The Maine Cancer Genomics Initiative: Implementing a Community Cancer Genomics Program Across an Entire Rural State

PURPOSE

The Maine Cancer Genomics Initiative (MCGI) aimed to overcome patient- and provider-level barriers to using genomic tumor testing (GTT) in rural practices by providing genomic tumor boards (GTBs), clinician education, and access to comprehensive large-panel next-generation sequencing to all patients with cancer in Maine. This paper describes the successful implementation of the initiative and three key services made operative between 2016 and 2020.

METHODS

A community-inclusive, hub-and-spoke approach was taken to implement the three program components: (1) a centralized GTB program; (2) a modular online education program, designed using an iterative approach with broad clinical stakeholders; and (3) GTT free of charge to clinicians and patients. Implementation timelines, participation metrics, and survey data were used to describe the rollout.

RESULTS

The MCGI was launched over an 18-month period at all 19 oncology practices in the State. Seventy-nine physicians (66 medical oncologists, 5 gynecologic oncologists, 1 neuro-oncologist, and 7 pediatric oncologists) enrolled on the study, representing 100% of all practicing oncologists in Maine. Between July 2017 and September 2020, 1610 patients were enrolled. A total of 515 cases were discussed by 47 (73%) clinicians in 196 GTBs. Clinicians who participated in the GTBs enrolled significantly more patients on the study, stayed in Maine, and reported less time spent in clinical patient care.

CONCLUSION

The MCGI was able to engage geographically and culturally disparate cancer care practices in a precision oncology program using a hub-and-spoke model. By facilitating access to GTT, structured education, and GTBs, we narrowed the gap in the implementation of precision oncology in one of the most rural states in the country.

INTRODUCTION

Precision oncology enabled by comprehensive genomic analysis of tumors to individualize therapy¹ has made unprecedented advances in recent years. Barriers to implementation include limited access to targeted therapies, inconsistent insurance reimbursement policies, difficulties in interpreting genomic data, and a paucity of clinical decision support.² Several groups have described initiatives to implement precision oncology,^3,4 but these programs have largely been based in urban areas and led by large academic medical centers or integrated health systems. Many patients with cancer in rural areas face disadvantages compared with urban areas, including lack of access to health services such as novel precision medicine technologies.^5,6 These disparities likely contribute to slower progress in the reduction of cancer mortality in rural areas.⁷

CONTEXT

• Key Objective

• Precision oncology has become a critically important and rapidly developing field in the practice of oncology. It has been firmly implemented at large academic medical centers but widespread adoption in rural areas has not yet taken place. To address this gap, we created the Maine Cancer Genomics Initiative, a statewide program in Maine that included all oncology practices in the State.

• Knowledge Generated

• This paper describes the implementation of the program in the State, including physician- and provider-based metrics. It specifically focuses on genomic tumor boards, which are specialized case conferences aimed at interpreting complex genomic tumor information for clinicians.

• Relevance

• This paper provides a roadmap on how to implement a precision oncology program in rural practices across a geographic region. It also provides data on physician characteristics associated with participation versus nonparticipation, which could be helpful to others seeking to build a similar program.

The Maine Cancer Genomics Initiative (MCGI), a philanthropy-funded, multi-institution, collaborative partnership, aimed to overcome patient- and provider-level barriers in rural practices^8,9 to utilization of genomic tumor testing (GTT), a lynchpin for the implementation of precision medicine. The MCGI was designed to disseminate and implement precision oncology in diverse community practice settings throughout Maine, one of the most rural states in the United States (Fig 1A), by providing three critical services: (1) decision support for oncology clinicians through a centrally accessible genomic tumor board (GTB); (2) clinician education on precision oncology; and (3) free access to comprehensive GTT to all patients with cancer in the State of Maine. This paper describes the creation and successful implementation of the first phase of the initiative underpinned by the three key services made available between 2016 and 2020.

FIG 1.

Population density in Maine and per capita patient enrollment in the MCGI. (A) Population density shown per municipality. Gray areas represent uninhabited areas according to Maine state population data. (B) MCGI enrollment, per HSA defined by the Dartmouth Atlas Project.¹⁰ MCGI enrollment was highest on a per capita basis in rural and sparsely populated areas in the northernmost parts of the State and in coastal communities in the Mid Coast and Downeast region. Gray areas represent areas without HSA. This map also shows all 19 MCGI-participating oncology practices in the State. AR, Arthur Robinson; HSA, hospital service area, a collection of ZIP codes whose residents receive most of their hospitalizations from the hospitals in that area; MCGI, Maine Cancer Genomics Initiative; MDI, Mount Desert Island; NECS, New England Cancer Specialists; NL, Northern Light.

