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M. Soares
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P3.02a - Poster Session with Presenters Present (ID 470)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02a-028 - Anaplastic Lymphoma Kinase Fusion Oncogene Positive Non-Small Cell Lung Cancer - The Experience of an Institution (ID 5783)
14:30 - 14:30 | Author(s): M. Soares
- Abstract
Background:
Approximately 3–7% of lung tumors harbor Anaplastic Lymphoma Kinase (ALK) fusions. The aim of the current study was to characterize the population of patients with ALK positive non small cell lung cancer (NSCLC) treated at our Institution.
Methods:
Retrospective analysis of 26 ALK positive NSCLC, diagnosed between December/2008 and February/2016. Eligible patients had lung adenocarcinoma harboring ALK translocation according to fluorescent in situ hybridization. Best response was assessed using RECIST (version 1.1).
Results:
Twenty six patient cases are reported, diagnosed between 01/12/2008 and 29/02/2016. Median age was 56 years, 60.7% of patients were women, and 71.4% were never-smokers. Twenty-four (92.3%) were adenocarcinomas. All patients were EGFR negative. Twenty (76.9%) were stage IV. Fifteen patients (57.7%) were treated in first line with palliative chemotherapy (CT), thirteen of them with platinum/pemetrexed. Twelve patients (46.1%) were treated with crizotinib, two in first line, nine in second line and one in third line; one patient was treated with ceritinib in fourth line. As major adverse events there were eight cases (30.7%) of venous thromboembolism, including five (19.2%) pulmonary embolisms. ALK directed therapy, namely crizotinib, was safe and well-tolerated. Most of the patients (91.7%) were treated with the standard dose of 250mg twice per day. One patient needed dose reduction due to hepatotoxicity (G3, CTCAE.V4). The most frequent treatment-related adverse events were emesis (G1) vision disorders (G1), and increased AST/ALT (G3). Three patients treated with CT had grade 3 toxicity (pneumonia with respiratory failure, anemia, peripheral neuropathy). Median follow-up of study population was 13.5 months. In patients treated with crizotinib objective response rate (ORR = complete response + partial response) was 50% and clinical benefit (CB = complete response + partial response + stable disease) was 75%. In patients treated with CT ORR was 6.7% and CB was 73%. Seven (26.9%) patients died during the study period. Median overall survival has not been reached.
Conclusion:
ALK directed therapy provided increased benefit and lower toxicity compared to CT. During the study period, there were several treatment guidelines updates impacting the patient’s management. Presented results are consistent with the published literature.
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P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02b-088 - TKI as First Line Treatment in Advanced Non-Small-Cell Lung Cancer with EGFR Mutations (ID 5241)
14:30 - 14:30 | Author(s): M. Soares
- Abstract
Background:
Erlotinib and gefitinib are reversible, first-generation, single-target tyrosine kinase inhibitors (TKIs) to EGFR/ERBB1 receptor. Testing for epidermal growth factor receptor (EGFR) mutations is recommended in patients with nonsquamous non-small cell lung cancer (NSCLC) or NSCLC not otherwise specified as the mutations are predictive biomarkers of response to EGFR TKI therapy. We aim to assess the real world effectiveness of these agents in the setting of the largest Oncologic Centre in Portugal.
Methods:
Retrospective analysis of a consecutive series of patients with stage IIIB/IV NSCLC, EGFR mutated, treated with erlotinib or gefitinib as first line treatment, since January 2012 at Instituto Português de Oncologia do Porto, Portugal. Descriptive statistics were used to describe demographics. Treatment effectiveness was assessed by overall survival (OS) and progression free survival (PFS) calculated by Kaplan-Meier method and treatment adverse events (AEs).
Results:
Of 86 patients with stage IIIB/IV NSCLC, EGFR mutated, treated with TKI therapy at our center, 64% were female and the mean age was 65.9 years (range 41-85). The majority of patients were non-smokers (80.2%) and the most frequent histology was adenocarcinoma (97.7%). The most commonly found EGFR mutations were deletions in exon 19 and mutation in exon 21. Fifty-one patients (59.3%) received erlotinib as first line treatment. As of May 2016, 39 patients (45.3%) are still on first line treatment, with a median follow-up time of 11 months. Median OS was 24 months (CI 95%: 16.7 – 31.3). The overall response rate (ORR) in the erlotinib group and gefitinib group was 41.2% and 34.3%, respectively, with no significant difference between groups (p value 0.652). Overall median PFS was 10 months (CI 95%: 7.4 – 12.6), being higher in the erlotinib treatment group (11 versus 7 months). Ten patients in the erlotinib group required dose reductions because of drug related toxic effects, 9 because of rash grade 3 and 1 because of hepatotoxicity. One patient in the gefitinib group suspended treatment because of arthritis. Diarrhea was the second most frequent toxicity related to TKIs (38.4%).
Conclusion:
Based on our experience, real world effectiveness of erlotinib and gefitinib are similar. Patients treated with gefitinib tend to have less adverse events.
