Author of

• 14306

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  P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)

  • Event: WCLC 2015
  • Type: Poster
  • Track: Treatment of Advanced Diseases - NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)

  • 14386

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    P2.01-080 - Pemetrexed, Carboplatin and Bevacizumab in Patients with Non-Squamous NSCLC without or with Activating EGFR Mutation (CJLSG0909/0910) (ID 615)

    09:30 - 09:30  |  Author(s): J. Shindoh
    • Abstract

    Background:
    Treatment strategies for advanced non-squamous (sq) non-small cell lung cancer (NSCLC) are divided by EGFR mutations. However, there has been no previous report about efficacy of cytotoxic agents separated by EGFR mutations. In addition, the influence of the EGFR mutations on the maintenance therapy with pemetrexed (Pem) or bevacizumab (Bev) has not been elucidated. We planned two studies designed to evaluate the efficacy and safety of combination therapy with Pem, carboplatin (Cb) and Bev followed by Pem and Bev maintenance therapy for non-sq NSCLC patients without or with activating EGFR mutation.
    
    Methods:
    We undertook two multicenter, open-label, single-arm, phase II studies. Patients with wild type EGFR or with EGFR mutation (exon 19 deletions or exon 21 point mutation) entered CJLSG0909 or 0910, respectively. Patients received Pem 500mg/m[2], Cb AUC 6, and Bev 15mg/kg day1, every 3 weeks, 4 to 6 cycles (induction therapy). Patients who had achieved disease control received Pem+Bev maintenance therapy until progressive disease or unacceptable adverse event. Key inclusion criteria were stage IIIB, IV, or recurrent disease after surgery, no prior chemotherapy, age 20 to 74. The primary endpoint was the objective response rate (ORR), and the secondary endpoints were the disease control rate (DCR), progression free survival (PFS), overall survival (OS) and safety. (Unique trial Number; UMIN000003736/UMIN000003737)
    
    Results:
    In CJLSG0909, 50 patients received induction treatment. They had a median age of 64 years and were predominantly men (40 [80%]) with adenocarcinoma (47 [94%]), stage IV (40 [80%]), and a performance status (PS) of 1 (40 [80%]). The median of induction therapy was 5 cycles. Thirty-five (70%) patients received maintenance therapy, and the median of maintenance therapy was 5 cycles. Partial response was observed in 25 patients with a ORR of 50.0% (95% confidence interval, 33.7–62.6%). Stable disease was observed in 21 patients and the DCR was 92%. Median PFS was 6.8 months and median OS was 19.4 months. Grade 3/4 toxicities during induction therapy included neutropenia (40 [80%]), thrombocytopenia (12 [24%]), anemia (8 [16%]), nausea (4 [8%]), anorexia (3 [6%]), ALT elevation (3 [6%]), AST elevation (2 [4%]), vomiting, periodontal, hemoptysis, thrombosis and proteinuria (1 [2%]) respectively. In CJLSG0910, 30 patients received induction treatment. They had a median age of 65.5 years and were predominantly women (17 [57%]) with adenocarcinoma (29 [97%]), stage IV (27 [90%]), and a PS of 0 (23 [77%]). The median of induction therapy was 6 cycles. Twenty-five (83%) patients received maintenance therapy, and the median of maintenance therapy was 8.5 cycles. Partial response was observed in 15 patients with a ORR of 50.0% (95% confidence interval, 33.9–66.1%). Stable disease was observed in 15 patients and the DCR was 100%. Median PFS was 10.0 months and median OS was 41.4 months. Grade 3/4 toxicities during induction therapy included neutropenia (14 [47%]), thrombocytopenia (6 [20%]), anemia (6 [20%]), diarrhea (2 [7%]), nausea, anorexia, amylase elevation (1 [3%]) respectively.
    
    Conclusion:
    These studies suggested that chemotherapy with Pem+Cb+Bev, including Pem+Bev maintenance therapy is candidate for first line therapy in non-sq NSCLC patients regardless of the activating EGFR mutations.