Author of

• 10720

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  P1.09 - Poster Session 1 - Combined Modality (ID 212)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Combined Modality
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10742

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    P1.09-022 - A Multicenter, Randomized, Open-label, Phase II Trial of Erlotinibversus Etoposideplus Cisplatinwith Concurrent Radiotherapy in UnresectableStage III Non-smallCell Lung Cancer (NSCLC) with Activating Mutation of Epidermal Growth Factor Receptor (EGFR) in Exon 19 or 21(RECEL, ML28545, NCT01714908) (ID 1553)

    09:30 - 09:30  |  Author(s): S. Ma
    • Abstract

    Background
    The standard treatment for unresectable stage IIIA/IIIB NSCLC patients with good PS is concurrent chemo-radiotherapy. However, local tumor control remains suboptimal and distant metastases remain the major failure. Moreover, the treatment related toxicities limit application. EGFR-targeting agents including tyrosine kinase inhibitor (TKI)such as erlotinibwere demonstrated to sensitize tumor cells to radiation by a variety of mechanisms in preclinical studies. Subsequently, Phase I/II studies forcombination of TKI with radiotherapy in different cancer types have been conducted. Based on those findings, the RECEL study is comparing efficacy and tolerability of erlotinib versus etoposide plus cisplatin with concurrent radiotherapy in unresectablestage III NSCLC with activating mutation of epidermal growth factor receptor (EGFR) in exon 19 or 21.

    Methods
    The study was designed as a prospective, open-labeled, randomized, multicenter phase II clinical trial.Patients aged between 18 and 75 with ECOG PS 0–1IIIA/IIIB NSCLCconfirmed by histopathology or cytology and clinically unresectablewith activating mutation ofEGFR in exon 19 (loss) or 21 (L858R point mutation)will be enrolled (n=100). The enrolled patientswould be randomly assigned (1:1) into two arms: erlotinibarm(erlotinib 150mg/day taken orally for up to 2 years which begin on day 1 of radiation) or EP chemotherapy arm(etoposide50mg/m[2]I.V. on days 1-5 and days29-33,cisplatin50mg/m[2]I.V. after etoposideon days 1,8,29,36. 28-day schedule for 2 cycleswhich begin on day 1 of radiation).Concurrent radiotherapy in both arms is prescribed at 200cGy/day, 5 days/week for a total of 30-33 fractions, total dose of 6000-6600cGy. Duration of the recruitment will be 36 months. Patients will receive long-term follow-up including chest and upper-abdominal CT scan every 3months, brain MRI every 6 months and bone scan every 12 months. Primary endpoint is progress free survival (PFS). Secondary endpoints areobjective response rate(ORR), local control rate (LCR), overall survival (OS), quality of life (QoL) and safety.Biomarker profile will be the exploratory research.

    Results
    Till June 2013, 24 patients were screened for EGFR mutation, and 4patient has been enrolled.

    Conclusion
    Concurrent erlotinib with radiation therapy might be a promising treatment strategy.