21 Oct Overall survival data from LUX-Lung 7 head-to-head trial of Afatinib versus Gefitinib
MedicalResearch.com Interview with:
Dr. Shirish Gadgeel
Shirish Gadgeel, MD
Leader of the Thoracic Oncology Multidisciplinary team
Professor at Karmanos Cancer Institute
Detroit
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: LUX-Lung 7 is the first global, head-to-head trial comparing second- and first-generation EGFR-directed therapies (afatinib and gefitinib respectively) for patients with EGFR mutation-positiveNon-Small Cell Lung Cancer NSCLC who received no prior treatment. The Phase IIb trial included 319 patients with advanced stage NSCLC harboring common EGFR mutations (del19 or L858R). The trial’s co-primary endpoints were progression-free survival (PFS) by independent review, time to treatment failure and overall survival (OS); and the secondary endpoints included ORR, disease control rate, tumor shrinkage, patient-reported outcomes and safety.
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The median survival of patients treated with afatinib was 27.9 months compared to 24.5 months for those receiving gefitinib, without reaching significance. OS outcomes observed with afatinib were consistent across common EGFR mutation types. Both afatinib and gefitinib demonstrated similar improvements in patient-reported outcome measures with no significant differences in health-related quality of life. Treatment with both afatinib and gefitinib was generally well tolerable, leading to an equal rate of treatment-related discontinuation in both arms (6%).
MedicalResearch.com: What should readers take away from your report?
Response: At the ESMO Congress, updated results confirmed the primary analysis that showed the trial met two of its three co-primary endpoints of PFS by independent review and time to treatment failure. Results from the primary analysis, presented in 2015, showed that afatinib significantly reduced the risk of lung cancer progression and the risk of treatment failure, both by 27% versus gefitinib. The improvement in PFS became more pronounced over time. After two years of treatment, more than twice as many patients on afatinib were alive and progression-free than those on gefitinib (after 18 months; 27% vs 15% and after 24 months; 18% vs 8%). Analysis of overall survival, the third primary endpoint, was also presented, showing that the median survival of patients treated with afatinib was 27.9 months compared to 24.5 months for those receiving gefitinib, without reaching significance.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: As a result of this study, future research is required to see how other drugs or drug combinations will improve upon results achieved with current treatments.
MedicalResearch.com: Is there anything else you would like to add?
Response: For the LUX-Lung 7 trial, dose modification of afatinib was available in patients who met a set criteria in order to better manage AEs. A recent post-hoc analysis of the LUX-Lung 3 and LUX-Lung 6 trials (comparing afatinib versus chemotherapy as first-line treatment for patients with EGFR mutation-positive, advanced and metastatic NSCLC), published in Annals of Oncology, showed that adjusting afatinib dosing based on tolerability reduced the incidence and severity of treatment-related adverse events, with no apparent impact on efficacy.
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Citation:
ESMO 2016 abstract discussing:
Overall survival data from LUX-Lung 7 head-to-head trial of Gilotrif® (afatinib) versus Iressa® (gefitinib)
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Last Updated on October 21, 2016 by Marie Benz MD FAAD