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J.K. Salama



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    MINI 06 - Quality/Prognosis/Survival (ID 111)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Treatment of Localized Disease - NSCLC
    • Presentations: 1
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      MINI06.03 - Improved Survival in Patients with Stage I-II NSCLC Treated with Surgery or Radiotherapy in the Department of Veterans Affairs (ID 1276)

      16:45 - 18:15  |  Author(s): J.K. Salama

      • Abstract
      • Presentation
      • Slides

      Background:
      Recent advancements in surgical and radiotherapy techniques for early stage NSCLC have demonstrated improved outcomes in clinical trials and case series. However, their impact on large populations remains poorly studied. We therefore analyzed Department of Veterans Affairs (VA) data to evaluate temporal trends in survival within a large integrated healthcare system during the decade these techniques were introduced.

      Methods:
      Using VA Central Cancer Registry and vital status data, patients diagnosed with stage I-II NSCLC between 1/1/2001-12/31/2010 were identified. Patient characteristics assessed included age, race, stage, histology, Charlson comorbidity index, specific comorbid conditions, and smoking status. Descriptive and chi-square statistics were used to compare patient characteristics and outcomes.

      Results:
      18,442 patients were identified with stage I-II NSCLC. The primary modality of treatment was surgery in 10,754 (58%), radiotherapy in 3,708 (20%), and another or no therapy in 3,980 (22%). Patients treated with surgery were younger (median age 66 vs 72%, p<0.0001), were more likely to have a comorbidity index of 0 (28% vs 18%, p<0.0001), and were less likely to have COPD (41% vs 58%, p<0.0001), diabetes (22% vs 25%, p=0.0026), peripheral vascular disease (16% vs 20%,P<0.0001), and coronary vascular disease (9 vs 12%,p<0.0001). Surgery patients were more likely to be current (52% vs 45%, p<0.0001) and less likely to be former (39% vs 45%,p<0.0001) smokers. Equal percentages of surgery and radiation patients were black (14% vs 15%) and white (86% vs 85%). Compared to radiotherapy, surgery patients were more likely to have earlier stage disease (stage I: 79% vs 70%, p<0.0001), and adenocarcinoma (45% vs 22%, p<0.0001). The number of stage I-II NSCLC patients treated with radiotherapy or surgery increased by 50% (667 to 1,001) and 35% (1,845 to 2,496), respectively. The percentage treated each year with surgery increased from 56% in 2001 to a peak of 61% in 2004-2005, decreasing back to 56% in 2010. Inversely, the percentage treated each year with radiation decreased from 21% in 2001, to 17% in 2005 and increased to 24% in 2010. The use of other/no therapy remained unchanged. The Southern region comprised almost half of all treated lung cancer diagnoses (46%), followed by the Midwest (21%), the West (17%), and the Northeastern Region (14%). Between 2001-2010, the number of patients receiving therapy (radiation or surgery) increased each year (p=0.0017). The 4-year survival rate was 54% for surgery patients and 19% for radiotherapy patients (p<0.0001), which varied based on stage (stage I: 58% vs 22%; stage II: 41% vs 13%, respectively). Between 2001-2010, patients treated with either surgery or radiotherapy had a 12% absolute improvement in 4 year OS, representing a 100% survival improvement with radiotherapy (12% to 24%) and a 24% improvement with surgery (49% to 61%).

      Conclusion:
      The Department of Veterans Affairs is treating increasing numbers of patients with stage I-II NSCLC. Following a decade when advanced technologies were introduced for surgery and radiotherapy, survival rates have improved significantly for both treatment modalities. The largest gains were observed among patients treated with radiotherapy with a doubling of 4-year survival.

