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Susana Noemi Sena
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EP1.04 - Immuno-oncology (ID 194)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.04-41 - Efficacy of Immunotherapy in Elderly Patients with Non-Small Cell Lung Cancer: A Multicentric Experience from Argentina (ID 1900)
08:00 - 18:00 | Author(s): Susana Noemi Sena
- Abstract
Background
Immunotherapy (IO) has become a standard of care in NSCLC. Aging is associated with structural and functional changes in the immune system; hence, elderly patients could obtain less benefit from IO. Although randomized clinical trials showed benefit regardless of age, elderly are underrepresented, though its role in this population remains uncertain.
Method
We conducted a retrospective analysis of patients (pts) with NSCLC treated with IO at six centers between Nov 2013 and Feb 2019. We categorized patients in two groups (≥ 75 and < 75 years old) and evaluated overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety. Correlations were assessed using Fisher’s exact tests. Kaplan-Meier was used to estimate survival rates and compared using log-rank testing. Cox proportional hazard models were used to evaluate prognostic factors for PFS and OS.
Result
A total of 269 NSCLC pts treated with ICIs were included, 49 pts were ≥ 75 years old. Among them, 27 pts (55.1%) were male, 42 (85.7%) current or former smokers and 39 (79.5%) had PS 0-1; baseline brain metastases were present in 5 pts (10.2%). PDL-1 tumor proportion score (TPS) was ≥ 50% in 13/32 pts (41%), 31% received IO in first-line. There were no statistical significant differences in baseline characteristics between both groups. There was similar rate of G3-4 adverse events (18.4% vs. 17.7%, p=1.00) and treatment discontinuation (8.2% vs. 11% p=0.15, respectively) for ≥ 75 and < 75 years respectively. ORR was 18.4% (9/49) vs. 33.2% (73/220) p=0.06, DCR was 47% (23/49) vs. 65.9% (145/220) p=0.01, for ≥ 75 and < 75 years respectively. Median follow-up from IO was 15.9 months [95%CI 12.1 – 19.7]. Median PFS was 3.5 months [95%CI 2.4 – 4.6] vs. 9.8 months [95%CI 7.35 – 12.3] p<0.001 and median OS was 8.7 months [95%CI 5.4 – 12.0] vs. 18.8 months [95%CI 11.8 – 25.8] p=0.008, for ≥ 75 and < 75 years pts respectively. Histology (p=0.032), baseline corticoid treatment (p<0.001), first-line (p=0.004) and G3-4 toxicity (p=0.005) were significantly associated with OS in multivariate analysis.
Conclusion
In our cohort, immunotherapy demonstrated to be safe for elderly pts showing similar toxicity profile compared to their younger counterparts; however, elderly pts achieve less benefit than younger patients. Further assessment in larger cohorts is warranted, considering the high prevalence of lung cancer among this subset of patients.
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P1.04 - Immuno-oncology (ID 164)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.04-82 - Toxicity as a Clinical Marker for Efficacy of Immunotherapy in NSCLC: A Multicentric Experience from Argentina (Now Available) (ID 1950)
09:45 - 18:00 | Author(s): Susana Noemi Sena
- Abstract
Background
Immunotherapy (IO) has become standard of care in NSCLC. Immune-related adverse events (irAEs) have shown to be associated with survival benefit in several tumor types in small reports. However, its predictive role as a clinical marker for efficacy to PD-1 inhibition in NSCLC remains uncertain.
Method
We conducted a retrospective analysis of patients (pts) with NSCLC treated with IO at six centers between Nov 2013 and Feb 2019. We categorized patients in two groups (irAEs and no-irAEs group) and evaluated overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS). A 6-week cutoff was established to evaluate the impact of early vs. late onset of irAEs. Correlations were assessed using Fisher’s exact tests. Kaplan-Meier was used to estimate survival rates and compared using log-rank.
Result
A total of 269 NSCLC pts treated with ICIs were included, 48 pts (17.8%) developed Grade 3-4 irAEs. Among them, median age 66 years [range 47 - 86], 31 (65%) were male, 42 (87.5%) current or former smoker and 42 (87.5%) had PS 0-1, PDL-1 tumor proportion score (TPS) was ≥ 50% in 17/26 pts (65.4%), 5 pts (11%) received baseline corticoids; 15 pts (31%) were treated in first-line. No statistical significant differences in baseline characteristics were observed. Median follow-up from IO was 15.8 months [95%CI 12.1 – 19.7]. Median number of cycles to toxicity was 5 [range 1 – 60]. Most common grade 3-4 events were pneumonitis (n=12), adrenal insufficiency (n=7), thyroiditis (n=7), rash (n=6) and nephritis (n=6). There were 5 (10%) treatment-related deaths. Patients with irAEs had significantly higher ORR and DCR vs. no-irAEs: 48% (23/48) vs. 26.7% (59/221) p=0.005 and 83% (40/48) vs. 58% (128/221) p<0.001, respectively. Similarly, median PFS and OS were significantly prolonged in pts with irAEs vs. no-irAEs: 17.1 months [95%CI 8.1 – 25.9] vs. 6.6 months [95%CI 4.9 – 8.3] p=0.02 and 29.4 months [95%CI NR] vs. 12.9 months [95%CI 10.0 – 15.9] p=0.01, respectively. Early onset of irAEs (≤6 weeks) had significantly shorter PFS and OS vs. late onset (>6 weeks): 2.43 months [95%CI 0 - 9.02] vs 21.0 months [95%CI 14.57 - 27.44] p=0.006 and 3.94 months [95%CI NR] vs NR p=0.010, respectively.
Conclusion
In our cohort, we observed a correlation between irAEs and efficacy in NSCLC patients treated with IO. This potential predictive value needs to be validated in larger prospective cohorts to drive definitive conclusions.
