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Gianluca Spitaleri



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    Lunch & Poster Display session (ID 58)

    • Event: ELCC 2019
    • Type: Poster Display session
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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      144P - Clinical and treatment features associated with improved 5-year survival rate in ALK-positive lung cancer treated with ALK-TKIs (ID 329)

      12:30 - 13:00  |  Author(s): Gianluca Spitaleri

      • Abstract
      • Slides

      Background

      ALK rearrangement predicts for prolonged survival in pts with metastatic NSCLC treated with ALK TKIs. Long-term survival, however, remains undefined in a real-world population. The objective of this study was to determine the 5-years survival in these patients and identify clinical factors associated with OS improvement.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Pts with ALK-rearranged metastatic NSCLC who had been treated with ALK TKIs at European Institute of Oncology between 2013 and 2018 were retrospectively reviewed and analyzed for efficacy outcomes.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      Among 105 pts, mPFS and mOS were 13.6 mos (95% CI: 9.8 – 17.3) and 40.4 mos (95% CI: 33.6 – 47.1), respectively. 5-year survival rate was 21%, and more than half of overall pts population (51.4%) were treated with different ALKis for more than 3 yrs. The 55.2%, 42.8% and 2% of pts received one, two or three TKIs, respectively. In 99 pts, crizotinib was the first ALKi used with a mPFS of 13.6 (9.8 - 17.3) mos. Univariate analysis showed a positive correlation between mOS and age (< vs ≥ 65 yrs) (42.9 vs 36.3 mos; HR = 0.58, 95% CI: 0.34 – 0.98, p = 0.042), ECOG PS 0/1 vs 2 (44.4 vs 18.4 mos; HR = 0.23, 95% CI: 0.12 – 0.44, p < 0.001) and absence of baseline brain metastases (44.5 vs 22.9 mos; HR = 0.59, 95% CI: 0.35 – 0.97, p = 0.04). Multivariate analysis, adjusted for age, sex, smoking status and ECOG PS, showed that over young age (< 65) and good ECOG PS (0/1), the number of the metastatic sites (< 3 vs ≥ 3) (54.1 vs 36.3 mos; HR = 0.58, 95% CI: 0.34 – 0.98, p = 0.045) and the use of RT for oligoprogression/palliative management (48.4 vs 36.3 mos; HR = 0.58, 95% CI: 0.35 – 0.95, p = 0.033) were significantly associated with prolonged OS. Median IC-PFS was 40 (23.6 – 56.3) mos. Pts without baseline brain metastases reported a significantly longer IC-PFS (55.0 vs 17.3 mos, IC95% HR 0.51, p = 0.029).

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      In this broad real-world population, the clinical benefit was consistent with a 5-year survival of 21%. The absence of brain metastases, the use of palliative RT and the tumour burden resulted as independent positive prognostic factors associated with a statistically significant improvement of prolonged survival. Based on these findings, clinicians can gain an enhanced estimation of long-term outcomes in this population.

      b651e8a99c4375feb982b7c2cad376e9 Legal entity responsible for the study

      The authors.

      213f68309caaa4ccc14d5f99789640ad Funding

      Has not received any funding.

      682889d0a1d3b50267a69346a750433d Disclosure

      All authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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      152P - Correlation among different KRAS alterations, genetic co-mutations and PD-L1 expression in patients treated with immunotherapy in metastatic NSCLC (ID 365)

      12:30 - 13:00  |  Author(s): Gianluca Spitaleri

      • Abstract
      • Slides

      Background

      No molecularly driven strategy against KRAS demonstrated convincing activity in clinical trials. The introduction of immune checkpoints inhibitors (IO) represents a paradigm shift in treatment of NSCLC without gene target. Considering the association with smoke, the high mutational burden, the high PDL1 expression and the abundance of T-cell infiltrating lymphocyte, KRAS mutant tumors have been considered an attractive target for IO.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Patients (pts) with stage IV NSCLC harboring KRAS mutation treated with IO in our Institution between 2016 and 2018 were retrospectively identified by electronic medical record review. All pts provided written informed consent for the collection of clinical, demographic and molecular data.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      A total number of 328 consecutive pts with KRAS mutant NSCLC were identified, of them 32 received IO. All eligible pts had PDL1 testing and in 21 cases (65.6%) NGS was available. Median age was 63 (range 44-78). Male/female were 17/15. Most pts had an adequate ECOG PS (0/1 18.7%/65.6% respectively). 29 pts (90.6%) were smokers. According to the setting, 10 pts were treated in 1st-line, 9 in 2nd-line and 13 in further lines. Between the 9 subtypes of KRAS mutation identified in our cohort, G12C was the commonest (14, 43.8%). 15 pts (46.9%) had PDL1≥50%, 10 (31.2%) had PD-L1 between 1-49%, and 7 (21.9%) were negative. 8 pts (25%) had co-occurring gene mutations. With a median follow-up of 5.1 mos (0.4-28.6), the mPFS and mOS for ITT population were 4.47 (95% CI 2.5-6.4) and 7.73 (95% CI 6-14.5) mos.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      Our preliminary results, contrary to findings in other oncogene driven NSCLC, showed that the presence of KRAS mutations seems to be irrelevant for the selection of patients for IO. Furthermore, neither the association of co-mutation (found in the 25% of cases) nor the type of KRAS variant or the treatment setting (1st vs further lines) seems to have an impact on the effectiveness of IO in KRAS NSCLC pts. Data about clinical efficacy according to PD-L1 expression will be presented at the meeting.

      b651e8a99c4375feb982b7c2cad376e9 Legal entity responsible for the study

      The authors.

      213f68309caaa4ccc14d5f99789640ad Funding

      Has not received any funding.

      682889d0a1d3b50267a69346a750433d Disclosure

      All authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.