Toxicities and Adverse Drug Reactions Experienced During Anticancer Treatment

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  Toxicities and Adverse Drug Reactions Experienced During Anticancer Treatment: It Is Desirable to Consider the Problem Within the International System of Pharmacovigilance

To the Editor:

We read with much pleasure the article by Di Maio et al.¹ (Toxicities and Adverse Drug Reactions Experienced During Anticancer Treatment: It Is Desirable to Consider the Problem Within the International System of Pharmacovigilance) It is quite unusual to deal with articles reporting treatment-related toxicities as experienced and reported by patients in scientific literature. A major strength of this article is the authors' ability to share data with three sponsors. Promoters of clinical trials usually tend to emphasize, for obvious commercial reasons, their effectiveness rather than their negative implications, like adverse effects.^2,3 The authors consistently discussed important issues; however, we would like to add the following considerations that may reinforce their results.

1. The authors highlight the potential for a strong under-reporting of toxicities experienced by patients; this is particularly relevant in the field of 
   oncology⁴..... 
   
   
2. The authors highlight that underestimation of the absolute rate of toxicity is a highly relevant problem for clinicians, patients, and regulatory bodies..... 
   
   
3. The authors report data from three clinical trials........
   
   
4. In our opinion, poor sharing of information and lack of interest among health professionals cause under-reporting of toxicities......
   
   
5. There is a need to pursue postgraduate training or continuing medical education......

REFERENCES

1. 1.↵
   1. Di Maio M,
   2. Gallo C,
   3. Leighl NB,
   4. et al.

   (2015) Symptomatic toxicities experienced during anticancer treatment: Agreement between patient and physician reporting in three randomized trials. J Clin Oncol 33:910–915.

   Abstract/FREE Full Text

    

   Abstract

   Purpose Information about symptomatic toxicities of anticancer treatments is not based on direct report by patients, but rather on reports by clinicians in trials. Given the potential for under-reporting, our aim was to compare reporting by patients and physicians of six toxicities (anorexia, nausea, vomiting, constipation, diarrhea, and hair loss) within three randomized trials.

   
   

   Conclusion Subjective toxicities are at high risk of under-reporting by physicians, even when prospectively collected within randomized trials. This strongly supports the incorporation of patient-reported outcomes into toxicity reporting in clinical trials.

   Footnotes

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   • Terms in blue are defined in the glossary, found at the end of this article and online at www.jco.org.