Author of

• 18374

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  P3.02b - Poster Session with Presenters Present (ID 494)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 18461

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    P3.02b-087 - Dose Escalation Study of CDDP plus PEM with Erlotinib and Bev Followed by PEM with Erlotinib and Bev for Non-SQ NSCLC Harboring EGFR Mutations (ID 5891)

    14:30 - 14:30  |  Author(s): Y. Naito
    • Abstract

    Background:
    Cisplatin and pemetrexed with or without bevacizumab is the most effective treatment for advanced non-squamous NSCLC patients without EGFR mutations. On the other hand, erlotinib and bevacizumab is the most effective treatment for advanced non-small cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor (EGFR) mutations. There have not been any evidence-based studies of erlotinib and bevacizumab in combination with platinum-doublet therapy for advanced non-squamous NSCLC patients with EGFR mutations, therefore we performed Quartet trial to determine the safety and efficacy of quartet chemotherapy with cisplatin plus pemetrexed with erlotinib and bevacizumab as a first-line treatment.
    
    Methods:
    Patients received escalated doses of cisplatin plus pemetrexed with erlotinib and bevacizumab every 3 weeks for 4 cycles. We examine the dose limiting toxicity (DLT) to determine the maximum tolerated dose (MTD) and recomended dose (RD) of quartet chemotherapy.
    
    Results:
    10 patients were enrolled in Quartet trial. 3 patients were men and 7 patients were women. Median age was 69 (65-75) years old. 4 patients had exon19 mutation and 6 patients had exin21 mutation. Of a total of 10 patients, 8 patients received maintenance therapy without unexpected or cumulative toxicities. One of six patients experienced DLT (vagal reflex of grade3) at 60mg/m[2] cisplatin plus 500 mg/m[2 ]pemetrexed with 150mg erlotinib and 15mg/kg bevacizumab (RD). Four patients experienced no DLT, however one patient experienced severe toxicities (gastrointestinal hemorrhage of grade3) during 2 cycle of induction chemotherapy and dose reduction was needed at 75mg/m[2] cisplatin plus 500 mg/m[2 ]pemetrexed with 150mg erlotinib and 15mg/kg bevacizumab (MTD). In DLT phase, most frequent adverse events were nausea, anorexia and fatigue. In Quartet trial study, the overall response rate was 100%. Furthermore, progression free survival and overall survival were not reached.
    
    Conclusion:
    This quartet chemotherapy was a tolerable and effective regimen, and we determined the combination of cisplatin at 60mg/m[2] plus 500 mg/m[2 ]pemetrexed with 150mg erlotinib and 15mg/kg bevacizumab was RD and the combination cisplatin at 75mg/m[2 ]was MTD in chemotherapy-naïve advanced non-squamous NSCLC patients harboring EGFR mutations (UMIN000012536).