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R.V. Orlova
Author of
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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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P1.01-056 - Quality of Life and Clinical Outcomes of Nivolumab as 2+ Line Treatment in Advanced Refractory NSCLC Pts: Interim Analysis (ID 8452)
09:30 - 09:30 | Author(s): R.V. Orlova
- Abstract
Background:
We aimed to evaluate quality of life (QoL) and clinical outcomes of nivolumab (Nivo) as ≥ 2nd line treatment within the expanded access program in NSCLC pts. The QoL changes, response rates, survival and safety were studied within the multicenter prospective observational study.
Method:
Adult pts with advanced refractory NSCLC were enrolled in 7 centers in RF. All the pts received Nivo 3 mg/kg q2w. Tumor response was assessed using RECIST v. 1.1, adverse events (AEs) with NCI CTCAE v3.0; QoL by SF-36 and symptoms by ESAS-R at baseline, 4 and 12 weeks after treatment start. Overall survival (OS) and progression-free survival (PFS) curves were evaluated from the start of Nivo treatment by the Kaplan-Meyer method and compared by the log rank test. For QoL analysis Generalized Estimating Equations (GEE) method was used.
Result:
The interim analysis was performed in the group of 172 pts with the median follow-up – 4.7 mos (65% – males; median age – 62 (29−80); ECOG PS 0-1/2-3 – 81%/19%; former/current smokers – 71%; non squamous NSCLC – 65%; ≥2 lines of previous treatment – 51%). After 2 cycles of Nivo QoL improvement was registered in 53% pts, after 6 cycles – in 60% pts; mean QoL index increased by 59% and 51%, respectively. Upon GEE, significant improvement of QoL index during 6 cycles was revealed (p<0.05). The most severe and frequent baseline symptoms, fatigue and shortness of breath, decreased after 2 cycles in 44% and 33% of pts as compared to baseline, and after 6 cycles – in 54% and 46% pts, respectively.Efficacy was evaluated in 118 pts (median first evaluation – 2.2 mos): PR – 9%, SD – 44%, PD – 47%. 14 pts died before first efficacy evaluation. 40 pts were not evaluated for response on cut-off. In the group of pts who completed Nivo treatment (n=116) median PFS was 2.7 mos (95%CI 2.1–3.3), median OS – 8.4 mos (95%CI 6.2–10.7); median follow-up – 4.6 mos. Pts with brain mts (median OS 2.5 mos vs 9.0 mos) and pts with ECOG PS 2-3 (median PFS 2.5 mos vs 3.2 mos) had worse survival; p<0.05. AEs were registered in 54 pts; among them 14 had grades 3-4 AEs.
Conclusion:
Early data from this study supports the acceptable efficacy (53% pts had PR/SD) and safety of Nivo (11% pts with 3-4 grades AEs) in NSCLC pts. Nivo treatment leads to meaningful QoL improvement in this patient population.
