Abstract:
:This article describes the treatment rationale and study-related procedures for the A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small-Cell Lung Cancer Following Disease Progression after One Prior Platinum-Based Therapy (REVEL) study (I4T-MC-JVBA; ClinicalTrials.govNCT01168973). This international, randomized, placebo-controlled, double-blinded phase III trial examines the efficacy and safety of ramucirumab treatment administered in combination with docetaxel, as compared with docetaxel administered with placebo, in patients with stage IV non-small-cell lung cancer (NSCLC) whose disease progressed during or after first-line platinum-based chemotherapy with or without maintenance treatment. The primary end point is overall survival; secondary end points include progression-free survival, objective response rate, disease control rate, patient-reported outcomes, and assessment of safety and tolerability of ramucirumab. Eligible patients (enrollment N = 1242) are randomized at a 1:1 ratio to receive either docetaxel (75 mg/m(2)) plus ramucirumab (10 mg/kg) (Arm A) or docetaxel (75 mg/m(2)) plus placebo (Arm B). Both drugs are administered via intravenous infusion once every 3 weeks until evidence of disease progression, unacceptable toxicity, noncompliance, or patient's consent withdrawal. Efficacy and safety will be compared between the study arms and in patient subgroups including patients with nonsquamous versus squamous tumor histology and patients who received prior bevacizumab treatment. Multiple blood and tumor tissue biomarker samples are collected during the study. The goal of the REVEL study is to demonstrate that ramucirumab in combination with docetaxel improves overall survival of patients with NSCLC with progressive disease after first-line therapy, and to advance our knowledge of the role of angiogenesis blockade in patients with NSCLC by identifying patients who are likely to experience maximum benefit based on extensive clinical biomarker correlative analysis.
journal_name
Clin Lung Cancerjournal_title
Clinical lung cancerauthors
Garon EB,Cao D,Alexandris E,John WJ,Yurasov S,Perol Mdoi
10.1016/j.cllc.2012.06.007subject
Has Abstractpub_date
2012-11-01 00:00:00pages
505-9issue
6eissn
1525-7304issn
1938-0690pii
S1525-7304(12)00139-8journal_volume
13pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND:The primary objective of this study was to evaluate the association between radiation sensitivity of the lungs and candidate single nucleotide polymorphisms (SNP) in genes implicated in radiation-induced toxicity. METHODS:Patients with lung cancer who received radiation therapy (RT) had pre-RT and serial po...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2012.10.006
更新日期:2013-05-01 00:00:00
abstract:BACKGROUND:Serum tumor markers are considered a negative prognostic factor in early-stages NSCLC but its role in advanced disease is controversial. The aim of this study is to analyze the prognostic value of tumor markers in advanced NSCLC. PATIENTS AND METHODS:Two hundred and seventy seven patients diagnosed in our i...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2011.03.019
更新日期:2011-05-01 00:00:00
abstract::Implementation of positron-emission tomography (PET) is variable depending on jurisdiction in part due to uncertainty about cost-effectiveness. Our objective was to perform a systematic review describing cost-effectiveness of PET in staging of non-small-cell lung cancer (NSCLC) and management of solitary pulmonary nod...
journal_title:Clinical lung cancer
pub_type: 杂志文章,评审
doi:10.1016/j.cllc.2011.09.002
更新日期:2012-05-01 00:00:00
abstract::Activating mutations in the epidermal growth factor receptor (EGFR) gene are extremely rare in small-cell lung cancer (SCLC). Here, we present a case of an EGFR-mutant gefitinib-responsive non-small-cell lung cancer (NSCLC) of adenocarcinoma histology occurring in a never-smoker followed by subsequent diagnosis of met...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.3816/CLC.2010.n.046
更新日期:2010-09-01 00:00:00
abstract::Recent developments in the chemotherapy of advanced and metastatic non small-cell lung cancer have led to significant, albeit modest, improvements in survival and quality of life. The plethora of new agents with activity in this disease has led to questions as to how these drugs can best be added to existing regimens....
