Author of

• 11692

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  P2.10 - Poster Session 2 - Chemotherapy (ID 207)

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

  • 11711

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    P2.10-019 - A prospective cohort study of non-squamous non-small cell lung cancer patients treated with bevacizumab (ID 1288)

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

    Background
    In several clinical trials, first line combination chemotherapies with bevacizumab (Bev) have been reported to improve clinical outcomes in patients with advanced non-squamous non-small cell lung cancer (non-sq NSCLC). Although Bev was approved for NSCLC in autumn of 2009 in Japan, there are not enough data regarding the efficacy and toxicity with Bev treatment in real-world clinical practice in Japan. We have evaluated the efficacy and safety of the combination chemotherapy with Bev in patients with non-sq NSCLC at four major hospitals in Shinjuku area, Tokyo, Japan.

    Methods
    From August 2010 to July 2012, 102 patients planned to treat with Bev was prospectively enrolled in this study with written informed consent. Eligible patients were histlogically or cytologically documented non-sq NSCLC with advanced stage (IIIB-IV) or recurrence, ECOG-PS 0-2, and adequate organ function for cytotoxic chemotherapy. Patients received Bev (15mg/kg, every 3 weeks) plus any chemotherapy (physician’s choice) followed by maintenance Bev. The primary endpoints were safety and efficacy (PFS). Patients were treated at four major hospitals (three university hospitals and one national center) participating in Shinjuku Thoracic Oncology Group (STOG).

    Results
    Patients characteristics: median age (range) 64 (36-85) years, male/female = 60/42, clinical staging: IIIB/IV/post-operation recurrence/others ＝ 8/77/15/1, ECOG-PS 0/1/2 = 66/34/2, adenocarcinoma/others = 98/4, non-smoker/smoker = 40/60, EGFR mutation (+)/(-)/unknown ＝ 43/56/3, 1[st ]line /2[nd] line />=3[rd] line ＝ 56/23/23, Bev combination regimen: CBDCA+PEM/ CDDP+PEM/ CBDCA+PTX/ others ＝ 40/22/18/22. At the time of April 2013, median Bev administration number (range) was 7 (1-29) in total; 7.5 (1-29) in 1[st] line, 8 (1-24) in 2[nd] line, 7 (1-21) in >= 3[rd] line. With evaluable 102 cases, response rate (RR) was 39.2%, disease control rate (DCR) was 90.2%, median PFS was 321 (95%CI: 195-410) days (10.6 months (M)). Median overall survival was not reached. RR, DCR, and PFS were 46.4%, 96.4%, 10.9M with 1[st] line, 39.1%, 87.0%, 9.1M with 2[nd] line, 21.7%, 78.3%, 9.3M with >= 3[rd] line. Hematological toxicities (>=G3): leucocytopenia 24%, neutropenia 40%, anemia 8%, thrombocytopenia 5%, febrile neutropenia 3%. Bev related adverse events (>=G3): Hypertension 28%, proteinuria 5%, thromboembolism 5%, hemosputum 1%. There was no treatment related death.

    Conclusion
    Combination chemotherapy with Bev was effective for the patients with non-sq NSCLC in real-world clinical practice in Japan, as similar or superior efficacy as clinical trials. Also, adverse events were well tolerated. The efficacy was good at 1[st] line and also at 2[nd] line and thereafter.