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Cancers 2018, 10(10), 384; https://doi.org/10.3390/cancers10100384

Risk Factors for Severe Diarrhea with an Afatinib Treatment of Non-Small Cell Lung Cancer: A Pooled Analysis of Clinical Trials

1
College of Medicine and Public Health, Flinders University, Adelaide 5042, Australia
2
Department of Medical Oncology, Flinders Medical Centre, Adelaide 5042, Australia
*
Author to whom correspondence should be addressed.
Received: 13 September 2018 / Revised: 3 October 2018 / Accepted: 10 October 2018 / Published: 15 October 2018
(This article belongs to the Special Issue Epidermal Growth Factor Receptor Signaling in Cancer)
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Abstract

Afatinib is an effective therapy for metastatic non-small cell lung cancer (NSCLC) but it is associated with a relatively high incidence of severe diarrhea. The association between pre-treatment candidate predictors (age, sex, race, performance status, renal function, hemoglobin, and measures of body mass) and severe (grade ≥ 3) diarrhea was evaluated using logistic regression with pooled individual participant data from seven clinical studies. A risk score was developed based on the count of major risk factors. Overall, 184 of 1151 participants (16%) experienced severe diarrhea with use of afatinib. Body weight, body mass index, and body surface area all exhibited a prominent non-linear association where risk increased markedly at the lower range (p < 0.005). Low weight (<45 kg), female sex, and older age (≥60 years) were identified as major independent risk factors (p < 0.01). Each risk factor was associated with a two-fold increase in the odds of severe diarrhea, and this was consistent between individuals commenced on 40 mg or 50 mg afatinib. A simple risk score based on the count of these risk factors identifies individuals at lowest and highest risk (C-statistic of 0.65). Risk of severe diarrhea for individuals commenced on 40 mg afatinib ranged from 6% for individuals with no risk factors to 33% for individuals with all three risk factors. View Full-Text
Keywords: EGFR inhibitor; diarrhea; toxicity; prediction model; adverse event EGFR inhibitor; diarrhea; toxicity; prediction model; adverse event
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Hopkins, A.M.; Nguyen, A.-M.; Karapetis, C.S.; Rowland, A.; Sorich, M.J. Risk Factors for Severe Diarrhea with an Afatinib Treatment of Non-Small Cell Lung Cancer: A Pooled Analysis of Clinical Trials. Cancers 2018, 10, 384.

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