Lung Cancer: Adjusting Afatinib Dose Reduced Side Effects With No Impact on Efficacy Interview with:

Chih-Hsin Yang MD PhD Department of Oncology National Taiwan University Hospital

Dr. Chih-Hsin Yang

Chih-Hsin Yang MD PhD
Department of Oncology
National Taiwan University Hospital What is the background for this study? What are the main findings?

Response: LUX-Lung 3 and LUX-Lung 6 are multicenter, randomized, open-label, Phase III trials of afatinib versus chemotherapy (pemetrexed / cisplatin and gemcitabine / cisplatin, respectively) as first-line treatment for patients with EGFR mutation-positive, advanced and metastatic non-small-cell lung cancer (NSCLC). Both trials met their primary endpoint of PFS with afatinib significantly delaying tumor growth when compared to standard chemotherapy.

A post-hoc analysis of the studies was conducted to look at the incidence and severity of common adverse events (AEs) before and after afatinib dose reduction and the PFS was compared between patients who dose reduced within the first 6 months of treatment and those who did not.

The results showed dose reductions were associated with decreases in the incidence and severity of treatment-related AEs, while median progression-free survival (PFS) was similar in patients who dose-reduced within the first six months of treatment versus those who did not (LUX-Lung 3, 11.3 vs 11 months; LUX-Lung 6, 12.3 vs 11 months). What should readers take away from your report?

Response: The post-hoc analysis of the LUX-Lung 3 and LUX-Lung 6 trials showed that adjusting afatinib dosing based on tolerability reduced the incidence and severity of treatment-related adverse events with no apparent impact on efficacy. What recommendations do you have for future research as a result of this study?

Response: Boehringer Ingelheim is setting up a non-interventional study in order to evaluate the situation in a real-world setting: Is there anything else you would like to add?

Response: These data on dose modification add to the robust body of evidence for afatinib. The analysis suggests that dosing of afatinib can be adjusted to help manage a patient’s treatment-related adverse events, without any apparent reduction in efficacy. Adjusting the dose where needed provides healthcare professionals and patients with increased flexibility and confidence in the appropriate use of afatinib to help address adverse events. Thank you for your contribution to the community.


C.-H. Yang, L. V. Sequist, C. Zhou, M. Schuler, S. L. Geater, T. Mok,C.-P. Hu, N. Yamamoto, J. Feng, K. O’Byrne, S. Lu, V. Hirsh, Y. Huang,M. Sebastian, I. Okamoto, N. Dickgreber, R. Shah, A. Märten, D. Massey,S. Wind, and Y.-L. Wu
Effect of dose adjustment on the safety and efficacy of afatinib for EGFRmutation-positive lung adenocarcinoma: post hoc analyses of the randomized LUX-Lung 3 and 6 trials
Ann Oncol first published online September 6, 2016 doi:10.1093/annonc/mdw322

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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