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Initiative for Early Lung Cancer Research on Treatment: Development of Study Design and Pilot Implementation
Journal of Thoracic Oncology ( IF 21.0 ) Pub Date : 2018-03-23
Raja Flores, Emanuela Taioli, David F. Yankelevitz, Betsy Jane Becker, Artit Jirapatnakul, Anthony Reeves, Rebecca Schwartz, Rowena Yip, Esther Fevrier, Kathleen Tam, Benjamin Steiger, Claudia I. Henschke, Raja Flores, Andrew Kaufman, Dong-Seok Lee, Daniel Nicastri, Andrea Wolf, Kenneth Rosenzweig, Jorge Gomez, Mary Beth Beasley, Maureen Zakowski, Michael Chung, David Yankelevitz, Claudia Henschke, Rita Futamura, Sydney Kantor, Carly Wallace, Faiz Bhora, Wissam Raad, Andrew Evans, Walter Choi, Zrzu Buyuk, Adie Friedman, Ronald Dreifuss, Stacey Verzosa, Mariya Yakubox, Karina Aloferdova, Patricia Stacey, Simone De Nobrega, Rita Futamura, Sydney Kantor, Carly Wallace, Ardeshir Hakami, Kathleen Tam, Carly Wallace, Harvey Pass, Berne Crawford, Jessica Donnington, Benjamin Cooper

Purpose

To maximize the benefits of CT screening for lung cancer, optimal treatment is for small, early lung cancers is needed. Limiting the extent of surgery spares lung tissue, preserves pulmonary function, and decreases operative time, complications, and morbidities. It also increases the likelihood of resecting future new primary lung cancers. The goal is to assess alternative treatments in a timely manner.

Methods

The focus sessions with patients and physicians separately highlighted the need to consider their perceptions. Literature reviews and analyses of treatment results using large databases were performed to formulate critical questions about long-term treatment outcomes, recurrence, and quality of life (QoL) of alternative treatments. Based on these analyses, the investigators developed a prospective multi-institutional cohort study, the Initiative for Early Lung Cancer Research for Treatment (IELCART), to compare treatments for Stage I non-small-cell lung cancer (NSCLC). HIPAA compliant IRB approval was obtained and we performed a feasibility study of the first 200 surgical patients.

Results

Lobectomy was performed in 89 (44.5%) patients and sublobar resection in 111 (55.5%). Mediastinal lymph node resection was performed in 162 (81.0%) patients, 8 had N1 and 2 N2 lymph node metastases. Patients stated that both the surgeon’s opinion (93%) and the patient’s own opinion (93%) were extremely important, followed by the patients’ view that the chosen procedure would provide the best QoL (90%).

Conclusions

It was feasible to obtain pre- and post-surgical information from patients and surgeons. We anticipate statistically meaningful results about treatment alternatives in 3 to 5 years.



中文翻译:

早期肺癌治疗研究计划:研究设计开发和试点实施

目的

为了最大化CT筛查对肺癌的益处,需要针对小型早期肺癌的最佳治疗方法。限制手术范围可以节省肺组织,保留肺功能,并减少手术时间,并发症和发病率。它还增加了切除未来新发原发性肺癌的可能性。目的是及时评估替代治疗。

方法

与患者和医生的专题讨论会分别强调需要考虑他们的看法。使用大型数据库进行文献综述和治疗结果分析,以制定有关替代治疗的长期治疗结果,复发和生活质量(QoL)的关键问题。基于这些分析,研究人员开展了一项前瞻性多机构队列研究,即早期肺癌治疗研究计划(IELCART),以比较I期非小细胞肺癌(NSCLC)的治疗方法。获得了符合HIPAA要求的IRB批准,并且我们对前200名手术患者进行了可行性研究。

结果

89例(44.5%)患者进行了肺叶切除,111例(55.5%)进行了肺叶切除。162例(81.0%)患者进行了纵隔淋巴结切除,其中8例发生了N1和2 N2淋巴结转移。患者表示,外科医生的意见(93%)和患者自己的意见(93%)都非常重要,其次是患者认为所选程序将提供最佳的QoL(90%)。

结论

从患者和外科医生那里获得手术前后的信息是可行的。我们预计在3到5年内,关于替代治疗的统计意义上有意义的结果。

更新日期:2018-03-24
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