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Giovanni Selvaggi



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    P1.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 944)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.12-21 - Developing a Real-World 3L Comparator to CheckMate 032: Overall Survival (OS) in Patients with Small Cell Lung Cancer (SCLC) (ID 13791)

      16:45 - 18:00  |  Author(s): Giovanni Selvaggi

      • Abstract
      • Slides

      Background

      In the US, no approved standard of care exists for the treatment of relapsed SCLC in 3L setting. This study describes 3L outcomes in US patients with SCLC and creates a matched real-world historical comparator to CheckMate 032, highlighting the relative benefit that nivolumab treatment may offer to patients.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Adult patients receiving 3L therapy for SCLC were selected from the Flatiron Health electronic health record (EHR) database (01Jan2011-30Sep2017). Index date was SCLC diagnosis. A matched cohort was constructed and evaluated based on Inclusion (I)/Exclusion (E) criteria of CheckMate 032. Patients were included if: pretreated with ≥1one platinum-containing regimen; ECOG score of 0 or 1; ≥2 months of continuous medical data. Patients were excluded if: treated with immunotherapy; had brain metastases; autoimmune disease (except type I diabetes); HIV; Hep B/Hep C on/after diagnosis; on immunosuppressive doses of systemic corticosteroids. Kaplan-Meier curves were generated for patients with 3L SCLC from treatment initiation to death. Duration of therapy (DoT) was analyzed as time from start to end of 3L

      4c3880bb027f159e801041b1021e88e8 Result

      2,209 SCLC patients initiated 1L, of which 218(9.8%) received 3L treatment. 92 patients with SCLC matched I/E criteria as in CM 032. Mean age was 64 years; 53% were female; 68% were white; 99% had a history of smoking; and 94% of patients were treated in a community setting. Median follow-up exceeded 15 months. Median and landmark OS (1-year, 18-months, 2-year) and DoT including data for a subset of 3L patients, matched for I/E criteria to CheckMate 032 (n=92), are reported in the table.

      Table: Overall Survival in Third-line SCLC Treatment

      Flatiron Electron Health Record

      CheckMate 032

      All 3L Patients with SCLC

      (N = 218)

      I/E Matched 3L Patients with SCLC

      (N = 92)

      All 3L+ Patients with SCLC

      Median OS (95% CI), months

      3.8 (3.0, 4.2)

      3.8 (2.8, 4.9)

      [Data to be presented at conference]

      1-year OS rate (95% CI), %

      14.1 (9.3, 19.9)

      11.2 (4.9, 20.4)

      18-month OS rate (95% CI), %

      6.7 (3.4, 11.6)

      7.5 (2.5, 15.9)

      2-year OS rate (95% CI), %

      6.0 (2.9, 11.7)

      7.5 (2.5, 15.9)

      Median DoT (SD), months

      2.7 (2.6)

      2.8 (2.2)

      Abbreviations: 3L, third-line; CI, confidence interval; DoT, duration of treatment; Exc, exclusion criteria; Inc, inclusion criteria; OS, overall survival; SCLC, small-cell lung cancer; SD, standard deviation

      8eea62084ca7e541d918e823422bd82e Conclusion

      Poor survival among US patients treated for 3L SCLC emphasizes the need for more effective and tolerable therapies. In CheckMate 032, nivolumab demonstrated considerable activity in heavily pretreated patients when compared to real-world data and may represent a therapeutic option over available treatments.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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