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Sergey Orlov

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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): Sergey Orlov

      • Abstract
      • Slides


      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.


      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.


      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%.

      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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