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Giuseppe Bronte



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    EP1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 206)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.16-04 - Real World Clinical Outcomes for Metastatic Non-Small Cell Lung Cancer (mNSCLC) at IRST Italy (Now Available) (ID 2307)

      08:00 - 18:00  |  Author(s): Giuseppe Bronte

      • Abstract
      • Slides

      Background

      This study sought to evaluate the real word clinical outcomes concerning overall survival (OS) for patients in first-line treatment for metastatic non-small cell lung cancer (mNSCLC) prior to the availability of immunotherapies in any line.

      Method

      Patients who received systemic anti-cancer treatment for mNSCLC at IRST between Jan2014-Jun2017 with a minimum follow-up of six months were included. The clinical dataset was obtained from data registered in electronic health records maintained during clinical practice. OS was defined as the interval from start of first-line therapy until death or follow-up end, whichever occurred first. Death information was detected from mortality register. OS was estimated using the Kaplan-Meier method stratified by type of first-line treatment.

      Result

      Among the 428 first-line patients analyzed, 64.5% were over 65 years old and 62.6% were men (Table 1). A total of 79.0% patients had non-squamous histology whereas 15.0% had squamous histology, with the remaining 6% other histologies. EGFR mutation was detected in 15.7% and ALK translocation in 8.4% of patients. In the first-line the majority (57.0%) of patients received platinum-doublet (mainly platinum+pemetrexed) while single agent chemotherapy was administered in 23.8%, whereas 10.0% received targeted therapy. Conversely overall 9.0% were enrolled in clinical trials, while 0.2% received Immunotherapies. Median OS was 19.9 months (95%CI:9.2-21.7) with targeted therapy, 8.5 months (95%CI:4.8-13.6) for patients enrolled in clinical trials, 6.4 months (95%CI:5.8-7.6) with platinum-doublet and 4.4 months (95%CI:3.7-5.7) with single agent chemotherapy. A total of 34.5% of first-line patients continued to receive second-line treatment.

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      Conclusion

      In this analysis prior to the introduction of immunotherapies for NSCLC, OS was similar to real world OS in the published literature. The survival was worse in the single agent chemotherapy group while it is superior in platinum doublets group. Overall survival was longest in patients treated with targeted therapy.

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    P1.14 - Targeted Therapy (ID 182)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Targeted Therapy
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.14-05 - TP53 Exon 8 Mutation and Prognosis in EGFR-Mutated NSCLC Patients Treated with First-And-Second-Generation TKIs (ID 457)

      09:45 - 18:00  |  Author(s): Giuseppe Bronte

      • Abstract
      • Slides

      Background

      TP53 mutation seems to be associated with a worse prognosis in epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC) treated with first generation tyrosine kinase inhibitors (TKIs). We previously showed that this was mainly significant for exon 8 TP53 mutations (Canale M et al, Clin Cancer Res 2017). However, its role on survival, as well as in relation to response to second generation TKIs is not clearly established.

      Method

      A retrospective cohort of 270 EGFR-mutated NSCLC treated with first- (gefitinib and erlotinib) and second- (afatinib) generation TKIs, in the first line setting, were considered. TP53 status was evaluated by Sanger Sequencing or Next generation Sequencing. The different mutations were evaluated in relation to disease control rate (DCR), objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).

      Result

      One hundred and forty-four patients (53.3%) received a treatment with gefitinib, 84 (31.1%) with erlotinib and 42 (15.7%) with afatinib. In the overall cohort, ORR and DCR were 61.5% and 86.4%, respectively, with about 50% of patients responsive for more than 10 months. Median PFS and OS were of 11.08 (95% CI 9.3-12.6) and 22.9 (95% CI 20.4-27.5) months, respectively. Overall, 79 (30.7%) patients showed a TP53 mutation. The presence of TP53 exon 8 mutation was associated with a worse outcome with respect to patients wt or with other TP53 mutations. In particular, a lower ORR and DCR were observed for patients with TP53 exon 8 mutation (ORR 94.16% vs 5.84%, p=0.05, and DCR 94.04% vs 5.96%, p<0.001, respectively), together with a worse PFS (HR 1.88 [95% CI 1.20-2.96], p=0.006). These results was even more significant in the subgroup of patients with EGFR exon 19 deletion, where TP53 exon 8 mutation was associated with both worse PFS (HR 4,72 [95% CI 2.31-9.65], p<0,001) and OS (HR 2.60 [95% CI 1.11-6.04], p=0.027).

      At the multivariable analysis, EGFR exon 19 deletion and TP53 exon 8 mutation remained independently associated with PFS (HR 0.56 [95% CI 0.35-0.89], p=0.014 and HR 1.81 [95% CI 1.13-2.88], p=0.013, respectively). Moreover, EGFR exon 19 deletion and age resulted independently associated with OS (HR 0.52 [95% CI 0.26-1.03], p=0.059, and HR 1.02 [95% CI 1.01-1.04], p=0.009, respectively). No other patient and clinical covariate showed an association with PFS and OS in the multivariable models.

      Conclusion

      Our results confirm that TP53 exon 8 mutation confers a worse outcome in patients treated with first and second generation TKIs and that this is particularly evident in patients with EGFR exon 19 deletion.

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