title: Clinical Trial Accrual Targeting Genomic Alterations After Next-Generation Sequencing at a Non-National Cancer Institute-Designated Cancer Program.
abstract: OBJECTIVE
  Successful clinical trial accrual targeting uncommon genomic alterations will require broad national participation from both National Cancer Institute (NCI)-designated comprehensive cancer centers and community cancer programs. This report describes the initial experience with clinical trial accrual after next-generation sequencing (NGS) from three affiliated non-NCI-designated cancer programs.
  
  
  METHODS
  Clinical trial participation was reviewed after enrollment of the first 200 patients undergoing comprehensive genomic profiling by NGS as part of an institutional intuitional review board-approved protocol at three affiliated hospitals in Rhode Island and was compared with published experience from NCI-designated cancer centers.
  
  
  RESULTS
  Patient characteristics included a median age of 64 years, a median of two lines of prior therapy, and a predominance of GI carcinomas (58%). One hundred sixty-four of 200 patients (82%) had adequate tumor for NGS, 95% had genomic alterations identified, and 100% had variants of unknown significance. Fifteen of 164 patients (9.2%) enrolled in genotype-directed clinical trials, and three patients (1.8%) received commercially available targeted agents off clinical trials. The reasons for nonreceipt of NGS-directed therapy were no locally available matching trial (48.6%), ineligibility (33.6%) because of comorbidities or interim clinical deterioration, physician's choice of a different therapy (6.8%), or stable disease (11%).
  
  
  CONCLUSIONS
  This experience demonstrates that a program enrolling patients in specific targeted agent clinical trials after NGS can be implemented successfully outside of the NCI-designated cancer program network, with comparable accrual rates. This is important because targetable genes have rare mutation rates and clinical trial accrual after NGS is low.
authors.affiliation: Rhode Island Hospital; The Miriam Hospital, Providence; Memorial Hospital of Rhode Island, Pawtucket; and Newport Hospital, Newport, RI kmantripragada@lifespan.org.
authors.forename: Kalyan C
authors.initials: KC
authors.lastname: Mantripragada
authors.affiliation: Rhode Island Hospital; The Miriam Hospital, Providence; Memorial Hospital of Rhode Island, Pawtucket; and Newport Hospital, Newport, RI.
authors.forename: Adam J
authors.initials: AJ
authors.lastname: Olszewski
authors.affiliation: Rhode Island Hospital; The Miriam Hospital, Providence; Memorial Hospital of Rhode Island, Pawtucket; and Newport Hospital, Newport, RI.
authors.forename: Andrew
authors.initials: A
authors.lastname: Schumacher
authors.affiliation: Rhode Island Hospital; The Miriam Hospital, Providence; Memorial Hospital of Rhode Island, Pawtucket; and Newport Hospital, Newport, RI.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Perez
authors.affiliation: Rhode Island Hospital; The Miriam Hospital, Providence; Memorial Hospital of Rhode Island, Pawtucket; and Newport Hospital, Newport, RI.
authors.forename: Ariel
authors.initials: A
authors.lastname: Birnbaum
authors.affiliation: Rhode Island Hospital; The Miriam Hospital, Providence; Memorial Hospital of Rhode Island, Pawtucket; and Newport Hospital, Newport, RI.
authors.forename: John L
authors.initials: JL
authors.lastname: Reagan
authors.affiliation: Rhode Island Hospital; The Miriam Hospital, Providence; Memorial Hospital of Rhode Island, Pawtucket; and Newport Hospital, Newport, RI.
authors.forename: Anthony
authors.initials: A
authors.lastname: Mega
authors.affiliation: Rhode Island Hospital; The Miriam Hospital, Providence; Memorial Hospital of Rhode Island, Pawtucket; and Newport Hospital, Newport, RI.
authors.forename: Humera
authors.initials: H
authors.lastname: Khurshid
authors.affiliation: Rhode Island Hospital; The Miriam Hospital, Providence; Memorial Hospital of Rhode Island, Pawtucket; and Newport Hospital, Newport, RI.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Bartley
authors.affiliation: Rhode Island Hospital; The Miriam Hospital, Providence; Memorial Hospital of Rhode Island, Pawtucket; and Newport Hospital, Newport, RI.
authors.forename: Alise
authors.initials: A
authors.lastname: Lombardo
authors.affiliation: Rhode Island Hospital; The Miriam Hospital, Providence; Memorial Hospital of Rhode Island, Pawtucket; and Newport Hospital, Newport, RI.
authors.forename: Rachael
authors.initials: R
authors.lastname: Rossiter
authors.affiliation: Rhode Island Hospital; The Miriam Hospital, Providence; Memorial Hospital of Rhode Island, Pawtucket; and Newport Hospital, Newport, RI.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Papa
authors.affiliation: Rhode Island Hospital; The Miriam Hospital, Providence; Memorial Hospital of Rhode Island, Pawtucket; and Newport Hospital, Newport, RI.
authors.forename: Pamela
authors.initials: P
authors.lastname: Bakalarski
authors.affiliation: Rhode Island Hospital; The Miriam Hospital, Providence; Memorial Hospital of Rhode Island, Pawtucket; and Newport Hospital, Newport, RI.
authors.forename: Howard
authors.initials: H
authors.lastname: Safran
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002173:Cancer Care Facilities; D002986:Clinical Trials as Topic; D005260:Female; D020869:Gene Expression Profiling; D014644:Genetic Variation; D023281:Genomics; D005838:Genotype; D059014:High-Throughput Nucleotide Sequencing; D006801:Humans; D008297:Male; D008875:Middle Aged; D058990:Molecular Targeted Therapy; D009369:Neoplasms / Q000175:diagnosis / Q000235:genetics* / Q000628:therapy*; D018579:Patient Selection; D014481:United States