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M. Zukin



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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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      P1.11-045 - Cost-Effectiveness of Carboplatin and Pemetrexed Versus Single Agent Pemetrexed in Patients with Advanced NSCLC and Performance Status of 2 (PS2) (ID 2993)

      09:30 - 09:30  |  Author(s): M. Zukin

      • Abstract

      Background
      Health care expenditures have increased dramatically over the past 20 years. Particularly in oncology new technologies may be accompanied by higher costs but a mild health gain. As part of decision-making process, not only effective, but economic value evidence is mandatory in many developed countries. We have recently shown that the combination of carboplatin and pemetrexed improves survival in a dedicated ECOG PS2 population when compared to pemetrexed alone (Zukin et al. J Clin Oncol 2013). Because combination chemotherapy tends to increase toxicity and costs, a cost-effective analysis was performed in that PS2 dedicated trial.

      Methods
      Clinical data and resource consumptions were obtained from the multicenter phase III randomized trial which tested carboplatin and pemetrexed vs. pemetrexed alone in 205 patients with advanced NSCLC and PS 2. Direct costs were estimated based on Brazilian public health care system. Life time was divided into stable disease stage, progression stage and death. Utilities for each stage were taken from the literature. One-way sensitivity analysis and non-parametric bootstrapping approach were performed to explore the uncertainties regarding the results.

      Results
      Combination chemotherapy demonstrated a gain in 0.22 life years (LY) and 0.15 quality-adjusted life year (QALY) compared to single therapy at an additional cost of $1,667.28 (in 2012 USD). The incremental cost-effectiveness ratio (ICER) was $7,436.79/LY and $10,949.88/QALY. Estimates of ICER were more sensitive to change by the influence of stable disease utility and pemetrexed cost. The probability of being cost-effective at a threshold of $36,000 (3 times Brazilian GDP per capita) per additional QALY was > 99%.

      Conclusion
      Adding carboplatin to pemetrexed therapy for advanced NSCLC patients with PS2 status is cost-effective when compared to pemetrexed alone. To the best of our knowledge this is the first report on cost-effectiveness in a dedicated NSCLC PS2 population. This finding adds up to the efficacy data favoring the combination arm and may support health care policies in that subpopulation. This analysis is particularly relevant for countries with limited health care resources.

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    P2.21 - Poster Session 2 - Diagnosis and Staging (ID 170)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Prevention & Epidemiology
    • Presentations: 1
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      P2.21-009 - Results of Epidermal Growth Factor Receptor (EGFR) Reflex Testing implementation in the Brazilian National Cancer Institute (INCA) (ID 3337)

      09:30 - 09:30  |  Author(s): M. Zukin

      • Abstract

      Background
      Patients with advanced lung cancer and EGFR mutations can derive significantly benefit by receiving first line EGFR tyrosine kinase inhibitor (TKI) therapy. Multiple trials have showed that clinical selection is not sufficient and that EGFR mutations test should be requested for all non-squamous patients. Moreover there is a suggestion that a lag time between diagnosis and molecular test could harm patients. In this retrospective trial we describe EGFR mutation analysis after the implementation of reflex testing in a cohort of Brazilian patients.

      Methods
      After May 2011 EGFR reflex testing was recommended for all stage IVA and IVB non-squamous lung cancer patients treated at INCA. EGFR exons 18, 19, 20 and 21 were examined using a commercially available Polymerase chain reaction and Sanger sequencing assay. We retrospectively reviewed clinical and EGFR tests characteristics from medical charts of all patients with available results.

      Results
      From May 2011 to May 2013 samples from 189 patients (56.2%) out of 336 were screened for EGFR mutations. Main reason for non-testing was insufficient material. Turn around time for EGFR mutation processing substantially improved over this period, from over three weeks to less than 5 working days. Of those patients tested 58.8% were women and 22% were non-smokers or light smokers. Results were obtained from cytological specimen in 33 cases (17.4%). Most patients had adenocarcinoma (95.2%) with only 6 cases (3.2%) of unspecified carcinoma. EGFR mutations were detected in 52 patients (27.5%). The incidence of mutations was higher in females (58.8%) and non-or light smokers (56%). Of the mutations identified 18 (34.6%) were in frame deletions in exon 19, and 8 (15.3%) were exon 21 L858R. Exon 18 G719A and exon 20 insertions were detected in only 1 (1.9%) and 2 (3.9%) cases respectively. We found a high incidence of atypical mutations (44.3%). All of them were single aminoacidic substitutions in exon 18 (7 cases; 30.5%), exon 19 (5 cases; 21.7%), exon 20 (5 cases; 21.7%), exon 21 (5 cases; 21.7%), and a single case of double mutation (exons 19 and 20). We did not detect any de novo T790M exon 20 mutation.

      Conclusion
      The results of the first 2 years of reflex molecular testing at a single Brazilian institution reported demonstrate the feasibility and potential for a non-clinical selective approach. This high frequency of atypical mutations must be further investigated since to date there are no published data regarding EGFR mutations in the Brazilian population.

