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Paclitaxel in Combination With Bevacizumab in Patients With Stage IV NSCLC. (AVATAX)

2020年11月20日 更新者:Centre Hospitalier Annecy Genevois

Retrospective Multicenter Study of Paclitaxel in Combination With Bevacizumab in Patients With Stage IV Non-small Cell Lung Cancer (NSCLC).

The aim of the study is to evaluate the paclitaxel-bevacizumab combination retrospectively and multicenter in current practice, with subgroup analyses of the following patients: patients who have previously received immunotherapy, patients with an EGFR or ALK oncogenic addiction pathway, patients who have previously received taxanes or anti-angiogenic agents.

研究概览

地位

完全的

详细说明

Lung and bronchopulmonary cancer is the leading cause of cancer death in France and worldwide. It is diagnosed at the metastatic stage from the outset in approximately 50% of cases. Non-small cell lung cancers (NSCLC) are the most frequent histological forms of lung cancer (approximately 85% of cases) with a predominance of the non-epidermal type.

The increase in the number of treatments available, improved supportive care and better patient selection have, in recent years, made it possible to expand the range of first-line chemotherapy treatments available at delà̀ and have contributed to the increase in overall survival (OS). As a result, nearly 80% of patients with metastatic NSCLC receive a second line of treatment. The main objective in these often symptomatic patients is a satisfactory tumor control rate with acceptable tolerability.

For a long time, the second-line reference chemotherapy has been docetaxel or pemetrexed as monotherapy with modest results. Alternative treatments such as the combination of paclitaxel (chemotherapy)-bevacizumab (anti-angiogenic monoclonal antibody) have been studied. Since 2010, by analogy with breast cancer and in the absence of therapeutic alternatives, the paclitaxel-bevacizumab doublet has been used in non-epidermal stage IV NSCLC in France. The value of combining taxane chemotherapy with an anti-angiogenic molecule has been demonstrated in two Phase 3 clinical trials. Thus, this combination is an integral part of the possible treatments in 2nd line and beyond, registered since 2016 in the treatment guidelines for non-epidermal NSCLC.

The first-line therapeutic strategy will also be redefined in 2019 with the use of immunotherapy for a majority of patients. Subsequent treatment lines will be modified, with a focus on chemotherapy, in particular the paclitaxel-bevacizumab combination.

As this combination has been used in current practice for several years, and in view of the upcoming changes to the first and second line of NSCLC treatment, data on the efficacy and tolerance of this combination in real life are needed to guide our practices. Recent studies are also looking at the efficacy of chemotherapy, particularly taxane chemotherapy associated with an anti-angiogenic agent after a previous line including immunotherapy, with a favorable signal.

The aim of the study is to evaluate the paclitaxel-bevacizumab combination retrospectively and multicenter in current practice, with subgroup analyses of the following patients: patients who have previously received immunotherapy, patients with an EGFR or ALK oncogenic addiction pathway, patients who have previously received taxanes or anti-angiogenic agents.

研究类型

观察性的

注册 (实际的)

320

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Boulogne Billancourt、法国
        • Hôpital Ambroise Paré AP-HP
      • Brest、法国
        • Centre Hospitalier Universitaire Brest
      • Chambéry、法国
        • Centre Hospitalier Metropole Savoie
      • Créteil、法国
        • Centre Hospitalier Intercommunal De Créteil
      • Grenoble、法国
        • Centre Hospitalier Universitaire Grenoble Alpes
      • Le Chesnay、法国
        • Centre Hospitalier de Versailles André Mignot
      • Lille、法国
        • Centre Hospitalier Universitaire de Lille
      • Lyon、法国
        • Hospices Civils de Lyon
      • Lyon、法国
        • Centre Léon Bérard Lyon
      • Mantes-la-Jolie、法国
        • Centre Hospitalier François Quesnay
      • Metz-Tessy、法国、74374
        • Centre Hospitalier Annecy Genevois
      • Paris、法国
        • Institut Curie
      • Saint-Cloud、法国
        • Institut Curie Saint Cloud
      • Saint-Étienne、法国
        • Institut de Cancérologie Lucien Neuwirth
      • Suresnes、法国
        • Hopital Foch

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

The study will include all eligible patients who started paclitaxel-bevacizumab between January 1, 2010 and May 1, 2018. The number of patients is estimated to be approximately 200.

