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NCORP Updates from Mike Thompson

News about the National Cancer Institute’s Community Oncology Research Program.

Monday, October 24, 2016

NCORP NCI Annual Meeting Update

The National Cancer Institute (NCI) Community Oncology Research Program (NCORP) Annual Meeting took place Oct. 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. This is year 3 of the NCORP, which started Aug. 1, 2016. I've given highlights on a selection of many of the topics and interactions over that meeting.

In the 2 years of NCORP, there were 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—e.g., 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 NCTN precision medicine clinical trials include MATCH, ALCHEMIST, LungMAP, and the Exceptional Responders Initiative. Greater than one-third of LungMAP and ALCHEMIST screened patients were from NCORP sites.

The goal of ALCHEMIST (A151216) is 8000 screened pts. As of 10/13/165 1265 patients are n screening. Patients on drug include: A081105 - EGFR 68, E4512 - ALK 25, EA5142 nivolumab (which opened 5/2016) – 17.

NCI MATCH (Molecular Analysis for Therapy Choice) had 795 patients screened I the first 4 months. An interim analysis was previously published: Ecog-acrin.org/nci-match-eay131/interim-analysis. MATCH re-opened May 2016. The new plan is 5,000-6,000 patients screened (up from 3,000) to complete 24+ phase II trials. MATCH will target 25 percent "rare" tumors. The primary endpoint is of ORR. MATCH anticipates more arms around January 2017 (likely 8-10 more). The stated median turnaround time is now 13 days (on Oct. 13, 2016). Additionally, there are plans for further modifications including: 1) Pediatric MATCH; 2) combination targeted agent studies; and 3) adding a broader range of hematologic malignancies (e.g., multiple myeloma). Information will be stored in the NCI data commons and may inform many upcoming NCTN precision medicine trials in specific tumor types. The COMET (COMmunication & Education in Tumor Profiling) ECOG-ACRIN study EAQ152 is an ancillary to NCI MATCH EAY131 with the principle investigator Dr. Bradbury.

Howard H. Koh, MD, MPH (@DrHowardKoh) gave the Key Note 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."

And how that related to his recent JAMA editorial: "Improving Health and Health Care in the United States: Toward a State of Complete Well-Being." He 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)

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 NCI Clinical Trials Network (NCTN) were reviewed 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. Some issues with reimbursement for screening and meeting eligibility criteria. Noted wish to allow 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-specific 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 date will be used to determine the volume or effort in screening to support NOCRP'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 February 22, 2016. To date 79% sites submitted applications, 20% sites are accruing, and 845 pts approached to participate (82% - 695 consented, and 18% pts refused to provide consent).

Biomarker Analyses for Symptom Control (Michelle Janelsins, PhD – URCC and Vered Stearns, MD – ECOG-ACRIN). ECOG-ACRIN builds on legacy accomplishments of the prior separate and ECOG and ACRIN groups including in radiology.

Breakout Sessions on day 2 included sessions on mentoring, CCDR, accrual strategies, integrating disparities research within the NCORP, and leveraging teams. Dr. Saphner reviewed accrual "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 the 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 is August 28 & 29, 2017 on the NIH Campus in the Natcher Building (same place as 2016). 

 

NCORP resources

• New NCORP link: http://ncorp.cancer.gov/

• Current NCORP sites can be found at http://ncorp.cancer.gov/about/sites.html

• Twitter hashtags: #NCORP, #CCDR

•  #NCORP hashtag influencers, transcript and analytics via @symplur at http://ow.ly/AdIMM

 

Links and Hashtags for NCORP / NCTN Research Bases

• Alliance - @ALLIANCE_Org, #AllianceNCTN (http://www.allianceforclinicaltrialsinoncology.org/main/)

• Children's Oncology Group (COG) (http://www.childrensoncologygroup.org/)

• Cancer Trials Support Unit (CTSU) (https://www.ctsu.org)

• ECOG-ACRIN - @EAOnc, #EAOnc (http://ecog-acrin.org/)

• NRG - @nrgonc, #nrgoncology (http://www.nrgoncology.org/)

• SWOG - @SWOG, #SWOGOnc (http://www.swog.org/)

• Wake Forest (http://www.wakehealth.edu/cancer/researchbase/)

• University of Rochester Cancer Center (URCC) (http://urcc-ncorp.org/)

 

Upcoming NCORP Research Base and Related Meetings

2016

Nov 3-5 – Alliance - Chicago, IL

 Nov 10-12 - ECOG-ACRIN – Orlando, FL

 

2017

Feb 9-12 – NRG – Houston

Apr 26-29 – SWOG – San Francisco

May 4-6 – ECOG-ACRIN – Washington, DC

May 11-13 – Alliance - Chicago

Jul 13-16 – NRG - Philadelphia

Aug 28 & 29 – NCI NCORP Annual Meeting – Bethesda, MD

Sep 24-25- ASCO Research Community Forum – Alexandria, VA

Oct 11-14 – SWOG – Chicago

Oct 26-28 – ECOG-ACRIN – Orlando, FL

Nov 2-4 – Alliance - Chicago

 

2018

Jan 25-28 – NRG - Phoenix, AZ

May 3-5 – ECOG-ACRIN – Chicago

Jul 12-15 – NRG – Philadelphia            

Oct 25-27 – ECOG-ACRIN – Fort Lauderdale, FL

 

2019

May 2-4 – ECOG-ACRIN – Boston

Oct 24-26 – ECOG-ACRIN – Fort Lauderdale