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Cancer Chemotherapy and Pharmacology

, Volume 72, Issue 5, pp 1103–1110 | Cite as

A multicenter phase II study of docetaxel, oxaliplatin, and bevacizumab in first-line therapy for unresectable locally advanced or metastatic non-squamous cell histology non-small-cell lung cancer (NSCLC)

  • Luis E. Raez
  • Edgardo S. Santos
  • R. Timothy Webb
  • James Wade
  • Roger A. Brito
  • Melissa Karr
  • Andra Kennah
  • Barrett H. Childs
Original Article

Abstract

Introduction

Platinum-based doublets are standard of care for advanced non-small-cell lung cancer (NSCLC). The combination of docetaxel and oxaliplatin has shown acceptable toxicity and encouraging activity. This phase II study aimed to determine the safety and efficacy of this doublet with bevacizumab as first-line treatment for stage IIIB/IV NSCLC.

Methods

Newly diagnosed patients ≥18 years with histologically proven non-squamous NSCLC and Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2 received six 21-day cycles of docetaxel, oxaliplatin, and bevacizumab followed by single-agent bevacizumab for a total of 1 year. Primary efficacy end point was radiographically documented progression-free survival (PFS); secondary end points included objective response rate (ORR), overall survival (OS), time to treatment failure, and safety.

Results

Fifty-three patients were enrolled. Median age was 62.0 years, 71.7 % male, 79.2 % Caucasian. A total of 88.7 % had stage IV or recurrent disease; 94.3 % adenocarcinoma; and 94.3 % ECOG PS 0 or 1. Efficacy results are as follows: median PFS 5.6 months, ORR 30.2 % (complete response 1.9 %, partial response 28.3 %); 37.7 % stable disease; and OS 14.0 months. At least one adverse event (AE) was reported in all patients (n = 52); 98.1 % of AEs were treatment related. The most common treatment-emergent grade ≥3 AEs were neutropenia (15.4 %), diarrhea (13.5 %), and fatigue (11.5 %). A serious AE was present in 32.7 %; the most common were pneumonia (7.7 %) and abdominal pain (5.8 %). Dehydration, diarrhea, febrile neutropenia, sepsis, and supraventricular tachycardia each occurred in 3.8 %.

Conclusions

The addition of bevacizumab to docetaxel/oxaliplatin is effective with an acceptable safety profile in patients with chemotherapy-naïve advanced NSCLC.

Keywords

Oxaliplatin Docetaxel Bevacizumab Non-small-cell lung cancer Metastatic disease 

Notes

Acknowledgments

Dr. Luis E. Raez was a member of the Speakers’ Bureau of Genentech, sanofi-aventis, and Eli Lilly US Oncology. Dr. Raez receives research support from Genentech and Eli Lilly Oncology. Dr. Edgardo S. Santos is a member of the Speakers’ Bureau of Genentech, sanofi-aventis, and Eli Lilly US Oncology. This study was sponsored by Sanofi US. All summaries and statistical analyses were performed by United BioSource Corporation.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  • Luis E. Raez
    • 1
  • Edgardo S. Santos
    • 2
  • R. Timothy Webb
    • 3
  • James Wade
    • 4
  • Roger A. Brito
    • 5
  • Melissa Karr
    • 6
  • Andra Kennah
    • 7
  • Barrett H. Childs
    • 7
  1. 1.Thoracic Oncology ProgramMemorial Cancer Institute, Memorial Health Care SystemPembroke PinesUSA
  2. 2.Thoracic and Head and Neck Cancer Programs, Lynn Cancer InstituteBoca Raton Regional HospitalBoca RatonUSA
  3. 3.Genesis Cancer CenterHot SpringsUSA
  4. 4.Decatur Memorial HospitalDecaturUSA
  5. 5.Hematology and Medical OncologyBoynton BeachUSA
  6. 6.Sylvester Comprehensive Cancer CenterMiamiUSA
  7. 7.SanofiBridgewaterUSA

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