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A. Lau



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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 - 09:30  |  Author(s): A. Lau

      • 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.

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    P3.11 - Poster Session 3 - NSCLC Novel Therapies (ID 211)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.11-049 - Afatinib in advanced pretreated NSCLC - a Canadian experience (ID 3460)

      09:30 - 09:30  |  Author(s): A. Lau

      • Abstract

      Background
      Afatinib is an oral, irreversible pan-EGFR inhibitor with demonstrated superiority over first-line chemotherapy in advanced EGFR mutation positive NSCLC. It is also active after failure of chemotherapy and reversible EGFR tyrosine kinase inhibitor (TKI) therapy, with higher response rate and better progression-free survival than placebo (LUX-Lung 1, Miller et al. Lancet Oncol. 2012). Through a national special access program (SAP), Canadian patients with advanced NSCLC, similar to those in the LUX-Lung 1 trial, may access afatinib after exhausting all other available therapies. We report our Canadian experience with afatinib at the two largest centres participating in the SAP.

      Methods
      Retrospective chart review of SAP participants was undertaken at 2 major Canadian cancer centres, the British Columbia Cancer Agency (Vancouver) and Princess Margaret Cancer Centre (Toronto). Demographic, disease and treatment data were abstracted, including toxicity, response (clinically documented tumour reduction), treatment duration and overall survival.

      Results
      From July 2010 to the present, 54 patients at the two sites were treated with afatinib through the SAP. Median age was 59.5 (range 37 to 88 years), 57% were female, 52% were never smokers (7% current, 35% former smokers), 67% had adenocarcinoma histology and 28% were East Asian. 26% had known EGFR mutations (7% wild type, 67% unknown), most commonly exon 19 deletions. Patients received a median of 3 previous therapies (range 2 to 5). All had received prior EGFR TKI therapy (81% erlotinib, 11% gefitinib, 6% both, 2% dacomitinib). Half (47%) had a response to prior EGFR TKI therapy, and 37% experienced grade ≥2 rash and 9% grade ≥2 diarrhea on prior EGFR TKI. The median time from metastatic diagnosis to starting afatinib was 23.1 months. The median treatment duration was 2 months (range 0 – 26). 21% of patients had a response (tumour reduction) to afatinib, 20% stable disease and 50% disease progression as their best response. Median survival from the time of afatinib start was 5 months (95% CI: 2-12 months). The average starting dose of afatinib was 40 mg (6% 50 mg, 94% 40 mg), with 11% requiring dose reduction. One third of patients (34%) stopped treatment for disease progression, 17% for toxicity, 30% for clinical deterioration and 19% for other or unknown reasons. The rate of grade ≥2 diarrhea, rash, paronychia, or stomatitis with afatinib was 17%, 20%, 9%, and 9% respectively (grade ≥3 in 10%, 11%, 5% and 5%). Response (non-RECIST) to afatinib was seen in EGFR wild type (2/4) and mutation positive (3/13) patients. Response to erlotinib or gefitinib was non-significantly associated with response to afatinib (OR 3.3, p=0.22). A similar non-significant association was seen with rash (OR 1.7, p=0.22), but not with diarrhea, (OR 0.37, p=0.45).

      Conclusion
      Afatinib demonstrates activity in clinical practice similar to that reported in LUX-Lung 1. While some required dose reduction, toxicity from afatinib appeared manageable for the majority. Although not significant, there was a propensity to experience response or rash on afatinib if seen with prior EGFR TKI, although this was not seen with diarrhea.