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

  • 11696

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    P2.10-004 - Addition of bevacuzimab (BEV) to pemetrexed (PEM) plus cisplatin (CIS) induction and PEM maintenance therapy in 1st line setting for treatment of advanced nonsquamous non small cell lung cancer (NS-NSCLC) - final results and safety update from a phase 2 study (ID 234)

    09:30 - 09:30  |  Author(s): G. Hoeffken
    • Abstract

    Background
    1st line PEM+CIS induction chemotherapy (CT) followed by PEM maintenance and 1st line BEV-based CT followed by BEV maintenance offer clinical benefit (progression-free and overall survival; PFS and OS) in NS-NSCLC. This study explored efficacy and safety of 1st line induction PEM+CIS+BEV followed by maintenance PEM+BEV.

    Methods
    Patients with advanced NS-NSCLC and ECOG performance status (PS) 0-1 were planned to receive 4 cycles PEM 500 mg/m[2], CIS 75 mg/m[2], BEV 7.5 mg/kg, given every 3 weeks. In the absence of progressive disease (PD) and in the case of ECOG PS 0-1, patients could continue on PEM+BEV until PD or unacceptable toxicity. All patients received vitamin supplementation as per PEM label. Primary endpoint was PFS; secondary endpoints included OS, response rate and toxicity. PFS without Grade (G)4 toxicity was additionally assessed.

    Results
    109 patients were enrolled in 5 countries. Characteristics: median age 61 years, males/females 59/41%, ECOG PS 0/1 54/46%, stage IIIB/IV 9/91%, adenocarcinoma 91%. 72 patients (66%) received maintenance CT. Overall median (maximum) number of cycles were 8(34) for PEM+BEV and 4(4) for CIS. Median PFS was 6.9 months (90% CI 5.7, 8.3). Table 1 summarizes efficacy data; Table 2 presents G1-4 adverse event (AE) data, including AEs of special interest regarding BEV. 2 patients died from study-drug related toxicity (GI hemorrhage, pneumonia aspiration; during induction CT). Figure 1 Figure 2

    Conclusion
    In this study of PEM+CIS+BEV induction CT followed by PEM+BEV maintenance, median PFS was 6.9 months. The addition of BEV to PEM-CIS induction and PEM maintenance was associated with acceptable and expected toxicities. Main G3/4 toxicities included neutropenia and fatigue, hypertension was less common.