Author of

• 12592

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  P3.10 - Poster Session 3 - Chemotherapy (ID 210)

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

  • 12615

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    P3.10-023 - Phase II study of Pemetrexed + Carboplatin as first line therapy for advanced non-squamous non-small cell lung cancer without EGFR Mutation. : CENTRAL JAPAN LUNG STUDY GROUP (CJLSG) 0906 TRIAL (ID 1511)

    09:30 - 09:30  |  Author(s): Y. Yukita
    • Abstract

    Background
    In advanced non-squamous non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) status is important to determine the treatment. However, many previous studies of NSCLC were investigated regardless of EGFR mutation status. Therefore, we thought that the trial only for EGFR wild-type (WT) patients (pts) is required. We evaluated the efficacy and safety of combination therapy with pemetrexed (Pem) and carboplatin (Cb) for advanced non-squamous NSCLC EGFR-WT pts.

    Methods
    This study was multicenter, phase II trial. We recruited non-Sq NSCLC patients without EGFR mutation. Eligibility criteria were as follows; stage IIIB or IV, or recurrent disease after surgery (rec), no prior chemotherapy, age 20 to 74, ECOG PS: 0-1, and adequate organ function. We evaluated the efficacy and safety of Pem 500mg/m2 and Cb AUC 6 on day1, every 3 weeks, for 3 to 6 cycles. The primary endpoint was response rate (RR) and secondary endpoints were safety and disease control rate (DCR). We planned the sample size was 48 patients and recruited 54 pts. (Unique trial Number; UMIN000003393)

    Results
    From March 2009 to February 2012, 54 pts were enrolled from 18 centers. Of 53 evaluable for analysis, the median age was 65 years (range, 45–73); 41/12 males/females; 6/44/3 with IIIB/IV/rec; 47/3/3 with adenocarcinoma/large cell carcinoma/NSCLC. The median number of cycles was 4 (range, 1–6). There were 19 partial responses with an RR of 35.8% (95% CI, 23.6–51.0%). SD was observed in 20 pts and DCR was 73.6%. Median PFS was 5.2 months and median OS was 12.months. Major adverse event was grade 3–4 neutropenia in 19 pts (35.8%), anemia in 16 pts (30.2%), thrombocytopenia in 17 pts (32.1%). There was no treatment-related death.

    Conclusion
    Combination chemotherapy with Pem and Cb showed efficacious and well tolerated in advanced non-Sq NSCLC without EGFR mutation. This combination could include one of the options in standard regimen for 1[st] line therapy for advanced non-Sq NSCLC.