August 1, 2016 marked the start of year 3 of the National Cancer Institute (NCI) Community Oncology Research Program (NCORP). The NCORP Annual Meeting took place on October 17-18 at the NCI campus (Natcher Conference Center, Building 45) in Bethesda, MD. The slides from the meeting are on the NCORP online portal. Below, I’ve given highlights on a selection of many of the topics and interactions over that meeting.
In the 2 years since NCORP’s launch, its sites have had 7,527 cancer control and 6,742 treatment accruals, for a total of 14,269. There are currently 45 active NCORP clinical trials and 50 trials active in follow up. Nineteen trials have launched since the start of NCORP. Ten trials are currently in review. There are a number of collaborative studies, such as the NHLBI-MDS-ECOG-ACRIN The National Myelodysplastic Syndrome (MDS) Study.
There was an update on Precision Medicine Trials Update and Future Directions (Meg Mooney, MD). Examples of NCI Clinical Trials Network (NCTN) precision medicine clinical trials include NCI-MATCH, ALCHEMIST, Lung-MAP, and the Exceptional Responders Initiative. More than one-third of Lung-MAP- and ALCHEMIST-screened patients were from NCORP sites.
The goal of ALCHEMIST (A151216) is 8,000 screened patients. As of October 16, 2016, 1,265 patients are in screening. Patients on drug include 68 on A081105 (erlotinib, EGFR), 25 on E4512 (crizotinib, ALK), and 17 on EA5142 (nivolumab, PD-L1), which opened in May 2016.
NCI-MATCH (Molecular Analysis for Therapy Choice) screened 795 patients in the first 4 months. An interim analysis was previously published. MATCH re-opened in May 2016. The new plan is to screen 5,000 to 6,000 patients (up from 3,000) to complete 24 or more phase II trials. MATCH will target 25% “rare” tumors. The primary endpoint is overall response rate. MATCH anticipates more arms around January 2017 (likely eight to 10 more). The stated median turnaround time is now 13 days (as of October 13, 2016). Additionally, there are plans for further modifications, including Pediatric MATCH, combination targeted agent studies, and adding a broader range of hematologic malignancies (e.g., multiple myeloma). Information will be stored in the NCI Genetic Data Commons and may inform many upcoming NCTN precision medicine trials in specific tumor types. The ECOG-ACRIN COMET study EAQ152 is an ancillary to NCI MATCH EAY131, with Dr. Angela R. Bradbury as principal investigator.
Howard H. Koh, MD, MPH, (@DrHowardKoh) gave the keynote address on “Community Investigators—Obligations in Shaping and Contributing to Public Health.” He reflected upon the WHO definition of Health: “Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.” During his address, he related that definition to his recent JAMA editorial, “Improving Health and Health Care in the United States: Toward a State of Complete Well-being.” Dr. Koh noted that, as community sites, the NCORP is in the middle of helping treat disease as well as improve wellness.
NCORP Working Groups reported on:
Accessing AYA—Pediatric/Adult Oncology Collaborations (Ann O’Mara, PhD, RN): Adolescent and young adult (AYA) opportunities in NCORP and discussion on role of community and academic sites for AYA.
Radiation Therapy Working Group Report (Sandra Russo, MD, PhD, MPH): Group evaluated barriers and potential solutions for sites. Out of 856 total sites, there were 385 sites that were active radiation therapy sites. Of those, 212 were credentialed, and only 88 credentialed to perform radiosurgery. Imaging and Radiation Oncology Core (IROC) is evaluating issues related to credentialing.
Non-Oncology Specialists Working Group Efforts (Eileen Dimond, RN, MS): Improving teamwork and considering how to optimize coordination in studies, including radiology, ophthalmology, etc.
NCORP Succession Planning (Jay Bearden, MD, and Amarinthia “Amy” Curtis, MD): How to mentor and coordinate leadership successions in organizations such as the NCORP.
