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V.E. Sherry



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    P3.02c - Poster Session with Presenters Present (ID 472)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 3
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      P3.02c-028 - Outcomes of Nivolumab in Elderly Patients (pts) with Non-Small Cell Lung Cancer (NSCLC) (ID 5084)

      14:30 - 15:45  |  Author(s): V.E. Sherry

      • Abstract

      Background:
      In randomized trials of nivolumab in NSCLC, less than 10% of pts were ≥75 years old, and all had Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1. The effectiveness of nivolumab in elderly pts with NSCLC treated in routine practice has not been previously described.

      Methods:
      We conducted a retrospective cohort study of pts with advanced NSCLC treated with nivolumab outside of clinical trials at the University of Pennsylvania between March 2015 and March 2016. Logistic regression and Cox proportional hazards models were used to evaluate the association of age (≥75 vs. <75 years) with overall response rate (ORR), progression-free survival (PFS), and overall survival (OS), adjusting for ECOG PS (0-1 vs. ≥2), sex, smoking history [heavy (≥10 pack-years) vs. light/never (<10 pack-years)], and number of prior systemic therapies (1 vs. ≥2).

      Results:
      Of 175 pts treated with nivolumab, 43 (25%) were ≥75 years old and 42 (24%) had ECOG PS ≥2. Ninety-five pts (54%) were female, 147 (84%) had heavy smoking history, and 81 (46%) had received ≥2 prior systemic therapies. ORR was 19.4%, with median PFS and OS of 2.1 and 6.5 months, respectively. Age ≥75 years was not associated with ORR (OR 1.0, 95% CI 0.4-2.5; p=0.97), PFS (HR 0.71, 95% CI 0.5-1.1; p=0.12), or OS (HR 0.8, 95% CI 0.5-1.4; p=0.4; Figure 1). ECOG PS ≥ 2 was associated with lower ORR (7.1% vs. 23.3%; OR 0.25, 95% CI 0.07 – 0.88; p=0.03), inferior PFS (median 1.8 vs. 2.3 months; HR 1.9, 95% CI 1.3 – 2.8; p=0.001), and inferior OS (median 3.6 vs. 7.8 months; HR 2.6, 95% CI 1.6 – 4.1; p<0.001). Figure 1



      Conclusion:
      In a large NSCLC cohort treated outside of clinical trials, elderly pts gained similar benefit from nivolumab compared to younger pts. Pts with poor performance status had inferior outcomes regardless of age.

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      P3.02c-029 - Immune-Related Adverse Events and Their Effect on Outcomes in Patients (pts) with Non-Small Cell Lung Cancer (NSCLC) Treated with Nivolumab (ID 5206)

      14:30 - 15:45  |  Author(s): V.E. Sherry

      • Abstract

      Background:
      Immune checkpoint inhibitors are associated with immune-related adverse events (irAEs). While the incidence of irAEs in routine practice and their effect on outcomes have been well characterized in melanoma, a similar analysis has not been previously reported in NSCLC pts treated with anti-programmed death 1 (PD-1) therapy.

      Methods:
      We conducted a retrospective cohort study of pts with advanced NSCLC who received nivolumab outside of clinical trials between March 2015 and March 2016 at the University of Pennsylvania. irAEs were graded using the Common Terminology Criteria for Adverse Events version 4.0. Data collected included demographics, timing and treatment of irAEs, and dates of disease progression and death or last follow-up. To analyze the effect of irAEs on progression-free survival (PFS) and overall survival (OS), landmark analyses were used beginning from 3 months after start of treatment. Pts who reached the PFS or OS endpoints prior to 3 months were excluded. Cox proportional hazards models were used to assess for differences in PFS and OS according to the occurrence of an irAE, adjusting for age, sex, and Eastern Cooperative Oncology Group Performance Status (ECOG PS).

