A prospective cohort study of patients with non-squamous non-small cell lung cancer treated with bevacizumab

Katsuhiko Naoki, Yuichiro Takeda, Kenzo Soejima, Daisuke Arai, G. O. Naka, Seisuke Nagase, Ken Arimura, Toshinori Kanemura, Tatsuo Ohhira, Norihiko Ikeda

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

First-line chemotherapy regimens that include bevacizumab (Bev) have been hypothesized to improve outcomes in patients with advanced non-squamous non-small cell lung cancer (non-sq NSCLC). Although approved to treat NSCLC in 2009, insufficient data exist on the clinical uses of Bev in Japan. The present study prospectively evaluated the efficacy and safety of Bev-containing combination chemotherapy. Eligible patients exhibited histologically or cytologically documented advanced or recurrent non-sq NSCLC. Patients were administered 15 mg/kg Bev with standard chemotherapy followed by maintenance Bev. The primary endpoints were progression-free survival (PFS) and safety. A total of 102 patients with non-sq NSCLC were enrolled, 44.1% of whose tumor carried epidermal growth factor receptor (EGFR) mutations. The overall response rate to the intervention was 44.1%, and the median PFS was 8.3 months [95% confidence interval (CI)=6.4-10.2 months]. The median overall survival was 26.3 months (95% CI=22.2-30.4 months). The incidence of Bev-associated severe adverse events was similar to those in previous trials, excluding a grade 3-4 hypertension rate of 30.4% in the present study. Multivariate analysis revealed that a higher TNM classification of malignant tumor staging-T factor, adjusted hazard ratio (HR)=1.33 (95% CI=1.10-1.61), and poor performance status [adjusted HR=1.63 (1.02-2.60)] were associated with significantly shorter PFS, whilst the EGFR exon 19 deletion was significantly associated with prolonged PFS [adjusted HR=0.47 (0.25-0.87)]. Bev-containing chemotherapy was safe and effective for patients with non-sq NSCLC in clinical settings in Japan. The EGFR exon 19 deletion was suggested as a positive predictive factor for the efficacy of Bev-containing chemotherapy.

Original languageEnglish
Pages (from-to)3285-3290
Number of pages6
JournalOncology Letters
Volume13
Issue number5
DOIs
Publication statusPublished - 2017 May 1

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Non-Small Cell Lung Carcinoma
Cohort Studies
Prospective Studies
Disease-Free Survival
Epidermal Growth Factor Receptor
Drug Therapy
Neoplasm Staging
Confidence Intervals
Exons
Japan
Safety
Bevacizumab
Combination Drug Therapy
Multivariate Analysis
Maintenance
Hypertension
Mutation
Survival
Incidence
Neoplasms

Keywords

  • Bevacizumab
  • Cohort study
  • Endothelial growth factor receptor
  • Non-small-cell lung cancer
  • Prospective

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

A prospective cohort study of patients with non-squamous non-small cell lung cancer treated with bevacizumab. / Naoki, Katsuhiko; Takeda, Yuichiro; Soejima, Kenzo; Arai, Daisuke; Naka, G. O.; Nagase, Seisuke; Arimura, Ken; Kanemura, Toshinori; Ohhira, Tatsuo; Ikeda, Norihiko.

In: Oncology Letters, Vol. 13, No. 5, 01.05.2017, p. 3285-3290.

Research output: Contribution to journalArticle

Naoki, K, Takeda, Y, Soejima, K, Arai, D, Naka, GO, Nagase, S, Arimura, K, Kanemura, T, Ohhira, T & Ikeda, N 2017, 'A prospective cohort study of patients with non-squamous non-small cell lung cancer treated with bevacizumab', Oncology Letters, vol. 13, no. 5, pp. 3285-3290. https://doi.org/10.3892/ol.2017.5796
Naoki, Katsuhiko ; Takeda, Yuichiro ; Soejima, Kenzo ; Arai, Daisuke ; Naka, G. O. ; Nagase, Seisuke ; Arimura, Ken ; Kanemura, Toshinori ; Ohhira, Tatsuo ; Ikeda, Norihiko. / A prospective cohort study of patients with non-squamous non-small cell lung cancer treated with bevacizumab. In: Oncology Letters. 2017 ; Vol. 13, No. 5. pp. 3285-3290.
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abstract = "First-line chemotherapy regimens that include bevacizumab (Bev) have been hypothesized to improve outcomes in patients with advanced non-squamous non-small cell lung cancer (non-sq NSCLC). Although approved to treat NSCLC in 2009, insufficient data exist on the clinical uses of Bev in Japan. The present study prospectively evaluated the efficacy and safety of Bev-containing combination chemotherapy. Eligible patients exhibited histologically or cytologically documented advanced or recurrent non-sq NSCLC. Patients were administered 15 mg/kg Bev with standard chemotherapy followed by maintenance Bev. The primary endpoints were progression-free survival (PFS) and safety. A total of 102 patients with non-sq NSCLC were enrolled, 44.1{\%} of whose tumor carried epidermal growth factor receptor (EGFR) mutations. The overall response rate to the intervention was 44.1{\%}, and the median PFS was 8.3 months [95{\%} confidence interval (CI)=6.4-10.2 months]. The median overall survival was 26.3 months (95{\%} CI=22.2-30.4 months). The incidence of Bev-associated severe adverse events was similar to those in previous trials, excluding a grade 3-4 hypertension rate of 30.4{\%} in the present study. Multivariate analysis revealed that a higher TNM classification of malignant tumor staging-T factor, adjusted hazard ratio (HR)=1.33 (95{\%} CI=1.10-1.61), and poor performance status [adjusted HR=1.63 (1.02-2.60)] were associated with significantly shorter PFS, whilst the EGFR exon 19 deletion was significantly associated with prolonged PFS [adjusted HR=0.47 (0.25-0.87)]. Bev-containing chemotherapy was safe and effective for patients with non-sq NSCLC in clinical settings in Japan. The EGFR exon 19 deletion was suggested as a positive predictive factor for the efficacy of Bev-containing chemotherapy.",
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