Effect of clinical NGS-based cancer genomic profiling on physician treatment decisions in advanced solid tumors.
Molecular Diagnostics and Imaging
2014 ASCO Annual Meeting
J Clin Oncol 32:5s, 2014 (suppl; abstr 11109)
2014 ASCO Annual Meeting!
Session: Tumor Biology
Type: General Poster Session
Time: Saturday May 31, 1:15 PM to 5:00 PM
Location: S Hall A2
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Author(s): Fadi S. Braiteh, Jeff Porter Sharman, Donald A. Richards, Matthew Rama Skelton, Linda Cheryl DeMarco, Sasha Vukelja, Ian Schnadig, Sharon Wilks, Christopher A. Yasenchak, Jerome H. Goldschmidt, Regina Resta, Stephen Lane Richey, John W. Smith, Lina Asmar, Yunfei Wang, Ann Morcos, Tracy Locke, Yali Li, Gary A. Palmer; Comprehensive Cancer Centers of Nevada, Las Vegas, NV, and US Oncology Research, Houston, TX; Willamette Valley Cancer Institute and Research Center/US Oncology Research, Springfield, OR; Tyler Cancer Center, US Oncology Research, McKesson Specialty Health, Houston, TX; Blue Ridge Cancer Care, US Oncology Research, McKesson Specialty Health, Roanoke, VA; New York Oncology Hematology PC, US Oncology Research, McKesson Specialty Health, Hudson, NY; Texas Oncology - Tyler, US Oncology Research, McKesson Specialty Health, Tyler, TX; Compass Oncology, US Oncology Research, McKesson Specialty Health, Tualatin, OR; Cancer Care Centers of South Texas, US Oncology Research, McKesson Specialty Health, San Antonio, TX; Compass Oncology/US Oncology Research, McKesson Specialty Health, Tualatin, OR; Oncology and Hematology Associates of Southwest Virginia, US Oncology Research, McKesson Specialty Health, Christiansburg, VA; New York Oncology Hematology, US Oncology Research, McKesson Specialty Health, Hudson, NY; Texas Oncology - Fort Worth, US Oncology, McKesson Specialty Health, Fort Worth, TX; Compass Oncology, US Oncology Research, McKesson Specialty Health, Portland, OR; US Oncology Research, LLC, McKesson Specialty Health, The Woodlands, TX; Foundation Medicine, Inc., Cambridge, MA
Background: Next generation sequencing (NGS) of routinely fixed tissue from pts with advanced solid tumors may inform treatment planning. Foundation Medicine has developed a CLIA-certified, CAP-accredited test (FoundationOne, F1) to simultaneously characterize all 4 classes of genomic alterations in 236 (originally 182) cancer genes. Primary study objective was to determine how many physicians would change treatment approach based on F1 results (switch rate=SR). An exploratory objective was to compare PFS impact of any switches. Methods: This was a prospective, multicenter, single-arm trial in pts with refractory metastatic solid tumors of any type. Eligible pts must have been receiving second- or third-line therapy (first-line for pancreatic) and were initially registered within 10 weeks of beginning a regimen and before response assessment reimaging. Tumors were assayed with F1 after initial registration. Upon progression and documentation of next proposed therapy, they were re-registered and results of F1 were provided to doctors. If F1 caused a change in proposed therapy, a switch was recorded. Results: 233 pts were eligible; 103 were not re-registered (pt died, investigator decision, withdrew consent). Two questionnaires were missing; 128 pts were included in this analysis. Median age 61 yrs; female (65.6%). Tumor types mainly included breast (20%), lung (16%), and colon (13%). The SR was 28.1% (36 switch, 92 no switch). For 95 treated pts, the SR was 27.4% (26 received switch drug, 69 received initial recommendation; [33 pts did not receive Rx due to PD, death, hospice, or pt decision]). All of the major tumor types above had switch rates above 20%. In 77% of nonswitch cases, physicians reported that there were “not enough” treatment options available. Data collection for PFS analysis and correlation of results to tumor genomic profiles are ongoing. Conclusions: Comprehensive NGS-based profiling resulted in altered therapeutic choice in 28% of advanced solid tumor patients in the community setting, highlighting the current broad applicability of this approach. As more targeted therapeutics advance to larger trials and become approved, the impact of comprehensive testing may be expected to increase.
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