METHODS

Organizational Structure

The Jackson Laboratory (JAX) Cancer Center is a National Cancer Institute (NCI)–designated basic cancer center, headquartered in Maine, focused on the functional genomics of cancer with specific expertise in genomic technologies. Recognizing the need for rapid translation of genomic discoveries into clinical practice, JAX observed that Maine used GTT in a limited manner. Therefore, the MCGI was established through a philanthropic gift in 2016 from the Harold Alfond Foundation with the goal of providing educational and clinical support to enable oncologists across the entire State to optimally use GTTs in their practices as a gateway to precision oncology.

The MCGI was structured as a community-based study that assessed the impact of the intervention on the utilization of GTTs and clinicians' acceptance and knowledge of genomic technologies. The initiative was organized in a hub-and-spoke model (Fig 2). The hub consisted of the JAX progam leadership team and researchers from the Center for Interdisciplinary Population and Health Research at MaineHealth (CIPHR), who provided expertise in health outcomes research and behavioral science. The JAX hub implemented all MCGI-related components, provided central study oversight, and functioned as a central research coordination site for small geographically dispersed rural practices. Spoke sites consisted of 19 heterogeneous oncology groups, ranging from smaller rural practices with 1-2 permanent oncologists and rotating locum tenens physicians, to larger urban practices with 10+ permanent medical, pediatric, gynecologic, and/or neurologic oncologists, and one private oncology practice.

FIG 2.

MCGI hub-and-spoke structure. The Clinical Steering Committee, comprising 19 physician leaders representing all oncology practices in Maine, provided community feedback over all aspects of the MCGI. The MCGI Central Office acted as a research-engaged spoke site for patient enrollment and formed the hub with the CIPHR. Spoke sites consisted of 14 hospital-based practices operated by five health systems (MaineHealth, Northern Light Health, MaineGeneral Health, Central Maine Health, and Covenant Health), four oncology practices providing services for independent hospitals (Cary Medical Center, Mount Desert Island Hospital, Mid Coast Hospital, and York Hospital), and one private oncology practice serving three locations (New England Cancer Specialists). Purple circles: research-engaged hospital or private practice; blue circles: practices for which the central MCGI office provided research services. AR, Arthur Robinson; CIPHR, Center for Interdisciplinary Health Research; EMMC, Eastern Maine Medical Center; HACCC, Harold Alfond Center for Cancer Care; MCGI, Maine Cancer Genomics Initiative; MDI, Mount Desert Island; ME, Maine; MMP, Maine Medical Partners.

A key to community engagement was the MCGI Clinical Steering Committee (CSC), composed of 19 physician leaders from oncology practices throughout Maine. The committee provided MCGI leadership with guidance on program development and implementation, study protocol–related issues, and educational efforts in monthly scheduled and ad hoc meetings.

Program Design and Implementation

Year 1 (July 2016-June 2017) focused on (1) building relationships between JAX, CIPHR, and the clinical practices using dedicated visits with every oncology practice in Maine, (2) introducing the study protocol to all clinical practices in Maine, and (3) developing key components of the MCGI on the basis of feedback from the CSC. Importantly, JAX's position as a research organization was viewed as beneficial and noncompetitive, facilitating its ability to serve a central coordinating role for MCGI operations.

Enrollment in the MCGI study protocol was open to all Maine physicians and advanced practice providers in medical oncology, gynecologic oncology, neuro-oncology, or pediatric oncology (Fig 3). Patients with solid tumor malignancies (all stages) treated by an enrolled clinician and an Eastern Cooperative Oncology Group performance status ≤2 were eligible. The MCGI study protocol integrated qualitative and quantitative methods to evaluate program effectiveness, patient outcomes, and behavioral science aspects of precision oncology involving patients and physicians.^11-14 Patients and physicians provided informed consent for participation.

FIG 3.

