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image of Adverse Drug Reaction Profile of Capecitabine-based Chemotherapy Regimen and its Predisposing Factors in Patients Attending a Tertiary Care Hospital in South India

Abstract

Introduction

Capecitabine is known to be associated with many Adverse Drug Reactions (ADRs). Due to a lack of prospective studies, we aimed to determine the frequency and pattern of the ADR profile associated with the Capecitabine-based Chemotherapy Regimen (CBCR).

Methods

A prospective observational study was carried out at a tertiary care hospital in South India. ADRs in patients on CBCR were evaluated throughout the complete course of chemotherapy. They were graded for severity as per CTCAE criteria (v4.03) and assessed for causality and preventability. The Chi-squared test was used to analyze differences in the frequency of ADRs among cancer types, gender, and chemotherapy regimens.

Results

Most ADRs (96.6%) reported were related to the gastrointestinal system, followed by neurological events (93.3%) among 120 cancer patients on CBCR. Among the detected ADRs, skin/nail discoloration and fatigue/weakness were the most frequently reported. The majority of ADRs were classified as “possible” (50.5% by WHO and 50.9% by the Naranjo scale). Most ADRs were of grade I severity (54.5%) and were deemed “probably preventable.”

Discussion

The observed frequency of ADRs was similar to a few reported studies, but differed on the basis of the type of ADR. There is a lack of literature on the causality and preventability of ADRs with CBCR.

Conclusion

CBCR was associated with several ADRs, although most were of grade I severity and involved the gastrointestinal system. The majority of ADRs were classified as “possible” based on causality analysis, and most were deemed “probably preventable.” Future research should focus on mitigating these ADRs to avoid dose adjustments or discontinuation of chemotherapy.

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2025-06-12
2025-09-14

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Adverse Drug Reaction Profile of Capecitabine-based Chemotherapy Regimen and its Predisposing Factors in Patients Attending a Tertiary Care Hospital in South India
Bentham Science Publishers ; https://doi.org/10.2174/0115748863366875250526114841
/content/journals/cds/10.2174/0115748863366875250526114841
/content/journals/cds/10.2174/0115748863366875250526114841
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  • Article Type:     Research Article
Keywords: Capecitabine ; adverse drug reactions ; chemotherapy ; causality analysis ; naranjo ; preventability

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