Author of

• 10720

  +

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

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Combined Modality
  • Presentations: 2
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10732

    +

    P1.09-012 - Pemetrexed as first-line treatment in combination with early radiotherapy in advanced non-squamous non-small cell lung cancer: a retrospective analysis (ID 1427)

    09:30 - 09:30  |  Author(s): X. Fu
    • Abstract

    Background
    Pemetrexed plus platinum recommended as first-line treatment for patients with advanced non-squamous non-small cell lung cancer (NSCLC) were more effective in East Asian patients. Few studies have evaluated the role of radiotherapy in combination with pemetrexed in advanced NSCLC. We hypothesized that pemetrexed plus platinum at full dose in combination with early radiotherapy can improve the clinical efficacy in advanced NSCLC, especially for selected patients.

    Methods
    Patients of stage IIIB or IV non-squamous NSCLC with unknown epidermal growth factor receptor (EGFR) mutation status were treated with pemetrexed plus platinum at full dose as first-line chemotherapy. All patients underwent concomitant chemoradiotherapy for primary cancer with or without radiotherapy for metastases. No patients had maintenance therapy with TKI after chemotherapy.

    Results
    Figure 1From January 2009 to July 2012, 43 patients were included, 21 of which were stage IIIB diseases (19 with stage N3- IIIB). In the 22 patients with stage IV disease, 17 had oligometastases (≤5) and 5 had polymetastases. The median chemotherapy cycles was 4.27 patients (62.8%) received ≥ 4 cycles of chemotherapy and 16 patients (37.2%) received <4 cycles. 36 patients (83.7%) received radical dose radiotherapy (≥60 Gy) and 7 patients (16.3%) received palliative dose to primary tumor. The median radiation dose was 60Gy. The median follow-up time of survival patients was 17.0months (range, 5.8 to 45.2 months). The median progression free survival (PFS) was 12 months. 12-, 18- and 24-months PFS rate were 50.4% （95%CI, 35.3-65.5%）, 25.1% (95%CI, 21-39.2%) and 21.5% (95%CI, 7.8-35.2%), respectively. 12-, 18- and 24-months overall survival (OS) rate were 90.1% (95%CI, 75.8-96.2%), 72.2% (95%CI, 54.2-84.1%) and 65.7% (95%CI, 44.3-80.5%), respectively. The median OS was not reached. Toxicities were better tolerated except one death of radiation-induced pneumonitis.

    Conclusion
    Pemetrexed plus platinum as first-line treatment in combination with early radiotherapy had encouraging short term efficacy with acceptable toxicity in selected patients with advanced NSCLC. Although the long-term efficacy needs further observation, the result showed potential advantage of early radiotherapy in Asian patients with advanced non-squamous NSCLC, especially stage IV.

  • 10742

    +

    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): X. Fu
    • 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.