Overview of the MCGI study protocol: To systematically evaluate the impact of the MCGI on patients and physicians, the MCGI used a study protocol focused on three outcomes: (1) feasibility and acceptability of NGS tests; (2) clinician and patient experiences with NGS tests; and (3) technical outcomes of care (treatment decision making, morbidity, quality of life, and mortality). Each clinician participated in the study both as a study subject and as a patient-enrolling subinvestigator. The protocol-designated GTT was ordered by the enrolling physician to inform clinical care of the enrolled patient. GTTs, GTBs, and the education program were the central components of the program. GTB, genomic tumor board; GTT, genomic tumor testing; MCGI, Maine Cancer Genomics Initiative; NGS, next-generation sequencing.

Decision Support for Oncology Clinicians: GTBs

Discussions with stakeholders at rural hospitals revealed provider-level concern of inadequate decision support for the use of advanced GTTs, including limited administrative resources to organize GTBs and a lack of scientific experts able to guide clinicians on how to use complex GTT in patient care. To address this issue, a centrally coordinated GTB program was developed and implemented.^15-17

Each MCGI GTB session was organized and moderated by an MCGI team member. The treating oncologist was asked to attend, along with precision oncology experts from national and international academic precision oncology programs, PhD experts from the JAX CLIA Laboratory and the JAX Clinical Knowledgebase (JAX CKB¹⁸; Appendix 2), a relational knowledgebase that integrates cancer-associated genomic variants, therapeutic efficacy, and clinical trials.¹⁹ The GTBs were initially conducted in a hybrid format using both in-person visits at nine clinical practices and video- or tele-conferencing platforms. During the COVID-19 pandemic, GTBs were converted to videoconference only, allowing greater flexibility for participation and administration. GTB cases were selected either by the treating oncologist or MCGI leadership; selections were based on the potential clinical impact or perceived educational value of the case. The GTBs followed a standardized framework (Appendix Table A1).

Clinician Education in Genomic Medicine

To address the provider-level barrier of clinician knowledge of and confidence in precision oncology,²⁰ the MCGI additionally offered both online educational resources and an in-person annual professional conference (the MCGI Forum), aimed at building clinicians' competence and confidence in using GTTs.

Educational programs.

The JAX Clinical Education Program and the MCGI team developed webinars, online Continuing Medical Education/Continuing Nursing Education (CME/CNE) courses, and targeted information sheets focused on enhancing the understanding of GTT.²¹

MCGI Forum.

A 2-day CME-accredited forum was held each spring to provide educational as well as networking and team building opportunities. MCGI forum participation and all other education and GTB offerings were open to referring physicians as well as clinical and research staff (eg, nurses, administrators, pharmacists, and research coordinators) at oncology practices in Maine.

Access to Large-Panel GTT

To address patient-level barriers to GTT access during the study period of 2016-2020, the MCGI supported free CLIA-certified and CAP-accredited GTT for eligible patients. The MCGI provided access to three solid tissue GTTs: ActionSeq Plus, ActionSeq 2.0 Plus, which included an RNA-Seq–based Fusion analysis²² (all provided by JAX), and TruSight Tumor 170 (Navican TheraMap; Appendix 2 for more details on the tests). GTT were labeled "successful tests" if any of the test components (DNA- or RNA-based NGS or IHC for PD-L1) were technically completed successfully. Clinicians were also provided access to JAX CKB as an additional tool for interpreting genomic test results.

RESULTS

Practice and Physician Enrollment

After IRB approval of the study protocol in May 2017, the MCGI study opened at 19 Maine oncology practices over a period of approximately 18 months (Appendix Fig A1A). Between June 2017 and September 2020, 79 physicians enrolled on the study, representing 100% of all eligible, practicing oncologists in Maine at the study's conclusion. Of those 79 enrolled physicians, 66 (84%) enrolled at least one patient, and 64 received a successful test report on at least one patient.

Patient Enrollment

A total of 1,610 patients were enrolled between July 2017 and October 2020. On the basis of patients who self-reported ZIP codes matched to Maine Rural-Urban Continuum Codes codes²³ (n = 1,311), 73% of participants lived in rural areas (Appendix Fig A2A). Highest per capita enrollment occurred in rural areas with relatively low population densities (Fig 1B). The MCGI office supported seven small, rural community practices (staffed by one to two oncologists), which contributed substantially (35%) to the enrollment of rural patients (Appendix Fig A2B).

Patient enrollment increased steadily from 15 patients in the third quarter of 2017, to 162 in the fourth quarter of 2018, when all practices had been onboarded (Appendix Fig A1).

