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Ivan Stilidi



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    EP1.14 - Targeted Therapy (ID 204)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Targeted Therapy
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.14-51 - Lorlatinib in Crisotinib-Resistant ALK+ NSCLC Patients. Our Experience (ID 1630)

      08:00 - 18:00  |  Author(s): Ivan Stilidi

      • Abstract
      • Slides

      Background

      Background: Lorlatinib is the third generation inhibitor of ALK and ROS1 tyrosine kinase has shown activity in patients with crisotinib-refractory ALK-positive NSCLC most of whom had CNS metastases . We report results of the overall and intracranial antitumor activity of patients with crisotinib-refractory ALK-positive NSCLC.

      Method

      Patients with ALK and ROS1-positive NSCLC who had progressed after crisotinib and at least one regimen of chemotherapy with or without CNS metastases with ECOG PS was 0-2 and adequate organ functions were given lorlatinib 100 mg orally once daily continuously. Primary endpoint - overall and intracranial objective response, secondary endpoint – safety of lorlatinib.

      Since January 2017 to July 2018 39 patients were enrolled: ALK+- 36, ROS1+ - 3 pts. Median age 49 years. Patient characteristics summarised in Table 1.

      Table 1. Baseline characteristics

      Снимок.jpg

      Result

      Objective response was achieved in 22 pts (56, 4%) – 3 complete (7,7%) and 19 partial (48,7%) responses. 16 pts( 41%) had stabilization as the best response, 1 ALK+ pt progressed. So disease control is 97,4%. Among 27 pts with brain metastases intracranial objective responses were observed in 20 pts (74%), included 8 complete (30%) and 12 patial responses (44%), 7 pts (26%) had stable disease . Thus all pts with intracranial lesions had disease control . 18 pts underwent previous brain radiotherapy of whom 12 pts received whole-brain radiotherapy, 5pts - stereotactic radiosurgery, and 1 received both. Their objective intracranial response was 61%. All patients without previous brain radiotherapy had objective intracranial response (100%).

      At data cut-off (20.03.2019) median duration of treatment was 12 mon. 6 pts stopped receiving lorlatinib: 4 due to disease progression and 2 due to the deterioration of concurrent diseases.

      Side effects of lorlatinib were mild or moderate. The most frequent events were hypercholesterolaemia (82%, 3-4 grade 25%), oedema ( 71,8%), weight increased ( 38.5%). Only 5 pts (12.8%) needed in dose reduction.

      Conclusion
      Our results confirmed that lorlatinib is an effective treatment option for pretreated ALK+/ROS1+ patients with high intracranial activity and good safety profile.

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