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.3816/clc.1999.n.009
更新日期:1999-11-01 00:00:00
abstract:INTRODUCTION:Small-cell lung cancer is an aggressive disease for which the mainstay of treatment is chemotherapy. Despite good initial responses most patients will relapse. Some will receive second-line therapy with clinical benefit, but for third-line chemotherapy there is little evidence to guide treatment decisions ...
journal_title:Clinical lung cancer
pub_type: 杂志文章,多中心研究
doi:10.1016/j.cllc.2013.11.003
更新日期:2014-03-01 00:00:00
abstract:INTRODUCTION:Prophylactic cranial irradiation (PCI) has proven to decrease the incidence of brain metastases (BMs), with a modest improvement in survival. PATIENTS AND METHODS:The impact of PCI was evaluated in 184 patients treated with chemoradiotherapy. PCI was applied to patients with disease with partial and compl...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2016.11.005
更新日期:2017-07-01 00:00:00
abstract::Radiation Therapy Oncology Group (RTOG) 3505 is a randomized phase 3 study of concurrent chemoradiation followed by immune checkpoint inhibitor therapy or placebo in patients with locally advanced non-small-cell lung cancer (NSCLC). Patients with surgically unresectable stage 3 NSCLC will receive thoracic radiotherapy...
journal_title:Clinical lung cancer
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cllc.2016.10.009
更新日期:2017-05-01 00:00:00
abstract::Historically, malignant pleural mesothelioma patients with potentially resectable disease have been treated with surgery and radiation alone. With improvements in systemic and intrapleural treatment options, a movement toward multi-modality therapy has become more common. Systemic treatment options largely consist of ...
journal_title:Clinical lung cancer
pub_type: 杂志文章,评审
doi:10.3816/CLC.2009.n.005
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND:While lepidic-predominant lung adenocarcinomas are known to have better outcomes than similarly sized solid tumors, the impact of smaller noninvasive foci within predominantly solid tumors is less clearly characterized. We tested the hypothesis that lung adenocarcinomas with even a small ground-glass opacity...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2017.06.020
更新日期:2018-01-01 00:00:00
abstract:BACKGROUND:In lung adenocarcinoma, inactivation of the tumor suppressor p53 may abrogate a safeguard mechanism preventing the development of tumors with activating mutations in EGFR or KRAS. To assess this hypothesis, we analyzed TP53 mutations and downregulation of p14(arf), a negative regulator of p53 activated by on...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2013.08.003
更新日期:2014-03-01 00:00:00
abstract:BACKGROUND:The optimal treatment strategy for locoregional recurrences developing after surgical resection in patients with non-small-cell lung cancer (NSCLC) is yet to be clearly established. PATIENTS AND METHODS:To investigate the efficacy and safety of radiotherapy (RT) and chemoradiotherapy (CRT), we reviewed the ...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2017.05.005
更新日期:2017-11-01 00:00:00
abstract:BACKGROUND:We investigated the effect of downstaging on OS in LD-SCLC patients treated with first-line treatment. PATIENTS AND METHODS:We retrospectively reviewed 210 LD-SCLC patients who were treated with first-line treatment at Seoul National University Hospital between April 1999 and November 2012. Compared with in...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2013.09.003
更新日期:2014-03-01 00:00:00
abstract:BACKGROUND:A few reports have evaluated the outcomes of concurrent chemoradiotherapy (CRT) for patients with postoperative recurrence of non-small cell lung cancer (NSCLC). PATIENTS AND METHODS:From 2000 through 2011, 1237 consecutive patients with NSCLC underwent pulmonary resection at our institution. Of those, 280 ...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2014.06.001
更新日期:2015-01-01 00:00:00
abstract::After decades of platinum-based chemotherapy for advanced small-cell lung cancer, there has finally been a therapeutic advance. The combination of a platinum chemotherapy, etoposide, and an immune checkpoint inhibitor has yielded overall survival benefits in two successive phase 3 trials. Unfortunately, these trials o...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2020.04.006
更新日期:2020-11-01 00:00:00
abstract:INTRODUCTION:The objective of this study was to present the outcomes of moderately hypofractionated helical intensity-modulated radiation therapy (HT) with/without simultaneous integrated boost (SIB) on fluorodeoxyglucose-positron emission tomography (FDG-PET) positive areas (gross tumor volume [GTV]-PET) for patients ...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2018.08.019
更新日期:2019-01-01 00:00:00
abstract::Bevacizumab is the first molecularly targeted agent associated with improved outcomes in combination with chemotherapy in previously untreated patients with non-small-cell lung cancer (NSCLC). The addition of bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), to carboplatin and pacli...
journal_title:Clinical lung cancer
pub_type: 杂志文章,评审
doi:10.3816/CLC.2008.s.009
更新日期:2008-03-01 00:00:00
abstract::The ability to reliably distinguish synchronous primary non-small-cell lung cancer (NSCLC) from intrapulmonary metastatic spread affects staging and treatment decisions in resected NSCLC. Adjuvant therapy for early-stage NSCLC is complicated and recommendations are primarily based on older data from trials that used n...
journal_title:Clinical lung cancer
pub_type: 杂志文章,评审
doi:10.1016/j.cllc.2015.03.004
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND:Patients with advanced non-small-cell lung cancer (NSCLC) and poor performance status (PS) are often excluded from trials. Gefitinib is a safe oral agent that may benefit these patients. PATIENTS AND METHODS:Seventy-two patients with poor PS and advanced NSCLC were enrolled onto this study of gefitinib 250 ...