Decision Support for Oncology Clinicians (GTBs)

Between August 2017 and June 2021, 515 patient cases (39% of all MCGI patients with a successful test) were presented at 196 GTBs. The MCGI GTBs averaged 18 attendees per session. Oncologists represented 36% of GTB attendees, followed by oncology nurses and other oncology staff members together at 26% (Appendix Fig A3). Fully remote sessions in response to the COVID-19 pandemic led to an increase in both attendance and number of cases discussed per GTB session compared with similar months in the year before (Appendix Fig A4).

The majority of physicians who enrolled patients in MCGI (47/64 physicians with at least one successful test; 73%) presented at least one patient at a GTB (Fig 4). The percentage of cases presented by each physician averaged 46% (4%-100%) of each physician's enrolled cases. Physicians from small rural practices were among the highest overall GTB presenters (Fig 4), suggesting that the most isolated practices needed the GTBs the most. A detailed analysis comparing the characteristics of physicians (Table 1) who presented at least one case at the GTB (GTB) with the physicians who presented no cases (no GTB) showed that clinicians participating in GTBs enrolled significantly more patients in the MCGI study than those who did not participate in GTBs (mean 26 v 9; P < .001). Furthermore, there was a trend for a higher proportion of physicians in the no GTB group to move away from the State or retire either during or after the MCGI study period (59% v 30%; P = .068). Finally, GTB physicians reported a lower percentage of time in clinical care (85%) versus non-GTB physicians (92%; P = .021). Other parameters, including scores of genomic confidence,¹³ were equivalent between both groups. Common topics raised in the GTBs included germline implications of somatic testing, identifying clinical trial options, and prioritizing targeted treatment options when multiple alterations were present (Appendix Table A3).

FIG 4.

GTB case presentation per physician. Bars represent total case result numbers per physician (each column presenting one physician, each physician assigned a random number): dark blue bars represent cases presented at GTB, and light blue bars represent cases not presented at GTB. Forty-seven of 67 (72%) physicians (enrolling at least one patient on the study) presented at least one patient at the GTB. ^aFour physicians working in rural areas with highest per capita patient enrollment in the MCGI. GTB, genomic tumor board; MCGI, Maine Cancer Genomics Initiative.

TABLE 1.

Physician Characteristics of GTB Physicians (presented at least one case at a GTB) Versus Non-GTB Physicians (presented no cases at a GTB)

Physicians and nonphysician staff reported that the GTBs were useful in clinical practice. In 2019, 40 physicians and nonphysician clinical staff provided feedback in the annual CME survey. The majority (approximately 90%) of participating clinicians (physicians and nonphysicians) either chose “agree” or “strongly agree” when asked if the GTBs helped them increase knowledge and skills, interpret results, and improve patient outcomes (Fig 5A). A similar distribution in responses was observed among physicians only (Fig 5B).

FIG 5.

Physician attitudes about the value of GTBs. Black dots represent means. Error bars represent standard error of the mean. Colored dots represent each participant's response (position jittered to avoid overplotting). The x-axis labels reflect the response labels on surveys questions: 1 = strongly disagree to 5 = strongly agree (intermediate options were not labeled). Survey responses of (A) all GTB participants and (B) physician participants only. GTB, genomic tumor board.

Clinician Education in Genomic Medicine

Educational modules.

All CME/CNE-accredited self-directed educational resources, focused on basic concepts of somatic tumor testing, were developed for MCGI.²¹ There were 53 course enrollments in Maine during the study period: nurses (32%) outnumbered physicians (22%); the remaining 46% were research staff or “other”. More than 90% of those completing a module rated its educational value high (4 or 5 on a scale from 1 = poor to 5 = excellent), and 43% reported that their practice would change as a result of the training. Additional feedback identified a need for educational modules specifically targeting nurses and research coordinators.

In response to this interest from nonphysician staff, the JAX Clinical Education Program developed online resources and a two-part virtual interactive workshop specifically for nurses and research coordinators. This workshop provided a case-based introduction to identifying patients for GTT, reading test reports, and matching results to targeted treatments. The majority of the nurses (76%) indicated that they would change their practice on the basis of the education.

MCGI Forum.

The Annual MCGI Forum was hosted three times. Attendance increased from 80 in 2017 to 120 in 2019 and participation, measured by continuing education (CE) credits claimed by participants, increased from 52 credits in 2017 to 110 in 2019 (Appendix Table A2). In addition, the MCGI Forum served as an important networking event and established a learning community of diverse health care providers.

