Author of

• 11673

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  P2.09 - Poster Session 2 - Combined Modality (ID 213)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Combined Modality
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 11691

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    P2.09-018 - Incorporating erlotinib into induction chemotherapy followed by concurrent chemoradiation of unresectable stage III non-small cell lung cancer according to EGFR mutation status: preliminary result of a randomized phase II study (ID 3178)

    09:30 - 09:30  |  Author(s): K.H. Cho
    • Abstract

    Background
    EGFR tyrosine kinase inhibitors (TKIs) showed great survival benefit in the selected patients with stage IV non-small cell lung cancer (NSCLC) harboring TKI-sensitive EGFR mutations. Assuming that if the cases were properly selected, EGFR-TKIs would be integrated into treatment paradigms of stage III NSCLC as more effective systemic therapy, we designed this study to evaluate the efficacy and toxicity of erlotinib and chemotherapy in the combined-modality treatment of unresectable stage III NSCLC patients according to EGFR mutation status.

    Methods
    Patients over 18 years with unresectable stage IIIA (N2) or stage IIIB NSCLC, ECOG performance status 0–1, and adequate organ function are eligible. The mutational analysis of EGFR (exon 18–21) is performed using direct sequencing in tissue sample. EGFR mutation-positive patients initially receive 3 cycles of erlotinib and then are treated by concurrent chemoradiotherapy (CRT) with either erlotinib (Arm A) or irinotecan-cisplatin (IP) (Arm B). After CRT, patients in Arm A receive consolidation therapy with 6 cycles of erlotinib while those in Arm B are observed until progression. EGFR mutation-negative or unknown patients are treated either with 3 cycles of IP followed by CRT with IP (Arm C) or vice versa (Arm D). Erlotinib is given at 150mg daily with 3-week cycle. IP is given with cisplatin 30mg/m[2] (day 1 and 8) and irinotecan 60mg/m[2] (day 1 and 8) during radiotherapy (total 60 Gy/ 2.4 Gy/fr) or with cisplatin 30mg/m[2] (day 1 and 8) and irinotecan 65mg/m[2] (day 1 and 8) during induction or consolidation therapy with 3-week cycle. The primary endpoint is response rate (RR), toxicity, and survival estimation. Erlotinib and irinotecan were provided by Roche Korea and Pfizer, Inc., respectively

    Results
    From February 2008 to February 2013, 62 patients were screened and 50 patients were randomized into Arm A (n= 6), Arm B (n= 4), Arm C (n= 19), and Arm D (n= 21). The EGFR mutation status was positive in 10 (20.0%) patients, negative in 23 (46.0%), and unknown in 17 (34%). The median age was 65 years. The proportion of never smoker and adenocarcinoma histology was 80% (event/ total No. = 8/10) and 90% (9/10) in the EGFR mutation-positive group, 13% (3/23) and 48% (11/23) in the EGFR mutation-negative group, and 6% (1/17) and 18% (3/17) in the EGFR mutation-unknown group. The median follow-up time was 34.7 months (range, 3.8−53.8 months). The completion rate of planned treatment was 66.7% (4/6), 100% (4/4), 78.9% (15/19), and 76.2% (16/21) from Arm A to Arm D. For induction therapy, the RR to elrotinib of the EGFR mutation-positive group was 70.0% (7/10). Moreover, the subgroup harboring TKI-sensitive EGFR mutations (exon 19 deletion and exon 21 L858R mutations) showed the RR to erlotinib of 87.5% (7/8). The RR to IP induction therapy was 41.7% (5/12) in the EGFR mutation-negative group, 0% (0/4) in the EGFR mutation-unknown group, and thus 31.1% (5/16) in the EGFR mutation-negative or unknown patients.

    Conclusion
    The combined-modality treatment by molecular diagnostics was feasible in stage III NSCLC and accrual is ongoing.