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Cliff Molife



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    P2.01 - Advanced NSCLC (Not CME Accredited Session) (ID 950)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.01-12 - Ramucirumab+Docetaxel Usage Following Rapid Disease Progression in Real World Advanced Non-Small Cell Lung Cancer Patients (ID 14359)

      16:45 - 18:00  |  Author(s): Cliff Molife

      • Abstract
      • Slides

      Background

      In the Phase III REVEL study, the overall treatment effect of ramucirumab+docetaxel (ram+doc) in patients with rapid disease progression (RDP), defined as disease progression ≤ 12 weeks after start of prior platinum-based chemotherapy, was consistent with that observed in the intent-to-treat population. This real-world, retrospective study described baseline characteristics, treatment patterns, and clinical outcomes among RDP patients subsequently treated with ram+doc in the United States.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Advanced non-small cell lung cancer (aNSCLC) patients receiving ram+doc as 2nd line or 3rd line therapy between March 2015 - May 2017 after platinum-based chemotherapy, with ≥ 3 months of potential follow-up, were identified in the Flatiron Health EHR-derived database. Analyses were conducted for RDP and non-RDP patients. Overall survival (OS) was measured from start of 1st line therapy. Real-world progression-free survival (rwPFS) and time-to-progression (rwTTP) were measured from start of ram+doc. OS, rwPFS, and rwTTP were estimated using Kaplan-Meier method.

      4c3880bb027f159e801041b1021e88e8 Result

      Baseline characteristics were generally similar across RDP (n=49) and non-RDP (n=123) patients with respect to age, gender, and race. Non-RDP patients more often had stage IV disease at diagnosis and non-squamous histology. Among patients with ECOG performance status (PS) reported (n=101, 58.7%), a higher proportion of RDP patients had ECOG PS > 2 (18.4%) than non-RDP patients (9.8%). The majority of patients received ram+doc as 3rd line therapy and the median duration of ram+doc treatment was similar for RDP and non-RDP patients. The most frequently administered chemotherapy regimen prior to ram+doc was carboplatin+pemetrexed for RDP patients and carboplatin+pemetrexed+bevacizumab for non-RDP patients.

      RDP was associated with shorter median OS (13.2 [95% CI: 10.3 - 15.8] vs. 21.6 [95% CI: 17.1-24.1] months, log-rank P < 0.01) whereas median rwPFS (3.0 [1.8 - 4.1] vs. 3.6 [2.9 - 4.1] months, log-rank P = 0.74) and median rwTTP (4.6 [95% CI: 3.5 - 7.9] vs. 5.5 [95% CI: 4.1 - 7.4] months, log-rank P = 0.81) on ram+doc were similar between the RDP vs. non-RDP groups, respectively.

      8eea62084ca7e541d918e823422bd82e Conclusion

      While this real-world cohort shows that RDP correlates with poorer OS, similar rwPFS and rwTTP were observed with ram+doc among aNSCLC patients with RDP vs. non-RDP. This study did not assess the effects of ram+doc vs. other subsequent treatments in patients with RDP. Further research is needed to identify RDP risk factors and to aid in development of optimal treatments for aNSCLC patients with the most aggressive disease.

      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: 2
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.01-110 - Defining Aggressive Disease in Patients With Advanced NSCLC Receiving Second-Line Treatment: A Systematic Review (ID 11820)

      12:00 - 13:30  |  Presenting Author(s): Cliff Molife

      • Abstract
      • Slides

      Background

      Recent randomized clinical trials (RCTs) have explored survival benefits of second-line treatments (2LTs) in patients who have rapidly progressed and/or are refractory to first-line treatment, and these trials have determined an existing unmet need for these patients with aggressive non-small cell lung cancer (NSCLC). However, specific characterization of aggressive NSCLC is lacking, thus a systematic literature review was conducted to explore the definitions of aggressive NSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We systematically searched Medline, Embase, BioSciences Information Service, the Cochrane Library, and abstracts from scientific meetings (through October 2017) to identify RCTs reporting the efficacy and/or safety of select 2LTs in patients with advanced NSCLC who have characteristics associated with aggressive disease (AD). Six potential overarching categorizations of these characteristics (based on expert clinical opinion) were explored: (1) refractory and/or progressive disease as best response to prior treatment, (2) rapid progression, (3) short duration on previous treatment, (4) high tumor burden or size, (5) short duration since start of last treatment, and (6) high symptom burden.