Access to Free Large-Panel GTT

A total of 1292 patients had successful GTTs and received a test report (80% of enrolled patients). For the remaining 320 patients, tissue could not be analyzed as the available tissue amount was insufficient, the submitted specimen had limited neoplastic content or extracted nucleic acid quantity or quality was too low (Appendix Fig A1B). In response to this significant failure rate, we implemented two strategies that led to a significant improvement over time: (1) guidance to oncology and pathology practices in selection of appropriate specimens, and (2) implementation of less restrictive specimen requirements for the offered GTTs. Engaging the ordering oncologists directly in this process constituted a key to success of the MCGI as it enhanced the sense of clinician participation in the project.

DISCUSSION

Genomic testing is an indispensable step for precision oncology, and has been shown to improve overall patient survival and enable lower per week health care costs than matched controls.²⁴ Patients with cancer in rural communities have poorer access to cancer care in general²⁵ and are less likely to use complex technologies such as GTTs.⁶ As precision oncology advances, these longstanding disparities in access to precision medicine technologies will only widen the outcome gaps further.^8,9 We addressed this problem by establishing the MCGI, a statewide, multi-institution, collaborative partnership aimed at overcoming barriers to the implementation of precision oncology in a rural state.

The MCGI was able to broadly engage clinicians representing every oncology practice in the State of Maine—a significant accomplishment that has not, to our knowledge, been achieved elsewhere. Other initiatives have been led by single academic institutions,²⁶ large health systems, pre-existing groups of independent oncology practices,² or the Veterans Affairs health system.³ However, our program is unique in that it covered all practices across an entire state.

In 2016, when there was significant ambiguity with respect to test reimbursement and out-of-pocket costs to patients, the provision of free-of-charge GTT was a key driver of patient enrollment to the MCGI as suggested by initial interviews with MCGI physicians. Financial barriers to testing have diminished since the Center for Medicare and Medicaid Services determination in 2018 that next-generation sequencing tests are reasonable and necessary and covered nationally.²⁷ This determination reduced the need for providing free GTT as attested by the continued high utilization of our GTBs in our new MCGI 2.0 program (2020-present) despite the elimination of subsidies for GTT by the MCGI except for uninsured patients.

We discovered that GTBs were the most impactful intervention in supporting the interpretation and appropriate use of GTTs. The MCGI-provided GTBs were used by 73% of the participating oncologists, which represented the highest engagement of all the educational interventions. The characteristics of engaged practitioners showed that oncologists who used the GTBs enrolled more patients in the MCGI and continued to practice in Maine. Thus, individual commitment is associated with increased participation in enabling education. Interestingly, the non-GTB participant group also reported a higher percentage of time involved in patient care, suggesting that time constraints play a role in physicians' participation in GTBs.

We observed that nurses, nurse practitioners, physician assistants, and other clinical staff showed a strong interest in the GTBs and claimed benefit from participating in the GTBs and in the educational modules. This finding is consistent with a recent publication²⁸ showing that tailored support and training to all clinical care team members is needed for adopting genomic testing into clinical practice.

A major component of MCGI's successes was the broad engagement of Maine oncologists and practices, and the creation of the CSC with representatives from all practices in the State. This inclusive stakeholder approach functioned as a learning collaborative focused on continuous process improvement. It is noteworthy that 67 physicians enrolled 1,610 patients over a 3-year time frame, which is more patients than 145 physicians enrolled in the initial phase of the Intermountain Healthcare precision oncology program.² Although this comparison is difficult to interpret on the basis of several intrinsic differences between the two programs, it shows that the MCGI had significant buy-in from physicians and higher-than-average patient participation.

An ongoing challenge in Maine remains access to targeted medications. We reported previously that Maine oncologists had relatively low confidence that patients would be able to access targeted therapies¹³ and this concern is supported by existing literature, which has identified drug access as a global barrier to the effective implementation of precision oncology.^29-31 Responding to this, MCGI's hub-and-spoke model was leveraged to bring more precision oncology clinical trials to Maine through NCI-MATCH and the TAPUR trial,³² an important initial step for increasing access to therapies.

