Afatinib (A) vs erlotinib (E) as second-line treatment of patients (pts) with advanced squamous cell carcinoma (SCC) of the lung following first-line platinum-based chemotherapy: Patient-reported outcome (PRO) data from the LUX-Lung 8 Phase III global trial.
Bildiriler > Özet Bildiri
Yazarlar: Shirish M. Gadgeel, Manuel Cobo Dols, Enriqueta Felip, Jean-Charles Soria, Ki Hyeong Lee, Shun Lu, Vassilis Georgoulias, Andrea Fulop, Erdem GÖKER, Konstantinos N. Syrigos, Alessandro Morabito, Hasan Senol Coskun, Salih Zeki Guclu, Wei Li, Sanjay Popat, Andrea Ardizzoni, Juliane Lungershausen, Bushi Wang, Vikram K. Chand, Glenwood D. Goss, LUX-Lung 8 Investigators
Journal of Clinical Oncology, , , Uluslararası, Özet Bildiri, Wos, cilt 33, ss 8100-8100
DOI: 10.1200/jco.2015.33.15_suppl.8100
Özet
8100 Background: A is an irreversible ErbB family blocker that has shown clinical activity in pts with SCC of the head/neck and lung. The LUX-Lung 8 Phase III global trial compared A and E in pts with SCC of the lung following failure of platinum-based chemotherapy. Between Mar 2012 and Jan 2014, 795 stage IIIB/IV SCC pts were randomized 1:1 to receive A (40 mg/day) or E (150 mg/day) until progression. The primary endpoint of PFS, assessed after 414 events, was significantly higher for A than E (median: 2.4 vs 1.9 months; HR [95% CI]: 0.82 [0.68–1.00]; p = 0.04). PRO analyses of the PFS dataset are presented here. Updated PRO analysis of the OS dataset (to be undertaken after 632 deaths) will be available at the meeting. Methods: PROs were collected every 28 days until progression using the EORTC QLQ-C30/LC13 questionnaires. Percentage of pts improved on therapy, time-to-deterioration (TTD) and changes over time were analyzed for the pre-specified SCC symptoms: cough, dyspnea, and pain. Results: Improvement in global health status (GHS)/QoL was significantly greater with A than E (36.4 vs 27.1% pts; p = 0.026). More pts had an improvement in cough with A vs E (43.6 vs 32.6%; p = 0.010). The proportion of pts with improvements in dyspnea and pain were 49.4 vs 44.8% and 37.5 vs 37.5% with A and E, respectively. There were no significant differences in TTD of symptoms between treatment groups. However, trends favoring A were reported for dyspnea (HR [95% CI]: 0.82 [0.66–1.01]), fatigue (HR [95% CI]: 0.89 [0.73–1.09]), physical (HR [95% CI]: 0.81 [0.64–1.02]), and role (HR [95% CI]: 0.83 [0.67–1.03]) functioning. Changes in mean scores over time significantly favored A vs E for cough (p = 0.007), dyspnea (p = 0.021), and pain (p = 0.024), including chest pain, as well as fatigue (p = 0.006) and role (p = 0.001)/physical (0.024) functioning. Conclusions: Compared to E, A improved SCC symptoms, SCC symptoms over time, and overall GHS/QoL. PRO analyses of LUX-Lung 8 complement the significant improvement observed in PFS with second-line A vs E in pts with SCC of the lung. Clinical trial information: NCT01523587.