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Sheenu Chandwani



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    EP1.01 - Advanced NSCLC (ID 150)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.01-21 - Time on Treatment of First-Line PD-1 Inhibitor Monotherapy for Metastatic Non-Small Cell Lung Cancer Patients: Real-World Experience Data (Now Available) (ID 764)

      08:00 - 18:00  |  Author(s): Sheenu Chandwani

      • Abstract
      • Slides

      Background

      Clinical trials have established the role of immune checkpoint inhibitors for metastatic NSCLC treatment, but real-world data are limited. We describe the first report of a prospective study on real-world time on treatment (rwTOT) for first-line (1L) anti-PD-1 monotherapy in metastatic NSCLC in a 2.3 million member public health provider in Israel.

      Method

      Newly diagnosed stage IV NSCLC patients who initiated 1L anti-PD-1 therapy in 2017 were identified from the national cancer registry. rwTOT was defined as the length of time between first and last administration date of anti-PD-1 therapy. Patients were considered discontinued if they had a record of next line of therapy, or death, or whose last activity date was ≥120 days from the last administration date; others were censored. The Kaplan-Meier (KM) median and restricted mean (rMean) rwToT were estimated. Jun 2018 data cutoff was utilized to allow minimum 6 months follow-up.

      Result

      A total of 63 patients initiated 1L anti-PD-1 monotherapy; of these, 59 were PD-L1 TPS≥50%, one was TPS<50% and 3 unknown. This cohort comprised of 97% pembrolizumab monotherapy, 65% males, median age=59 yrs, 76% ever smokers, 71% adenocarcinomas, 11% brain metastases, and 62%/14%/24% with 0-1/2-4/unknown ECOG status. The median rwToT was 4.6 (95% CI 2.8-12.8) mo and estimated rMean at 24 months using parametric extrapolation was 10.9 mo (4.3-16.8). Patients with ECOG 0-1, n=39, had a median rwTOT of 10.6 mo (1.9-19.2).

      Time on treatment for anti-PD-1 monotherapy

      1L anti-PD-1 Monotherapy

      N=63

      1L Pembrolizumab Monotherapy

      N=61

      N discontinued (%)

      38 (60.3)

      36 (59.0)

      KM Median rwToT (95% CI)

      4.6 (2.8-12.8)

      5.0 (3.5-NE)

      rMean rwToT @ 12 months (95% CI)

      6.5 (5.3-7.7)

      6.7 (5.4-7.9)

      Parametric (extrapolated) rMean rwToT @ 24 months (95% CI)

      10.9 (4.3-16.8)

      [Gompertz]

      11.2 (4.4-17.1)

      [Gompertz]

      6 months on treatment rate, % (95% CI)

      44.1 (31.6-55.9)

      45.5 (32.7-57.5)

      12 months on treatment rate, % (95% CI)

      39.7 (27.3-51.9)

      41.0 (28.3-53.4)

      Conclusion

      The results of this unselected real-world cohort of metastatic NSCLC patients treated with 1L anti PD-1 monotherapy show that rwTOT rates compare favorably with published data from clinical trials and other real-world studies.

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    EP1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 206)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.16-04 - Real World Clinical Outcomes for Metastatic Non-Small Cell Lung Cancer (mNSCLC) at IRST Italy (Now Available) (ID 2307)

      08:00 - 18:00  |  Author(s): Sheenu Chandwani

      • Abstract
      • Slides

      Background

      This study sought to evaluate the real word clinical outcomes concerning overall survival (OS) for patients in first-line treatment for metastatic non-small cell lung cancer (mNSCLC) prior to the availability of immunotherapies in any line.

      Method

      Patients who received systemic anti-cancer treatment for mNSCLC at IRST between Jan2014-Jun2017 with a minimum follow-up of six months were included. The clinical dataset was obtained from data registered in electronic health records maintained during clinical practice. OS was defined as the interval from start of first-line therapy until death or follow-up end, whichever occurred first. Death information was detected from mortality register. OS was estimated using the Kaplan-Meier method stratified by type of first-line treatment.

