title: Prospective Clinical Study of Precision Oncology in Solid Tumors.
abstract: Systematic studies evaluating clinical benefit of tumor genomic profiling are lacking. We conducted a prospective study in 250 patients with select solid tumors at the Cleveland Clinic. Eligibility required histopathologic diagnosis, age of 18 years or older, Eastern Cooperative Oncology Group performance status 0-2, and written informed consent. Tumors were sequenced using FoundationOne (Cambridge, MA). Results were reviewed at the Cleveland Clinic Genomics Tumor Board. Outcomes included feasibility and clinical impact. Colorectal (25%), breast (18%), lung (13%), and pancreatobiliary (13%) cancers were the most common diagnoses. Median time from consent to result was 25 days (range = 3-140). Of 223 evaluable samples, 49% (n = 109) of patients were recommended a specific therapy, but only 11% (n = 24) received such therapy: 12 on clinical trials, nine off-label, three on-label. Lack of clinical trial access (n = 49) and clinical deterioration (n = 29) were the most common reasons for nonrecommendation/nonreceipt of genomics-driven therapy.
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH (DPSS, BIR, AAK, RD, JA, GWP, YS, NAP, JPS, RP, BE, DS, PF, PE, DJA, BJB); University of Virginia School of Medicine, Charlottesville, VA (RD). sohald@ccf.org.
authors.forename: Davendra P S
authors.initials: DP
authors.lastname: Sohal
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH (DPSS, BIR, AAK, RD, JA, GWP, YS, NAP, JPS, RP, BE, DS, PF, PE, DJA, BJB); University of Virginia School of Medicine, Charlottesville, VA (RD).
authors.forename: Brian I
authors.initials: BI
authors.lastname: Rini
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH (DPSS, BIR, AAK, RD, JA, GWP, YS, NAP, JPS, RP, BE, DS, PF, PE, DJA, BJB); University of Virginia School of Medicine, Charlottesville, VA (RD).
authors.forename: Alok A
authors.initials: AA
authors.lastname: Khorana
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH (DPSS, BIR, AAK, RD, JA, GWP, YS, NAP, JPS, RP, BE, DS, PF, PE, DJA, BJB); University of Virginia School of Medicine, Charlottesville, VA (RD).
authors.forename: Robert
authors.initials: R
authors.lastname: Dreicer
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH (DPSS, BIR, AAK, RD, JA, GWP, YS, NAP, JPS, RP, BE, DS, PF, PE, DJA, BJB); University of Virginia School of Medicine, Charlottesville, VA (RD).
authors.forename: Jame
authors.initials: J
authors.lastname: Abraham
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH (DPSS, BIR, AAK, RD, JA, GWP, YS, NAP, JPS, RP, BE, DS, PF, PE, DJA, BJB); University of Virginia School of Medicine, Charlottesville, VA (RD).
authors.forename: Gary W
authors.initials: GW
authors.lastname: Procop
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH (DPSS, BIR, AAK, RD, JA, GWP, YS, NAP, JPS, RP, BE, DS, PF, PE, DJA, BJB); University of Virginia School of Medicine, Charlottesville, VA (RD).
authors.forename: Yogen
authors.initials: Y
authors.lastname: Saunthararajah
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH (DPSS, BIR, AAK, RD, JA, GWP, YS, NAP, JPS, RP, BE, DS, PF, PE, DJA, BJB); University of Virginia School of Medicine, Charlottesville, VA (RD).
authors.forename: Nathan A
authors.initials: NA
authors.lastname: Pennell
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH (DPSS, BIR, AAK, RD, JA, GWP, YS, NAP, JPS, RP, BE, DS, PF, PE, DJA, BJB); University of Virginia School of Medicine, Charlottesville, VA (RD).
authors.forename: James P
authors.initials: JP
authors.lastname: Stevenson
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH (DPSS, BIR, AAK, RD, JA, GWP, YS, NAP, JPS, RP, BE, DS, PF, PE, DJA, BJB); University of Virginia School of Medicine, Charlottesville, VA (RD).
authors.forename: Robert
authors.initials: R
authors.lastname: Pelley
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH (DPSS, BIR, AAK, RD, JA, GWP, YS, NAP, JPS, RP, BE, DS, PF, PE, DJA, BJB); University of Virginia School of Medicine, Charlottesville, VA (RD).
authors.forename: Bassam
authors.initials: B
authors.lastname: Estfan
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH (DPSS, BIR, AAK, RD, JA, GWP, YS, NAP, JPS, RP, BE, DS, PF, PE, DJA, BJB); University of Virginia School of Medicine, Charlottesville, VA (RD).
authors.forename: Dale
authors.initials: D
authors.lastname: Shepard
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH (DPSS, BIR, AAK, RD, JA, GWP, YS, NAP, JPS, RP, BE, DS, PF, PE, DJA, BJB); University of Virginia School of Medicine, Charlottesville, VA (RD).
authors.forename: Pauline
authors.initials: P
authors.lastname: Funchain
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH (DPSS, BIR, AAK, RD, JA, GWP, YS, NAP, JPS, RP, BE, DS, PF, PE, DJA, BJB); University of Virginia School of Medicine, Charlottesville, VA (RD).
authors.forename: Paul
authors.initials: P
authors.lastname: Elson
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH (DPSS, BIR, AAK, RD, JA, GWP, YS, NAP, JPS, RP, BE, DS, PF, PE, DJA, BJB); University of Virginia School of Medicine, Charlottesville, VA (RD).
authors.forename: David J
authors.initials: DJ
authors.lastname: Adelstein
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH (DPSS, BIR, AAK, RD, JA, GWP, YS, NAP, JPS, RP, BE, DS, PF, PE, DJA, BJB); University of Virginia School of Medicine, Charlottesville, VA (RD).
authors.forename: Brian J
authors.initials: BJ
authors.lastname: Bolwell
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000494:pharmacology; D001661:Biliary Tract Neoplasms / Q000188:drug therapy / Q000235:genetics; D001943:Breast Neoplasms / Q000188:drug therapy / Q000235:genetics; D015179:Colorectal Neoplasms / Q000188:drug therapy / Q000235:genetics; D004273:DNA, Neoplasm / Q000032:analysis*; D005240:Feasibility Studies; D005260:Female; D020869:Gene Expression Profiling; D015972:Gene Expression Regulation, Neoplastic; D006801:Humans; D008297:Male; D008495:Medical Oncology / Q000639:trends*; D008875:Middle Aged; D058990:Molecular Targeted Therapy / Q000639:trends; D009369:Neoplasms / Q000188:drug therapy* / Q000235:genetics*; D010190:Pancreatic Neoplasms / Q000188:drug therapy / Q000235:genetics; D057285:Precision Medicine; D011446:Prospective Studies; D017422:Sequence Analysis, DNA
chemical_list: D000970:Antineoplastic Agents; D004273:DNA, Neoplasm