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      A multicenter, open‐label, phase II trial of pemetrexed plus bevacizumab in elderly patients with previously untreated advanced or recurrent nonsquamous non‐small cell lung cancer

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          Abstract

          Background

          Although the incidence of lung cancer in elderly individuals has been increasing in recent years, the number of clinical trials designed specifically for elderly patients with advanced non‐small cell lung cancer (NSCLC) is still limited. To fulfill this unmet medical need, we conducted a phase II study to elucidate the efficacy of pemetrexed (PEM) plus bevacizumab (Bev) combination chemotherapy in elderly patients with nonsquamous NSCLC.

          Methods

          A total of 29 elderly patients (≥75 years old) with nonsquamous NSCLC were enrolled in this multicenter, open‐label, phase II study, and 27 patients were finally analyzed. PEM at 500 mg/m 2 on day 1 plus Bev at 15 mg/kg on day 1 were administered triweekly. The primary endpoint was the investigator‐assessed objective response rate.

          Results

          The median age at initiating chemotherapy was 80 years old. Almost all patients (92.6%) had adenocarcinoma histology. The median number of cycles administered was 6, and the objective response rate was 40.7%. The median progression‐free survival, overall survival and 1‐year survival were 8.8 months, 27.2 months and 79%, respectively. The treatment was well‐tolerated, and no treatment‐related death was observed.

          Conclusion

          Combination chemotherapy with PEM plus Bev in elderly patients with previously untreated advanced non‐squamous NSCLC exhibited favorable antitumor activity and tolerability, suggesting that a combination of PEM plus Bev might be a promising treatment option for this population.

          Abstract

          We conducted a multicenter, open‐label, phase II trial of PEM plus Bev in elderly patients with advanced or recurrent Non‐Sq NSCLC. Combination chemotherapy with PEM plus Bev exhibited favorable antitumor activity and tolerability, suggesting that a combination of PEM plus Bev might be a promising treatment option in elderly patients with previously untreated advanced or recurrent Non‐Sq NSCLC.

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          Most cited references30

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          Investigation of the freely available easy-to-use software ‘EZR' for medical statistics

          Y Kanda (2012)
          Although there are many commercially available statistical software packages, only a few implement a competing risk analysis or a proportional hazards regression model with time-dependent covariates, which are necessary in studies on hematopoietic SCT. In addition, most packages are not clinician friendly, as they require that commands be written based on statistical languages. This report describes the statistical software ‘EZR' (Easy R), which is based on R and R commander. EZR enables the application of statistical functions that are frequently used in clinical studies, such as survival analyses, including competing risk analyses and the use of time-dependent covariates, receiver operating characteristics analyses, meta-analyses, sample size calculation and so on, by point-and-click access. EZR is freely available on our website (http://www.jichi.ac.jp/saitama-sct/SaitamaHP.files/statmed.html) and runs on both Windows (Microsoft Corporation, USA) and Mac OS X (Apple, USA). This report provides instructions for the installation and operation of EZR.
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            Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer.

            Bevacizumab, a monoclonal antibody against vascular endothelial growth factor, has been shown to benefit patients with a variety of cancers. Between July 2001 and April 2004, the Eastern Cooperative Oncology Group (ECOG) conducted a randomized study in which 878 patients with recurrent or advanced non-small-cell lung cancer (stage IIIB or IV) were assigned to chemotherapy with paclitaxel and carboplatin alone (444) or paclitaxel and carboplatin plus bevacizumab (434). Chemotherapy was administered every 3 weeks for six cycles, and bevacizumab was administered every 3 weeks until disease progression was evident or toxic effects were intolerable. Patients with squamous-cell tumors, brain metastases, clinically significant hemoptysis, or inadequate organ function or performance status (ECOG performance status, >1) were excluded. The primary end point was overall survival. The median survival was 12.3 months in the group assigned to chemotherapy plus bevacizumab, as compared with 10.3 months in the chemotherapy-alone group (hazard ratio for death, 0.79; P=0.003). The median progression-free survival in the two groups was 6.2 and 4.5 months, respectively (hazard ratio for disease progression, 0.66; P<0.001), with corresponding response rates of 35% and 15% (P<0.001). Rates of clinically significant bleeding were 4.4% and 0.7%, respectively (P<0.001). There were 15 treatment-related deaths in the chemotherapy-plus-bevacizumab group, including 5 from pulmonary hemorrhage. The addition of bevacizumab to paclitaxel plus carboplatin in the treatment of selected patients with non-small-cell lung cancer has a significant survival benefit with the risk of increased treatment-related deaths. (ClinicalTrials.gov number, NCT00021060.) 2006 Massachusetts Medical Society
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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.

              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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                Author and article information

                Contributors
                yasuhiko@tokushima-u.ac.jp
                Journal
                Thorac Cancer
                Thorac Cancer
                10.1111/(ISSN)1759-7714
                TCA
                Thoracic Cancer
                John Wiley & Sons Australia, Ltd (Melbourne )
                1759-7706
                1759-7714
                17 September 2023
                November 2023
                : 14
                : 32 ( doiID: 10.1111/tca.v14.32 )
                : 3232-3239
                Affiliations
                [ 1 ] Department of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences Tokushima University Tokushima Japan
                [ 2 ] Department of Community Medicine for Respirology, Hematology and Metabolism, Graduate School of Biomedical Sciences Tokushima University Tokushima Japan
                [ 3 ] Department of Clinical Investigation National Hospital Organization Kochi Hospital Kochi Japan
                [ 4 ] Department of Respiratory Medicine Tokushima Prefectural Central Hospital Tokushima Japan
                [ 5 ] Department of Respiratory Medicine Japanese Red Cross Matsuyama Hospital Matsuyama Japan
                [ 6 ] Department of Pulmonary Medicine St. Luke's International Hospital Tokyo Japan
                [ 7 ] Department of Internal Medicine Japanese Red Cross Kochi Hospital Kochi Japan
                [ 8 ] Department of Respiratory Medicine Center Hospital of the National Center for Global Health and Medicine Tokyo Japan
                [ 9 ] Department of Community Medicine for Respirology, Graduate School of Biomedical Sciences Tokushima University Tokushima Japan
                Author notes
                [*] [* ] Correspondence

                Yasuhiko Nishioka, Department of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Science, Tokushima University, 3‐8‐15 Kuramoto‐cho, Tokushima, 780‐8503, Japan.

                Email: yasuhiko@ 123456tokushima-u.ac.jp

                Author information
                https://orcid.org/0000-0003-1541-9747
                https://orcid.org/0000-0002-9124-7978
                https://orcid.org/0000-0002-1219-6966
                https://orcid.org/0000-0001-6311-1654
                Article
                TCA15115
                10.1111/1759-7714.15115
                10643789
                37718463
                19c6711d-a4f5-4694-9411-b99ca1e70771
                © 2023 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                : 05 September 2023
                : 06 June 2023
                : 06 September 2023
                Page count
                Figures: 2, Tables: 5, Pages: 8, Words: 6145
                Categories
                Original Article
                Original Articles
                Custom metadata
                2.0
                November 2023
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.3.4 mode:remove_FC converted:14.11.2023

                bevacizumab,elderly patients,pemetrexed,previously untreated nonsquamous non‐small cell lung cancer

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