Neglected and Underrepresented Subpopulations: Elderly and Performance Status 2 Patients with Advanced-Stage Non-Small-Cell Lung Cancer

2006 ◽  
Vol 7 ◽  
pp. S126-S137 ◽  
Author(s):  
Corey J. Langer
Lung Cancer ◽  
2012 ◽  
Vol 75 ◽  
pp. S52
Author(s):  
E. Larbi ◽  
G. Middleton ◽  
T. Partridge-James ◽  
S. Quirin ◽  
V. Hardacre ◽  
...  

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18144-e18144
Author(s):  
Ramzi George Salloum ◽  
Thomas J Smith ◽  
Gail Jensen ◽  
Jennifer Elston-Lafata

e18144 Background: Evidence-based guidelines recommend chemotherapy for medically fit patients with advanced stage non-small cell lung cancer (NSCLC). Performance status (PS) is a commonly used factor in determining the appropriateness for chemotherapy for this group of patients.The prevalence of poor PS and impact of chemotherapy on survival among NSCLC patients has not been studied in community populations. Methods: Insured patients, aged 50+ years, diagnosed with advanced stage NSCLC between 2000 and 2007 were identified via tumor registry (n=292) and linked to medical record abstracted PS, automated medical claims, and Census tract information. A multivariate Cox proportional hazards model was used to determine the factors associated with survival. Tests of statistical significance were two sided. We defined PS 3 or 4 as “poor” since the NCCN and ASCO guidelines agree that those patients should not routinely receive chemotherapy. Results: Of 292 stage IIIB-IV patients, 82 (28%) had PS 3 or 4, and 39% of PS 3-4 patients received first line chemotherapy. Those who received chemotherapy lived 4.8 months compared to 2.4 months for those who did not. Factors associated with a reduced likelihood of death included receipt of chemotherapy (hazard ratio [HR], 0.67) and surgery (HR, 0.27), and female gender (HR, 0.69). Conclusions: In advanced stage NSCLC, poor PS is common, and oncologists are treating about 40% of those patients with the same drugs as for PS 0-2. Modern chemotherapy is associated with positive effects on survival for poor PS patients, as for good PS patients, but we cannot tell if this is due to chemotherapy or some other factor. Further trials, especially randomized trials, in this common but neglected subgroup are indicated.


2011 ◽  
Vol 29 (34) ◽  
pp. 4574-4580 ◽  
Author(s):  
Suresh S. Ramalingam ◽  
David R. Spigel ◽  
David Chen ◽  
Martin B. Steins ◽  
Jeffrey A. Engelman ◽  
...  

PurposeR1507 is a selective, fully human, recombinant monoclonal antibody (immunoglobulin G1 subclass) against insulin-like growth factor-1 receptor (IGF-1R). The strong preclinical evidence supporting coinhibition of IGF-1R and epidermal growth factor receptor (EGFR) as anticancer therapy prompted this study.Patients and MethodsPatients with advanced-stage non–small-cell lung cancer (NSCLC) with progression following one or two prior regimens, Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2, and measurable disease were eligible. Patients were randomly assigned to receive erlotinib (150 mg orally once a day) in combination with either placebo, R1507 9 mg/kg weekly, or R1507 16 mg/kg intravenously once every 3 weeks. Treatment cycles were repeated every 3 weeks. The primary end point was comparison of the 12-week progression-free survival (PFS) rate.ResultsIn all, 172 patients were enrolled: median age, 61 years; female, 33%; never-smokers, 12%; and performance status 0 or 1, 88%. The median number of R1507 doses was six for the weekly arm and 3.5 for the every-3-weeks arm. Grades 3 to 4 adverse events occurred in 37%, 44%, and 48% of patients with placebo, R1507 weekly, and R1507 every 3 weeks, respectively. The 12-week PFS rates were 39%, 37%, and 44%, and the median overall survival was 8.1, 8.1, and 12.1 months for the three groups, respectively, with statistically nonsignificant hazard ratios. The 12-week PFS rate in patients with KRAS mutation was 36% with R1507 compared with 0% with placebo.ConclusionThe combination of R1507 with erlotinib did not provide PFS or survival advantage over erlotinib alone in an unselected group of patients with advanced NSCLC. Predictive biomarkers are essential for further development of combined inhibition of IGF-1R and EGFR.


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