The hub-and-spoke model of the MCGI's design has similarities with ProjectECHO, which has been effective in improving patient and provider outcomes in cancer care^33-35 and for other diseases.³⁶ Most critically, the provision of research support services from the hub to the most rural spoke sites enabled participation by physicians and patients who are often left behind by emerging health care innovations. Higher per capita enrollment in rural areas than at urban sites suggests the highest perceived benefit of the MCGI is in rural areas. These MCGI findings are consistent with those observed generally in ProjectECHO's³⁷ across the nation.

In summary, the MCGI is a uniquely collaborative statewide precision oncology effort in a rural state. Our results indicate that engagement of disparate cancer care settings in a large-scale program is possible with a hub-and-spoke model. By facilitating access to GTT, structured online education, and GTBs, we have taken first steps in narrowing the implementation gap in precision oncology in one of the most rural states in the country. Although the free testing was important in starting the MCGI program in 2016, it ultimately catalyzed the use of GTTs among oncologists in Maine as they now have converted to using commercial GTTs. Thus, we were successful in building a continuous education process through the GTBs that integrates precision oncology into their daily workflows. Moving forward, in our successor program, the MCGI 2.0, we will continue to iteratively improve access to GTBs, will assist in GTT and drug access through a central clinical genomic navigatorand work on bringing additional clinical trials to Maine.

APPENDIX 1. MCGI WORKING GROUP

Maine Cancer Genomics Initiative Clinical Steering Committee Members.

Central Maine Medical Center, Lewiston: Nicholette Erickson; Dahl-Case Pathology Associates: Mayur Movalia, Marek Skacel; Jefferson Cary Cancer Center, Caribou: Allan Espinosa; MaineGeneral Medical Center, Augusta: Ridhi Gupta, Rachit Kumar, Richard Polkinghorn; Maine Medical Center, Portland: Christopher Darus, Scot Remick, Leslie Bradford; Maine Medical Center, Spectrum Medical Group, Portland: Robert Christman, Karen Rasmussen; Northern Light Eastern Maine Medical Center, Bangor: Philip Brooks, Catherine Chodkiewicz, Antoine Harb; Southern Maine Health Care Biddeford: Peter Rubin: Waldo County General Hospital, Belfast: Elizabeth Connelly; York Hospital, York: Peter Georges.

The Jackson Laboratory.

Linda Choquette, Ken Fasman, Kunal Sanghavi, Richard Lussier, Andrew Hesse, Matthew Prego, Gregory Omerza, Kevin Kelly, Shannon Rowe, Qian Nie, Pavalan Panneer Selvam, Bridgette Sisson Sara Patterson, Cara Statz, Taofei Yin, Shannan Morris, Kathleen Q. Adams.

Center for Interdisciplinary Population and Health Research, Maine Health Institute for Research (formerly Center for Outcomes Research and Evaluation, Maine Medical Center).

Anny Fenton, Caitlin Gutheil, Ally Hinton, Michael Kohut, Susan Leeds, Lee Lucas, Elizabeth Scharnetzki, Leo Waterston, Lisbeth Wierda, Jessica Dibiase.

TABLE A1.

Agenda of Each GTB

TABLE A2.

MCGI Forum Topics and Speakers (2017-2019)

TABLE A3.

Example Case Discussion and Key Points From GTBs

FIG A1.

Practice and patient enrollment, test result return, and GTB discussion data. Data broken down by calendar quarters between Q3 2017 (start of enrollment) to Q3 2020 (end of enrollment). (A) Practice enrollment starting with seven practices that were enrolled in Q3 2017 to all 19 practices by the end of Q4 2018. (B) Patient enrollment by quarter, shown as the total of each column. Dark teal: Number of case results discussed at GTB, expressed as % of patients enrolled during that calendar quarter. Light teal: Number of case results returned that were not discussed at GTBs. Gray: Number of cases that did not return a result report either to nonsubmitted specimen or specimen failure in the laboratory. GTB, genomic tumor board.

FIG A2.

Study enrollment on the basis of rurality. (A) Number of patients enrolled in the MCGI who provided their ZIP code (n = 1,313). The rurality of each participant's primary residence was determined via the USDA's Rural-Urban Commuting Area codes, which use measures of population density, urbanization, and daily commuting to map ZIP codes to urban/rural categories. Because of small numbers of participants in some categories, we collapsed the 11 primary RUCA codes (1-10, 99) into four categories: 1 = metro, 2-6 = large rural, and 7-9 and >10 = small rural, 10 = isolated rural. (B) Percent of patients enrolled by the central hub office or by the independent sites for each rurality category. MCGI, Maine Cancer Genomics Initiative; USDA, United States Department of Agriculture.