      Result

      Among the 428 first-line patients analyzed, 64.5% were over 65 years old and 62.6% were men (Table 1). A total of 79.0% patients had non-squamous histology whereas 15.0% had squamous histology, with the remaining 6% other histologies. EGFR mutation was detected in 15.7% and ALK translocation in 8.4% of patients. In the first-line the majority (57.0%) of patients received platinum-doublet (mainly platinum+pemetrexed) while single agent chemotherapy was administered in 23.8%, whereas 10.0% received targeted therapy. Conversely overall 9.0% were enrolled in clinical trials, while 0.2% received Immunotherapies. Median OS was 19.9 months (95%CI:9.2-21.7) with targeted therapy, 8.5 months (95%CI:4.8-13.6) for patients enrolled in clinical trials, 6.4 months (95%CI:5.8-7.6) with platinum-doublet and 4.4 months (95%CI:3.7-5.7) with single agent chemotherapy. A total of 34.5% of first-line patients continued to receive second-line treatment.

      tab1.png

      Conclusion

      In this analysis prior to the introduction of immunotherapies for NSCLC, OS was similar to real world OS in the published literature. The survival was worse in the single agent chemotherapy group while it is superior in platinum doublets group. Overall survival was longest in patients treated with targeted therapy.

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    MA19 - Looking at PROs in Greater Detail - What Patients Actually Want and Expect (ID 147)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Now Available
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      MA19.03 - Differences in Symptom Burden Between Responsive and Progressive Disease in Advanced Non-Small Cell Lung Cancer (aNSCLC) (Now Available) (ID 845)

      11:30 - 13:00  |  Author(s): Sheenu Chandwani

      • Abstract
      • Presentation
      • Slides

      Background

      We have established a real-world Advanced Non-Small Cell Lung Holistic Registry (ANCHoR) to assess how immunotherapy impacts treatment choice, clinical outcomes, and patient-reported outcomes (PROs) of aNSCLC. Our aim in this analysis was to assess the ability of the MDASI-LC to differentiate between patients who are responding or who are progressing during treatment.

      Method

      Between May 2017 and December 2018, patients with aNSCLC at a single institution were enrolled in ANCHoR and completed the MDASI-LC prior to therapy (PTT) and at routine clinic visits. The MDASI-LC consists of 16 symptom severity and 6 interference items rated on 0-10 scales (0 = no symptom or interference, 10 = worst imaginable symptom or complete interference). MDASI-LC scores from PTT to first recorded response determination (FRD) were compared by response group using linear mixed modeling (LMM).

      Result

      One hundred one patients completed the MDASI-LC PTT and at FRD. Mean patient age was 63.8 years (standard deviation = 10.29) and 55% were males. Fifty percent of patients received chemotherapy (CTX), 22% immunotherapy (IM), 19% CTX+IM or angiogenesis inhibitor, and 9% targeted therapy. Median time from PTT to FRD was 105 days (lower quartile = 63, upper quartile = 224). Forty-six percent of patients had a complete or partial response (RECIST criteria CR, PR), 14% had stable disease (RECIST SD), and 41% progressed (RECIST PD). LMM showed progressing patients had significantly more fatigue (estimated effect [est] =1.39; p = 0.031), sleep disturbance (est=1.37; p = 0.046), and drowsiness (est=1.33; p = 0.037) and reported significantly more interference with work (est=1.67; p = 0.016) over time than responding patients.

      Conclusion

      The MDASI-LC differentiated the symptom burden of patients with responding disease from that of patients with progressive disease. Patients with progressive disease had more fatigue, disturbed sleep, drowsiness, and greater interference with work than those with responsive disease. Further research is needed to determine if the MDASI-LC can predict response to therapy in patients and may be useful in delineating treatment benefit.

