Liquid Formulation of Gemcitabine Increases Venous Pain in Patients With Cancer: A Retrospective Study

Autor: Hitoshi Kawazoe, Natsuki Mori, Tomonori Nakamura, Shizuka Ido, Misako Yamauchi, Akane Takeuchi, Masaki Nakai, Kikue Tsuneoka, Satomi Sumikawa, Mayumi Matsuo, Yoshihiro Yakushijin, Ryuji Uozumi
Rok vydání: 2019
Předmět:
Adult
Male
medicine.medical_specialty
Antimetabolites
Antineoplastic
medicine.medical_treatment
Drug Compounding
Pain
02 engineering and technology
030204 cardiovascular system & hematology
Deoxycytidine
03 medical and health sciences
020210 optoelectronics & photonics
0302 clinical medicine
Risk Factors
Internal medicine
Neoplasms
Injection site reaction
0202 electrical engineering
electronic engineering
information engineering
medicine
Clinical endpoint
Humans
Pharmacology (medical)
Vein
Infusions
Intravenous
Aged
Retrospective Studies
Pharmacology
Aged
80 and over
Chemotherapy
business.industry
Common Terminology Criteria for Adverse Events
Retrospective cohort study
Odds ratio
Middle Aged
medicine.disease
Gemcitabine
medicine.anatomical_structure
Freeze Drying
Female
business
medicine.drug
Zdroj: Clinical therapeutics. 42(4)
ISSN: 1879-114X
Popis: Venous pain induced by peripheral intravenous infusion of gemcitabine has remained an unresolved issue in clinical practice. This study aimed to identify differences between gemcitabine formulations as well as risk factors associated with gemcitabine-induced venous pain in patients with cancer.We retrospectively analyzed data from consecutive patients with cancer who had received chemotherapy including a lyophilized or liquid formulation of gemcitabine diluted with 5% glucose solution via a peripheral vein. The study was conducted at Ehime University Hospital using electronic medical records dated between January 2015 and July 2017. The primary end point was the prevalence of venous pain at the administration site during gemcitabine infusion, classified as injection site reaction of grade ≥2 according to the Common Terminology Criteria for Adverse Events, version 4.0. A multivariate logistic regression analysis with generalized estimating equations for longitudinal data was used to identify risk factors for venous pain during all courses of gemcitabine treatment.A total of 1150 treatment courses in 141 Japanese patients were evaluated in this study. Venous pain occurred in 115 courses (10.0%) and in 49 patients (34.8%). The multivariate logistic regression analysis with generalized estimating equations revealed that a dose increase of gemcitabine and use of the liquid formulation of gemcitabine were significantly associated with an increased risk for venous pain (dose increase, adjusted odds ratio [OR] = 1.25; 95% CI, 1.11-1.40 [P 0.001]; and liquid formulation, adjusted OR = 12.43, 95% CI, 5.61-27.51 [P 0.001]), whereas age, course number of gemcitabine, and use of the soft-back product of 5% glucose solution were significantly associated with a reduced risk for venous pain (age, adjusted OR = 0.75; 95% CI, 0.57-0.98 [P = 0.037]; course number, adjusted OR = 0.96; 95% CI, 0.92-0.99 [P = 0.023]; and soft back, adjusted OR = 0.39; 95% CI, 0.21-0.74 [P = 0.004]).The use of the liquid formulation of gemcitabine was associated with a significant increase in the frequency of gemcitabine-induced venous pain despite dilution with 5% glucose solution compared to that with the lyophilized formulation. The lyophilized formulation of gemcitabine should hence be used in peripheral intravenous infusion for the treatment of patients with cancer.
Databáze: OpenAIRE
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