Author of

• 25921

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  P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

  • Event: WCLC 2018
  • Type: Poster Viewing in the Exhibit Hall
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall

  • 26256

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    P1.01-25 - Carboplatin and Pemetrexed Plus Bevacizumab After Failure of First-Line EGFR-TKI Therapy for NSCLC Harboring EGFR Mutation (CJLSG 0908) (ID 12798)

    16:45 - 18:00  |  Author(s): Tomoki Kimura
    • Abstract
    • Slides

    Background
    

    Epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) is a standard treatment for untreated, advanced non-small cell lung cancer (NSCLC) harboring an activating EGFR mutation. Many patients who had disease progression after EGFR-TKI are treated with chemotherapy including a platinum agent, but optimal regimen has not been established. This study was designed to evaluate the efficacy and safety of combination therapy with pemetrexed, carboplatin and bevacizumab after the failure of EGFR-TKI treatment.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    This study was a multicenter, phase II trial. Patients who experienced disease progression after first-line EGFR-TKI treatment for stage IIIB/IV or recurrent non-squamous NSCLC patients with an activating EGFR mutation (exon 19 deletions or exon 21 L858R point mutation) were eligible. Patients were treated with pemetrexed (500 mg/m²), carboplatin (AUC=5), and bevacizumab (15 mg/kg) intravenously on day 1 every 3 weeks. After 4 cycles, patients who had achieved disease control received a maintenance therapy with pemetrexed and bevacizumab every 3 weeks until disease progression or unacceptable toxicity. Response was evaluated by CT scans after every 2 cycles, and toxicity was assessed. Primary endpoint was response rate. Secondary endpoint included disease control rate, progression-free survival, overall survival, and safety.

    4c3880bb027f159e801041b1021e88e8 Result
    

    Twenty-seven patients were enrolled between March 2011 and April 2015. The median age was 64 years (range: 44-74), and 21 patients were female. All the patients had adenocarcinoma, 17 patients had exon 19 deletion, and 10 had L858R mutation. 9 patients were ex-smoker, and 18 patients were nonsmoker. There were 11 partial responses with an response rate of 41% (95%CI, 22 – 61%). Stable Disease was observed in 16 patients and disease control rate was 100% (95%CI, 87 - 100%). 22 patients (81%) subsequently underwent maintenance therapy. The median progression-free survival was 7.8 months. The median overall survival from enrollment and from the start of first-line EGFR-TKI were 21.6 months and 36.9 months, respectively. Major adverse event was grade 3 and 4 neutropenia in 5 patients (19%), grade 3 hypertension in 3 patients (11%). Grade 3 gastrointestinal hemorrhage occurred in one patient, and grade 1 epistaxis occurred in 6 patients. No treatment-related death was observed.

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    The present study reveals that carboplatin and pemetrexed plus bevacizumab therapy is effective and feasible for the patients with NSCLC after the failure of first-line EGFR-TKI.

    6f8b794f3246b0c1e1780bb4d4d5dc53

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• 25936

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  P1.16 - Treatment of Early Stage/Localized Disease (Not CME Accredited Session) (ID 948)

  • Event: WCLC 2018
  • Type: Poster Viewing in the Exhibit Hall
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall

  • 26731

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    P1.16-21 - Phase I / II Study of Carboplatin, Nab-Paclitaxel, and Concurrent Radiotherapy for Patients with Locally Advanced NSCLC (ID 12112)

    16:45 - 18:00  |  Author(s): Tomoki Kimura
    • Abstract

    Background
    

    We performed an open-label, multicenter phase I/II study (UMIN ID 000012719) to prospectively evaluate the efficacy and safety of the combination of nab-paclitaxel plus carboplatin (nab-P/C) with concurrent thoracic radiotherapy in unresectable stage III non-small cell lung cancer.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    In the phase I study (standard 3+3 design), escalating doses of weekly nab-paclitaxel were given along with weekly carboplatin area under the plasma concentration time curve (AUC) 2 and concurrent radiotherapy 60 Gy in 30 fractions, followed by 2 cycles of nab-paclitaxel (100 mg/m² on Days 1, 8 and 15) plus carboplatin (AUC 6 on Day 1). In the phase II study, nab-P/C at recommend dose (RD) was administered.

    4c3880bb027f159e801041b1021e88e8 Result
    

    In the Phase I study, 11 patients were enrolled with 9 evaluable for dose limiting toxicity (DLT). At level 1 (nab-paclitaxel 40mg/m²), none of 3 patients experienced DLT. At level 2 (nab-paclitaxel 50mg/ m²), 1 of 6 patients experienced DLT: grade 3 leukopenia requiring a second consecutive skip in the administration of weekly nab-P/C. Level 2 was defined as the RD. A total of 56 patients including 6 patients who received at dose of RD, were evaluable for the efficacy and safety. Of the 56 patients for safety analysis, common toxicities in the concurrent phase included grade 3/4 leukopenia (60.7 %), neutropenia (26.8 %), anemia (7.1 %), anorexia (7.1 %), esophagitis (5.4 %) and febrile neutropenia (1.8 %). In one patient, grade 3 pneumonitis was observed. There were no treatment-related deaths. The objective response rate was 76.8 % (95% confidence interval (CI), 64.2 to 85.9 %). The median progression-free survival was 11.8 months (60% CI, 10.6 to 16.2 months, 95% CI, 8.2 to 20.8 months), and the median overall survival was not reached.

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    This is the first study to demonstrate encouraging feasibility and activity for concurrent chemoradiation with nab-paclitaxel 50 mg/m² and CBDCA AUC 2 in patients with locally advanced NSCLC.

    6f8b794f3246b0c1e1780bb4d4d5dc53