Capecitabine safety profile, innovative and generic adjuvant formulation of nonmetastatic colorectal cancer

Farm Hosp. 2019 Sep 1;43(5):158-162. doi: 10.7399/fh.11161.

Abstract

Objective: To analyze adverse reactions in patients with nonmetastatic colorectal cancer due to treatment with either innovative or generic capecitabine and/or to the chemotherapeutic regimen employed, to the capecitabine alone, or in combination with oxaliplatin (XELOX).

Method: Descriptive retrospective study carried out in a secondary level hospital in two study periods (November 2013-April 2014 and August 2016-May 2017). The collected variables were: exposure (chemotherapy scheme and/or received medication), control (demographics, disease and treatment data), and response (adverse reactions). The statistical analysis of data was performed with the SPSS® 15.0 program. Results: Fifty patients were included. According to the administered chemotherapeutic scheme, statistically significant differences were found in the appearance of palmar-plantar erythrodysesthesia, which is more frequent with monotherapy (p < 0.05), and neurotoxicity, thrombocytopenia and neutropenia, which is more frequent with XELOX (p < 0.05). Concerning the capecitabine drug administered, no statistically significant differences were found in the studied adverse reactions.

Conclusions: The safety profile of two capecitabine formulations - innovative and generic- appears to be associated with the chemotherapy scheme employed, and not the drug itself. Most palmar- plantar erythrodysesthesia for monotherapy is likely due to the higher dose of capecitabine used in said scheme. The increase in neurotoxicity, thrombocytopenia and neutropenia for XELOX is probably due to cumulative toxicity of two antineoplastic drugs.

Objetivo: Analizar las reacciones adversas en pacientes con cáncer colorrectal no metastásico debidas al tratamiento con capecitabina innovadora o genérica, y/o al régimen quimioterápico empleado, capecitabina en monoterapia o en combinación con oxaliplatino (XELOX).Método: Estudio descriptivo retrospectivo llevado a cabo en un hospital de segundo nivel en dos periodos de estudio (noviembre de 2013-abril de 2014 y agosto de 2016-mayo de 2017). Las variables recogidas fueron variables de exposición (esquema quimioterápico y/o medicamento recibido), variables de control (datos demográficos, de enfermedad y de tratamiento) y variables de respuesta (reacciones adversas). El análisis estadístico de los datos se efectuó con el programa SPSS® 15.0.Resultados: Se incluyeron 50 pacientes. Según el esquema quimioterápico administrado, se encontraron diferencias estadísticamente significativas en la aparición de eritrodisestesia palmo- plantar, más frecuente con monoterapia (p < 0,05), y neurotoxicidad, trombopenia y neutropenia, más frecuentes con XELOX (p < 0,05). Según el medicamento de capecitabina administrado, no se observaron diferencias estadísticamente significativas en las reacciones adversas estudiadas.Conclusiones: El perfil de seguridad de dos formulaciones de capecitabina, innovadora y genérica, parece estar asociado al esquema quimioterápico empleado, y no al medicamento en cuestión. La mayor eritrodisestesia palmo-plantar para monoterapia se debe probablemente a la mayor dosis de capecitabina empleada en dicho esquema, y la mayor neurotoxicidad, trombopenia y neutropenia para XELOX se debe probablemente a la toxicidad acumulada de dos fármacos antineoplásicos.

Publication types

  • Comparative Study

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Aged
  • Aged, 80 and over
  • Antimetabolites, Antineoplastic / adverse effects*
  • Antimetabolites, Antineoplastic / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Capecitabine / administration & dosage
  • Capecitabine / adverse effects*
  • Capecitabine / therapeutic use
  • Colorectal Neoplasms / drug therapy*
  • Dose-Response Relationship, Drug
  • Drug Compounding
  • Drugs, Generic
  • Female
  • Gastrointestinal Diseases / chemically induced
  • Hand-Foot Syndrome / etiology
  • Humans
  • Male
  • Middle Aged
  • Mucositis / chemically induced
  • Neutropenia / chemically induced
  • Oxaliplatin / administration & dosage
  • Peripheral Nervous System Diseases / chemically induced
  • Retrospective Studies
  • Thrombocytopenia / chemically induced

Substances

  • Antimetabolites, Antineoplastic
  • Drugs, Generic
  • Oxaliplatin
  • Capecitabine