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Thomas Burke
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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
- Moderators:Joaquim Bosch-Barrera, Virginia Calvo De Juan
- Coordinates: 9/10/2019, 11:30 - 13:00, Interlaken (1988)
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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): Thomas Burke
- Abstract
- Presentation
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): Thomas Burke
- 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).
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): Thomas Burke
- 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): Thomas Burke
- 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).
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): Thomas Burke
- 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.
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): Thomas Burke
- 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.
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.
