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S. Sena
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P1.01 - Advanced NSCLC (ID 757)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.01-058 - Real World Data with Nivolumab: Experience in Argentina (ID 8800)
09:30 - 09:30 | Author(s): S. Sena
- Abstract
Background:
Nivolumab has improved overall survival (OS) in metastatic non-small cell lung cancer (NSCLC) patients. Analysis of the use of these drugs in real world provides more evidence about efficacy and toxicity. We describe here the experience of the use of nivolumab in NSCLC in Argentina.
Method:
NSCLC patients (pts) who received nivolumab between 6/2015 - 12/2016. Patients consented their respective physicians to be treated on a drug expanded access program. Data was collected retrospectively by the physician. Images and follow up were done according to physician´s discretion. Adverse events were classified according to CTC3.1. Responses were evaluated according to RECIST 1.1 criteria. DFS and OS was assessed. All pts who received at least one dose of Nivolumab were evaluated for toxicity.
Result:
N 109. Fup 8.83 m (IQR 3.4-12.67). 57.8% men, 29.4% current smoker, 78.0% non-squamous, 8.3% EGFR mutated. Chemotherapy lines before nivolumab 2 md (r 1-4), and 59.6% received radiotherapy. 89% received previously platinum based chemotherapy. Sites of relapse or progression before nivolumab were: lung (75.2%), lymph nodes (47.7%), bone (19.3%), liver (11.9%), central nervous system (11.0%), and adrenal gland (13.8%). PS 0 26.6%, 1 56.0%, 2 13.8% and 3 1.8%. Cycles of nivolumab 10 Md (IQR 3-18). Drug related toxicity 78.9%. Grade 2-3 28.4%. Corticoid use 33.9%. Responses were evaluated in 104 pts who had as best response CR 2/104 (2%), PR 28/104 (27. %), SD 33/104 (32%) and PD 41/104 (39.%). Time to the best response was 4.0 m (IQR 2.3-5.9). DFS 6.1 m (IQR 2.4-13.1) and OS 12.3 m (IQR 4.1-NR). Univariate analysis revealed that absence of corticoids use (p=0.034), toxicity grade 1-3 (p=0.0025), PS≤1 (p=0.049), age<=50 (p= 0.0011) were associated with longer DFS; PS≤1 (p<0.001) and toxicity grade 1-3 (p=0.001) were associated with longer OS. In multivariate cox regression analysis, toxicity grade 1-3 (HR 0.44 CI95% 0.24-0.81, p=0.008) and age<=50 (HR 0.28 CI95% 0.13-0.61, p=0.001) were associated with longer DFS while corticoids use was associated with shorter DFS (HR 2.06 CI95% 1.22-3.48, p=0.007); toxicity grade 1-3 (HR 0.28 CI95% 0.14-0.54, p<0.0001) and PS≤1 (HR 0.16 CI95% 0.08-0.31, p<0.0001) were associated with longer OS.
Conclusion:
The use of Nivolumab in a real world setting, in heavily pre-treated NSCLC patients was well tolerated and showed promising clinical efficacy. PS, the use of corticoids and immune-mediated toxicity seem to be conditions which could affect clinical outcomes.
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P2.03 - Chemotherapy/Targeted Therapy (ID 704)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.03-039 - Compassionate Use of Osimertinib: Argentine Experience (ID 9447)
09:30 - 09:30 | Author(s): S. Sena
- Abstract
Background:
EGFR is one of the most commonly mutated proto-oncogenes in lung cancer. The frequency of these mutations varies from approximately 10% of lung adenocarcinomas in North American and European populations to 50% in Asia. The leucine to arginine substitution at position 858 (L858R) in exon 21 and short in-frame deletions in exon 19 are the most common sensitizing mutations, comprising approximately 90% of cases. Approximately 50% of EGFR TKI resistance is due to a second site mutation, the T790M mutation occurring within exon 20.
Method:
To describe the "real life" experience in our country regarding the compassionate use of Osimertinib in patients with diagnosis of lung cancer with EGFR mutation and progression to tyrosine kinase inhibitors with detectable T790M mutation. We also include patients with de novo T790M mutation. We evaluated demographic data, the diagnostic method of resistance, sites of disease progression, toxicities and treatment efficacy.
Result:
We analyzed 17 patients from 10 different centers in Argentina in the period between January 2016 and May 2017. Median age: 61 years old, female 76%, PS: 0-1: 86%, non-smokers: 59%, histology: 15 adenocarcinoma and 2 undifferentiated, 14/17 with stage IV at diagnosis. EGFR mutations: Exon 19: 9 patients, 3 patients with evidence of T790M de novo, the remainder between exons 21 and 18. At the time of diagnosis, 13 patients start treatment with tyrosine kinase inhibitors, and the median time of response was 17 months. The most frequent site of progression was lung/pleura (85%) and liver (21%). Re-biopsy was performed in 13/17 patients. The major difficulty for successful biopsy was the site or the complexity of the procedure to be performed. A liquid biopsy was performed in 6 of 17 patients, 4 were positive. ORR with Osimertinib was 68%. The most common side effects were diarrhea: 31% (only 1 patient with grade 3), rash 18%. One patient had liver toxicity (grade 3 hepatitis).
Conclusion:
Osimertinib showed better adhesion and tolerance profile than tyrosine kinase inhibitors. Osimertinib offers an excellent toxicity profile with overall response rates similar to those described in publications.
