Visual effects in anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) patients treated with crizotinib.

Abstract

7596 Background: Crizotinib is an ALK inhibitor indicated in the US for advanced ALK-positive NSCLC. Visual effects reported by patients treated with crizotinib were characterized using the Visual Symptom Assessment Questionnaire (VSAQ). Methods: Patients with previously treated, advanced ALK-positive NSCLC were administered 250 mg BID crizotinib in an ongoing phase II study (PROFILE1005, NCT00932451; Pfizer). Patients completed the VSAQ at day 1 of each 21 day cycle and at end of treatment. The VSAQ has a recall period of 3 weeks and consists of 7 questions assessing presence, frequency, timing, duration and degree of bother of visual effects and their impact on Activities of Daily Living (ADL). The visual effects assessed included appearance of overlapping shadows/after images, flashing lights and streamers/strings/floaters, difficulty adapting to lights and seeing at night. Patients rated degree of bother on a 5-point scale ranging from ‘not at all’ to ‘extremely’. Impact on ADL was measured using a 10-point scale (0: no effect; 10: completely prevented ADL). Frequency analyses were performed. Results: As of June 1 2011, visual effects as identified by VSAQ were reported by 63% (114/182) of patients at cycle 2 (C2), 57% at C3 (85/149), 52% at C4 (64/123) and 41% at C5 (46/112). The most commonly experienced visual events were appearance of flashing lights (C2:81%; C3:82%; C4:84%; C5: 76%), streamers/strings/floaters (C2: 83%; C3:78%; C4: 81%; C5:87%) and overlapping shadows/after images (C2:70%; C3:77%; C4:87%; C5:84%). Most patients reported each event to last ≤1 minute (C2:61%; C3:71%; C4:77%; C5: 70%). Majority of patients reported event frequency at each cycle of < 7 days/wk (50–78%). Patients reported that the visual effects occurred mostly in the morning (52–62%) and/or evening (62–73%). Majority of patients reported that visual effects were not at all or a little bothersome (C2:62%; C3:61%; C4:66%; C5:65%). Majority of patients indicated no or minimal impact on ADL (C2:80%; C3:80%; C4:83%; C5:87%). Conclusions: Visual effects identified by VSAQ in patients treated with crizotinib were frequent, but were reported to be transient with no or minimal impact on ADL.