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Tanja Cufer
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P1.01 - Advanced NSCLC (ID 158)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.01-118 - Overall Survival in Pts with EGFRm+ NSCLC Receiving Sequential Afatinib and Osimertinib: Updated Analysis of the GioTag Study (ID 2211)
09:45 - 18:00 | Author(s): Tanja Cufer
- Abstract
Background
With three generations of EGFR tyrosine kinase inhibitors (TKIs) now available for the treatment of EGFR mutation-positive (EGFRm+) NSCLC, it will be important to identify the optimal sequence of EGFR TKIs to maximise survival. The observational GioTag study (NCT03370770) investigated outcomes in patients with EGFRm+ NSCLC who were treated with sequential afatinib and osimertinib in a ‘real-world’ clinical setting, including patients with poor prognosis (ECOG PS ≥2: 15%; stable brain metastases: 10%).1 Time to treatment failure (TTF) was encouraging (overall: 27.6 months; Del19-positive patients: 30.3 months; Asians: 46.7 months). In this updated analysis, we report OS and updated TTF.
Method
Data were retrospectively collected between Dec 2017 and June 2018 for 203 pts with EGFRm+ (Del19, L858R) NSCLC who had T790M-positive disease after first-line afatinib and subsequently received osimertinib. TTF was the primary outcome; OS analysis was exploratory. Data were collected from electronic health records (EHRs; n=126) or medical charts (n=77). For logistical reasons, this interim analysis includes updated data (as at April 2019) from patients with available EHRs (all from USA; n=94); final analysis incorporating updated data from manual chart reviews is anticipated in early 2020.
Result
After a median follow-up of 30.3 months, median OS was 41.3 months (90% CI: 36.8–46.3) in the overall dataset (n=203) and 45.7 months (90% CI: 45.3–51.5) in Del19-positive patients (n=149); 80% of patients were alive after 2 years. OS in Asians was immature. Updated median TTF was 28.1 months (90% CI: 26.8–30.3) in the overall dataset, and 30.6 months (90% CI: 27.6–32.0) in Del19-positive patients. Outcomes were not affected by afatinib starting dose. Median TTF with osimertinib was 15.6 months (90% CI: 13.8–17.1) in the overall dataset, and 16.4 months (90% CI: 14.9–17.9) in Del19-positive patients.
Conclusion
Sequential afatinib and osimertinib is associated with encouraging OS and TTF in pts with EGFR T790M-positive NSCLC, especially in Del19-positive patients, indicating that the sequential regimen is a feasible option in this setting. Of note, prior treatment with afatinib did not preclude prolonged TTF with second-line osimertinib (15.6 months overall; 16.4 months in Del19-positive patients). The final analysis will provide further insights into the long-term OS of patients treated with sequential afatinib–osimertinib, including Asians.
1. Hochmair MJ, et al. Future Oncol. 2018;14:2861–74.
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P2.09 - Pathology (ID 174)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Pathology
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.09-30 - PD-L1 Testing and Clinical Benefit in Patients Treated with CPI (Now Available) (ID 1672)
10:15 - 18:15 | Author(s): Tanja Cufer
- Abstract
Background
PD-L1 expression in tumor cells should predict better response rate in lung carcinoma patients treated with immune checkpoint inhibitors.
Method
Retrospective analysis of 46 NSCLC lung cancer patients with cytology/pathology samples from primary tumor/metastasis tested for PD-L1 expression and comparing the PD-L1 testing results with clinical benefit. Follow-up period was 6 to 24 months. Samples were stained with PD-L1 mouse monoclonal antibody (clone 22C3, DAKO, Denmark) or with rabbit monoclonal antibody (clone SP263, Ventana/Roche, USA) on an automated staining platform (Benchmark ultra, Ventana/Roche, USA). Samples were divided into four categories: Cytology, histology, primary tumor and metastasis. Number of positive tumor cells was assessed semiquantitatively and divided into three categories: 0%, 1 to 49% and 50 to 100%. We compared PD-L1 expression with clinical course of patients treated with immune checkpoint inhibitors (nivolumab, pembrolizumab and atezolizumab), considering complete response, partial response and stable disease (RECIST criteria) as clinical benefit. Progress of the disease was considered as no clinical benefit.
Result
We had 37% cytological and 63% histological samples. Overall PD-L1 expression was present in 76% of all samples (1 to 49% and 50 to 100% categories, 13% and 63%, respectfully). We observed clinical benefit in 33 patients (5, 5 and 23 with 0%, 1 to 49% and 50 to 100%, respectively). Progress of the disease was observed in 13 patients (6, 1 and 6 with 0%, 1 to 49% and 50 to 100%, respectively). Out of 29 patients with histological samples, 22 had clinical benefit (2, 5 and 15 with 0%, 1 to 49% and 50 to 100%, respectively). Progress of the disease was observed in 7 patients (5, 0 and 2 with 0%, 1 to 49% and 50 to 100%, respectively). Out of 17 patients with cytological samples 11 had clinical benefit (3, 0 and 8 with 0%, 1 to 49% and 50 to 100%, respectively). Progress of the disease was observed in 6 patients (1, 1 and 4 with 0%, 1 to 49% and 50 to 100%, respectively). We had 29 samples from primary tumor and 17 samples from metastasis. 23 patients with primary tumor sample (2, 4 and 16 with 0%, 1 to 49% and 50 to 100%, respectively) and 10 with metastasis sample (3, 0 and 7 with 0%, 1 to 49% and 50 to 100%, respectively) had clinical benefit. Progress of the disease was observed in 6 patients with primary tumor sample (4, 0 and 2 with 0%, 1 to 49% and 50 to 100%, respectively) and in 7 patients with metastasis sample (2, 1 and 4 with 0%, 1 to 49% and 50 to 100%, respectively) .
Conclusion
Histological samples from primary tumors seem to have the best, while cytological samples from metastases the poorest predictive value for assessment of clinical benefit for NSCLC patients treated with immunotherapy.