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    P1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 186)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 3
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.16-15 - Rates of Systemic Anticancer Therapy (SACT) for Advanced Non-Small Cell Lung Cancer (aNSCLC) in the US, 2011–2018 (ID 2704)

      09:45 - 18:00  |  Author(s): Sheenu Chandwani

      • Abstract

      Background

      The SACT options for aNSCLC continue to increase each year with approvals of more effective therapies that improve long-term outcomes, such as immunotherapies (IO). Our aim was to examine trends in SACT rates from 2011-2018 for patients with aNSCLC and no known EGFR/ALK aberrations at US community oncology practices.

      Method

      We used the nationwide Flatiron Health EHR-derived database (data cutoff: 31Jan2019), which incorporates oncologist-defined, rule-based lines of therapy. Adults with aNSCLC diagnosis date from Jan2011-Jun2018, inclusive, with recorded EHR activity ≤90 days after diagnosis, were eligible. Patients with known EGFR/ALK-positive tumors, or nonsquamous histology (NSQ) with unknown or untested EGFR/ALK status, were excluded. We summarized no-treatment and first-line (1L) SACT rates as a proportion of aNSCLC diagnosed from 2011-2018, while limiting 2L and 3L SACT rates to aNSCLC diagnoses from 2011-2016 in order to have sufficient follow-up. Results were stratified by NSQ and squamous (SQ) histology, as well as by pre-IO and post-IO years of aNSCLC diagnosis, defined broadly as 2011-2014 and 2015+, respectively, based on the earliest IO approval for 2L therapy in Mar2015.

      Result

      The figure depicts 1L, 2L, and 3L SACT rates by year of aNSCLC diagnosis for EGFR/ALK-negative NSQ and for SQ. For NSQ, the pre-IO and post-IO no-treatment rates were 28% (2286/8246) and 22% (2520/11,639), respectively. For SQ, the pre-IO and post-IO no-treatment rates were 34% (1781/5200) and 26% (1549/6040).

      #2704 figure.png

      Conclusion

      For both EGFR/ALK-negative NSQ and SQ aNSCLC, 1L SACT rates are trending upward, with no-treatment rates showing substantial drops in the post-IO (versus pre-IO) period. The 2L and 3L SACT rates are variable for both NSQ and SQ; and SACT rates for NSQ tend to be substantially greater than for SQ across all lines of therapy and years of diagnosis.

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      P1.16-31 - Body Mass Index Relating to Patient-Reported Symptoms in First-Line Treatment of Metastatic Non-Small Cell Lung Cancer (ID 2619)

      09:45 - 18:00  |  Author(s): Sheenu Chandwani

      • Abstract

      Background

      Patient-reported outcomes (PROs) provide information on patient treatment experience. Our aim in this analysis was to assess the longitudinal relationship between body mass index (BMI) with patient-reported symptom severity and interference during treatment.

      Method

      Between May 1, 2017 and December 7, 2018, patients with mNSCLC at a single institution were enrolled in a real-world Advanced Non-Small Cell Lung Holistic Registry (ANCHoR) and completed the MDASI-LC prior to start of therapy and at routine clinic visits. MDASI-LC consists of 16 symptom severity and 6 symptom interference items rated on 0-10 scales (0 = no symptom or interference, 10 = worst imaginable symptom or complete interference). BMI was measured at the same schedule as MDASI-LC. Mixed-effects models were used to examine the longitudinal association between BMI and symptom levels during treatment.

      Result

      103 patients completed the MDASI-LC prior to start of therapy and at least 2 follow-up assessments. Mean patient age was 64.3 years (standard deviation = 11.5) and 50% were males. 22% of patients received chemotherapy (CTX), 34% immunotherapy (IM), 23% CTX+IM or angiogenesis inhibitor, and 20% targeted therapy. The median pre-treatment BMI was 25.2 (inter quartile range, 5.2). BMI did not change during treatment and no significant difference was found among treatment groups. Compared with the obese group (BMI≥30), the overweight group (25≤BMI<30) experienced lowest levels of fatigue (estimation(est)=-1.23, standard error (SE)=0.49, p=0.016), disturbed sleep (est=-1.66, SE=0.49, p=0.002), distress (est=-0.90, SE=0.40, p=0.030) and less interference on mood (est=-1.03, SE=0.46, p=0.030) and interference with walking (est=-1.50, SE=0.51, p=0.005). The normal group (BMI<25) demonstrated lower levels of fatigue (est=-1.05, standard error (SE)=0.47, p=0.032) and disturbed sleep (est=-1.15, SE=0.47, p=0.018), compared with the obese group.

