非小细胞肺癌治疗性临床试验入组障碍。

Barriers to enrollment in non-small cell lung cancer therapeutic clinical trials.

机构信息

Division of Oncology, Department of Medicine, Washington University School of Medicine, St Louis, Missouri, USA.

出版信息

J Thorac Oncol. 2011 Jan;6(1):98-102. doi: 10.1097/JTO.0b013e3181fb50d8.

DOI:10.1097/JTO.0b013e3181fb50d8

PMID:21150469

Abstract

INTRODUCTION

Despite recent advances in treatment, lung cancer remains the leading cause of cancer-related mortality in the United States. Therefore, there is a strong need for developing clinical trials in lung cancer therapeutics. Only a small fraction of patients with lung cancer are enrolled in clinical trials. It is critical to understand the barriers to participation in lung cancer clinical trials.

METHODS

We reviewed the outpatient charts of consecutive patients with non-small cell lung cancer who presented for initial evaluation or consultation for further therapeutic management to the thoracic medical oncology group at the Alvin J. Siteman Cancer Center between January 1, 2006, and December 31, 2006. Available and appropriate clinical trials specific to the histologic subtype and stage were presented to the patients routinely, and reasons for nonenrollment were documented. We collected information on age, gender, ethnicity, histology, stage, performance status (PS), and insurance status.

RESULTS

During the study period, 263 patients with non-small cell lung cancer were identified for the study. After initial screening, 183 patients had clinical trials available, which were appropriate for their diagnosis and stage of disease. One hundred one patients (55.2%) were ineligible for enrollment in a clinical trial. The most common reasons for ineligibility were poor PS (18%), need for emergent radiation (12%), lack of adequate staging information (6%), and comorbid conditions (4.9%). Despite being eligible for participation, 57 patients (31.1%) did not enroll in a clinical trial. Patient refusal accounted for 8.7%. The problems with transportation and distance from the medical center were reasons given for nonparticipation by 7.1%. Eleven patients (6%) did not participate in a clinical trial because of insurance issues. Ultimately, 25 patients (13.7%) were enrolled in a clinical trial.

CONCLUSIONS

Poor PS, the need for emergent radiation, and patient refusal were the most common reasons for not participating in a clinical trial.

摘要

简介

尽管治疗方法近年来取得了进展，但肺癌仍是美国癌症相关死亡的主要原因。因此，对于肺癌治疗的临床试验，有着强烈的需求。只有一小部分肺癌患者参与了临床试验。了解参与肺癌临床试验的障碍至关重要。

方法

我们回顾了 2006 年 1 月 1 日至 2006 年 12 月 31 日期间，在 Alvin J. Siteman 癌症中心胸部肿瘤内科就诊的连续非小细胞肺癌患者的门诊病历。我们常规向患者提供与组织学亚型和分期相对应的、合适的临床试验，并记录未入组的原因。我们收集了患者的年龄、性别、种族、组织学、分期、体能状态（PS）和保险状况等信息。

结果

在研究期间，我们确定了 263 名非小细胞肺癌患者。经过初步筛选，有 183 名患者有合适的临床试验，这些试验适合他们的诊断和疾病分期。101 名患者（55.2%）不符合入组临床试验的条件。不符合入组条件的最常见原因是 PS 较差（18%）、需要紧急放疗（12%）、分期信息不足（6%）和合并症（4.9%）。尽管有资格参与，但仍有 57 名患者（31.1%）未参加临床试验。患者拒绝参加占 8.7%。交通不便和距离医疗中心远是 7.1%患者未参与的原因。有 11 名患者（6%）因保险问题未参加临床试验。最终，25 名患者（13.7%）入组了临床试验。