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J. Moon
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MO13 - SCLC I (ID 118)
- Event: WCLC 2013
- Type: Mini Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:C.K. Liam, E.S. Santos
- Coordinates: 10/29/2013, 10:30 - 12:00, Bayside 201 - 203, Level 2
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MO13.01 - Disease control rate at 8 weeks predicts subsequent survival in platinum-treated extensive stage small cell lung cancer (ES-SCLC): a patient level analysis of SWOG trials (ID 967)
10:30 - 10:35 | Author(s): J. Moon
- Abstract
- Presentation
Background
Disease control rate (DCR) – the sum of partial (PR) and complete response (CR) plus stable disease (SD) – is a significant predictor of subsequent survival following platinum-based chemotherapy in patients with advanced non-small cell lung cancer (Lara, et al. JCO 2008). We evaluated whether this observation is also relevant in patients with platinum-treated ES-SCLC on investigational systemic therapy.Methods
Updated patient-level data from recent SWOG trials in 2[nd] and/or 3[rd] line ES-SCLC (S0802: topotecan + aflibercept; S0435: sorafenib; and S0327: PS-341) were pooled. Landmark analysis was performed among patients still alive at 8 weeks for overall survival (OS) measured from the 8-week landmark. Association of clinical prognostic factors (including age, sex, platinum sensitivity status, number of prior chemo, weight loss, and LDH, among others) with DCR was assessed using logistic regression. A Cox proportional hazards model was used to assess the associations between DCR at the landmark time and subsequent OS, adjusted for prognostic factors.Results
319 patients were included: median age = 63 years; male sex = 51%; PS 1 = 68%; weight loss > 5% = 29%; > 2 prior chemo = 16%; and elevated LDH = 43%. Only 8 patients had PR by RECIST for an overall response rate of 2.5%. Disease control at 8 weeks was observed in 74 patients (8 PR + 64 SD), for a DCR of 23.2%. Bivariate analysis of OS from the 8-week landmark revealed that only DCR (Hazard Ratio [HR] 0.53, p<0.0001) and elevated LDH (HR 1.69, p=0.001) were significantly associated with OS. Multivariable analysis showed that only DCR remained as an independent predictor of subsequent survival from the 8-week landmark (HR=0.58, p=0.002).Conclusion
In this large 2[nd]- and 3[rd]-line ES-SCLC database, DCR at 8 weeks was found to be the strongest predictor of subsequent survival in patients receiving investigational therapy. Thus, DCR at 8 weeks should be considered for use as a surrogate clinical trial endpoint to screen for drug activity against ES-SCLC. These results have critical implications in the design of future prospective trials in ES-SCLC.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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O21 - SCLC II (ID 119)
- Event: WCLC 2013
- Type: Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:M. Ahn, P. Lara
- Coordinates: 10/29/2013, 16:15 - 17:45, Parkside Ballroom B, Level 1
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O21.07 - A new prognostic model for relapsed/refractory extensive stage small cell lung cancer (ES-SCLC) derived from prospective SWOG trials: implications for study design (ID 966)
17:20 - 17:30 | Author(s): J. Moon
- Abstract
- Presentation
Background
ES-SCLC patients (pts) with progressive disease (PD) following plat-based chemo have traditionally been categorized as plat-sensitive (PD >/= 90 days from last plat dose) or refractory (PD < 90 days). Plat-sensitivity status has previously been strongly associated with response and survival in the 2[nd]/3[rd] line treatment setting. However, in a recent pooled analysis of SWOG trials in 2[nd]/3[rd] line SCLC pts, plat-sensitivity status was found to no longer be a significant independent variable for survival (Lara, ASCO 2013). We subsequently developed a new SCLC prognostic model for overall survival (OS) for potential clinical trial and bedside application.Methods
Updated data from recent SWOG trials in 2nd and/or 3rd line ES-SCLC (S0802: topotecan + aflibercept: S0435: sorafenib; and S0327: PS-341) were pooled. Accrual goals were specified for sensitive and refractory in each trial. Hazard ratios (HRs) for OS were calculated using Cox Proportional Hazard (PH) models [unadjusted and adjusted]. To investigate a predictive model for OS, recursive partitioning was performed using the likelihood tree model of LeBlanc and Crowley. The minimum node size was set at 20.Results
Of 329 pts, 151 were classified as sensitive, 178 refractory; median age = 63 years; males = 52%; Performance Status (PS) 1 = 67%; weight loss >5% = 28%; > 2 prior chemo = 16%; and elevated LDH = 43%. HRs from unadjusted Cox models for OS for refractory vs. sensitive were 1.0 (95% CI 0.81-1.25, p=0.98) and 1.24 (95% CI 0.99, 1.57; p=0.06). Cox PH models adjusted for baseline prognostic factors showed that plat-sensitivity status was not significantly associated with OS. Elevated LDH was significantly associated with PFS while LDH, PS, weight loss, and male sex were independently associated with OS. Clinically relevant prognostic risk groups (High, Intermediate, and Low) were identified by recursive partitioning analysis, as shown below (MST= median survival time). High Risk (MST = 2 months: Elevated LDH And > 5% Weight Loss Or PS >0) Intermediate Risk (MST = 5 months: Elevated LDH but not High Risk Or Male) Low Risk (MST=8 months: Normal LDH And Female)Conclusion
In this large database analysis, clinically relevant prognostic risk groups were identified, categorized as low, intermediate, and high risk, with differential survival outcomes observed for each group. Validation of these risk groups in an independent SCLC dataset is warranted. If validated, these risk groups will have important implications for individualized patient counseling in clinic and stratification of patients in prospective trials in the second and third line setting.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
