Local Consolidative Therapy Vs. Maintenance Therapy or Observation for Patients With Oligometastatic Non–Small-Cell Lung Cancer: Long-Term Results of a Multi-Institutional, Phase II, Randomized Study
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- Daniel R. Gomez
- The University of Texas MD Anderson Cancer Center, Houston, TX
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- Chad Tang
- The University of Texas MD Anderson Cancer Center, Houston, TX
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- Jianjun Zhang
- The University of Texas MD Anderson Cancer Center, Houston, TX
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- George R. Blumenschein
- The University of Texas MD Anderson Cancer Center, Houston, TX
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- Mike Hernandez
- The University of Texas MD Anderson Cancer Center, Houston, TX
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- J. Jack Lee
- The University of Texas MD Anderson Cancer Center, Houston, TX
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- Rong Ye
- The University of Texas MD Anderson Cancer Center, Houston, TX
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- David A. Palma
- London Health Sciences Center, London, Ontario, Canada
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- Alexander V. Louie
- London Health Sciences Center, London, Ontario, Canada
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- D. Ross Camidge
- University of Colorado School of Medicine, Aurora, CO
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- Robert C. Doebele
- University of Colorado School of Medicine, Aurora, CO
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- Ferdinandos Skoulidis
- The University of Texas MD Anderson Cancer Center, Houston, TX
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- Laurie E. Gaspar
- University of Colorado School of Medicine, Aurora, CO
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- James W. Welsh
- The University of Texas MD Anderson Cancer Center, Houston, TX
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- Don L. Gibbons
- The University of Texas MD Anderson Cancer Center, Houston, TX
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- Jose A. Karam
- The University of Texas MD Anderson Cancer Center, Houston, TX
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- Brian D. Kavanagh
- University of Colorado School of Medicine, Aurora, CO
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- Anne S. Tsao
- The University of Texas MD Anderson Cancer Center, Houston, TX
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- Boris Sepesi
- The University of Texas MD Anderson Cancer Center, Houston, TX
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- Stephen G. Swisher
- The University of Texas MD Anderson Cancer Center, Houston, TX
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- John V. Heymach
- The University of Texas MD Anderson Cancer Center, Houston, TX
Description
<jats:sec><jats:title>PURPOSE</jats:title><jats:p> Our previously published findings reported that local consolidative therapy (LCT) with radiotherapy or surgery improved progression-free survival (PFS) and delayed new disease in patients with oligometastatic non–small-cell lung cancer (NSCLC) that did not progress after front-line systemic therapy. Herein, we present the longer-term overall survival (OS) results accompanied by additional secondary end points. </jats:p></jats:sec><jats:sec><jats:title>PATIENTS AND METHODS</jats:title><jats:p> This multicenter, randomized, phase II trial enrolled patients with stage IV NSCLC, three or fewer metastases, and no progression at 3 or more months after front-line systemic therapy. Patients were randomly assigned (1:1) to maintenance therapy or observation (MT/O) or to LCT to all active disease sites. The primary end point was PFS; secondary end points were OS, toxicity, and the appearance of new lesions. All analyses were two sided, and P values less than .10 were deemed significant. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> The Data Safety and Monitoring Board recommended early trial closure after 49 patients were randomly assigned because of a significant PFS benefit in the LCT arm. With an updated median follow-up time of 38.8 months (range, 28.3 to 61.4 months), the PFS benefit was durable (median, 14.2 months [95% CI, 7.4 to 23.1 months] with LCT v 4.4 months [95% CI, 2.2 to 8.3 months] with MT/O; P = .022). We also found an OS benefit in the LCT arm (median, 41.2 months [95% CI, 18.9 months to not reached] with LCT v 17.0 months [95% CI, 10.1 to 39.8 months] with MT/O; P = .017). No additional grade 3 or greater toxicities were observed. Survival after progression was longer in the LCT group (37.6 months with LCT v 9.4 months with MT/O; P = .034). Of the 20 patients who experienced progression in the MT/O arm, nine received LCT to all lesions after progression, and the median OS was 17 months (95% CI, 7.8 months to not reached). </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> In patients with oligometastatic NSCLC that did not progress after front-line systemic therapy, LCT prolonged PFS and OS relative to MT/O. </jats:p></jats:sec>
Journal
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- Journal of Clinical Oncology
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Journal of Clinical Oncology 37 (18), 1558-1565, 2019-06-20
American Society of Clinical Oncology (ASCO)
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Details 詳細情報について
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- CRID
- 1363107370304419200
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- ISSN
- 15277755
- 0732183X
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- Data Source
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- Crossref