A randomized phase II study comparing paclitaxel-carboplatin-bevacizumab with or without nitroglycerin patches in patients with stage IV nonsquamous nonsmall-cell lung cancer: NVALT12 (NCT01171170)†

Annals of Oncology : Official Journal of the European Society for Medical Oncology
A-M C DingemansNVALT study group

Abstract

Nitroglycerin (NTG) increases tumor blood flow and oxygenation by inhibiting hypoxia-inducible-factor (HIF)-1. A randomized phase II study has shown improved outcome when NTG patches were added to vinorelbine/cisplatin in patients with advanced nonsmall-cell lung cancer (NSCLC). In addition, there is evidence that the combination of bevacizumab and HIF-1 inhibitors increases antitumor activity. In this randomized phase II trial, chemo-naive patients with stage IV nonsquamous NSCLC were randomized to four cycles of carboplatin (area under the curve 6)-paclitaxel (200 mg/m(2))-bevacizumab 15 mg/kg on day 1 every 3 weeks with or without NTG patches 15 mg (day -2 to +2) followed by bevacizumab with or without NTG until progression. Response was assessed every two cycles. Primary end point was progression-free survival (PFS). The study was powered (80%) to detect a decrease in the hazard of tumor progression of 33% at α = 0.05 with a two-sided log-rank test when 222 patients were enrolled and followed until 195 events were observed. Between 1 January 2011 and 1 January 2013, a total of 223 patients were randomized; 112 control arm and 111 experimental arm; response rate was 54% in control arm and 38% in experimental arm. Median [95%...Continue Reading

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Citations

Sep 8, 2016·European Journal of Nuclear Medicine and Molecular Imaging·Evelyn E C de JongAnne-Marie C Dingemans
Sep 20, 2017·Journal of the National Cancer Institute·Ahmed SalemCorinne Faivre-Finn
Aug 24, 2017·Acta Oncologica·Evelyn E C de JongAnne-Marie C Dingemans
Oct 21, 2015·Nature Reviews. Clinical Oncology·Francesco BertoliniGauthier Bouche
Jul 14, 2016·Médecine sciences : M/S·Stéphanie PlenchetteAli Bettaieb
Aug 8, 2018·Disease Models & Mechanisms·Rom Keshet, Ayelet Erez
Jul 7, 2020·Analytical Sciences : the International Journal of the Japan Society for Analytical Chemistry·Haitao FengYoshiki Katayama
Jan 16, 2019·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Pauline L de GoejeJoachim G J V Aerts
Jan 31, 2021·Vaccines·Joel MintzHimanshu Arora
Mar 2, 2021·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·Lizza E L HendriksEgbert F Smit
Feb 6, 2020·Clinical and Translational Radiation Oncology·Bart J T ReymenPhilippe Lambin
Jul 25, 2021·Cancers·Julien AncelValérian Dormoy
May 16, 2017·Journal of Medicinal Chemistry·Zhangjian HuangYihua Zhang
Aug 28, 2021·International Journal of Molecular Sciences·Sarra BouaouicheStéphanie Plenchette

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