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      The efficacy and safety of paclitaxel and carboplatin with versus without bevacizumab in patients with non-small-cell lung cancer: a systematic review and meta-analysis

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          Abstract

          Objectives

          To investigate the efficacy and safety of Bevacizumab (Bev) used in combination with paclitaxel and carboplatin (PC), compared with PC alone in patients with advanced non-small-cell lung cancer (NSCLC).

          Materials and Methods

          We searched the PubMed, EMBASE, Cochrane Central Register of Controlled Trials and Chinese Biomedical Literature electronic databases, to identify randomized controlled trials of PC plus Bev versus PC alone for the treatment of NSCLC. The meta-analysis was performed using Reviewer Manager Version 5.3 software provided by the Cochrane Collaboration. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were overall survival (OS), objective response rate (ORR), the incidence of severe adverse events and treatment-related deaths.

          Results

          The final analysis included 5 trials with a total of 1486 patients. Compared with PC alone, the regimen of PC plus Bev resulted in significantly longer PFS (HR = 0.57; 95% CI = 0.46 to 0.71; p < 0.00001), longer OS (HR = 0.81; 95% CI = 0.71 to 0.92; p = 0.0009) and higher response rates (RR = 2.06; 95% CI = 1.73 to 2.44; p < 0.00001). However, grade ≥ 3 neutropenia, haemoptysis, hypertension, proteinuria and bleeding events were more common among patients who received Bev, and these patients also experienced increased rates of treatment-related death.

          Conclusions

          Compared with PC alone, the combination of PC with Bev could prolong PFS, OS and RR for patients with advanced non-squamous NSCLC. However, this combination could lead to a higher toxicity profile. Therefore, the benefits and risks should be considered before making treatment decisions.

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          Most cited references22

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          Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints.

          M Parmar, V. Torri, L. Stewart (1998)
          Meta-analyses aim to provide a full and comprehensive summary of related studies which have addressed a similar question. When the studies involve time to event (survival-type) data the most appropriate statistics to use are the log hazard ratio and its variance. However, these are not always explicitly presented for each study. In this paper a number of methods of extracting estimates of these statistics in a variety of situations are presented. Use of these methods should improve the efficiency and reliability of meta-analyses of the published literature with survival-type endpoints.
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            Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil.

            Martin Reck, Joachim von Pawel, Petr Zatloukal … (2009)
            Bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor, improves survival when combined with carboplatin/paclitaxel for advanced nonsquamous non-small-cell lung cancer (NSCLC). This randomized phase III trial investigated the efficacy and safety of cisplatin/gemcitabine (CG) plus bevacizumab in this setting. Patients were randomly assigned to receive cisplatin 80 mg/m2 and gemcitabine 1,250 mg/m(2) for up to six cycles plus low-dose bevacizumab (7.5 mg/kg), high-dose bevacizumab (15 mg/kg), or placebo every 3 weeks until disease progression. The trial was not powered to compare the two doses directly. The primary end point was amended from overall survival (OS) to progression-free survival (PFS). Between February 2005 and August 2006, 1,043 patients were randomly assigned (placebo, n = 347; low dose, n = 345; high dose, n = 351). PFS was significantly prolonged; the hazard ratios for PFS were 0.75 (median PFS, 6.7 v 6.1 months for placebo; P = .003) in the low-dose group and 0.82 (median PFS, 6.5 v 6.1 months for placebo; P = .03) in the high-dose group compared with placebo. Objective response rates were 20.1%, 34.1%, and 30.4% for placebo, low-dose bevacizumab, and high-dose bevacizumab plus CG, respectively. Duration of follow-up was not sufficient for OS analysis. Incidence of grade 3 or greater adverse events was similar across arms. Grade > or = 3 pulmonary hemorrhage rates were < or = 1.5% for all arms despite 9% of patients receiving therapeutic anticoagulation. Combining bevacizumab (7.5 or 15 mg/kg) with CG significantly improved PFS and objective response rate. Bevacizumab plus platinum-based chemotherapy offers clinical benefit for bevacizumab-eligible patients with advanced NSCLC.
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              Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer.

              David Johnson, Louis Fehrenbacher, William F. Novotny … (2004)
              To investigate the efficacy and safety of bevacizumab plus carboplatin and paclitaxel in patients with advanced or recurrent non-small-cell lung cancer. In a phase II trial, 99 patients were randomly assigned to bevacizumab 7.5 (n = 32) or 15 mg/kg (n = 35) plus carboplatin (area under the curve = 6) and paclitaxel (200 mg/m(2)) every 3 weeks or carboplatin and paclitaxel alone (n = 32). Primary efficacy end points were time to disease progression and best confirmed response rate. On disease progression, patients in the control arm had the option to receive single-agent bevacizumab 15 mg/kg every 3 weeks. Compared with the control arm, treatment with carboplatin and paclitaxel plus bevacizumab (15 mg/kg) resulted in a higher response rate (31.5% v 18.8%), longer median time to progression (7.4 v 4.2 months) and a modest increase in survival (17.7 v 14.9 months). Of the 19 control patients that crossed over to single-agent bevacizumab, five experienced stable disease, and 1-year survival was 47%. Bleeding was the most prominent adverse event and was manifested in two distinct clinical patterns; minor mucocutaneous hemorrhage and major hemoptysis. Major hemoptysis was associated with squamous cell histology, tumor necrosis and cavitation, and disease location close to major blood vessels. Bevacizumab in combination with carboplatin and paclitaxel improved overall response and time to progression in patients with advanced or recurrent non-small-cell lung cancer. Patients with nonsquamous cell histology appear to be a subpopulation with improved outcome and acceptable safety risks.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Oncotarget
                Journal ID (iso-abbrev): Oncotarget
                Journal ID (publisher-id): Oncotarget
                Journal ID (publisher-id): ImpactJ
                Title: Oncotarget
                Publisher: Impact Journals LLC
                ISSN (Electronic): 1949-2553
                Publication date Collection: 6 March 2018
                Publication date (Electronic): 23 December 2017
                Volume: 9
                Issue: 18
                Pages: 14619-14629
                Affiliations
                1 Institute of Tropical Medicine, Third Military Medical University, Chongqing 400038, China
                2 Battalion 17 of Students, College of Preventive Medicine, Third Military Medical University, Chongqing 400038, China
                3 Department of Epidemiology, Third Military Medical University, Chongqing 400038, China
                Author notes
                Correspondence to: Zhijia Ye, zjye@ 123456tmmu.edu.cn
                Article
                Publisher ID: 23657
                DOI: 10.18632/oncotarget.23657
                PMC ID: 5865694
                PubMed ID: 29581868
                SO-VID: 7942216c-8229-4251-9e2c-6f9c081da6d8
                Copyright © Copyright: © 2018 Han et al.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License 3.0 (CC BY 3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                Date received : 16 August 2017
                Date accepted : 28 October 2017
                Categories
                Subject: Meta-Analysis

                ScienceOpen disciplines: Oncology & Radiotherapy
                Keywords: bevacizumab,paclitaxel,carboplatin,non-small cell lung cancer,safety
                Data availability:
                ScienceOpen disciplines: Oncology & Radiotherapy
                Keywords: bevacizumab, paclitaxel, carboplatin, non-small cell lung cancer, safety

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