Abstract 1238P
Background
Health-related quality of life (HRQoL) provides information for comparing adjuvant gefitinib with chemotherapy in patients with early-stage non-small-cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) mutations.
Methods
In the phase III ADJUVANT trial (ClinicalTrials.gov, NCT01405079), patients with completely resected, stage II–IIIA (N1–N2), EGFR-mutant NSCLC were randomized (1:1) to receive either gefitinib for 24 months or vinorelbine plus cisplatin (VP) every 3 weeks for four cycles. HRQoL was assessed as a secondary endpoint using the Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L), Lung Cancer Symptom Scale (LCSS), and Trial Outcome Index (TOI) questionnaires. HRQoL dynamics, improvements, and time to deterioration were compared between groups.
Results
At baseline, 104 of 106, and 80 of 87 patients receiving gefitinib and VP, respectively, completed three questionnaires. Baseline scores were balanced between groups. HRQoL fluctuated and gradually improved in both groups. Longitudinally higher scores were reported with gefitinib than VP (FACT-L, odds ratio 418.16, 95% confidence interval [CI] 2.75–63509.05, p = 0.019; LCSS, 1.13, 1.04–1.22, p = 0.003; TOI, 88.39, 4.40–1775.05, p = 0.003). Time to deterioration in HRQoL was delayed with gefitinib compared with VP (FACT-L, median 69 vs 6 weeks, hazard ratio 0.62, 95% CI 0.42–0.90, p = 0.013; LCSS, median 45 vs 6 weeks, 0.63, 0.43–0.93, p = 0.020; TOI, median 164 vs 9 weeks, 0.51, 0.33–0.77, p = 0.001).
Conclusions
Adjuvant gefitinib is associated with better HRQoL than VP, supporting the use of this adjuvant therapy for this patient group.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Weimin Mao.
Funding
The work was supported by Guangdong Provincial Key Laboratory of Lung Cancer Translational Medicine; National Health and Family Planning Commission of People’s Republic of China; Guangzhou Science and Technology Bureau; AstraZeneca China; and the Chinese Thoracic Oncology Group (CTONG).
Disclosure
All authors have declared no conflicts of interest.