A phase II study of bevacizumab with carboplatin-pemetrexed in non-squamous non-small cell lung carcinoma patients with malignant pleural effusions: North East Japan Study Group Trial NEJ013A

North East Japan Study Group

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29 Citations (Scopus)

Abstract

Background Vascular endothelial growth factor (VEGF) plays a pivotal role in the pathogenesis of malignant pleural effusion (MPE). Here, a multicenter phase II trial to evaluate bevacizumab in non-squamous non-small cell lung carcinoma patients with MPE was conducted. Methods Patients having MPE with no prior treatment and performance status of 0–2 received carboplatin (area under the curve: AUC 6; up to 6 cycles) and pemetrexed (500 mg/m2) with bevacizumab (15 mg/kg) every 3 weeks. The primary endpoint was the control rate of MPE without pleurodesis at 8 weeks after treatment. VEGF levels in plasma and MPE were measured by enzyme immunoassay. Results Of 30 patients entered (median 66 years; 24 males; adenocarcinoma; 4 epidermal growth factor receptor: EGFR mutations), 28 patients (2 withdrawn patients) were given a median of 4 cycles of carboplatin, and 68% of the patients received maintenance pemetrexed with bevacizumab (median 8 cycles). At eight weeks, MPE was controlled without pleurodesis in 93% of treated patients (95% confidence interval: 77–99%). At the median follow-up time of 12.8 months, 78.6% of the cases required no pleurodesis. Response rate was 46%, and median progression-free survival (PFS) and overall survival (OS) were 8.2 months and 18.6 months, respectively. Toxicities of grade ≥3 included neutropenia (28.6%), thrombocytopenia (28.6%), proteinuria (3.6%), and hypertension (3.6%). Assessment of VEGF levels before treatment indicated that patients with low VEGF (<1000 pg/ml) in MPE frequently needed pleurodesis (p = 0.011), and that high VEGF (≥100 pg/ml) in plasma was indicative of poor prognosis in the context of PFS (p = 0.012). Conclusion The combination of bevacizumab with carboplatin and pemetrexed demonstrated efficacy with acceptable toxicities in patients with MPE.

Original languageEnglish
Pages (from-to)131-136
Number of pages6
JournalLung Cancer
Volume99
DOIs
Publication statusPublished - 2016 Sep 1

Keywords

  • Bevacizumab
  • Lung cancer
  • Malignant pleural effusions
  • Non-small cell lung cancer
  • Pemetrexed
  • Pleurodesis

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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