描述

Inclusion Criteria:

  • At least 18 years old;
  • Histologically or cytologically confirmed diagnosis of non-epidermal NSCLC;
  • Advanced stage IV disease at the start of treatment with paclitaxel-bevacizumab according to TNM 7/8th edition classification;
  • Treatment with paclitaxel-bevacizumab received as second-line therapy or beyond, in a clinical trial or not;
  • Alive patients not opposed to the use of their data

Exclusion Criteria:

  • Patient under guardianship or curatorship at the date of the study ;
  • Patients alive at the time of the study who are opposed to the use of their data
  • Opposition to the use of their data expressed during the lifetime of patients who died at the time of the study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Progression-free survival
大体时间:Up to 12 months
Progression-free survival with paclitaxel-bevacizumab, i.e., the time from the start of paclitaxel-bevacizumab treatment to cancer progression, estimated at 12 months in the general population.
Up to 12 months

次要结果测量

结果测量
措施说明
大体时间
Drugs administration dosage description
大体时间:Up to 12 months
Description of the different monthly drug administration regimens
Up to 12 months
Objective response rate and control rate
大体时间:Up to 12 months
Objective response rate and control rate according to RECIST 1.1 criteria in the general population
Up to 12 months
Overall survival Rate
大体时间:Up to 12 months
Overall survival, assessed on the whole population
Up to 12 months
Objective Response Rate
大体时间:Up to 12 months

Objective Response Rate in the following subgroups:

  • patients treated after immunotherapy and especially immediately after immunotherapy;
  • Patients with an oncogenic EGFR or ALK addiction pathway;
  • Patients previously treated with taxanes;
  • Patients previously treated with anti-angiogenic drugs;
Up to 12 months
Progression-Free Survival Rate
大体时间:Up to 12 months

Progression-Free Survival in the following subgroups:

  • patients treated after immunotherapy and especially immediately after immunotherapy;
  • Patients with an oncogenic EGFR or ALK addiction pathway;
  • Patients previously treated with taxanes;
  • Patients previously treated with anti-angiogenic drugs;
Up to 12 months
Disease Control Rate
大体时间:Up to 12 months

Disease Control in the following subgroups:

  • patients treated after immunotherapy and especially immediately after immunotherapy;
  • Patients with an oncogenic EGFR or ALK addiction pathway;
  • Patients previously treated with taxanes;
  • Patients previously treated with anti-angiogenic drugs;
Up to 12 months
Overall Survival Rate
大体时间:Up to 12 months

Overall Survival in the following subgroups:

  • Patients treated after immunotherapy and especially immediately after immunotherapy;
  • Patients with an oncogenic EGFR or ALK addiction pathway;
  • Patients previously treated with taxanes;
  • Patients previously treated with anti-angiogenic drugs;
Up to 12 months
Frequency of safety events
大体时间:Up to 12 months
Frequency of grade ≥3 adverse events and frequency of discontinuation of paclitaxel-bevacizumab for toxicity ;
Up to 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Chantal Decroisette、Ch Annecy Genevois

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年10月1日

初级完成 (实际的)

2020年6月5日

研究完成 (实际的)

2020年6月5日

研究注册日期

首次提交

2020年11月9日

首先提交符合 QC 标准的

2020年11月20日

首次发布 (实际的)

2020年11月23日

研究记录更新

最后更新发布 (实际的)

2020年11月23日

上次提交的符合 QC 标准的更新

2020年11月20日

最后验证

2020年11月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

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研究美国 FDA 监管的设备产品

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