Abstract B26: Addressing gaps in molecular testing for patients with lung cancer
Authors: King Jennifer C. , Ciupek Andrew , Perloff Tara , Blanchard Ashley , Mason Kimberly , Blais Edik , Halverson David , Bender Joseph , Madhavan Subha , Petricoin Emanuel 
Published: February 2019

Abstract
Background: For metastatic non-small cell lung cancer (NSCLC), guidelines include molecular testing for actionable biomarkers and recommend broad profile testing. Despite these recommendations, previous studies indicate that not all patients with NSCLC are receiving testing, even for actionable mutations in EGFR, ALK, and ROS. There are widespread gaps in the community setting, and Lung Cancer Alliance (LCA) data show that fewer than 50% of callers to the patient HelpLine have had molecular testing on their lung cancer.
Methods: To help address this problem, we developed an innovative program that combines direct patient services with increasing enrollment to clinical studies. Patients are recruited to the LungMATCH molecular testing program through conversations on the LCA HelpLine. They are then entered into the Perthera Program to receive a Perthera Report (PR) through consent into an IRB-approved registry protocol. The Program includes tissue acquisition, multi-omic molecular profiling, and collection of patient treatment history followed by integration into a computational pipeline with extensive drug and clinical trial databases to provide ranked therapeutic options matched to the patient. An every-patient, real-time medical review board then reviews and approves the PR. PRs are returned to both treating physicians and patients. Data are being collected longitudinally on treatment decisions, patient outcomes including progression-free and overall survival, and patient experience.
Results: In the first nine months, 72 patients were referred into the Program. The majority of the patients (76%) came from community centers across a wide geographic region in the United States. There were a number of barriers to signing informed consent and completing biopsy identified. Most common reasons included patients in poor health, cost concerns, unsupportive doctors, and patient loyalty to the physician (discomfort with advocating for the testing). Of the first 11 patients who received a PR, 9 had actionable alterations that indicated either a standard-of-care agent or a clinical trial. Actionable alterations were identified by next-generation sequencing, in situ hybridization, and immunohistochemistry. Two patients also had high tumor mutation burden.
Conclusions: We introduced a nonprofit-corporate partnership that navigates patients and their physicians through a comprehensive precision-therapy program. We have demonstrated that this type of program is feasible and there is broad patient interest, particularly from patients seen in nonacademic settings. A number of barriers were identified and are being addressed. Importantly, the majority of patients who received a completed PR (82%) had actionable molecular alterations, underscoring the potential impact of the program.
Citation Format: Jennifer C. King, Andrew Ciupek, Tara Perloff, Ashley Blanchard, Kimberly Mason, Edik Blais, David Halverson, Joseph Bender, Subha Madhavan, Emanuel Petricoin. Addressing gaps in molecular testing for patients with lung cancer [abstract]. In: Proceedings of the Fifth AACR-IASLC International Joint Conference: Lung Cancer Translational Science from the Bench to the Clinic; Jan 8-11, 2018; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2018;24(17_Suppl):Abstract nr B26.