      4c3880bb027f159e801041b1021e88e8 Result

      The 14 identified studies had one or more subgroups within five of the six categorizations (11, 2, 1, 2, and 4 studies presented subgroups within categories 1-5, respectively). No RCTs presenting a subgroup of patients for category 6 were identified. Within each category, the identified subgroup definitions varied (15, 4, 3, 2, and 7 different definitions within categories 1-5, respectively). Reporting of whether a subgroup was prespecified or not was limited and often unclear; 6 studies indicated that subgroup analyses of patients with AD characteristics were preplanned. Moreover, baseline characteristics for the subgroup of patients with AD were often not reported.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Definitions of AD varied, both across the identified studies of 2LTs and within the predetermined categorizations, with refractory being the most frequent followed by short duration since start of last treatment. With the emerging clinical importance of AD, more standard use of these definitions within RCTs may allow for greater comparison across 2LTs and will enable indirect treatment comparisons of the results. As with any subgroup, clarity on preplanned versus post hoc analysis is important for interpretation and should be specified. Additional studies powered to assess treatment benefits in advanced NSCLC patients with AD are needed.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P3.01-19 - Sequencing of Ramucirumab+Docetaxel Post-Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer Patients (ID 14281)

      12:00 - 13:30  |  Presenting Author(s): Cliff Molife

      • Abstract
      • Slides

      Background

      The Phase III REVEL study demonstrated the efficacy and safety of ramucirumab+docetaxel (ram+doc) in advanced non-small cell lung cancer (aNSCLC) patients who had disease progression on prior platinum-based chemotherapy (chemo). Given recent positive data disclosures supporting the use of chemo+immune checkpoint inhibitor (ICI) combinations in frontline, there is a need for additional data on the sequencing of ram+doc post-ICIs.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Baseline characteristics and outcomes were assessed for aNSCLC patients identified in the Flatiron Health EHR-derived database, who received ram+doc as 3rd line therapy (3L) between March 2015 - May 2017 in the United States after 1st or 2nd line platinum-based chemotherapy, with ≥ 3 months of potential follow-up. Analyses were conducted for the overall cohort and among the subset of patients who received 3L ram+doc post-ICI. Overall survival (OS) was calculated from start of 1st line therapy. Real-world progression-free survival (rwPFS) and time-to-progression (rwTTP) were measured from start of 3L ram+doc. OS, rwPFS, and rwTTP were estimated using Kaplan-Meier method.

      4c3880bb027f159e801041b1021e88e8 Result

      Among platinum-treated patients who subsequently received ram+doc in 3L overall (N=98), of whom the majority (n=65, 66.3%) received ram+doc post-ICI, the median age was 66 years and the majority were male (54.1%), Caucasian (67.4%), and had nonsquamous histology (81.6%). Of the 61 (62.2%) with available ECOG performance status (PS) data, 72.1% had ECOG PS of 0 or 1. Baseline characteristics were similar between the overall cohort and ram+doc post-ICI patients, as were clinical outcomes between the two groups (Table 1).

      Table 1. Clinical Outcomes for 3L Ram+Doc Treated Patients

      3L Ram+Doc (Overall)

      n=98

      3L Ram+Doc (Post-ICI)

      n= 65

      Median OS (95% CI), month

      19.1 (16.3 - 23.7)

      19.0 (15.7 - 23.7)

      Median PFS (95% CI), month

      3.6 (3.0 - 4.2)

      3.6 (3.0 - 4.6)

      Median TTP (95% CI), month

      5.5 (4.0 - 7.9)

      5.5 (3.6 - 7.9)

      8eea62084ca7e541d918e823422bd82e Conclusion

      In this real-world platinum-treated cohort, most 3L ram+doc usage was post-ICI. Clinical outcomes for ram+doc post-ICI patients were consistent with those for the overall 3L ram+doc cohort. These data may support the use of ram+doc post-ICI among platinum-treated patients with aNSCLC. Further research is needed to evaluate the efficacy and safety of ram+doc following chemo+ICI combinations.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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