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    P2.22 - Poster Session 2 - Epidemiology, Etiology (ID 167)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Prevention & Epidemiology
    • Presentations: 1
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      P2.22-013 - Evaluation of elderly patients with non-small-cell lung cancer in a private Cancer Center in Brazil. (ID 3298)

      09:30 - 09:30  |  Author(s): M. Zukin

      • Abstract

      Background
      At diagnosis approximately 25-40% of patients with non-small-cell lung cancer (NSCLC) are older 70 years. There is a scarcity of data on this elderly subpopulation. The aim of this study was to report clinical characteristics of this subpopulation, highlighting some challenges in their clinical management.

      Methods
      In this retrospective cohort, data from 631 patients with lung cancer diagnosed from 1995 to 2011 at a private Cancer Center in Brazil were analyzed.

      Results
      At diagnosis, 33% patients (n=214) were older than 70 years. Within this elderly group most patients (n=193; 90%) were classified as NSCLC and became the focus of our analysis. As expected, performance status (PS), staging and smoking were associated with survival (table1). Metastatic disease was present in 60% of this subpopulation, and most patients had good PS (PS0-1: 83%) and 84% were smokers. Additionally, 70% of this group with NSCLC had at least one comorbidity. The median overall survival time was 15 compared to 22 months for patients aged <70 years (p<0.001). In the metastatic group the majority of patients (62%) received only one cycle of chemotherapy (CT) and only 10% received more than 3 cycles. Of note, in patients with stage II and III adjuvant CT was correlated with survival (14 months vs 69 months in no adjuvant CT and adjuvant CT group respectively; p=0,02), although this therapy was administered in only 30% of patients with stage II and 20% of those with stage III. Figure 1

      Conclusion
      These data show that in this cohort elderly patients with NSCLC do constitute a special subpopulation with associated comorbidities. However, despite most of them had good PS at diagnosis, limited oncology treatment options were offered leading to suboptimal treatment. The fact that oncologists do not feel confortable to offer standard oncology treatment for this population may be due to the fact most of clinical trials exclude elderly patients. Although these data were generated in a private Cancer Center in Brazil we believe it mirrors the stiatuation across the country. These results highlight the urgent need for clinical trials focused on elderly patients, in order to provide a better care for those patients.

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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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      P3.11-039 - Exploration of patient health status as measured by the generic preference-based questionnaire EQ-5D alongside the START trial of tecemotide (L-BLP25) in non-small cell lung cancer (ID 2744)

      09:30 - 09:30  |  Author(s): M. Zukin

      • Abstract

      Background
      Tecemotide (L-BLP25) is a mucin 1 (MUC1) antigen-specific cancer immunotherapy investigated in patients not progressing after primary chemo-radiotherapy for stage III non-small cell lung cancer (NSCLC) in the phase III START study. The objective of this analysis was to explore patients’ health status alongside the study.

      Methods
      From January 2007 to November 2011, 1513 patients with unresectable stage III NSCLC that did not progress after chemo-radiotherapy (platinum-based chemotherapy and ≥50 Gy) were randomized (2:1; double-blind) to tecemotide (806 μg lipopeptide) or placebo SC weekly x 8 then Q6 weeks until disease progression or withdrawal. The analysis population (n=1239) was defined prospectively to account for a clinical hold of the study. The impact on patient health status was assessed as an exploratory endpoint using the EuroQoL 5 Dimensions (EQ-5D), a widely used generic preference-based questionnaire covering 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). EQ-5D index score can be calculated for which perfect health is given a value of 1 and death a value of 0. EQ-5D was collected at baseline, weeks 2, 5 and 8 and then every 6 weeks until end of treatment (EOT) visit (i.e. at time of disease progression), the EOT visit and every 12 weeks afterwards. Analysis of covariance (ANCOVA) was carried out to explore the change of EQ-5D index score over time in the overall population for patients on treatment. The change of EQ-5D to EOT visit was also estimated. Change of EQ-5D index score was explored using all data (i.e. collected both before and after EOT visit) using a linear growth curve model, with random intercept and slope, considering time as a continuous variable.

      Results
      EQ-5D compliance rates (percentage of patients still in the study who completed the questionnaire) were consistently above 85% for all visits of the treatment period in both treatment arms. Mean baseline EQ-5D score was 0.79 (sd=0.19) for both tecemotide and placebo arms. The results from ANCOVA on the overall population did not show any significant difference between the two arms during the treatment phase. Change in the EQ-5D index score from baseline to EOT visit was –0.102 (95%CI: –0.134, –0.071) for tecemotide and –0.136 (95%CI: –0.177, –0.095) for placebo. The linear growth model including the EQ-5D assessments before and after EOT showed that the EQ-5D index score decreased significantly over time in both treatment arms, but that the decrease was slightly slower in the tecemotide than in the placebo arm: –0.0076 per month in tecemotide patients vs. –0.01 in placebo (p=0.0498).

      Conclusion
      During treatment, there was no statistical difference in health status with tecemotide vs. placebo. This supports the good tolerability profile of tecemotide, with a lack of significant toxicity as compared to placebo. Disease progression was associated with a notable deterioration of patient health status, regardless of the treatment. Considering data from both before and after disease progression, patients’ health status appeared to worsen slightly over time, at a slower rate for patients treated with tecemotide.