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L.M. Hess
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MINI 04 - Clinical Care of Lung Cancer (ID 102)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:L. Gaspar, V. Westeel
- Coordinates: 9/07/2015, 16:45 - 18:15, Mile High Ballroom 2c-3c
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MINI04.12 - Systematic Review of Brain Metastases in Non-Small Cell Lung Cancer (NSCLC) in the United States, European Union, and Japan (ID 1591)
17:50 - 17:55 | Author(s): L.M. Hess
- Abstract
- Presentation
Background:
Prevalence of brain metastases (BRM) is increasing due to better detection methods and patients living longer with their disease, presenting an unmet need. Importantly, BRM are more common in NSCLC than most other cancers. Published literature offers incomplete data on prevalence, treatment, costs, and outcomes associated with BRM in NSCLC. This study was designed to better understand the epidemiology, treatment patterns, costs, and overall survival (OS) of NSCLC patients with BRM in the US, EU, and Japan.
Methods:
A systematic review was conducted by searching PubMed, Ovid, and Embase from January 2003 to December 2013 according to PRISMA guidelines. Keywords, MeSH, and Emtree terminology were used to define the search strategy. Eligible studies were observational, published in English, and peer-reviewed research of patients with NSCLC and BRM. Demographic, clinical, and outcomes data were extracted into Excel. Descriptive statistics were generated with SAS version 9.2. Demographics were summarized and treatment patterns and median OS were assessed by country.
Results:
The literature search identified 8,257 articles and 243 studies were eligible. There were 46,422 NSCLC cases included. Patient characteristics are summarized in Table 1. Treatment patterns for BRM from NSCLC were reported across the US, EU, and Japan. Median OS of NSCLC patients from the time of BRM diagnosis ranged from 5.0 to 13.1 months by country (Figure 1). The rate, by country, of radiation therapy among NSCLC patients with BRM ranged from 32.9% to 90.1%, systemic therapy ranged from 5.8% to 39.7%, and surgery was used in 2.2% to 31.6% of studies. Figure 1 Figure 2
Conclusion:
Reported median OS and treatment patterns were highly variable. Exposure to risk factors associated with BRM may help explain some of the geographic variability in survival. The lack of published cost data underscores the need to quantify the economic burden of BRM on patients and society.
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MINI 29 - Meta Analyses and Trial Conduct (ID 156)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:D. Morgensztern, M. Redman
- Coordinates: 9/09/2015, 18:30 - 20:00, Mile High Ballroom 2a-3b
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MINI29.08 - Innovation in Non-Small Cell Lung Cancer (NSCLC): Where Are the Clinically Meaningful Outcomes? (ID 1280)
19:10 - 19:15 | Author(s): L.M. Hess
- Abstract
- Presentation
Background:
The American Society of Clinical Oncology (ASCO) recently developed a set of recommended targets for clinically meaningful outcomes to encourage patients, advocates and investigators to expect more of clinical trials in the future and to encourage investigators to design trials and select agents that have the most promise. A systematic literature review was conducted to identify where and how research has successfully met the bar for meaningful improvements in NSCLC patient survival.
Methods:
A systematic search strategy was implemented in MedLine and EMBASE to identify randomized phase III trials reporting overall survival (OS) outcomes from 1974-present. Eligible studies were those that reported OS data in terms of a hazard ratio (HR) or median OS. Patients in the eligible randomized trials were NSCLC patients treated in the first (1L) or post-first line (2L+) setting. Data were extracted related to study population, histology, interventions, and survival from trials of patients with advanced or metastatic disease. All eligibility determinations and extracted data were reviewed by two researchers for accuracy.
Results:
The search strategy identified 2051 articles that were reviewed for eligibility. Of these, 245 were eligible for inclusion. 198 (80.8%) studied 1L, 45 (18.4%) 2L+, and 2 investigated both lines. Of all articles, 51 (20.8%) found significant improvement in survival (Figure 1). Of these, 45 (88.2%) were 1L (41 studies). 14/41 (34.1%) were terminated early or had major protocol changes during study enrollment, and 5/41 (12.2%) reported inconsistent outcomes. In significant 1L studies, the median OS improvement ranged from 0.3-7.0m and HRs ranged from 0.35 to 0.87. The 4 2L+ positive studies, OS improvement ranged from 1.4-2.8m and HRs from 0.70-0.86. Of all 198 1L publications, 12 studies met the significant HR <0.80 bar and an additional 12 studies reported statistically significant gains of ≥2.5m OS. Figure 1. Publications reporting significant improvement in survival Figure 1
Conclusion:
There is a need to improve survival outcomes for patients in NSCLC. In 1L, few studies would have met the ASCO target. Only four 2L+ trials were identified with significant improvements in NSCLC. The results of this systematic literature review inform the interpretation of research and the new bar recommended for meaningful outcomes.
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