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    MINI 37 - SCLC Therapy (ID 165)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Small Cell Lung Cancer
    • Presentations: 1
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      MINI37.07 - PCI Survival Improvement for Extensive Stage SCLC Limited to Patients on Maintenance Systemic Therapy: A Secondary Analysis of CALGB 30504 (ID 861)

      18:30 - 20:00  |  Author(s): J.K. Salama

      • Abstract
      • Presentation
      • Slides

      Background:
      PCI has become standard of care for extensive stage small cell lung cancer (ES-SCLC) patients. However, one recent randomized study establishing this standard did not require brain imaging prior to enrollment, and another, which did, failed to show a benefit for PCI. CALGB 30504 (Alliance) was a randomized phase II study of sunitinib vs placebo in ES-SCLC patients responding to at least 4 cycles of platinum based therapy requiring baseline brain imaging at enrollment. As this study spanned the introduction of PCI for ES-SCLC, PCI was left to the discretion of the treating team. Therefore, we performed a secondary analysis of CALGB 30504 to determine the impact of PCI on ES-SCLC patients.

      Methods:
      CALGB 30504 was a phase II randomized study in ES-SCLC comparing maintenance sunitinib versus placebo following SD or CR/PR to 4-6 cycles of etopside 100 mg/m[2] d1-3 and either carboplatin AUC=5 or cisplatin 80 mg/m[2] d1 q 21 days. Sunitinib was 150 mg PO d 1 then 37.5 mg PO qd until progression. The primary objective was to determine if maintenance sunitinib would improve PFS, as was recently reported. PCI was recommended at 25 Gy in 2.5 Gy fractions, within 4-6 weeks of chemotherapy, but not required. Sunitinib was to be held 2 days prior, during, and 2 days after the completion of PCI. All statistical analyses were performed by the statisticians at Alliance/CALGB Statistical and Data Center on the platform of SAS (version 9.3; SAS Institution Inc., Cary, North Carolina).

      Results:
      85 patients received maintenance therapy(41placebo, 44 sunitinib). 41 (48%) received PCI, 44 didn’t. All patients and tumor characteristics were balanced between PCI and no-PCI patients. PCI dose was 25 Gy for 31 patients (range: 25-37.5 Gy). Median time to PCI was 21 wks (range: 12-27 wks) from enrollment. For all patients, PCI was associated with an improvement in PFS (median 7.8 vs 6.5 mo HR=0.63 (95% CI: 0.41-0.98), p=0.037), but not OS (median 12.9 vs 13.2 mo, HR=1.01 (95% CI: 0.64-1.62), p=0.955). In placebo patients, there was no PFS or OS difference between patients receiving PCI or not. In patients randomized to sunitinib, PCI conferred a PFS benefit (9.7 vs 6.8 mo, HR=0.49 (95% CI: 0.26-0.92), p=0.024), but not an OS benefit (14.1 vs 13.5 mo, HR=0.85 (95% CI: 0.44-1.66), p=0.636). When restricted to patients who did not receive PCI, there was no difference in survival between sunitinib or placebo patients. In PCI patients, those receiving sunitinib had non-significant improvement in PFS (9.7 vs 6.7 months, HR=0.63 (95% CI: 0.34-1.20), p=0.158) and trended towards an improvement in OS (14.1 vs 10.6 months, HR=0.56 (95% CI: 0.29-1.10), p=0.087), which was magnified and approached significance when crossover patients were excluded (14.1 vs 10.0 mo, HR=0.49 (95% CI: 0.22-1.06), p=0.064).

      Conclusion:
      PFS, and trends for OS improvement were limited to patients receiving the combination of PCI and maintenance sunitinib. Placebo patients did not benefit from PCI. Improved outcomes for ES-SCLC patients with PCI are likely limited to patients who achieve both intracranial and extracranial disease control.

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    MTE 06 - Survivorship After Combined Modality Therapy (Imaging, Salvage Therapy) (Ticketed Session) (ID 58)

    • Event: WCLC 2015
    • Type: Meet the Expert (Ticketed Session)
    • Track: Treatment of Locoregional Disease – NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/07/2015, 07:00 - 08:00, 102+104+106
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      MTE06.02 - Survivorship After Combined Modality Therapy (Imaging, Salvage Therapy) (ID 1986)

      07:00 - 08:00  |  Author(s): J.K. Salama

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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