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M. Rajer



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    P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P2.01-023 - Intercalated Therapy with Gemcitabine, Cisplatin and Erlotinib May Be Superior to TKI Alone for Patients with Advanced EGFR Mutated NSCLC (ID 628)

      09:30 - 17:00  |  Author(s): M. Rajer

      • Abstract
      • Slides

      Background:
      The biological rationale for intercalated therapy in EGFR mutated NSCLC is to derive benefit both from cytotoxic and from targeted therapy, avoid their mutual antagonism, and prevent tumor repopulation during intervals of cytotoxic treatment. After a promising report from a single-arm trial of intercalated treatment (Zwitter et al, Radiol Oncol 2014;48:361), we here present a comparison to treatment with TKI alone on a similar population of patients.

      Methods:
      All patients were treatment-naive with metastatic EGFR mutated NSCLC, were in fair general condition and fulfilled the standard criteria for platin-based chemotherapy. Patients in the intercalated group joined a prospective clinical trial and signed informed consent. Treatment consisted of gemcitabine at 1250 mg/m2 on days 1 and 4, cisplatin at 75 mg/m2 on day 2 and erlotinib 150 mg on days 5 – 15 of a 3-weekly cycle for 4 to 6 cycles, followed by continuous erlotinib as maintenance. Due to reluctance of their physicians to join the intercalated trial, patients in the TKI alone group were treated with erlotinib or gefitinib as the standard treatment.

      Results:
      Regarding demographics and main prognostic factors, there was a slight disbalance in favor of the TKI alone group (Table). The intercalated trial recruited 38 patients. Treatment was well tolerated, with 6 cases of grade 4 toxicity. Complete or partial response was seen in 16 and 17 patients, respectively, for response rate of 87%. For 21 patients on TKI alone as standard treatment, precise evaluation of response was not feasible. Median time to progression was 24.3 months and 9.6 months (p < 0.05), and median survival was 34.9 and 25.8 months for the intercalated and TKI alone group, respectively.

      TKI alone 21 patients Intercalated schedule 38 patients
      Gender, Female/Male 13/8 21/17
      Age, median 63 61
      Age, range 42 – 70 37 – 74
      Performance status, 0 - 1 18 30
      Performance status, 2 – 3 3 8
      Brain metastases at diagnosis 5 13
      Figure 1



      Conclusion:
      In advanced EGFR mutated NSCLC, intercalated schedule appears superior to TKI alone. These observations should be confirmed in a randomized trial.

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