rocío García Dominguez, MD, Oncologist4, Gumersindo Pérez Manga, MD, Oncologist5, Norberto Batista, MD, Oncologist6, Amalio Ordóñez, MD, Oncologist7, Joaquin Montalar, MD, Oncologist8, Manuel Benavides, MD, Oncologist9, Miguel Angel Ruíz, PhD, Psychologist10, Jesús Garrido, PhD, Statistician10, Concha Alvarez Sanz, MD, PhD, Head of Pharmacoeconomics11Roche Farma S.A, Madrid, Spain; 2 Complejo Hospitalario Provincial de Pontevedra, Pontevedra, Spain; 3 Complejo Hospitalario Juan Ramón Jiménez, Huelva, Spain; 4 Hospital Universitario de Salamanca, Salamanca, Spain; 5 Hospital General Universitario Gregorio Marañón, Madrid, Spain; 6 Hospital Universitario de Canarias, La Laguna, Spain; 7 Hospital Universitario La Paz, Madrid, Spain; 8 Hospital Universitario La Fe, Valencia, Spain; 9 Complejo Hospitalario Carlos Haya, Málaga, Spain; 10 Universidad Autónoma de Madrid, Madrid, Spain
OBJECTIVES: Chemotherapy induced nausea and vomiting (CINV) has a negative impact on HRQoL, but little empirical data showing relation between failure to control CINV and QoL aspects other than directly related physical symptoms are available. The aim is to study dimensions of HRQoL more influenced by emesis. METHODS: Prospective, multi-center, observational study on 325 naïve patients recruited at 8 Spanish Oncology Services. Consecutive patients undergoing 1st cycle with moderate to highly emetogenic chemotherapy and scheduled antiemetic treatment based on granisetron or ondansetron were enrolled. After chemotherapy (day 0), daily maximum nausea intensity and number of vomiting episodes were recorded during 5 more days in a diary card and then FLIE and EORTC QLQ-C30 were self-administered. Acute CINV was defined as developed in day 0, and delayed CINV as developed or persisting in days 1-5. Antiemetic “complete” response was defined as: no emesis and no/mild nausea. RESULTS: Complete response (CI95%) against acute and delayed CINV were reported by 78.5% (74.0–83.0%) and 50.0% (44.5–55.0%) of patients. Response rate was not related to emetogenicity of chemotherapy (p>0.05). Physical Functioning, Dyspnoea, Constipation, Diarrhoea and Financial Dificulties from QLQ-C30 were not sensitive to antiemetic response against CINV (p>0.05). Reliability of FLIE improved when the 4-inverted VAS items were discarded, but discrimination between antiemetic response groups was maintained. Better response rates were obtained, in the granisetron arm, in the dimensions Constipation, Nausea and Vomiting of QLQ-C30 and Vomiting scale of FLIE (p<0.05). A cost minimization analysis of CINV global antiemetic treatment reflects higher treatment costs rates in the ondansetron arm. CONCLUSIONS: Complete CINV prevention agrees with literature but evidence of association between response rate and emotogenicity of chemotherapy was not found. Both QLQ-C30 and FLIE were sensitive to type of response showed by the patients. Reliability of FLIE Spanish version may be improved.
Conference/Value in Health Info
2006-10, ISPOR Europe 2006, Copenhagen, Denmark
Value in Health, Vol. 9, No.6 (November/December 2006)
Code
PCN67
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Oncology