FIG A3.

Breakdown of GTB participants between 2017 and 2020. Although a number of different groups attended the GTBs (left box), the core audience for the GTB are the clinicians, that is, clinical staff and physicians (right box). GTB, genomic tumor board; JAX, Jackson Laboratory.

FIG A4.

(A) GTB attendance and (B) GTB cases in 2019 (green columns) and 2020 (gray boxes) monthly. March 2020 showed a lower number of GTB participants and GTB cases (due to start of COVID-19 pandemic) but then rebounded and exceeded 2019 numbers in the subsequent year, likely due to a switch to fully virtual GTB format. Numbers shown from March through June as a representative time period of the COVID-19 pandemic. GTB, genomic tumor board.

APPENDIX 2. Genomic Tumor Tests Used in the MCGI

Between July 2017 and March 2019, 346 samples were analyzed using the ActionSeq Plus from the Jackson Laboratory (JAX) Clinical Genomics Laboratory. This test consisted of the DNA-based JAX ActionSeq assay analyzing single-nucleotide variants (SNVs), insertion/deletions (indels), and copy-number variants (CNVs) in 212 cancer-related gene exons, and the RNA-based JAX FusionSeq (ArcherDx), detecting fusions involving one or more of 53 genes known to be associated with various carcinomas, sarcomas, and hematologic malignancies.

Between June 2018 and September 2019, 416 samples were analyzed on the TruSight Tumor 170 (TST-170, Illumina Inc) NGS platform available through a partnership with Navican (Navican TheraMap). This panel evaluated the DNA of 156 cancer-related gene exons for SNVs, indels, CNVs, and the RNA of 54 cancer-related genes for fusions. The panel also reported out tumor mutation burden (TMB) on the basis of 500 kb of sequenced DNA and MSI status on the basis of a standard polymerase chain reaction. PD-L1 testing using the SP263 immunohistochemistry assay was available at the request of the ordering physician.

Between April 2019 and December 2020, 840 samples were tested on the new ActionSeq 2.0 Plus, which incorporates a DNA‐based panel (ActionSeq 2.0) comprising 501 cancer-related genes for which all coding exons are sequenced and clinically significant variants in 209 genes are reported, and a RNA‐Seq–based panel (FusionSeq 2.0) evaluating the transcriptome for 548 genes known to form fusions in solid tumors and reporting clinically significant fusions across 53 gene partners. TMB was calculated as the mutations per megabase (mut/Mb) across the approximately 2.3 Mb of coding DNA captured by the ActionSeq 2.0 panel. MSI status was evaluated on the basis of the number of measured frameshift mutations per Mb of DNA. PD-L1 testing was also available at the request of the ordering clinician. All the Maine Cancer Genomics Initiative–associated clinical tests were delivered in a comprehensive test report that provides information on the observed gene and the effect of the gene variant on gene/protein function, associated therapies, and potential clinical trial options for patients.

AUTHOR CONTRIBUTIONS

Conception and design: Jens Rueter, Leah C. Graham, Andrey Antov, Petra Helbig, Lory Gaitor, Jennifer Bourne, E. Kate Reed, Susan Mockus, Roger Inhorn, Sarah J. Sinclair, Christian A. Thomas, Philip L. Brooks, Karen Rasmussen, Paul Han, Edison T. Liu

Financial support: Edison T. Liu

Administrative support: Jens Rueter, Paul Han, Edison T. Liu

Provision of study materials or patients: E. Kate Reed, Christine Lu-Emerson, Roger Inhorn, Sarah J. Sinclair

Collection and assembly of data: Jens Rueter, Petra Helbig, Lory Gaitor, Jennifer Bourne, E. Kate Reed, Honey V. Reddi, Christine Lu-Emerson, Roger Inhorn, Sarah J. Sinclair, Karen Rasmussen, Paul Han

Data analysis and interpretation: Jens Rueter, Eric C. Anderson, Leah C. Graham, Emily Edelman, E. Kate Reed, Susan Mockus, John DiPalazzo, Roger Inhorn, Christian A. Thomas, Paul Han, Edison T. Liu

Manuscript writing: All authors

Final approval of manuscript: All authors

Accountable for all aspects of the work: All authors

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/po/author-center.

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