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M. Di Maio



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    MO24 - NSCLC - Chemotherapy III (ID 110)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO24.02 - Treatment decisions for elderly patients with advanced non-small cell lung cancer (NSCLC) in Italian clinical practice: results from the RIGHT-3 project by Italian Association of Medical Oncology (ID 3115)

      10:30 - 12:00  |  Author(s): M. Di Maio

      • Abstract
      • Presentation
      • Slides

      Background
      In 2004, the Italian Association of Medical Oncology (AIOM) created the RIGHT (Research for the identification of the most effective and highly accepted clinical guidelines for cancer treatment) program. The third step of the program, RIGHT3, aimed to evaluate the concordance between AIOM lung cancer guidelines and clinical practice in Italy. Description of treatment decisions for elderly patients with advanced non-small-cell lung cancer (NSCLC) was among the indicators. According to 2009 AIOM guidelines, single-agent chemotherapy with a third-generation agent was a reasonable choice for elderly patients with advanced NSCLC, whilst evidence about use of platinum-based treatment in the elderly population was judged potentially affected by selection bias and not conclusive.

      Methods
      RIGHT3 was a retrospective observational study conducted in a sample of 53 Italian lung cancer centers, representative of 230 AIOM centers. Patients with NSCLC diagnosis who had their first visit at the oncology center during 2010 and followed-up for at least 6 months were included. Proportion of elderly patients with stage IV disease receiving chemotherapy was among the 14 indicators evaluated.

      Results
      Overall, 306 pts with stage IV NSLSC were enrolled, and 299 were evaluable. Of these, 91 (30.4%) were older than 70. In the elderly subgroup, 81 pts (89%) were treated with first-line chemotherapy. In detail, a single-agent treatment was administered in 28 (34.6%) of cases, and a combination chemotherapy in the other 53 cases (65.4%). Among pts receiving platinum-containing doublets, carboplatin was more frequently used than cisplatin: carbo-gemcitabine (16 pts), carbo-pemetrexed (12 pts), cisplatin-pemetrexed (8 pts), cisplatin-gemcitabine (7 pts), carbo-vinorelbine (4 pts) were the 5 most frequently used regimens.Thirty pts (33%) received a second-line chemotherapy: single-agent in 23 cases, combination chemotherapy in 7 cases.

      Conclusion
      First-line platinum-based combination chemotherapy was commonly used in elderly patients with advanced NSCLC in 2010 by the Italian Lung cancer centers involved. First-line single-agent treatment, recommended by AIOM 2009 guidelines as the treatment choice with highest level of evidence, was used only in a minority of patients.

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    P1.10 - Poster Session 1 - Chemotherapy (ID 204)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.10-032 - Sensitivity and meta-regression analysis exploring potential outcomes predictors in randomized trials (RCTs) evaluating the benefit of 1st-line tyrosine kinase inhibitors (TKIs) for epidermal growth factor receptor (EGFR) mutant lung adenocarcinoma. (ID 1670)

      09:30 - 16:30  |  Author(s): M. Di Maio

      • Abstract

      Background
      Patients affected by lung adenocarcinoma carrying a EGFR sensitizing mutation of significantly benefit from TKIs in terms of progression free survival (PFS), activity and symptoms control. The potential predictive role of clinico-pathological predictors should be investigated in order to optimize the benefit of the currently available drugs.

      Methods
      A literature-based meta-regression and sensitivity analyses to investigate the differential effect of TKIs according to demographic and molecular factors, was accomplished, analyzing all RCTs exploring TKIs versus chemotherapy for 1[st]-line treatment of patients affected by EGFR mutant NSCLC.

      Results
      9 trials (3,741 patients) were identified (EGFR mutant: 1,797). 9 RCTs were evaluable for PFS (1,790 patients) and response (1,733 patients); 7/9 for survival (1,075 patients). With regard to PFS and response, a significant interaction according to ethnicity (Asian versus Caucasian versus mixed, p=0.006 [Cochrane-Q 10.275] and p=0.047 [6.129], respectively), and trial design (retrospective versus prospective EGFR analysis, p=0.024 [5.067] and p<0.0001 [13.633]), was found. No difference was observed in term of survival. A significant interaction for response was found, with an Odds Ratio in favour of afatinib, erlotinib and gefitinib (versus chemotherapy) of 2.70 (95% CI 2.11-3.45), 2.67 (95% CI 1.81-3.93) and 1.81 (95% CI 1.46-4.78).

      Interaction [Cochrane-Q] P value Interaction [Cochrane-Q] P value
      PFS Response
      Overall (ERL vs GEF vs AFA) [4.266] p=0.188 [9.924] p=0.007
      ERL vs AFA [3.321] p=0.068 [0.056] p=0.813
      ERL vs GEF [9.714] p=0.054 [5.169] p=0.023
      AFA vs GEF [0.002] p=0.962 [7.351] p=0.007

      Conclusion
      Although limited by the retrospective nature and the heterogeneity, these data indicate a differential effect of TKIs according to the design and the ethnicity, and in response according to TKIs. These data may constitute the background to develop a clinical predictive model to better estimate the expected benefit when using EGFR TKIs in patients with EGFR mutant NSCLC

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    P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.11-020 - Economic Analysis of TORCH: Erlotinib versus Cisplatin and Gemcitabine as First-Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) (ID 1645)

      09:30 - 16:30  |  Author(s): M. Di Maio

      • Abstract

      Background
      The TORCH (“Tarceva or Chemotherapy”) randomized phase III trial demonstrated that first-line erlotinib followed by second-line cisplatin-gemcitabine (N=380) compared to cisplatin/gemcitabine followed by erlotinib (N=380) in unselected advanced NSCLC patients yielded inferior survival, without major differences in first-line global quality of life. We determined the incremental costs and utility between arms, including in the EGFR mutation positive subgroup (N=39).

      Methods
      Direct medical resource utilization data and EQ5D scores were collected prospectively during the trial. Mean survival and quality-adjusted survival per arm were calculated for the entire study population and the subgroup with documented EGFR mutations. The analysis was conducted from the Canadian public health perspective, using a lifetime horizon. Costs for medications, outpatient visits, investigations and toxicity management including hospitalization were determined, and presented in 2012 Canadian dollars (CAD). The primary outcomes of the analysis included costs and outcomes per treatment arm, and the incremental cost per quality-adjusted life-year (QALY) gained in the EGFR mutation positive subgroup.

      Results
      The costs per patient in the chemotherapy were higher than in the erlotinib arm, with an incremental mean cost of $4,190 CAD. This was related to longer duration of chemotherapy treatment, associated with higher drug and outpatient visit costs. Higher costs from hospitalization and adverse event management were seen in the erlotinib arm, likely related to disease progression. Mean overall survival in the entire study population was longer in the chemotherapy arm , although mean quality-adjusted survival was similar (0.82 QALY in chemotherapy arm and 0.87 in erlotinib arm). In the EGFR mutation positive subgroup, mean survival was slightly higher in the chemotherapy arm, but quality-adjusted survival was longer in the erlotinib arm (1.19 QALYs versus 1.08 QALYs with chemotherapy). The incremental cost-effectiveness ratio for first-line erlotinib compared to chemotherapy in the EGFR mutation positive subgroup was $32,916 CAD per QALY.

      Conclusion
      While first-line platinum doublet chemotherapy remains the standard for unselected advanced NSCLC patients, first-line erlotinib appears to be cost effective in the EGFR mutation positive subgroup. This supports routine EGFR genotyping to select first-line therapy in advanced NSCLC, and targeted EGFR TKI therapy for those with EGFR mutation positive NSCLC.