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A. Guerin
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P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03a-044 - Severe Adverse Events Impact Overall Survival (OS) and Costs in Elderly Patients with Advanced NSCLC on Second-Line Therapy (ID 5064)
14:30 - 14:30 | Author(s): A. Guerin
- Abstract
Background:
Among elderly patients with advanced non-small cell lung cancer (aNSCLC), treatment beyond first-line therapy may be associated with higher risk of adverse events (AEs) due to patients’ poorer performance status and higher disease burden and comorbidities. This study assessed the impact of severe AEs during second-line (2L) therapy on OS and cost of care in elderly with aNSCLC.
Methods:
Patients aged ≥65 years, diagnosed with aNSCLC between 2007-2011 and receiving 2L chemotherapy/targeted therapy, were identified in the SEER-Medicare database (2006-2013). 57 AEs were identified by literature review and consultation with an oncologist. Severe AEs were operationalized as hospitalizations during which a diagnosis for ≥1 AEs was recorded. OS and all-cause healthcare costs post-initiation of 2L chemotherapy/targeted therapy were compared between patients with and without severe AEs.
Results:
Among 3967 patients initiating 2L, 1624 (41%) had ≥1 severe AEs where hypertension (26%), anemia (24%), and pneumonia (23%) were most commonly reported. Patients with and without severe AEs were similar in demographic and cancer characteristics at diagnosis and 2L treatment regimens; although patients with severe AEs had more comorbidities, notably anemia (69% vs 60%). Median OS for patients with severe AEs was almost half of that for patients without severe AEs (6 vs 11 months). After adjustment for potential confounders, patients with severe AEs had more than double risk of death than patients without severe AEs. Cost of caring for patients with severe AEs was more than twice higher than those patients without severe AEs ($16,135 vs $7,559 per-patient-per-month).OS With severe AEs cohort N = 1,624 Without severe AEs cohort N = 2,343 Kaplan-Meier rates (95% CI) 1 year post 2L initiation 26% (24 - 28) 46% (44 - 48) 2 years post 2L initiation 11% (9-13) 23% (21-25) Median survival time (in months) 6 11 Adjusted hazard ratio[1] (95% CI) 2.31 (2.16 - 2.47) [1] Patients with vs without severe AEs AE: adverse event; 2L: second line chemotherapy/targeted therapy; CI: confidence intervals
Conclusion:
Occurrence of severe AEs among elderly aNSCLC patients who are receiving 2L chemotherapy/targeted therapy is associated with worse clinical outcomes and a higher economic burden. Results of this analysis suggest that better tolerated therapies may improve outcomes for patients and reduce cost to the healthcare system.
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P3.02a - Poster Session with Presenters Present (ID 470)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02a-007 - Monitoring for and Characteristics of Crizotinib Progression: A Chart Review of ALK+ Non-Small Cell Lung Cancer Patients (ID 4443)
14:30 - 14:30 | Author(s): A. Guerin
- Abstract
Background:
Crizotinib is recommended as first-line therapy for non-small cell lung cancer (NSCLC) patients with ALK rearrangements. Following the approval of second-generation ALK inhibitors for patients who progress on or are intolerant to crizotinib, this study describes how physicians monitor for progression, diagnose progression, and alter treatments following progression on crizotinib therapy.
Methods:
A panel of US oncologists was surveyed regarding their monitoring practices and criteria for diagnosing progression on crizotinib. From March to June 2016, the oncologists provided data retrospectively from the medical charts of their adult patients diagnosed with locally-advanced or metastatic ALK+ NSCLC who progressed on crizotinib following the US approval of the first second-generation ALK inhibitor, ceritinib, in April 2014. Time to clinician-defined progression and treatment changes following progression were assessed using the medical chart data.
Results:
28 oncologists responded to the survey. Data was abstracted on 74 ALK+ NSCLC patients who progressed on crizotinib. 49% of the patients were male; 50% were never smokers. 81% of patients received crizotinib in first line; the median age at initiation was 61 years. Most physicians (71%) reported monitoring for radiographic progression every 3-4 months. In terms of course of action when new lesions are detected, physician response varied: most physicians (75%) prefer to add local therapy and resume crizotinib following a symptomatic isolated lesion, while, following multiple symptomatic lesions, 96% and 64% of physicians prefer to switch to a new therapy depending upon whether the lesions were systemic or isolated to the brain, respectively. Among the study sample, progression on crizotinib, as defined by physicians, was detected after a median of 10.4 months. 86% of patients discontinued crizotinib within 30 days of diagnosis of the physician-defined progression. Among all patients who discontinued, 77% switched to ceritinib, 14% to chemotherapy, and 1% to alectinib; the remaining 7% did not receive additional systemic antineoplastic therapy.
Conclusion:
The findings from this physician survey and retrospective chart review of ALK+ NSCLC crizotinib-treated patients suggest that physician response to the development of new lesions varies depending upon the location and extent of the lesions. Once physicians considered their patients to have progressed, most immediately switched their patients to ceritinib, a second-generation ALK inhibitor.
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P3.02a-023 - Treatment Patterns and Early Outcomes of ALK+ Non-Small Cell Lung Cancer Patients Receiving Ceritinib: A Chart Review Study (ID 4641)
14:30 - 14:30 | Author(s): A. Guerin
- Abstract
Background:
Ceritinib is the first second-generation ALK inhibitor approved in the US to treat ALK+ non-small cell lung cancer (NSCLC) patients who progressed on or were intolerant to crizotinib. This study provides the first real-world description of the characteristics, treatment patterns, and early outcomes of ALK+ NSCLC patients who received ceritinib in clinical practice.
Methods:
From March to June 2016, 23 US oncologists provided data retrospectively from the medical charts of their adult patients diagnosed with locally-advanced or metastatic ALK+ NSCLC who received ceritinib following crizotinib therapy. Clinical characteristics, treatment patterns, and early outcomes on ceritinib were assessed. Best response on ceritinib was evaluated using RECIST criteria.
Results:
Participating oncologists reviewed charts of 58 ALK+ NSCLC patients treated with ceritinib. 41% of the patients were male, 52% were never smokers, and median age at ceritinib initiation was 63 years. Patients started ceritinib following a median of 10.6 months on crizotinib; 21% of patients had prior chemotherapy experience. At ceritinib initiation, many patients had multiple distant metastases, most commonly in the liver (60%), bone (53%), and brain (38%). While 71% initiated ceritinib at 750mg once daily, 19% received 600mg once daily, and 10% received 450mg once daily. 17% of patients were instructed to take ceritinib with food; 50% were instructed to fast. Median follow-up after ceritinib initiation was 3.8 months. Although follow-up was short, most patients achieved either a complete (8%) or partial (61%) response on ceritinib, regardless of metastatic site present at initiation (Table). Among the 21 patients who discontinued ceritinib, 6 received alectinib, 2 chemotherapy, 2 immunotherapy, and 11 received no further antineoplastic therapy.
Conclusion:
These early findings of ceritinib use in clinical practice suggest that ceritinib is effective at treating crizotinib-experienced ALK+ NSCLC patients, regardless of the location of metastatic sites. Future studies with longer follow-up are warranted. Figure 1