journal_title:Clinical lung cancer
pub_type: 杂志文章,多中心研究
doi:10.3816/CLC.2005.n.028
更新日期:2005-09-01 00:00:00
abstract:BACKGROUND:Standard treatment for stage III non-small-cell lung cancer (NSCLC) is concurrent chemotherapy and radiation (chemo-RT). However, N3 stage IIIB disease portends a worse prognosis and the tolerability of chemo-RT in patients ≥70 years old is a concern. In this analysis, we evaluate the survival of patients wi...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2019.04.003
更新日期:2019-07-01 00:00:00
abstract::Lobectomy remains the standard procedure for early-stage non small-cell lung cancer (NSCLC). Advances in minimally invasive surgery allow lobectomy to be performed by videothoracoscopy (VATSLOBE). The objective of this study was to compare open thoracotomy (OPENLOBE) to VATSLOBE in the treatment of early-stage NSCLC. ...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.3816/clc.2000.n.018
更新日期:2000-08-01 00:00:00
abstract::An early phase II study of topotecan produced favorable results in a small number of untreated and previously treated patients with small-cell lung cancer (SCLC). This multicenter study was conducted in patients with relapsed SCLC at 19 medical institutions in Japan. Topotecan 1.0 mg/m2/day was administered for 5 cons...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.3816/clc.2003.n.002
更新日期:2003-01-01 00:00:00
abstract::Gefitinib is a small-molecule agent specifically targeted to inhibit the epidermal growth factor receptor-tyrosine kinase (EGFR-TK). Tumor responses have been achieved with gefitinib treatment in large, randomized monotherapy trials. In preclinical studies, gefitinib has shown additive and even supra-additive antitumo...
journal_title:Clinical lung cancer
pub_type: 杂志文章,评审
doi:10.3816/clc.2003.s.011
更新日期:2003-09-01 00:00:00
abstract:UNLABELLED:Small observational studies have demonstrated an association between high ERCC1 expression level and poor prognosis in advanced NSCLC treated with platinum-based chemotherapy. This meta-analysis presents pooled estimates of association from 11 studies. High ERCC1 patients had lower response rates and higher ...
journal_title:Clinical lung cancer
pub_type: 杂志文章,评审
doi:10.1016/j.cllc.2011.04.005
更新日期:2011-11-01 00:00:00
abstract:BACKGROUND:Third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are rapidly being developed for treatment of non-small-cell lung cancer (NSCLC) in patients harboring EGFR T790M mutations. This first-in-human phase 1 study evaluated the maximum tolerated dose, recommended phase 2 do...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2020.07.001
更新日期:2020-11-01 00:00:00
abstract:INTRODUCTION:For lung cancer screening, the available data are often derived from patients enrolled prospectively in clinical trials. We, therefore, investigated lung cancer screening patterns among individuals eligible for, but not enrolled in, a screening trial. PATIENTS AND METHODS:From February 2017 through Februa...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2020.02.010
更新日期:2020-07-01 00:00:00
abstract::The absolute number of patients with lung cancer is rising as a result of our aging population. Until recently, clinicians have been reluctant to aggressively treat elderly patients with non-small-cell lung cancer (NSCLC) because of a lack of supportive data and concern for potential toxicity. Recently, evidence has e...
journal_title:Clinical lung cancer
pub_type: 杂志文章,评审
doi:10.3816/CLC.2005.n.031
更新日期:2005-11-01 00:00:00
abstract:OBJECTIVE:Uncertainty exists regarding the optimal surveillance imaging schedule following definitive chemoradiation (CRT) for locally advanced non-small-cell lung cancer (LA-NSCLC) with regards to both frequency and modality. We sought to document the clinical impact of frequent (at least every 4 months) surveillance ...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2016.11.010
更新日期:2017-07-01 00:00:00
abstract::Antisense oligonucleotides (ASONs) are one of the new classes of molecularly targeted agents that have transitioned from the laboratory into clinical trials. Rational drug design has resulted in agents directed against a number of important cellular targets, including the mRNA of bcl-2, protein kinase (PK) C-alpha, PK...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.3816/clc.2003.s.007
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND:The optimal treatment of locally advanced non-small-cell lung cancer (NSCLC) remains controversial. We hypothesized that using a trimodality approach in selected patients with stage IIIA/IIIB disease would be both feasible and efficacious with reasonable toxicity. PATIENTS/METHODS:We enrolled 13 patients wi...
journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2011.06.003
更新日期:2011-09-01 00:00:00