Cancer drug alectinib less effective when taken with low-fat yogurt
Click Here to Manage Email Alerts
Key takeaways:
- Patients with ALK-positive NSCLC who took alectinib with low-fat yogurt vs. a continental breakfast had 14% less drug exposure.
- 35% of the low-fat yogurt cohort did not reach the exposure-response threshold.
Alectinib appeared less effective among patients with lung cancer when taken with low-fat yogurt compared with a fuller breakfast or lunch, according to data published in Journal of the National Comprehensive Cancer Network.
The study assessed absorption rates of the agent among patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer when taken with different types and sizes of meals.
“We expected to find a significant difference in alectinib exposure between intake with a low-fat diet and a continental breakfast, even though we only studied one of the two moments when alectinib is administered,” G.D. Marijn Veerman, MD, member of the department of medical oncology at Erasmus MC Cancer Institute at Erasmus University Medical Center, told Healio. “The more surprising result in our opinion is the unchanged exposure when alectinib is taken with an unrestricted lunch compared [with] a continental breakfast. This gives patients who are not able to eat a substantial (high-fat) breakfast in the morning the opportunity to postpone alectinib intake to a later moment at which they are capable of eating a meal with which alectinib is absorbed better.”
Background and methodology
As many as 5% of patients with NSCLC have ALK alterations. Alectinib (Alecensa, Genentech), an oral small-molecule kinase inhibitor, has been a safe and highly effective first-line treatment for these patients, according to study background. However, about 37% of patients do not reach the established 435 ng/mL exposure-response threshold.
Researchers conducted a randomized, three-period crossover study assessing the absorption rate of alectinib when taken with different diets.
Researchers assigned 23 patients to take the agent every 7 days with either a continental breakfast, 250 g of low-fat yogurt or a self-chosen lunch, with a second dose of the agent taken with a self-chosen dinner.
Researchers performed sampling for alectinib exposure on day 8 prior to alectinib intake.
Results, next steps
Results among 20 evaluable patients (median age, 65 years; 60% women) showed lower alectinib exposure when taken with low-fat yogurt compared with other meals.
Researchers noted 14% lower exposure than among patients who consumed a continental breakfast (P = .009) and 20% lower exposure than among patients who consumed a self-chosen lunch.
Administration with a self-chosen lunch did not alter exposure compared with a continental breakfast (7%; 95% CI, 2% to 17%).
About one-third (35%) of patients in the low-fat yogurt cohort did not reach the alectinib exposure-response threshold compared with only 5% of patients in the other groups (P < . 01).
“It is our strong belief that the results of this study could further individualize the treatment with alectinib for patients with NSCLC,” Veerman told Healio. “We already know that exposure to alectinib is important for its effectiveness, so this study shows the potential to increase that effectiveness without, for example, dosage escalation.”
Additional studies may be warranted to further study the relationship between specific diets and alectinib absorption, according to researchers.
“In the future, a prospective randomized-controlled trial should focus on the difference in effectiveness between alectinib treatment with dietary counseling and intensive follow-up (including alectinib exposure monitoring) and the current alectinib treatment without any dietary advises or restrictions,” Veerman said. “Additional endpoints must also include whether a significant difference in toxicity occurs when dietary advice will be followed.”
For more information:
G.D. Marijn Veerman, MD, can be reached at Erasmus University Medical Center, Dr. Molewaterplein 40, 3015 GD Rotterdam, the Netherlands.
Collapse
Read more about
Click Here to Manage Email Alerts