Original Articles
Symptom and Quality of Life Improvement in LUX-Lung 6: An Open-Label Phase III Study of Afatinib Versus Cisplatin/Gemcitabine in Asian Patients With EGFR Mutation-Positive Advanced Non–small-cell Lung Cancer

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Introduction

In the phase III, LUX-Lung 6 trial, afatinib prolonged progression-free survival (PFS) versus cisplatin/gemcitabine in Asian patients with epidermal growth factor receptor (EGFR) mutation-positive non–small-cell lung cancer (NSCLC). This article provides detailed assessments of patient-reported outcomes (PROs), a LUX-Lung 6 secondary end point, and explores the relationship between PFS and health-related quality of life (QoL) in these patients.

Methods

Patients (n = 364) were randomized (2:1) to oral afatinib (40 mg/day) or up to six cycles of cisplatin/gemcitabine (21-day cycle; cisplatin 75 mg/m2 [d1]; gemcitabine 1000 mg/m2 [d1,8]). QoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and its lung cancer-specific module. The relationship between PFS (investigator assessment and independent review) and QoL was evaluated using analysis of covariance and a longitudinal model.

Results

More patients treated with afatinib versus cisplatin/gemcitabine showed improvements in global health status/QoL (p < 0.0001) and physical (p < 0.0001), role (p = 0.013), and social (p < 0.001) functioning scales. Delayed symptom deterioration and better QoL over time was also observed with afatinib. QoL measured before tumor assessment was considerably poorer for patients with progression than those without progression, with significant differences in mean scores at multiple assessment time points. Results from the longitudinal analysis consistently demonstrated a significant negative impact of progression on QoL (p < 0.0001).

Conclusion

Afatinib improved PFS and PROs versus chemotherapy in EGFR mutation-positive NSCLC patients. Progression was associated with statistically significant worsening in QoL measured before tumor assessment, underscoring the value of PFS as a clinically relevant end point.

Key Words

Afatinib
Non–small-cell lung cancer
Progression-free survival
Patient-reported outcomes
Quality of life

Cited by (0)

Sarayut L. Geater and Chong-Rui Xu provided equal contribution.

S.L.G. has received honorarium from AstraZeneca. C.-R.X. has received payment for lectures including service on speaker bureaus from Eli Lilly and Roche. S.L. has received consulting fees from Boehringer Ingelheim, AstraZeneca, and Roche; payment for lectures including service on speakers bureaus from Lilly. M.P. has received money to his institution for grants and board membership from N Zero 1 Ltd. Y.S. and J.L. are full-time employees of Boehringer Ingelheim. Y.-L.W. has received consulting fees or honorarium from Roche, Eli Lilly, AstraZeneca, and Pfizer.

This study was funded by Boehringer Ingelheim. Medical writing assistance, supported financially by Boehringer Ingelheim, was provided by Katie McClendon, PhD, of GeoMed, an Ashfield company, part of UDG Healthcare plc, during the preparation of this article.

Presented, in part, at the 2014 European Society for Medical Oncology Meeting, September 26–30, 2014, Madrid, Spain; the 49th Annual Meeting of the American Society of Clinical Oncology, 31 May–4 June 2013, Chicago, IL; the 2013 European Respiratory Society International Congress, September 7–11, 2013, Barcelona, Spain; and the 16th Annual Meeting of the Chinese Society for Clinical Oncology, September 25–29, 2013, Xiamen, China.

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