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Beata Korytowsky
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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): Beata Korytowsky
- Abstract
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.
8eea62084ca7e541d918e823422bd82e ConclusionTable: 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
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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P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.01-57 - Real-World (RW) Predictors of Immuno-Oncology (IO) vs Chemotherapy (C) Use in Advanced Non-Small Cell Lung Cancer (aNSCLC) (ID 13002)
12:00 - 13:30 | Author(s): Beata Korytowsky
- Abstract
Background
For patients with aNSCLC without known mutations, demographic and clinical characteristics may impact second-line (2L) treatment decisions. Describing predictors of 2L RW drug utilization may help optimize outcomes of patients with aNSCLC who eventually progress. This study evaluated predictors for 2L IO vs. C use in patients with aNSCLC treated with 1L C (proxy for patients without treatment-altering mutations).
a9ded1e5ce5d75814730bb4caaf49419 Method
A retrospective cohort of continuously enrolled adult patients with lung cancer initiating 1L C ≤6 months of diagnosis was identified from Inovalon’s MORE2 Registry® claims post IO approval in lung cancer (Mar 2015 - Dec 2016). Patients receiving 2L systemic therapy following 1L C were selected, excluding patients with SCLC, treated for secondary malignancies, with <1 month follow-up, or on clinical trials. The influence of baseline characteristics on choice of 2L IO vs C was evaluated using binary multiple logistic regression (LR), excluding targeted therapy (TT) due to small sample. Odds ratio (OR) >1 indicated greater chance of IO use. P-value <0.05 was considered significant.
4c3880bb027f159e801041b1021e88e8 Result
Of 2,700 patients initiating 1L C, 829 (31%) received 2L: 539 (65%) received C, 262 (32%) IO, 28 (3%) TT. By subgroup (C, IO, TT), 46%, 54%, 57% (p=0.055) were female; mean age at 2L start was 65.3, 66.0, 61.0 years (p=0.045); Charlson comorbidity index: 2.8, 2.0, 1.5 (p=0.001); lines of therapy per patient: 2.4, 2.3, 2.5 (p=0.012); comorbidity count: 1.5, 1.1, 0.7 (p<0.001); follow-up from 1L start: 11.3, 10.9, 11.6 months (p=0.499); 18%, 26%, 21% (p=0.028) commercially insured; 70%, 68%, 39% (p=0.003) had evidence of smoking cessation/ counselling; 30%, 13%, 11% (p<0.001) had evidence of another malignancy at diagnosis; and 7%, 3%, 0% (p=0.032) had evidence of diabetes with chronic complications at diagnosis.
LR model showed factors increasing likelihood of 2L IO use included evidence of chronic obstructive pulmonary disease (COPD) at diagnosis (OR=1.54, p=0.025), longer time to 1L discontinuation (1.27, p<0.001), and commercial insurance (2.29, p=0.001). Factors negatively impacting IO choice were: 1L combination therapy use (0.48, p<0.001), evidence of secondary malignancy at diagnosis (0.21, p=0.001), and evidence of diabetes with chronic complications at diagnosis (0.33, p=0.031).
8eea62084ca7e541d918e823422bd82e Conclusion
This retrospective RW study showed that aNSCLC patients with COPD, longer 1L treatment, on 1L monotherapy, and private insurance are more likely to receive 2L IO vs C. As such, early consideration needs to be given in order to monitor these patients more closely.
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