• Martin Schuler, Jürgen R Fischer, Christian Grohé, Sylvia Gütz, Michael Thomas, Martin Kimmich, Claus-Peter Schneider, Eckart Laack, Angela Märten, and Afatinib Compassionate Use Consortium.
• Department of Medical Oncology, West German Cancer Center, University Hospital Essen, Essen, Germany; Division of Thoracic Oncology, Ruhrlandklinik, West German Lung Center, University Duisburg-Essen, Essen, Germany; German Cancer Consortium (DKTK), Heidelberg, Germany, Department of Medical Oncology, Klinik Löwenstein, Löwenstein, Germany; Department of Respiratory Medicine, Evangelische· Lungenklinik, Berlin, Germany; Department of Pneumology, Evangelisches Diakonissenkrankenhaus, Leipzig, Germany; Translational Lung Research Center Heidelberg, Heidelberg, Germany; Department of Pneumology and Thoracic Oncology, Klinik Schillerhoehe, Gerlingen, Germany; Department of Hematology and Medical Oncology, Zentralklinik, Bad Berka, Germany; Haemato-Oncology Hamburg, Hamburg, Germany; Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany martin.schuler@uk-essen.de.
• Oncologist. 2014 Oct 1; 19 (10): 1100-9.

BackgroundAfatinib, an irreversible ErbB family blocker, demonstrated superiority to chemotherapy as first-line treatment in patients with EGFR-mutated non-small cell lung cancer (NSCLC). Afatinib is also active in patients progressing on EGFR tyrosine kinase inhibitors (EGFR-TKIs). We report the results of a large cohort of NSCLC patients receiving afatinib within a compassionate-use program (CUP).Patients And MethodsPatients with advanced NSCLC progressing after one line or more of chemotherapy and one line or more of EGFR-TKI treatment with either an EGFR mutation or documented clinical benefit were enrolled. Data collection was not monitored or verified by central review. The intention of this CUP was to provide controlled preregistration access to afatinib for patients with life-threatening diseases and no other treatment option.ResultsFrom May 2010 to October 2013, 573 patients (65% female; median age: 64 years [range: 28-89 years]) were enrolled, with strong participation of community oncologists. Comorbidities were allowed, including second malignancies in 11% of patients. EGFR mutation status was available in 391 patients (72%), and 83% tested mutation positive. Median time to treatment failure (TTF) of 541 patients treated with afatinib was 3.7 months (range: 0.0 to >29.0 months). Median TTF was 4.0 and 2.7 months in patients with adenocarcinomas and squamous cell carcinomas, respectively, and 4.6 months in patients with EGFR-mutated NSCLC. Adverse events were generally manageable.ConclusionAfatinib was able to be given in a real-world setting to heavily pretreated patients with EGFR-mutated or EGFR-TKI-sensitive NSCLC. Acknowledging the constraints of data collection in a CUP, afatinib appears to be safe and to confer some clinical benefit in this population.©AlphaMed Press.

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