Abstract
e15570 Background: The anti-angiogenic fusion protein aflibercept targets VEGF-A, VEGF-B and PIGF. It is approved in combination with FOLFIRI for treatment of mCRC previously treated with an oxaliplatin-containing regimen. We evaluated the influence of RAS status and prior targeted therapy on the efficacy and safety of aflibercept plus FOLFIRI in daily practice. Methods: QoLiTrap is a large international (Germany, Austria, Switzerland), non-interventional study evaluating the quality of life (QoL), efficacy and safety of aflibercept plus FOLFIRI in daily clinical practice. The primary endpoint was QoL assessed by EORTC QLQ-C30 questionnaire. Secondary endpoints included overall survival (OS), progression-free survival (PFS), tumor response and safety. Patients were evaluable for primary and secondary endpoint analysis if they had a QoL questionnaire at baseline and at least 2 post baseline. Safety was analyzed in all patients exposed to at least one dose of study drug. We report here the results by RAS status and prior targeted therapy received. Results: 1277 patients with mCRC were treated (median age 66 years, males 64.8%, right colon tumor 27.6%, liver metastases 53.2% , ECOG 0-1 84.7%) mainly in second-line (50.3%) but also in third-line (23.1%) and fourth-line (11.9%) setting. Median duration of treatment was 12 weeks. Overall, 872 patients were evaluable for the efficacy analysis. At baseline, the global health (mean) score was 58.7 and the mean change from baseline over 12 weeks was -4.6%. A clinically meaningful decline of -10 points was not reached, regardless of RAS status and prior targeted therapy. Secondary endpoints are provided in the Table below. Most common all grade adverse events were diarrhea (34.2%), nausea (17.9%), fatigue (17.2%), stomatitis (17.2%) and hypertension (11.6%). Conclusions: Aflibercept plus FOLFIRI administered in daily practice shows no deleterious effect on QoL and retains its activity irrespective of RAS status and prior targeted therapy. The safety profile was manageable. Clinical trial information: AIO-LQ-0113. [Table: see text]
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