      Results:
      175 pts received a median of 5 cycles of nivolumab (range, 1-24, IQR, 3-9). Median age was 68 years (range, 33-88, IQR, 60-74). Forty-six percent of pts were male; 5% had an ECOG PS ≥ 2. Twenty-eight pts (16%) experienced an irAE of any grade and 6 (3%) had a grade 3/4 irAE. Median time to onset of the irAE was 3 cycles (range, 1-18, IQR, 2-6). Of the pts who experienced an irAE, 14 (50%) were treated with systemic corticosteroids. The most common irAEs were hypothyroidism/hyperthyroidism (n=8), pneumonitis (n=6; three grade 4), colitis (n=4; one grade 3), dermatitis (n=4), and arthritis (n=2). Less common irAEs (n=1 each) included hepatitis (grade 4), aseptic meningitis (grade 3), immune thrombocytopenia, and severe hypoalbuminemia that improved with steroids. Overall response rate was 19.4% (34 of 175), and median PFS and OS were 2.1 and 6.5 months, respectively. After adjusting for age, sex, and ECOG PS, landmark analyses revealed no difference in PFS (HR 1.3, 95% CI 0.4-3.8, p=0.7) or OS (HR 0.9, 95% CI 0.3-2.7, p=0.9) stratified by the presence or absence of an irAE.

      Conclusion:
      In NSCLC pts treated with nivolumab in typical practice, irAEs of any grade were uncommon, and grade 3/4 irAEs were rare. The occurrence of irAEs was not associated with PFS or OS.

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      P3.02c-069 - Pretreatment Neutrophil-to-Lymphocyte Ratio (NLR) Predicts Outcomes with Nivolumab in Non-Small Cell Lung Cancer (NSCLC) (ID 5218)

      14:30 - 15:45  |  Author(s): V.E. Sherry

      • Abstract

      Background:
      The NLR, a marker of systemic inflammation, has been associated with outcomes in multiple cancers. In patients (pts) with metastatic melanoma treated with ipilimumab, pre-therapy NLR < 5 has been associated with improved progression-free survival (PFS) and overall survival (OS). However, the utility of NLR as a marker of outcomes in pts with NSCLC treated with programmed-death 1 (PD-1) inhibitors is not known.

      Methods:
      We conducted a retrospective cohort study of pts with advanced NSCLC treated with nivolumab off clinical trials at the University of Pennsylvania between March 2015 and March 2016. NLR was calculated from complete blood counts obtained within two weeks of starting nivolumab. Pts were dichotomized based on a NLR <5 or ≥ 5. We calculated PFS and OS using the Kaplan-Meier method and used multivariate Cox proportional hazards models to adjust for sex, age, histology (squamous vs. non-squamous), Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0-1 vs. ≥ 2), smoking history [heavy (≥10 pack-years) vs. light/never (<10 pack-years)], and number of prior systemic therapies (1 vs. ≥ 2).

      Results:
      175 pts received a median of 5 cycles of nivolumab (range, 1-24; IQR 3-9). Median age was 68 years (range 33-88, IQR 60-74), 46% of pts were male, 75% were white, 25% had an ECOG PS ≥ 2, and 46% had ≥ 2 prior systemic therapies. Eighty-four percent of pts had a ≥10 pack-year smoking history, and 76% had non-squamous histology. Median baseline NLR was 5.5 (IQR, 3.1 – 9.4), with NLR < 5 in 73 pts (42%) and NLR ≥ 5 in 102 patients (58%). Through the date of this analysis (June 1, 2016), disease progression had occurred in 124 pts (71%), and 92 pts (53%) had died, resulting in median PFS and OS of 2.1 and 6.5 months, respectively. After controlling for the aforementioned clinical and demographic factors, pts with baseline NLR<5 had significantly improved PFS (median 2.8 vs. 1.9 months; adjusted HR=0.70, 95% CI: 0.50-0.99; p = 0.04) and OS (median 8.4 vs. 5.5 months; adjusted HR=0.54, 95% CI: 0.34-0.84; p = 0.007) compared to pts with NLR ≥ 5.

      Conclusion:
      Pre-therapy NLR is independently associated with PFS and OS in advanced NSCLC pts treated with nivolumab. It is unclear whether this marker is predictive or prognostic. Prospective studies are warranted to determine the utility of NLR in predicting outcome in the context of other biomarkers of PD-1 therapy.