Literature DB >> 21150469

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

Maria Q Baggstrom1, Saiama N Waqar, Ananth K Sezhiyan, Eve Gilstrap, Feng Gao, Daniel Morgensztern, Ramaswamy Govindan.   

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.

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Year:  2011        PMID: 21150469     DOI: 10.1097/JTO.0b013e3181fb50d8

Source DB:  PubMed          Journal:  J Thorac Oncol        ISSN: 1556-0864            Impact factor:   15.609


  25 in total

1.  Motivations of patients with pulmonary arterial hypertension to participate in randomized clinical trials.

Authors:  Ricki Carroll; Jules Antigua; Darren Taichman; Harold Palevsky; Paul Forfia; Steven Kawut; Scott D Halpern
Journal:  Clin Trials       Date:  2012-03-02       Impact factor: 2.486

2.  Thoracic Oncology Clinical Trial Eligibility Criteria and Requirements Continue to Increase in Number and Complexity.

Authors:  Sandra Garcia; Ajit Bisen; Jingsheng Yan; Xian-Jin Xie; Suresh Ramalingam; Joan H Schiller; David H Johnson; David E Gerber
Journal:  J Thorac Oncol       Date:  2017-08-09       Impact factor: 15.609

3.  Large clinical databases for the study of lung cancer: Making up for the failure of randomized trials.

Authors:  Chi-Fu Jeffrey Yang; Matthew G Hartwig; Thomas A D'Amico; Mark F Berry
Journal:  J Thorac Cardiovasc Surg       Date:  2015-09-05       Impact factor: 5.209

Review 4.  Strengths and limitations of large databases in lung cancer radiation oncology research.

Authors:  Vikram Jairam; Henry S Park
Journal:  Transl Lung Cancer Res       Date:  2019-09

5.  Efficacy and safety of pembrolizumab as first-line therapy in advanced non-small cell lung cancer with at least 50% PD-L1 positivity: a multicenter retrospective cohort study (HOPE-001).

Authors:  Motohiro Tamiya; Akihiro Tamiya; Kazutaka Hosoya; Yoshihiko Taniguchi; Toshihide Yokoyama; Yasushi Fukuda; Katsuya Hirano; Hirotaka Matsumoto; Ryota Kominami; Hidekazu Suzuki; Tomonori Hirashima; Junji Uchida; Mitsunori Morita; Masaki Kanazu; Nobuhiko Sawa; Yoshinori Kinoshita; Satoshi Hara; Toru Kumagai; Daichi Fujimoto
Journal:  Invest New Drugs       Date:  2019-08-07       Impact factor: 3.850

Review 6.  ALK inhibitors, resistance development, clinical trials.

Authors:  J M Rothenstein; N Chooback
Journal:  Curr Oncol       Date:  2018-06-13       Impact factor: 3.677

7.  Clinical trial participation among ethnic/racial minority and majority patients with advanced cancer: what factors most influence enrollment?

Authors:  Rachel Jimenez; Baohui Zhang; Steven Joffe; Matthew Nilsson; Lorna Rivera; Jan Mutchler; Christopher Lathan; M Elizabeth Paulk; Holly G Prigerson
Journal:  J Palliat Med       Date:  2013-02-05       Impact factor: 2.947

8.  Engaging patients and caregivers in patient-centered outcomes research on advanced stage lung cancer: insights from patients, caregivers, and providers.

Authors:  K M Islam; Samuel T Opoku; Bettye A Apenteng; Ann Fetrick; June Ryan; M Copur; Addison Tolentino; Irfan Vaziri; Apar K Ganti
Journal:  J Cancer Educ       Date:  2014-12       Impact factor: 2.037

9.  The bottleneck effect in lung cancer clinical trials.

Authors:  Luis E Gonzalez; Steven K Sutton; Christie Pratt; Matthew Gilbertson; Scott Antonia; Gwendolyn P Quinn
Journal:  J Cancer Educ       Date:  2013-09       Impact factor: 2.037

Review 10.  Designing therapeutic clinical trials for older and frail adults with cancer: U13 conference recommendations.

Authors:  Arti Hurria; William Dale; Margaret Mooney; Julia H Rowland; Karla V Ballman; Harvey J Cohen; Hyman B Muss; Richard L Schilsky; Betty Ferrell; Martine Extermann; Kenneth E Schmader; Supriya G Mohile
Journal:  J Clin Oncol       Date:  2014-08-20       Impact factor: 44.544

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