Clinical trial information for therapeutic, cancer prevention, and control, as well as cancer care delivery research (CCDR) from the NCTN were reviewed by representatives from Alliance, COG, ECOG-ACRIN, NRG, SWOG, Wake Forest, and the URCC.
Judith Hautala and Owen Grad elicited NCORP site feedback for the Science & Technology Policy Institute (STPI) “Opportunity for Input on NCORP.” Many sites have reported challenges with implementing precision medicine trials, as well as some issues with reimbursement for screening and meeting eligibility criteria. Participants noted a wish to allow the use of pre-existing molecular panel information for eligibility for NCI MATCH.
The DCP-001 Screening Log was reviewed by Diane St. Germain, RN, MS. The goal of the DCP-001 is to understand site- and trial-specific accrual barriers to develop effective strategies to improve accrual, particularly for minority and underserved populations, and to expand the collection of demographic information. The data will be used to determine the volume of effort in screening to support NCORP’s research portfolio. This has some similarities to a prior initiative, “Use of the National Cancer Institute Community Cancer Centers Program (NCCP) Screening and Accrual Log to Address Cancer Clinical Trial Accrual.” DCP-001 opened on February 22, 2016. To date, 79% of sites submitted applications, 20% of sites are accruing, and 845 patients were approached to participate (82%  consented, and 18% did not consent).
Biomarker Analyses for Symptom Control (Michelle Janelsins, PhD, of URCC, and Vered Stearns, MD, of ECOG-ACRIN): ECOG-ACRIN builds on legacy accomplishments of the prior separate organizations, ECOG and ACRIN, especially including the radiology expertise of ACRIN.
Breakout Sessions on the meeting’s second day included sessions on mentoring, CCDR, accrual strategies, integrating disparities research within the NCORP, and leveraging teams. Dr. Thomas J. Saphner reviewed accrual during “Insights From Building a New National Cancer Institute Community Oncology Research Program Site.”
Sean Hine reviewed the Grants Administration and Matt Boron, PharmD, gave an overview of the Registration and Credentialing Repository and Delegation of Tasks Log. Linda Parreco, RN, MS, discussed the NCI Central IRB (CIRB).
Marge Good, RN, MPH, OCN, closed out the meeting with a review of images from NCORP sites, reflecting on the diversity of locations and people all trying to bring cancer research to communities throughout the United States.
The 2017 NCI NCORP Meeting will take place on August 28-29, 2017, on the NIH campus in the Natcher Building (same location as 2016).
- New NCORP link
- Current NCORP sites
- Twitter hashtags: #NCORP, #CCDR
- #NCORP hashtag influencers, transcript, and analytics (via @symplur)
Links and Hashtags for NCORP/NCTN Research Bases
- Alliance: @ALLIANCE_Org, #AllianceNCTN
- Children’s Oncology Group (COG)
- Cancer Trials Support Unit (CTSU)
- ECOG-ACRIN: @EAOnc, #EAOnc
- NRG: @nrgonc, #nrgoncology
- SWOG: @SWOG, #SWOGOnc
- Wake Forest
- University of Rochester Cancer Center (URCC)
Upcoming NCORP Research Base and Related Meetings
- Feb 9-12: NRG, Houston, TX
- Apr 26-29: SWOG, San Francisco, CA
- May 4-6: ECOG-ACRIN, Washington, DC
- May 11-13: Alliance, Chicago, IL
- Jul 13-16: NRG, Philadelphia, PA
- Aug 28-29: NCI NCORP Annual Meeting, Bethesda, MD
- Sep 24-25: ASCO Research Community Forum, Alexandria, VA
- Oct 11-14: SWOG, Chicago, IL
- Oct 26-28: ECOG-ACRIN, Orlando, FL
- Nov 2-5: Alliance, Chicago, IL
- Jan 25-28: NRG, Phoenix, AZ
- May 3-5: ECOG-ACRIN, Chicago, IL
- Jul 12-15: NRG, Philadelphia, PA
- Oct 25-27: ECOG-ACRIN, Fort Lauderdale, FL