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Effect of Food on Lapatinib Pharmacokinetics

Azienda Ospedaliera-Universitaria Careggi, Firenze, Italy

To the Editor:

The observation by Ratain and Cohen¹ that "the degree of interpatient variability may be affected by food, although this was not demonstrated in the food effect study" is questionable because, as a matter of fact, the authors suggest that food is unlikely to increase the intersubject variability in lapatinib pharmacokinetics.

Fasting conditions are, by definition, reproducible, whereas taking a meal (along with a long-term drug administration by oral route) is an obvious source of heterogeneity in terms of interpatient and/or intrapatient pharmacokinetic variability. Given that the type of meal increases lapatinib bioavailability by an extent ranging from 167% for low-fat meals to 325% for high-fat meals, the risk of taking lapatinbwith food (no matter if standardized or not) is to generate grossly unpredictable plasma concentrations and to consequently worsen efficacy or adverse effects.

AUTHOR'S DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Although all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a "U" are those for which no compensation was received; those relationships marked with a "C" were compensated. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.

Employment or Leadership Position: None Consultant or Advisory Role: Andrea Messori, GlaxoSmithKline-Italy (U) Stock Ownership: None Honoraria: None Research Funding: None Expert Testimony: None Other Remuneration: None

REFERENCE

1. Ratain MJ, Cohen EE: The value meal: How to save $1,700 per month or more on lapatinib. J Clin Oncol 25:3397-3398, 2007[Free Full Text]

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