W Jeffrey Petty1, James J Urbanic2, Tamjeed Ahmed3, Ryan Hughes4, Beverly Levine5, Kyle Rusthoven6, Michael Papagikos7, Jimmy R Ruiz1, Brian E Lally8, Michael Chan8, Hollins Clark9, Ralph B D'Agostino5, A William Blackstock8. 1. Department of Medicine, Section on Hematology and Oncology, Wake Forest School of Medicine, Wake Forest University, Winston-Salem, North Carolina; Comprehensive Cancer Center of Wake Forest University, Wake Forest School of Medicine, Wake Forest University, Winston-Salem, North Carolina. 2. Comprehensive Cancer Center of Wake Forest University, Wake Forest School of Medicine, Wake Forest University, Winston-Salem, North Carolina; Department of Radiation Oncology, Wake Forest School of Medicine, Wake Forest University, Winston-Salem, North Carolina; Moores Cancer Center, University of California, San Diego, La Jolla, California. Electronic address: jurbanic@ucsd.edu. 3. Department of Medicine, Section on Hematology and Oncology, Wake Forest School of Medicine, Wake Forest University, Winston-Salem, North Carolina. 4. Department of Radiation Oncology, Wake Forest School of Medicine, Wake Forest University, Winston-Salem, North Carolina. 5. Comprehensive Cancer Center of Wake Forest University, Wake Forest School of Medicine, Wake Forest University, Winston-Salem, North Carolina; Department of Biostatistical Sciences, Wake Forest School of Medicine, Wake Forest University, Winston-Salem, North Carolina. 6. Eastern Radiation Oncology, Morehead City, North Carolina. 7. Coastal Carolina Radiation Oncology, Wilmington, North Carolina. 8. Comprehensive Cancer Center of Wake Forest University, Wake Forest School of Medicine, Wake Forest University, Winston-Salem, North Carolina; Department of Radiation Oncology, Wake Forest School of Medicine, Wake Forest University, Winston-Salem, North Carolina. 9. Department of Radiology, Wake Forest School of Medicine, Wake Forest University, Winston-Salem, North Carolina.
Abstract
PURPOSE: Recent data indicate consolidative radiation therapy improves progression-free survival (PFS) for patients with oligometastatic non-small cell lung cancer (NSCLC). Data on long-term outcomes are limited. METHODS AND MATERIALS: This prospective, multicenter, single-arm, phase 2 trial was initiated in 2010 and enrolled patients with oligometastatic NSCLC. Oligometastatic disease was defined as a maximum of 5 metastatic lesions for all disease sites, including no more than 3 active extracranial metastatic lesions. Limited mediastinal lymph node involvement was allowed. Patients achieving a partial response or stable disease after 3 to 6 cycles of platinum-based chemotherapy were treated with CRT to the primary and metastatic sites of disease, followed by observation alone. The primary endpoint was PFS, with secondary endpoints of local control, overall survival (OS), and safety. RESULTS: Twenty-nine patients were enrolled between October 2010 and October 2015, and 27 were eligible for consolidative radiation therapy. The study was closed early because of slow accrual but met its primary endpoint for success, which was PFS >6 months (P < .0001). The median PFS (95% confidence interval) was 11.2 months (7.6-15.9 months), and the median OS was 28.4 months (14.5-45.8 months). Survival outcomes were not significantly different for patients with brain metastases (P = .87 for PFS; P = .12 for OS) or lymph node involvement (P = .74 for PFS; P = .86 for OS). CONCLUSIONS: For patients with oligometastatic NSCLC, chemotherapy followed by consolidative radiation therapy without maintenance chemotherapy was associated with encouraging long-term outcomes.
PURPOSE: Recent data indicate consolidative radiation therapy improves progression-free survival (PFS) for patients with oligometastatic non-small cell lung cancer (NSCLC). Data on long-term outcomes are limited. METHODS AND MATERIALS: This prospective, multicenter, single-arm, phase 2 trial was initiated in 2010 and enrolled patients with oligometastatic NSCLC. Oligometastatic disease was defined as a maximum of 5 metastatic lesions for all disease sites, including no more than 3 active extracranial metastatic lesions. Limited mediastinal lymph node involvement was allowed. Patients achieving a partial response or stable disease after 3 to 6 cycles of platinum-based chemotherapy were treated with CRT to the primary and metastatic sites of disease, followed by observation alone. The primary endpoint was PFS, with secondary endpoints of local control, overall survival (OS), and safety. RESULTS: Twenty-nine patients were enrolled between October 2010 and October 2015, and 27 were eligible for consolidative radiation therapy. The study was closed early because of slow accrual but met its primary endpoint for success, which was PFS >6 months (P < .0001). The median PFS (95% confidence interval) was 11.2 months (7.6-15.9 months), and the median OS was 28.4 months (14.5-45.8 months). Survival outcomes were not significantly different for patients with brain metastases (P = .87 for PFS; P = .12 for OS) or lymph node involvement (P = .74 for PFS; P = .86 for OS). CONCLUSIONS: For patients with oligometastatic NSCLC, chemotherapy followed by consolidative radiation therapy without maintenance chemotherapy was associated with encouraging long-term outcomes.
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