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A.A. Badawy



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    MINI 15 - Chemotherapy Developments for Lung Cancer (ID 128)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      MINI15.13 - An Evaluation of Chemotherapy Regimens in an Unselected Population of NSCLC Patients (ID 2314)

      16:45 - 18:15  |  Author(s): A.A. Badawy

      • Abstract
      • Presentation
      • Slides

      Background:
      Randomized clinical trials have demonstrated the benefits of chemotherapy in carefully selected NSCLC patients. How generalizable these results are to the general population of NSCLC patients, who often have multiple comorbidities that would have rendered them ineligible for licensing trials, is unresolved.

      Methods:
      The outcomes of unselected patients with stage IV NSCLC who did not participate in a clinical trial and who were treated with standard chemotherapy regimens (paclitaxel/carboplatin; gemcitabine/carboplatin; pemetrexed/carboplatin; paclitaxel/carboplatin/bevacizumab) as first line therapy between 2002 and 2012 at a tertiary teaching hospital were compared to the reported outcomes observed in the licensing trials supporting the use of these drug regimens.

      Results:
      Results are summarized in Table 1 Patients treated with three-weekly paclitaxel plus carboplatin at recommended dosages had a median progression free survival of 4.9 months for patients responding to this regimen and an overall survival of 13.1 months for responders vs 9.2 months for non-responders. In patients’ treated with gemcitabine plus carboplatin on a three or four week cycle the median progression free survival was 4.8 months for patients responding to the regimen and overall survival of 13 months for responders vs 8.9 months for non-responder group of patients. For patients receiving pemetrexed plus carboplatin the median progression free survival was 7.1 months for patients responding to the regimen with an overall survival of 15.5 months for responders vs 5.9 months for non-responders. Those patients’ treated with paclitaxel plus carboplatin plus bevacizumab the median progression free survival was 7.3 months for patients responding to treatment and overall survival was 16.7 months vs 14.6 months for those patients who did not respond to this regimen as initial treatment. Table I: Patient demographics and results for each regimen

      paclitaxel and carboplatin N=105 Gemcitabine and carboplatin N=35 pemetrexed and carboplatin N=26 paclitaxel and carboplatin and bevacizumab N=28
      Age 70> 15.2% 31.4% 26.9% 25.0%
      < 70 84.8% 68.6% 73.1% 75.0%
      Gender Male Female 64.8% 35.2% 51.4% 48.6% 57.7% 42.3% 60.7% 39.3%
      Smoker 89.2% 91.2% 84.6% 71.4%
      ECOG 0 12.6% 12.1% 8.7% 23.1%
      1 68.9% 63.6% 47.8% 76.9%
      2 17.5% 24.2% 43.5% 0.0%
      3 1.0% 0.0% 0.0% 0.0%
      PFS (months) 4.9 4.8 7.1 7.3
      OS (months) PR PD 13.1 9.2 13 8.9 15.5 5.9 16.7 14.6


      Conclusion:
      Progression free survival in an unselected population of NSCLC patients was similar to that reported in clinical trials supporting the approval of these drugs and regimens. The present analysis provides further support for the use of combination chemotherapy in patients with stage IV NSCLC, including those who would have been ineligible for many clinical trials due to comorbidities. Further analysis is ongoing.

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    P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P3.01-041 - Treatment Beyond Second Line Chemotherapy Outside of a Clinical Trial Is Appropriate for Selected NSCLC Patients (ID 2316)

      09:30 - 17:00  |  Author(s): A.A. Badawy

      • Abstract
      • Slides

      Background:
      Guidelines generally recommend entry into a clinical trial or best supportive care for patients with NSCLC who progress after second line chemotherapy. We sought to explore whether this strategy remains valid with newer drugs and regimens and to evaluate the benefit of additional treatment beyond second line in advanced NSCLC.

      Methods:
      A retrospective analysis of stage IV NSCLC patients treated at a tertiary teaching hospital from 2002-2012 was undertaken. Demographics, details of treatment and overall survival was recorded for each patient. Patients who originally received adjuvant therapy and no further treatment upon recurrence and those receiving first line treatment on a clinical trial with no further therapy were excluded from analysis. Statistical analyses was performed using SPSS software and calculated using log-rank testing.

      Results:
      409 cases of NSCLC were included in this analysis. 239 (58.4%) patients received second line chemotherapy, 102 (24.9%) received third line treatment, 36 (8.8%) received fourth line treatment and 11 patients (2.7%) received fifth line therapy. The addition of second line treatment was associated with a statistically significant improvement in overall survival, with median survival for patients received second line treatment of 18.7 vs 9.1 months (p<0.001) for patients not receiving second line treatment. The most commonly used second line regimens were single agent docetaxel, single agent pemetrexed, tyrosine kinase inhibitors or combined chemotherapy doublets and there was no significant difference in overall survival based on what regimen was used as second line therapy.. The addition of third line treatment also was associated with a statistically significant improvement in overall survival, with a median survival for patients receiving third line therapy of 26.1 vs 11.3 months (p<0.001) for patients not receiving third line treatment. The most common therapeutics regimens for third line treatment were single agent docetaxel, single agent pemetrexed, single agent gemcitabine, single agent vinorelbine, tyrosine kinase inhibitors or combined chemotherapy doublet, and there is no significant difference between these regimens regarding overall survival. The addition of fourth and fifth line treatment also resulted in statistically significant improvements in overall survival with median survival compared to patients not receiving this treatment of 32.7 vs 13 months (p<0.001) and 40.3 vs 13.4 months (p=0.003) respectively.

      Conclusion:
      Although the present analysis is limited by its retrospective nature, our data suggest that continuing treatment after progression in patients who previously responded to chemotherapy is appropriate and is likely to prolong survival, provided their performance status and functional reserve are adequate to tolerate further treatment. In addition, the sequence of chemotherapy regimens did not appear to have a major impact on survival. Analysis is ongoing.

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