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Incidence density and factors associated with peripheral neuropathy among women with breast cancer during taxane-based chemotherapy


Design and setting

This prospective cohort study was performed to determine the incidence density of sensory and motor neuropathy as well as to examine the association between possible factors and TIPN incidence density among women with breast cancer during taxane-based chemotherapy. Patients were recruited from the National Cancer Institute of Thailand, King Chulalongkorn Memorial Hospital, and Bhumibol Adulyadej Hospital, Thailand, between October 2020 and July 2021.

Participants

One hundred and forty-one women with breast cancer participated in this cohort study. This research related to human use has complied with all relevant national regulations and institutional policies and has followed the tenets of the Declaration of Helsinki. The research was approved by the Ethics Review Committee for Research Involving Human Projects, Chulalongkorn University (COA No. 209/2020), National Cancer Institute of Thailand (COA No. 025/2020), King Chulalongkorn Memorial Hospital (COA No. 001/2021), and Bhumibol Adulyadej Hospital (under study ID: 13/63) before data collection.

The eligibility criteria were (1) age 35–65 years, (2) plan to be treated with taxane-based chemotherapy, and (3) ability to communicate and understand the Thai language. Patients were excluded if they (1) had musculoskeletal diseases or neurological conditions with peripheral neuropathic signs or (2) had received other chemotherapy agents.

Procedures

Before participating in this study, each participant was informed about the purpose of the study and testing procedures, and written informed consent was obtained. The participants were asked to report the number and type of medical comorbidities and the total number of types of medications usually taken. Participants were then allocated into two subgroups for further analysis: those aged equal to or older than 60 years and those under 60 years.

TIPN symptoms and severity were evaluated by the European Organization for Research and Treatment of Cancer CIPN specific self-report questionnaire (EORTC QOL-CIPN20; Thai version) at five time points: (1) before the initiation of baseline chemotherapy, (2–4) before the start of subsequent chemotherapy cycles, and (5) within 30 days after the last cycle of taxane-based chemotherapy was received. The EORTC QLQ-CIPN20 (Thai version) comprises 20 items divided into three subscales assessing sensory, motor, and autonomic symptoms. Each item is scored on a 4-point Likert scale ranging from 1 to 4 (1 = “not at all,” 2 = “a little,” 3 = “quite a bit,” 4 = “very much”)12. The EORTC QLQ-CIPN20 was already translated into Thai with good internal consistency (Cronbach’s α = 0.79)13. The psychometric properties of the EORTC QLQ-CIPN20 (Thai version) were completed before data collection. Excellent test–retest reliability (ICC3,1 = 0.84–0.95) and excellent inter-rather reliability (ICC2,1 = 0.78–0.94) were established. To identify sensory neuropathy, four items concerning finger and toe numbness or tingling were used. If the participants indicated severity at any level including a little, quite a bit, or very much in any category, they were identified as having sensory neuropathy symptoms14,15. In addition, four items related to difficulty in use or weakness of the hand or leg were used to identify motor neuropathy. If the participants indicated severity at any level including a little, quite a bit, or very much in any category, they were identified as having motor neuropathy symptoms.

Statistical analysis

Data were analyzed using SPSS Statistics version 23 for Windows (IBM, Armonk, NY, USA). Descriptive statistical analysis was used for baseline data and severity of TIPN symptoms. In terms of TIPN incidence density, a chance for initial sensory and motor neuropathy symptoms occurring during the period of taxane-based chemotherapy. The incidence density formula is given as the number of initial TIPN symptoms divided by the total person-days at risk. The person-days are an estimate of the actual days at risk of developing TIPN symptoms. The researchers totaled the days of observation from participant registration to the date of first TIPN symptoms, termination, last follow-up, and death. The Cox proportional-hazards model was used to determine the association between the relevant covariates and the initial TIPN symptoms and then reported as an unadjusted and adjusted hazard ratio (HR) with a 95% confidence interval (CI). Univariate analysis was used to describe the relationship between time to present the initial sensory and motor neuropathy symptoms and relevant covariates factors, including patient characteristics (age and BMI), the chemotherapy conditions (line of therapy, regimen, number of cycles received, and cumulative dose), and health and medical conditions (number and type of medical comorbidities, and number of tablets usually taken). The covariates factors with a p-value smaller than 0.25 were considered the retaining variables and used for the adjustment in the multivariate analysis16,17. Age, the number of cycles received, dyslipidemia, and diabetes were revealed as retaining variables for initial sensory neuropathy symptoms. Age, cumulative dose, hypertension, dyslipidemia, diabetes, other medication comorbidities, number of medication comorbidities, and number of tablets usually taken were revealed as retaining variables for initial motor neuropathy symptoms. Next, the multivariable regression model was performed with a backward stepwise approach, as well as the retaining variables. The incidence densities for sensory and motor neuropathy symptoms were evaluated by the Kaplan–Meier (KM) estimate and illustrated as a KM curve. The log-rank test was performed to examine the survival functions of sensory and motor neuropathy symptoms among participant subgroups based on potential risk factors. The significance level was set at p < 0.05.



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