Abstract
19041 Background: We previously presented a pooled analysis of 1623 patients (pts) from 15 SCLC trials exploring the prognostic importance of many baseline factors on overall survival (OS), among which PS, age, gender, and stage were found to be significant. This present study assessed the prognostic importance of PS in the presence of other baseline factors within limited-stage (LD-SCLC) and extensive disease (ED-SCLC) separately. Methods: Data on 688 pts with LD-SCLC and 935 pts with ED-SCLC disease were included. Age, gender, PS, body mass index, creatinine levels, hemoglobin levels, white blood cell counts, platelet counts, bilirubin levels, and number of metastatic sites were tested for prognostic significance for OS both univariately and multivariately using a Cox Model. Models were stratified by protocol, and analyses carried out on the complete data available based on the selected covariates within each stage. A split sample approach (70% and 30%) was used for model development and validation within each stage. Results: 92% of the LD-SCLC pts and 76% of the ED-SCLC pts had ECOG PS of 0–1. Poorer PS led to worse OS within ED- SCLC, but not within LD-SCLC (median OS for PS 0, 1, 2 within ED-SCLC were 11.2, 9.5, and 7.4 months, respectively). Other negative prognostic factors included increased age and male gender within LD-SCLC and ED-SCLC, and increased number of metastatic sites at baseline within ED-SCLC. Conclusions: PS is a strong and independent prognostic factor in ED-SCLC, and therefore it is critical to stratify for PS in this subgroup. More research is needed to assess the importance of PS within LD-SCLC. Title: Prognostic Factors for OS within LD-SCLC and ED- SCLC Factor (LD) HR 95% CI P (ED) HR 95% CI P Age (10 yr increase) 1.19 1.07- 1.32 0.001 1.10 1.01- 1.19 0.03 Gender (Male vs. Female) 1.25 1.05- 1.48 0.01 1.23 1.07- 1.41 0.004 PS 1 vs. PS 0 1.08 0.90- 1.29 0.45 1.24 1.04- 1.48 <0.0001 PS 2 vs. PS 0 1.23 0.87- 1.72 0.45 1.70 1.39- 2.09 <0.0001 No. of metastatic sites (2 + vs. 0, 1) NA NA NA 1.36 1.19- 1.56 <0.0001 LD = Limited Stage SCLC, ED = Extensive Stage SCLC, HR = Hazard Ratio, CI = Confidence Interval, P = p-value No significant financial relationships to disclose.
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