      Conclusion

      For patients with mNSCLC, obesity was related with higher symptom burden during active treatment. This analysis provides pilot data for future studies on balanced weight control and patients’ wellbeing during cancer treatment.

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      P1.16-42 - Real-World Trends in Systemic Anticancer Therapy (SACT) for Squamous Advanced NSCLC (aNSCLC) in the US, 2011–2018 (ID 2768)

      09:45 - 18:00  |  Author(s): Sheenu Chandwani

      • Abstract

      Background

      The SACT options for aNSCLC continue to increase each year with approvals of more effective therapies that improve long-term outcomes, as seen with immunotherapies (IO). Our aim was to examine real-world trends in SACT distribution and sequence from first- to second-line (1L-2L) for squamous aNSCLC from 2011-2018 at US community oncology practices.

      Method

      This study used the nationwide Flatiron Health de-identified, EHR-derived database (cutoff: 31Jan2019). Eligible patients were adults who initiated 1L SACT from Jan2011-Jun2018 for aNSCLC with squamous histology, excluding patients with known EGFR/ALK-positive tumors. Descriptive analyses included patients receiving ≥1 SACT dose, assigning all SACT regimens to mutually exclusive classes in hierarchical order (combination regimens assigned by highest component), from highest to lowest: (1) PD1/PD-L1 inhibitor (anti-PD1/L1)-based, (2) EGFR/ALK TKI-based, (3) platinum-based chemotherapy combination with vascular endothelial growth factor inhibitor (PBC+VEGF), (4) PBC only, (5) single agent chemotherapy, (6) others. The 2L regimens were examined for patients with 1L SACT initiation only through 2017 to enable sufficient follow-up. Results were stratified by years and by pre-IO and post-IO years of 1L initiation, defined as 2011-2014 and 2015-2018, respectively, based on the earliest IO approval for 2L therapy in Mar2015.

      Result

      For 1L therapy, in the pre-IO period, most patients were prescribed PBC (80%), and post-IO, most patients were prescribed PBC (68%) or anti-PD1/L1 (21%). Among patients prescribed 1L therapy, the percentages who received 2L therapy were 44%-53% following 1L PBC and 25%-37% following 1L anti-PD1/L1, with 19% of 2017 1L anti-PD1/L1 starts still on 1L therapy (table).

      #2768 (sq)_table.png

      Conclusion

      PBC remain the most common 1L SACT prescribed through mid-2018 for patients with squamous aNSCLC at US community oncology practices. Prescribing of PD1/PD-L1 inhibitors as 1L has gradually increased since regulatory approval starting in 2015. Approximately one-half of patients with squamous aNSCLC prescribed 1L PBC are treated with 2L therapy.

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    P2.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 187)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 2
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.16-17 - Real-World Trends in Systemic Therapy for Nonsquamous EGFR/ALK-Negative Advanced NSCLC (aNSCLC) in the US, 2011–2018 (ID 2744)

      10:15 - 18:15  |  Author(s): Sheenu Chandwani

      • Abstract

      Background

      Systemic anticancer therapy (SACT) options for aNSCLC continue to increase each year with approvals of more effective therapies that improve long-term outcomes, as seen with immunotherapies (IO). We aimed to examine real-world trends in SACT distribution and sequence from first- to second-line (1L-2L) for EGFR/ALK-negative nonsquamous aNSCLC from 2011-2018 at US community oncology practices.

