Author of

• 10801

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  P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10805

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    P1.11-004 - Phase II study of carboplatin-docetaxel-bevacizumab as front-line treatment in patients with stage IV non-squamous non-small-cell lung cancer. Analysis of the bevacizumab (BVZ) maintenance population (ID 3008)

    09:30 - 09:30  |  Author(s): N. Ramirez
    • Abstract

    Background
    BVZ combined with carboplatin-paclitaxel as initial treatment followed by BVZ maintenance improves overall survival in advanced non-squamous non-small-cell lung cancer. We conducted a phase II trial in order to study the efficacy and tolerability of a regimen consisting of BVZ-carboplatin-docetaxel in these patients. The objectives were to assess the efficacy and safety of this combination and to evaluate the impact of BVZ in patients who received maintenance BVZ after initial combined treatment compared with patients who did not continue with maintenance BVZ.

    Methods
    Patients were treated with carboplatin (AUC 5), docetaxel (75 mg/m2), and BVZ (7.5 mg/kg) on day 1 every 21 days, up to 6 cycles. Patients with an objective response or stable disease continued maintenance BVZ (7.5 mg/kg) every 21 days until disease progression or unacceptable toxicity . Performance Status-2, brain metastases, tumor cavitation, central tumors and mild hemoptysis were not exclusion criteria.

    Results
    Thirty-seven patients were enrolled into the study. 26 male, 11 female. Median age was 64 years (39 – 82). ECOG 0/1/2: 3.5%/70%/27.5%. 34 patients had adenocarcinoma and 3 undifferentiated large cell carcinoma. The median number of cycles for chemotherapy + BVZ was 6 (3-6) and 9 (3 – 22) for maintenance BVZ. All patients were evaluable for efficacy and toxicity. Overall response rate was 70.3% (complete response 2.7%, partial response 67.6%). 21.6% remained in stable disease and 8.15% progressed. Median progression-free survival was 10 months and median overall survival was 19 months. Patients who continued with maintenance BVZ obtained a significant benefit in progression-free survival (10 vs 6 months, p= 0.047) and median survival (20 vs 7 months, p= 0.003). The most frequent grade 3-4 adverse events were neutropenia in 18%, febrile neutropenia in 12%,nausea/vomiting in 12%, diarrhea, hemoptysis in 6% of the patients respectively. Two toxic deaths were observed.

    Conclusion
    A regimen consisting of carboplatin, docetaxel, and BVZ followed by maintenance BVZ has shown to be feasible and very effective as front-line treatment in a non-selected population. Maintenance BVZ obtains a significant impact in progression-free survival and overall survival.