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

  • 10736

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    P1.09-016 - A single arm, multi-center, phase II study of intercalated erlotinib with gemcitabine/cisplatin as neoadjuvant treatment in stage IIIA non-small cell lung cancer (CTONG 1101, NCT01297101): preliminary result (ID 2041)

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

    Background
    The optimal treatment for stage IIIA non-small cell lung cancer (NSCLC) disease is not well established with only 15% of 5-year survival rate, probably due toalready micro-metastatic lesion at the diagnosis. Thus, neoadjuvant therapy might be a good choice for IIIA NSCLC patients. The treatment modality of EGFR (TKI) intercalated with chemotherapy has been demonstrated to significantly improve objective response rate (ORR), progression free survival(PFS) and overall survival (OS) in advanced NSCLC patients with or without activating EGFR mutations. The objective of this study is to assess the efficacy and safety profile of intercalated erlotinib with gemcitabine/cisplatin as neoadjuvant treatment in stage IIIA NSCLC.

    Methods
    This is a single arm, multi-center, clinical phase II trial. Patients with untreated stage IIIA bulky N2 NSCLC and ECOG PS 0/1 were enrolled to received up to 2 cycles of gemcitabine 1,000 mg/m[2] on days 1 and 8 and cisplatin 75 mg/m[2] on day 1 or carboplatin AUC=5 d1, followed by oral erlotinib (150 mg, once a day) on days 15 to 28 as neoadjuvant therapy. A repeat computed tomography (CT) scan evaluated the response after induction therapy and eligible patients would undergo surgical resection. The primary endpoint was ORR, and secondary endpoints included pCR, resection rate, DFS (disease free survival) and OS , safety, QoL and biomarker analyses. Subgroup analysis of ORR by EGFR mutation status was also performed

    Results
    Between March 2011 and December 2012, a total of 39 patients were enrolled in the study, in which 36 patients (92.3% ITT population) have completed 2-cycle neoadjuvant treatment. According to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, 18 patients achieved partial response (PR) (ORR=46.2%) and 18 patients achieved stable disease (SD) (DCR=92.3%); 22(56.4%) patients underwent resection with 18 R0 (46.2%), 2 R1(5.1%),1 R2(2.6%),1 NE(2.6%). Fifteen patients have had EGFR mutation test, with 7 EGFR mutation and 8 EGFR wild type. ORR in patients with EGFR mutations and wild type was 85.7%(6/7) vs. 50%(4/8), respectively. Common toxicities included myelosuppression (38.5%), rash (28.2%), neutropenia (5.1%), alanine transaminase (ALT) elevation(5.1%), diarrhea(5.1%) , fatigue(2.6%) and alopecia(2.7%) . Five (12.8%) patients suffered from CTCAE ≥3. No CTCAE ≥4 complications were recorded perioperatively.

    Conclusion
    Two cycles of intercalated administered gemcitabine/cisplatin with erlotinib as an induction treatment is a feasible and efficacious approach for stage IIIA NSCLC, which provides evidence for the further investigation.