      Method

      This study used the nationwide Flatiron Health de-identified, EHR-derived database (cutoff: 31Jan2019). Eligible patients were adults with aNSCLC, nonsquamous histology with known EGFR/ALK-negative status, who initiated 1L SACT from Jan2011-Jun2018. SACT regimens were assigned to mutually exclusive classes in hierarchical order, from highest to lowest: (1) PD1/PD-L1 inhibitor (anti-PD1/L1)-based, (2) EGFR/ALK TKI-based, (3) platinum-based chemotherapy (PBC) combination with vascular endothelial growth factor inhibitor (PBC+VEGF), (4) PBC only, (5) single agent chemotherapy, (6) others. 2L regimens were examined for patients initiating 1L SACT only through 2017 to enable sufficient follow-up. Results were stratified by year and by pre-IO/post-IO years of 1L initiation, defined as 2011-2014/2015-2018, respectively, based on earliest IO approval for 2L therapy in Mar2015.

      Result

      For 1L, in the pre-IO period, most patients were prescribed PBC (53%) or PBC+VEGF (30%), and post-IO, most were prescribed PBC (43%), anti-PD1/L1 (25%), or PBC+VEGF (23%). Among patients prescribed 1L therapy, the percentages who received 2L therapy were 50%-62% post-1L PBC; 56%-62% post-1L PBC+VEGF; and 28%-38% post-1L anti-PD1/L1 (table). A substantial percentage (25%) of those initiating 1L anti-PD1/L1 in 2017 were still on therapy at cutoff.

      #2744 (nsq) table.png

      Conclusion

      Changing trends in real-world prescribing of 1L-2L SACT for EGFR/ALK-negative nonsquamous aNSCLC from Jan2011-Jun2018 include decreasing use of PBC in 1L and 2L, decreasing use of PBC+VEGF in 1L, and, increasing use of PD1/PD-L1 inhibitors in 1L and 2L. Slightly more than one-half of patients with nonsquamous aNSCLC prescribed 1L PBC are subsequently treated with 2L therapy.

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      P2.16-41 - Pembrolizumab for Previously Treated, PD-L1–Expressing Advanced NSCLC: Real-World Time on Treatment and Overall Survival (ID 2364)

      10:15 - 18:15  |  Author(s): Sheenu Chandwani

      • Abstract

      Background

      Information from real-world clinical settings remains limited regarding outcomes of pembrolizumab therapy for advanced NSCLC. Our aim was to examine real-world time on treatment (rwToT) and overall survival (OS) for patients prescribed pembrolizumab monotherapy for previously treated, PD-L1–expressing advanced NSCLC, thus clinically similar to patients in the KEYNOTE-10 (KN010) trial.

      Method

      This retrospective study used Flatiron Health’s nationally representative EHR-derived database to identify adult patients with histologically confirmed advanced NSCLC and PD-L1 tumor proportion score (TPS) ≥1% previously treated with platinum-containing chemotherapy (and appropriate TKI if nonsquamous NSCLC with EGFR/ALK aberration). Eligible patients initiated pembrolizumab monotherapy from January 1, 2016, to May 31, 2018; those with <6 months of follow-up were excluded. Kaplan-Meier (KM) rwToT and OS were calculated.

      Result

      Median follow-up was 15.6 months (range 6.0–32.8 months). Of 281 eligible patients (56% male), median age was 68 years; 36% had squamous NSCLC; 10% brain metastases; and 57%, 18%, and 25% ECOG performance status 0–1, ≥2, and unknown, respectively. Baseline characteristics were similar across PD-L1 TPS distributions. The table summarizes rwTOT and OS by PD-L1 TPS categories.

      #2364 table.png

      Conclusion

      Real-world patients treated with pembrolizumab monotherapy after platinum-containing chemotherapy for PD-L1–expressing advanced NSCLC experienced rwToT and OS benefits similar to findings in a clinical trial setting, validating KN010 findings and approved indication in second line.