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Clinical Trial
. 2017 Apr:106:125-130.
doi: 10.1016/j.lungcan.2017.02.004. Epub 2017 Feb 9.

Pilot phase II study of metronomic chemotherapy in combination with bevacizumab in patients with advanced non-squamous non-small cell lung cancer

Benjamin S Jones  1 , Mary S Jerome  1 , Deborah Miley  1 , Bradford E Jackson  1 , Mollie R DeShazo  1 , Vishnu V B Reddy  1 , Karan P Singh  1 , Olivia C Brown  1 , Francisco Robert  2
Affiliations
Clinical Trial

Pilot phase II study of metronomic chemotherapy in combination with bevacizumab in patients with advanced non-squamous non-small cell lung cancer

Benjamin S Jones et al. Lung Cancer. 2017 Apr.

Abstract

Introduction: The goal of this study was to explore the efficacy and tolerability of metronomic chemotherapy, a novel anti-angiogenic treatment strategy, in combination with bevacizumab in patients with advanced non-small cell lung cancer (NSCLC).

Methods: Subjects with newly diagnosed stage IV NSCLC were treated with 4-week cycles of paclitaxel 80mg/m2 and gemcitabine 300mg/m2 weekly for three weeks, plus bevacizumab 10mg/kg every two weeks. Radiologic assessments were performed every 8 weeks. The primary endpoint was progression free survival (PFS). An exploratory objective was to correlate plasma levels of angiogenic biomarkers with treatment response.

Results: Thirty-nine subjects were included in the intent to treat (ITT) analysis. The objective response rate (ORR) was 56%, the median PFS was 8.5 months, and median overall survival (OS) was 25.5 months. The PFS rate at 6, 12, and 24 months was 61%, 21%, and 11% respectively. The OS rate at 12 and 24 months was 74% and 53% respectively. Treatment was well tolerated, without significant myelosuppressive, gastrointestinal, or neurologic events. Subjects with less than median baseline values of angiopoietin-2 and IL-8 experienced significantly longer PFS. Longer OS was associated with subjects with less than the median baseline values for PLGF and angiopoietin-2. There were statistically significant differences in median values of several biomarkers between cycles 1 and 3 in subjects with objective responses.

Conclusions: The combination of paclitaxel and gemcitabine, delivered in a metronomic schedule, in combination with bevacizumab, appears to be an effective and tolerable treatment strategy in patients with advanced NSCLC.

Keywords: Bevacizumab; Metronomic chemotherapy; Non-small cell lung cancer.

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Figures

Figure 1
Figure 1
A: Kaplan-Meier Plot for PFS in ITT population B. Kaplan-Meier Plot for OS in ITT population C. Kaplan-Meier Plot for PFS in RE population D. Kaplan-Meier Plot for OS in RE population.
See this image and copyright information in PMC

References

    1. Mountain CF. The international system for staging lung cancer. Seminars in Surgical Oncology. 2000;18:106–115. - PubMed
    1. Schiller JH, Harrington D, Belani CP, et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. The New England Journal of Medicine. 2002;346:92–98. - PubMed
    1. Fossella F, Pereira JR, von Pawel J, et al. Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group. Journal of Clinical Oncology. 2003;21:3016–3024. - PubMed
    1. Kelly K, Crowley J, Bunn PA, Jr, et al. Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non--small-cell lung cancer: a Southwest Oncology Group trial. Journal of Clinical Oncology. 2001;19:3210–3218. - PubMed
    1. Kosmidis P, Mylonakis N, Nicolaides C, et al. Paclitaxel plus carboplatin versus gemcitabine plus paclitaxel in advanced non-small-cell lung cancer: a phase III randomized trial. Journal of Clinical Oncology. 2002;20:3578–3585. - PubMed

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