Sánchez-Gundín J1, Barreda-Hernández D1, Mulet-Alberola A1, Muñoz-Sánchez MM2, Martínez-Ortega P3, Santos-Roldán L3
1 Servicio de Farmacia. Hospital Virgen de la Luz. Cuenca (España)
2 Sección de Oncología. Hospital Virgen de la Luz. Cuenca (España)
3 Estudiantes quinto curso de Farmacia. Universidad Alcalá de Henares (España)
Rev. OFIL 2016, 26;3:197-203
Fecha de recepción: 24/08/2015 – Fecha de aceptación: 25/04/2016
Purpose: To analyze the association between capecitabine adverse events (AE) and brand-name/generic, drug dosage/chemotherapy cycles number, performance status (PS) or authorized/compassionate use.
Method: Observational retrospective study (November 2013-April 2014) of patients treated with capecitabine. Data collected: age, sex, diagnostic, PS, drug involved, initial dosage, cycles number, chemotherapy regimen received, authorized/compassionate use and AE reporting/toxicity degree: palmar-plantar erythrodysaesthesia syndrome, mucositis and diarrhoea grade 3-4 and blood disorders grade 2 or higher.
Patients were divided according to drug administered (group 1: brand-name, group 2: generic, group 3: brand-name+generic), cycles number (1-4, 5-8 and >8) and PS (0-1, 2-3). Data were collected from: medical and pharmaco-therapeutical record review.
Results: 99 patients: 61% treated with brand-name formulation, 15% generic y 24% both. Median age: 69 years-old, majority masculine (69%). The most frequent diagnostic: metastatic colorectal cancer (63%). 75% was authorized uses. Median PS: 1 and the most common chemotherapy regimen: monotherapy (49%). All initial dosages were according to product information and median cycles number: 5. There were no significant differences in age, sex, PS and chemotherapy regimen received.
73%, 80% y 75% of patients from group 1, 2 y 3 respectively showed any studied AE with difference toxicity degree, regardless drug administered (p=0.868/p=0.873). There was association between cycles number and AE reporting (p=0.040), but no with toxicity degree (p=0.222). Neither was associated PS (p=0.660/p=0.390) nor authorized/compassionate use (p=0.570 /p=0.452) with AE reporting/toxicity degree.
Conclusions: Capecitabine toxicity profile seems not to have relation with formulation involved, PS or authorized/compassionate use. However, there is a relation between cycles number/EA reporting.
Key Words: Capecitabine, generic drugs, brand-name drugs , toxicity, adverse effects.
Julia Sánchez Gundín
C/San Marcos, 1 – 3ºizq
Correo electrónico: firstname.lastname@example.org
Download full article in PDF: Capecitabina formulación innovadora y genérica: perfil de seguridad