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L. Bonanno



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    Poster Display Session (ID 63)

    • Event: ELCC 2017
    • Type: Poster Display Session
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1
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      104P - Efficacy of ceritinib in a "real-world" population of crizotinib-refractory ALK-positive NSCLCs: Results of the Italian compassionate use program (ID 422)

      12:30 - 13:00  |  Author(s): L. Bonanno

      • Abstract

      Background:
      Ceritinib has been approved by EMA for the treatment of patients (pts) with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who progress on crizotinib. Nevertheless, this drug is not reimbursed in Italy by the National Health Care System as of January 2017. The aim of this study was to assess the efficacy of ceritinib administered within a compassionate use (CU) program made available to crizotinib-refractory patients.

      Methods:
      This collaborative study involved multiple institutions in Italy. Clinical data from crizotinib-refractory pts with ALK-positive NSCLC who were requested ceritinib compassionate use (CU) were collected and analyzed.

      Results:
      Twenty-four centres took part to the study, for a total of 70 pts who were requested ceritinib CU. Of these, 63 pts received at least one dose of ceritinib 750 mg/d from July 2014 to January 2017. Pts characteristics were as follows: median age 56 years (22-86), 34/63 (54%) female, 43/63 (68%) never smokers, 12/63 (19%) ECOG PS ≥ 2, 13/63 (21%) pretreated with ≥ 2 lines of chemotherapy, 49/63 (78%) metastatic to the brain. Median time on prior crizotinib was 370 days (51-1644). The most common any grade treatment-related adverse events (TRAEs) were nausea (60%, 6% grade 3 or 4), vomiting (49%, 5% grade 3 or 4), diarrhea (51% 2% grade 3 or 4), ALT elevation (48%, 17% grade 3 or 4), AST elevation (49%, 17% grade 3 or 4), and fatigue (59%, 8% grade 3 or 4). Dose reduction due to TRAEs occurred in 31/63 pts (49%). Out of 31 pts, 15 pts (49%) reduced the dose to 600 mg/d, 10 pts (32%) to 450 mg/d, and 6 pts (19%) to 300 mg/d. Unusual TRAEs consisted of an increase in serum creatinine in 3 pts. Of the 55 patients who were evaluable for response, 21 pts (38%) responded to treatment. Overall, at a median follow-up of 6.2 months (0.5-26), median progression-free survival (PFS) was 7.6 months and 6-month PFS was 59%.

      Conclusions:
      The ceritinib CU program in Italy confirms the efficacy of the drug in a "real-world" setting, with a safety profile that is similar to that observed in clinical trials. A high rate of dose adjustments due to TRAEs was observed, which, however, did not appear to influence the activity of the drug.

      Clinical trial identification:
      NA

      Legal entity responsible for the study:
      N/A

      Funding:
      Associazione Italiana per la Ricerca contro il Cancro

      Disclosure:
      All authors have declared no conflicts of interest.

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      166P - Thymoma and thymic carcinoma: A real-life retrospective analysis (ID 472)

      12:30 - 13:00  |  Author(s): L. Bonanno

      • Abstract

      Background:
      Thymic epithelial tumors (TETs) include thymoma and thymic carcinoma, a group of rare and heterogeneous thoracic cancers. The management is primarily surgical, but pre- and post-operatory chemotherapy and radiotherapy are to be evaluated. Recurrences after surgery occur in 10-15% of resected tumors.

      Methods:
      We retrospectively collected TETs consecutively treated at our center between 2005 to 2016 and analyzed clinical and pathological features, response to treatment and patterns of relapse. Patients with uncomplete records or with less than 12-month follow-up were excluded from survival analysis.

      Results:
      Study population included 57 TETs. Median age was 55 years, male: female ratio was 1:1, all were ECOG PS 0-1 at diagnosis. Histologic subtype A to B1 thymoma was 21%, B2-B3 47.4%, thymic carcinoma 21%, others 11%. Paraneoplastic syndromes were present at diagnosis in 1/3 of the cases (85% myasthenia gravis), mainly less differentiated histologies (85% B2 thymoma or higher). C-kit immunohistochemistry has been evaluated only in 30 cases, 1/3 resulting positive, 80% associated to thymic carcinoma. 50 cases were included in survival analysis: median follow up was 52 months (m) (95%CI: 30-74m), median overall survival (OS) has not been reached (121m- NA) and was not affected by recurrences (p: 0.34). Treatments and relapse patterns are summarized in table. 66% of patients developed disease relapse (51% pleura) regardless of histology and radical surgery, median time to first relapse was 30 m (95% CI: 6-54m), median OSr (OS from first relapse) was not reached (47m-NA) and was significantly worse for thymic carcinomas (p: <0.0001); OSr was not affected by treatment type, number or site of relapse; the only variable able to affect time to relapse was histology: ῃ[2] 0.27.rnTable: 166PTreatment and relapse patterns in TETs [s: surgery; rt: radiotherapy; c: combined; r: relapse]rn

      rnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrn
      rnLocal treatment (s: rt: c)Systemic treatmentSystemic+ Local (s: rt: c)Best supportive care
      1[st] diagnosis (N:57)27 (12: 0: 15)327 (8: 4: 15)0
      1[st] r (N:33)14 (5: 2: 7)106 (1: 2: 3)3
      2[nd] r (N:17)9 (6: 1: 2)53 (1:1: 1)0
      3[rd] r (N:9)1 (1: 0: 0)51 (0: 0: 1)2
      4[th] r(N:4)1 (0: 0: 1)11 (0: 0: 1)1
      TOT5224386
      rn

      Conclusions:
      Real-life management of TETs include multidisciplinary evaluation, which is essential also at relapse to integrate local and systemic treatment.

      Clinical trial identification:


      Legal entity responsible for the study:
      Istituto Oncologico Veneto

      Funding:
      Istituto Oncologico Veneto

      Disclosure:
      All authors have declared no conflicts of interest.