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Fedor Moiseenko
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EP1.01 - Advanced NSCLC (ID 150)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.01-107 - Comparison of Outcomes in Responders and Nonresponders to Nivolumab as 2+ Line Treatment in Advanced Refractory NSCLC Pts (ID 550)
08:00 - 18:00 | Author(s): Fedor Moiseenko
- Abstract
Background
The extent to which treatment response to immunotherapy translates into quality-adjusted survival time in NSCLC pts is worthwhile. We aimed to evaluate survival outcomes adjusted to quality of life (QoL) in NSCLC pts who are responders (Rs) and nonresponders (nRs) to nivolumab (Nivo) as 2+ line treatment within expanded access program and in a real-world practice.
Method
Adult pts with advanced platinum refractory NSCLC were enrolled in 11 centers in RF. All the pts received Nivo 3 mg/kg q2w. Tumor response was assessed using RECIST v. 1.1, adverse events (AEs) – NCI CTCAE v3.0. Pts with complete/partial response or disease stabilization (CR/PR or SD) at first tumor evaluation were considered as Rs, with progression or early death due to disease – as nRs. For QoL assessment pts filled out RAND SF-36 at different times during Nivo treatment. Overall survival (OS) and progressive-free survival (PFS) curves were evaluated by the Kaplan-Meyer method and compared by the log-rank test. Quality-adjusted outcomes in Rs and nRs were compared using Q-TWiST method. UTWiST and UREL were calculated on the basis of SF6D.
Result
Overall, 200 pts were included in the analysis: 65% – males; median age – 62 y.o.; ECOG 0-1 – 81%; former/current smokers – 70.5%; non squamous NSCLC – 64%; ≥2 lines of previous treatment – 53%. Median follow-up – 7.5 mos; 195 pts completed Nivo treatment at cut-off. Out of 200 pts response was not evaluated in 7 pts; among 193 pts 58% were categorized as Rs, 42% – nRs (the median evaluation time – 2.1 mos). Responder status was not significantly associated with demographics, smoking status, or baseline ECOG. Median duration of PR/SD in Rs – 4.4 mos (CI 95% 0.7-33.4). Median follow-up in nRs – 1.8 mos (CI 95% 0.26-4.21). As compared with nRs, Rs had longer median OS (18.7 vs 3.5 mos, p<0.001) and PFS (9.1 vs 1.8 mos, p<0.001) as well as longer TWiST (mean 12.5 vs 1.9 mos, 95%CI of difference 8.4–12.9). Mean Q-TWiST in Rs was 11.8 mos vs 4.8 mos in nRs with 7.0 mos gain. Relative Q-TWiST gain is 88%.
Conclusion
The results obtained in this observational study demonstrate acceptable treatment outcomes of Nivo in advanced refractory NSCLC pts. Response to Nivo treatment is significantly associated with better median PFS and OS and accompanied with better quality-adjusted survival outcomes in this difficult patient cohort. The Q-TWiST provides a comprehensive assessment of the benefit of response to immunotherapy into quality-adjusted survival in NCSLC pts.
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P1.14 - Targeted Therapy (ID 182)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.14-49 - The Role of ctDNA Detection (Liquid Biopsy) in Patients with NSСLC (ID 2617)
09:45 - 18:00 | Author(s): Fedor Moiseenko
- Abstract
Background
The analysis of the circulating tumor DNA has attracted interest in the last 6-7 years and is being actively introduced into everyday practice. "Liquid biopsy" will eliminate the shortcomings of routine biopsy, accelerate the time of clinical decision-making, to conduct a more comprehensive study of the tumor in terms of personification of treatment and development of resistance. Results of liquid biopsy provide real-time information on the molecular pathologies and morphological features, identify early resistance to treatment and can modify the therapy regimen.
Method
From 2016 to 2018 year we studied patients with NSСLC. The ctDNA was detected in the baseline plasma samples and then every 2 months after treatment started by RT-PCR. The aim of the study was to assess the relationship between the presence of EGFR positive ctDNA in tumor tissue and blood plasma
Result
The study was 1050 patients, 462 cases are represented by adenocarcinoma of NSCLC. EGFR mutations was detected in 145/462 cases (31.38%). Among 145 person 109 were women (72.5%) and 36 were men (24.8%). The mean age was 65.18 (35 - 85). The mutational profile was heterogeneous: ex19del – 94/145 (63.8%), L858R – 47/145 (32.4%), others – 4/145 (2.8%). The results of the study demonstrated that analyzing ctDNA from plasma is feasible for the identification of EGFR mutations with mutation status concordance in 79 matched samples of 53.2% (EGFR mutation positive was detected in 42/79 samples).
The T790m resistance mutation was detected in the baseline plasma sample in 8/79 cases (10.1%). EGFR-activating mutations were identified in 13/56 (23.3%) plasma samples after 2 months of Gefitinib.
Among the 42 patients in whom the сtDNC was detected in the baseline, after 2 months of therapy was determined only in 6/42 (14.2%). Thus, the disappearance of the mutation was observed in 85.71% (36/42). Mediana of PSF for patients who retained ctDNA after 2 months was 16.25 months (Cl 95% 11.24 – 19.94), and for patients in whom the mutation disappeared after 2 months was 21.10 (Cl 19.21 - 22.98).
Currently the study of molecular genetic markers in blood plasma are continuing. The relationship between effectiveness of treatment and ctDNA detection in blood samples will be analyzed.
Conclusion
This new, minimally invasive method has the potential to change the prognostic and predictive landscape for lung cancer genotyping and patient management, which will improve treatment outcomes
