Submit Your Article CMED MEACR meeting
Home Print this page Email this page Users Online: 728
Home About us Editorial board Search Ahead of print Current issue Archives Submit article Instructions Subscribe Contacts Login 
ORIGINAL ARTICLE
Year : 2015  |  Volume : 4  |  Issue : 1  |  Page : 13-16

Adverse drug reaction profile of pegylated liposomal doxorubicin versus conventional doxorubicin: An observational study


1 Department of Radiotherapy, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal, India
2 Department of Radiotherapy, Medical College Hospital, Kolkata, West Bengal, India
3 Department of Radiotherapy, College of Medicine and SG Hospital, Kolkata, West Bengal, India
4 Department of Pharmacology, Institute of Post Graduate Medical Education and Research, ? Kolkata, West Bengal, India
5 Department of Anaesthesiology, R. G. Kar Medical College, Kolkata, West Bengal, India

Correspondence Address:
Aloke Ghosh Dastidar
Department of Radiotherapy, Institute of Post Graduate Medical Education and Research, 8/2, Dharmatala Road, Kolkata - 700 042, West Bengal
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2278-0513.149025

Rights and Permissions

Background : Potential life-threatening cardiac toxicities limit the lifetime dose of doxorubicin. The pegylation of the molecule protects the drug from detection by methoxypolyethylene glycol resulting increase of circulation time. Encapsulation of doxorubicin inside a pegylated liposome alters bioavailability, biodistribution and thus its biological activity significantly. We conducted an intensive monitoring of the adverse drug reactions (ADRs) profile of pegylated liposomal doxorubicin (PLD) in comparison with conventional doxorubicin in a tertiary care cancer center. Materials and Methods : ADR data were collected from 30 patients receiving PLD and 30 age-matched controls receiving conventional doxorubicin in this longitudinal observational study. Severity was graded as per US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAEs). For the evaluation of acute and chronic toxicities, we adopted the basic scale from CTCAE version 4 of the National Cancer Institute. Results : The median disease duration was greater in PLD arm. Totally, 357 ADRs were noted with PLD and 375 with conventional doxorubicin. Of these, 75 (21%, 95% confidence interval [CI] 13.69-28.33%) in the PLD group and 60 (16.26%, 95% CI: 9.74-22.78%) in the conventional doxorubicin group were of grade 3/4 severity. Common events included myelosuppression, nausea, vomiting, anorexia, stomatitis, palmer-planter erythrodysesthesia, alopecia with PLD and myelosuppression, nausea, vomiting, anorexia, stomatitis, alopecia, and cardio-toxicities with conventional doxorubicin. For hematological toxicities, there was no statistical significant difference between two arms. Furthermore, gastrointestinal toxicities (nausea, vomiting, diarrhea, anorexia and stomatitis) were same for both arms. Among the skin toxicities palmar-plantar-erythrodysesthesia grade 2 toxicity was found in 60% patients receiving liposomal doxorubicin (P = 0.046). In cardio-toxicities, left ventricular ejection dysfunction found in 60% patients of conventional doxorubicin arm (P - 0.038). Conclusions: This observational study suggests that PLD has a better tolerability with less ventricular dysfunction but increased yet manageable palmar-plantar-erythrodysesthesia. This needs confirmation through further interventional study.


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed1906    
    Printed44    
    Emailed1    
    PDF Downloaded69    
    Comments [Add]    

Recommend this journal