title: Efficacy and tolerance of frontline bevacizumab-based chemotherapy for advanced non-small cell lung cancer patients: a multicenter, phase IV study of the Hellenic Oncology Research Group (HORG).
abstract: BACKGROUND
  The addition of bevacizumab to the first-line chemotherapy of advanced non-small cell lung cancer (NSCLC) of non-squamous histology has been shown to improve survival. A multicenter, single-arm, phase IV study was conducted in order to evaluate the efficacy and toxicity of frontline bevacizumab-based chemotherapy regimens in real life.
  
  
  METHODS
  Patients with previously untreated recurrent or metastatic non-squamous, NSCLC, with no contraindications for bevacizumab, were enrolled. Bevacizumab (15 mg/kg every 3 weeks) was administered in combination with both platinum- and non-platinum-based chemotherapy doublets or with single-agent chemotherapy plus bevacizumab. Treatment with bevacizumab was continued until disease progression. The primary end point of the study was the safety profile of bevacizumab regimens, whereas the secondary end points included overall survival, progression-free survival, and overall response rate.
  
  
  RESULTS
  From February 2010 to April 2014, a total of 314 patients were enrolled in the study; the median age was 63, 74.8 % were men, 95.9 % had a performance status of 0-1, 90.4 % had metastatic disease, and 94.3 % had adenocarcinoma. Grade ≥3 neutropenia occurred in 11.5 % of the patients, 1.3 % experienced febrile neutropenia, 2.6 % grade ≥3 thrombocytopenia, 2.8 % thromboembolism, and 1.6 % severe bleeding. Treatment discontinuation occurred in 7.0 % of patients because of adverse events. There were three toxic deaths. Median progression-free survival was 7.7 months, and median overall survival was 17.6 months.
  
  
  CONCLUSIONS
  The combination of bevacizumab with chemotherapy in the first-line setting of NSCLC is safe and active when used in appropriately selected patients. CLINICALTRIALS.
  NCT01934465.
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471, Athens, Greece.
authors.forename: A
authors.initials: A
authors.lastname: Matikas
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471, Athens, Greece.
authors.forename: Ν
authors.initials: Ν
authors.lastname: Kentepozidis
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471, Athens, Greece.
authors.forename: A
authors.initials: A
authors.lastname: Ardavanis
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471, Athens, Greece.
authors.forename: M
authors.initials: M
authors.lastname: Vaslamatzis
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471, Athens, Greece.
authors.forename: A
authors.initials: A
authors.lastname: Polyzos
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471, Athens, Greece.
authors.forename: Ch
authors.initials: Ch
authors.lastname: Emmanouilides
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471, Athens, Greece.
authors.forename: P
authors.initials: P
authors.lastname: Katsaounis
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471, Athens, Greece.
authors.forename: F
authors.initials: F
authors.lastname: Koinis
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471, Athens, Greece.
authors.forename: S
authors.initials: S
authors.lastname: Xynogalos
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471, Athens, Greece.
authors.forename: A
authors.initials: A
authors.lastname: Christopoulou
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471, Athens, Greece.
authors.forename: N
authors.initials: N
authors.lastname: Ziras
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471, Athens, Greece.
authors.forename: Th
authors.initials: T
authors.lastname: Tegos
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471, Athens, Greece.
authors.forename: E
authors.initials: E
authors.lastname: Prinarakis
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471, Athens, Greece.
authors.forename: D
authors.initials: D
authors.lastname: Hatzidaki
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471, Athens, Greece.
authors.forename: V
authors.initials: V
authors.lastname: Georgoulias
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471, Athens, Greece. kotsakis@uoc.gr.
authors.forename: A
authors.initials: A
authors.lastname: Kotsakis
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000068258:Bevacizumab / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D018579:Patient Selection; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000068258:Bevacizumab
keywords: Bevacizumab; Bleeding; Metastatic; NSCLC; Thromboembolism; Toxicity