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

  • 26271

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    P1.01-40 - Randomized Phase II Study of Docetaxel Plus Bevacizumab or Pemetrexed Plus Bevacizumab for Elderly pts with Untreated Advanced NSCLC: TORG1323 (ID 12868)

    16:45 - 18:00  |  Author(s): Nobukazu Fujimoto
    • Abstract
    • Slides

    Background
    

    The addition of bevacizumab (B) to platinum doublets prolongs the survival for non-squamous NSCLC. The role of monotherapy with B is unclear for elderly non-squamous NSCLC pts.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    Pts were pathologically diagnosed untreated elderly (≥75 years old) non-squamous NSCLC, who were stage IIIB, IV, or recurrent disease, and PS 0-1. EGFR mutation or ALK rearranged pts were allowed after receiving each tyrosine kinase inhibitor. Pts were randomized 1:1 to receiving either docetaxel (D) or pemetrexed (P) with B. The primary endpoint was progression-free survival (PFS) assessed by independent review committee. B was administered 15 mg/kg, D was 50 mg/m², or P was 500 mg/m² every 3 weeks until disease progression or unacceptable toxicity based on our previous studies. Selection design was adopted for this study. The planned sample size was 120 pts to yield 80% power to select an optimal regimen correctly and PB is chosen for the further evaluation if the point estimate of hazard ratio (HR) for PFS was ≤1.20.

    4c3880bb027f159e801041b1021e88e8 Result
    

    Enrollment was terminated in early at the end of March 2017 because of slow accrual. Total 103 pts (DB/PB= 51/52 pts) were enrolled and 99 pts (49/50 pts) were full analysis set. Patient characteristics were well balanced between two arms. Median age was 78 (range: 75-88) in DB and 79 (75-94) in PB. EGFR mutation+/ALK translocation+/wild type/unknown= 13/0/34/2 in DB and 13/2/33/2 in PB. Total 77 events occurred at data cut-off, which corresponded to 77.7% power. The median PFS of DB and PB were 6.1 months and 4.6 months (HR 1.03, 95%C.I. 0.66-1.61: p=0.901). The response rates were 43% and 40% (p=0.840), respectively. The incident of ≥Grade 3 leukopenia (69% vs. 27%, p<0.001), neutropenia (86% vs. 44%, p<0.001) and fatigue (10% vs. 0%, p=0.027) were higher in DB. However, the frequency of febrile neutropenia was not different (16% vs.12%, p=0.578). One patient in PB was died of rupture of abdominal aortic aneurysm.

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    PB is less toxic and the efficacy is comparable between two arms for elderly (≥75 years old) advanced non-squamous NSCLC. PB is a candidate for the further evaluation. Clinical Trial information: UMIN000012786.

    6f8b794f3246b0c1e1780bb4d4d5dc53

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• 25943

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  P2.06 - Mesothelioma (Not CME Accredited Session) (ID 955)

  • Event: WCLC 2018
  • Type: Poster Viewing in the Exhibit Hall
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall

  • 27019

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    P2.06-10 - Combination Chemotherapy with Cisplatin, Pemetrexed, and Nivolumab for Malignant Pleural Mesothelioma: A Trial in Progress (ID 12210)

    16:45 - 18:00  |  Presenting Author(s): Nobukazu Fujimoto
    • Abstract
    • Slides

    Background
    

    Combination chemotherapy with cisplatin and pemetrexed is the standard treatment regimen for malignant pleural mesothelioma (MPM); however, the median overall survival (OS) is just about 12 months. Additional treatment options are urgently needed. The aim of this study is to assess the efficacy and safety of combination chemotherapy with cisplatin, pemetrexed, and nivolumab for unresectable MPM.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    This is a single-arm, prospective, non-randomized, non-comparative, open label, multicenter, phase II trial. This study will assess the efficacy and safety of the first-line combination therapy of cisplatin, pemetrexed, and nivolumab for advanced or metastatic MPM. Key inclusion criteria includes 1) age older than 20 years, 2) pathologically-confirmed MPM, 3) measurable lesion designated by modified RECIST criteria, 4) tumor sample available to test for Programmed Death-Ligand 1 (PD-L1) expression, 5) Eastern Cooperative Oncology Group Performance Status is 0 or 1. Combination chemotherapy with cisplatin (75 mg/m²), pemetrexed (500 mg/m²), and nivolumab (360 mg/body) is administered every 3 weeks for a total of 4 to 6 cycles. Then, maintenance therapy with nivolumab will be administered until disease progression, unacceptable toxicities, or the patient’s condition meets the withdrawal criteria. The primary endpoint is the centrally-reviewed overall response rate. The secondary endpoints include the disease control rate, overall survival, progression-free survival. Safety and adverse events will also be evaluated.

    4c3880bb027f159e801041b1021e88e8 Result
    

    This phase II trial commenced in January 2018. A total of 18 patients will be enrolled from four Japanese institutions within 1 year.

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    This is the first prospective trial to evaluate the effect of an anti-PD-1 antibody combined with cisplatin and pemetrexed for unresectable MPM. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000030892.

    6f8b794f3246b0c1e1780bb4d4d5dc53

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