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J.R. Penrod



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    ORAL 31 - PD1 Axis Inhibition (ID 143)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      ORAL31.03 - Evaluation of Disease-Related Symptoms in Patients with Advanced Squamous Non-Small Cell Lung Cancer Treated with Nivolumab or Docetaxel (ID 743)

      16:45 - 18:15  |  Author(s): J.R. Penrod

      • Abstract
      • Presentation
      • Slides

      Background:
      The CheckMate 017 (NCT01642004) randomized, open-label, global phase 3 study evaluated efficacy and safety of second-line nivolumab vs docetaxel in patients with advanced squamous (SQ) non-small cell lung cancer (NSCLC). Overall survival was significantly superior and duration of treatment longer for nivolumab vs docetaxel. The study also evaluated disease-related symptoms using the Lung Cancer Symptom Scale (LCSS).

      Methods:
      The LCSS includes 100 mm visual analog scales for 6 major lung cancer symptoms plus three global items evaluating the impact of symptoms; 0 represents the least severity and 100 the greatest severity. Assessment was performed every 4 weeks for nivolumab and every 3 weeks for docetaxel for the first 6 months on treatment, followed by every 6 weeks for the remainder of the treatment period for both study arms. Following treatment discontinuation, the LCSS also was assessed at two follow-up visits. The LCSS average symptom burden index (ASBI) was computed from the 6 individual symptom scores. Mean baseline and mean change from baseline of the LCSS ASBI at each assessment were summarized by treatment group. A study secondary endpoint was to estimate the proportion of patients whose LCSS ASBI showed a clinically meaningful improvement by week 12 (10 point or greater decrease, the minimally important difference [MID]), which was based on all randomized patients.

      Results:
      Patient baseline characteristics were generally balanced across treatment groups. LCSS completion rates for baseline and at least one subsequent assessment were 68.9% and 62.8% for nivolumab and docetaxel, respectively. Completion rates remained relatively consistent throughout assessments and by treatment arm. Baseline LCSS ASBI values were similar for nivolumab (29.6; standard deviation [SD] 16.4) and docetaxel (29.6; SD 14.7). By week 12, 20.0% (27/135; 95% CI: 13.6, 27.7) of nivolumab patients demonstrated clinically meaningful symptom improvement compared to 21.9% (30/137; 95% CI: 15.3, 29.8) of docetaxel patients. Examining mean changes from baseline in patients’ LCSS ASBIs at each assessment, the nivolumab group demonstrated statistically significant improvements from baseline at each assessment from week 12 through week 54, after which sample sizes dropped to fewer than 10 patients; from week 40 through 54, the mean improvements exceeded the MID. In contrast, docetaxel patients remaining on treatment had no statistically significant changes in LCSS ASBI through week 18, after which the sample dropped to fewer than 10 patients. In the two follow-up visits after treatment discontinuation, the mean of the LCSS ASBI for both nivolumab and docetaxel patients indicated similar worsening of symptoms relative to baseline (range, 5.5–9.5); for docetaxel patients, the differences from baseline were statistically significant.

      Conclusion:
      By week 12, the proportion of patients showing meaningful symptom improvement was similar for both the nivolumab and docetaxel groups. However, the overall average symptom burden while on nivolumab improved from baseline over most of the year of available follow up, while average symptom burden for docetaxel patients remained stable relative to baseline during their shorter time on treatment. These results show statistically and clinically significant reductions from baseline in lung cancer symptoms for patients with squamous NSCLC treated with second-line nivolumab.

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    P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P3.01-048 - Predictors of Subsequent Lines of Therapy (LOTs) in Non-Small Cell Lung Cancer (NSCLC) (ID 781)

      09:30 - 17:00  |  Author(s): J.R. Penrod

      • Abstract

      Background:
      In recent years, the number of NSCLC treatment options has increased. The majority of patients receiving first-line therapy (1L) for locally advanced or metastatic NSCLC progress; however, fewer than half receive subsequent treatment. This analysis investigated which factors might be predictive of patients receiving subsequent LOTs within a US community network.

      Methods:
      A retrospective data analysis was conducted using electronic health records in the US Oncology Network for adult patients with advanced NSCLC receiving second-line therapy from 3/1/10 to 12/31/12, with follow-up through 10/31/14. Patients receiving 1L tyrosine kinase inhibitors (EGFR/ALK+), with concurrent cancer diagnoses, or in a clinical trial were excluded. Data on monotherapy/combination treatments, LOT, staging, histology, ECOG performance status (PS), metastases, comorbidities, age, gender, geography and practice size were collected. Chi-square tests examined patient and disease factors related to the receipt of subsequent treatments (2L–3L and 3L–4L). Logistic regression was used to predict the likelihood of receiving a subsequent LOT in multivariate models. Overall survival (OS) was estimated from diagnosis and from the initiation of each LOT.

      Results:
      Of 2,122 patients receiving 2L treatment, 963 (45%) advanced to receive 3L and 319 (15%) advanced to receive ≥4L treatment. Median age at 2L was 67 years (range, 34–94); 58% were male. PS at 2L was available for 80% of patients; 8%, 68%, and 24% were PS 0, 1, or 2+, respectively. The histology breakdown was 54% non-squamous, 25% squamous, and 21% not-specified. In univariate analysis, significance (P<0.05) for receiving a 3L/4L+ therapy was found for age, PS, histology, and treatment type. Multivariate analysis results are presented (Table). Figure 1 Of patients receiving 2+ LOTs, median OS from advanced NSCLC diagnosis was 22 months (95% CI: 20, 23). Median OS from the start of 2L, 3L, and 4L was 8.9, 7.0, and 7.2 months, respectively. In 2L, median OS for patients who received a 3L compared to those who did not was 13.4 vs 5.0 months (P<0.0001); median OS in 3L for patients who received a 4L compared to those who did not was 12.9 vs 4.9 months (P<0.0001).



      Conclusion:
      Receiving subsequent LOTs is associated with improved OS in advanced NSCLC. Whether this represents the efficacy of therapeutic agents or an enrichment for patients capable of receiving additional therapy is unclear. Nonetheless, these data on patient and treatment predictive factors may assist in understanding how future treatments might allow more patients to advance to later LOTs.