NCORP Updates from Mike Thompson
News about the National Cancer Institute’s Community Oncology Research Program.

Monday, October 24, 2016

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


Tuesday, May 31, 2016

​A brief NCORP Update. I didn't attend the Spring NCTN Cooperative Group Meetings (on call) so, I don't have direct information about those, but thought I'd still consolidate some information before ASCO. The NCTN and NCORP continue to open and modify Precision Medicine clinical trials including ALCHEMIST, LungMAP, Exceptional Responders, and NCI MATCH as noted below.

 

NCI MATCH

I previously commented on the NCI Molecular Analysis for Therapy Choice (MATCH) in my "NCORP November 2015 Update" [11/23/15].

I noted that "response to molecular testing has been far more brisk and enthusiastic than anticipated" and the NCI issued an interim update on 5/6/16: http://ecog-acrin.org/nci-match-eay131/interim-analysis

Including links to the interim analysis slide deck, follow this link and a PDF version of the interim analysis executive summary here.

Recently [5/26/16] a Press Release indicated that May 31 will be the re-activation date

 

Changes include:

VersionOpenArmsScreenLab capacity (Pts/wk)
Initial8/12/1510300050
Re-open5/31/16245000100

 

It was also noted that:

"Trial leaders will strengthen communication with enrolling physicians about the importance of referring into the trial only those patients who have adequate function of major organs and are able to carry out light daily physical activities.

Patients must be able to withstand being off treatment for up to six weeks because the process of genetic testing can take up to three or four weeks to complete, starting from the time of the patient's tumor biopsy. Then, for patients who have a gene abnormality matching one of the 24 treatment arms, it can take up to two additional weeks to evaluate whether they meet the eligibility requirements for entering the specific treatment arm."

Arms include:

http://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/nci-match

EAY131-A: Afatinib/EGFR Activating Mutations
EAY131-B: Afatinib/HER2 Activating Mutations
EAY131-E: AZD9291/EGFR Mutations (T790M/Rare Activating)
EAY131-F: Crizotinib/ALK Translocations
EAY131-G: Crizotinib/ROS1 Translocations
EAY131-H: Dabrafenib and Trametinib: BRAF V600K/V600E Mutations
EAY131-I: GDC-0032 (taselisib)/PIK3CA Mutations
EAY131-N: GSK2636771/ PTEN Mutation or Deletion w/ PTEN Expression on IHC
EAY131-P: GSK2636771/ PTEN Loss by IHC
EAY131-Q: T-DM1/HER2 Amplification
EAY131-R: Trametinib: BRAF Fusions or non-V600K/non-V600E Mutations
EAY131-S1: Trametinib/ NF1 Mutations
EAY131-S2: Trametinib/GNAQ/GNA11 Mutations
EAY131-T: Vismodegib/SMO/PTCH1 Mutations
EAY131-U: Defactinib/NF2 Loss
EAY131-V: Sunitinib/cKIT Mutations
EAY131-X: Dasatinib/DDR2 Mutations
EAY131-C1: Crizotinib/MET Amplification 
EAY131-C2: Crizotinib/Exon 14 Skipping 
EAY131-W: AZD4547/FGFR Fusions, Mutations, and Amplifications 
EAY131-Y: AZD5363/AKT Mutations 
EAY131-Z1A: Binimetinib/NRAS Mutations Awaiting CRADA.
EAY131-Z1B: Palbociclib/CCND1,2,3 Amplification(and Rb protein expression by IHC)
EAY131-Z1D: Nivolumab/MMR deficiency (IHC: MLH1, MSH2)

Links and Hashtags for NCORP / NCTN Research Bases

 NCORP resources

ECOG-ACRIN Fall 2016 Group Meeting

Meeting Dates:
8:30 AM, Thursday, November 10 thru 1:00 PM, Saturday, November 12, 2016
The dates for this meeting are confirmed; however, the start and end times are subject to change.

Meeting Location:
JW Marriott Orlando Grande Lakes
4040 Central Florida Parkway
Orlando, FL 32837
Phone: 407.206.2300

Registration:
Registration for this meeting will open in early September 2016.

 

Future Group Meetings

Spring 2017: Washington, DC, May 4-6

Fall 2017: Orlando, FL, October 26-28

Spring 2018: Chicago, IL, May 3-5

Fall 2018: Fort Lauderdale, FL, October 25-27

Spring 2019: Boston, MA, May 2-4

Fall 2019: Fort Lauderdale, FL, October 24-26

 

Upcoming NCORP Research Base Meetings

 2016

  • Jul 14-17 – NRG - Dallas, TX
  • Sep 25, 26 - ASCO Research Community Forum (not NCORP, but relevant – COI: I am chairing meeting)
  • Oct 17, 18 - NCI NCORP Annual Meeting - NCI
  • Nov 3-5 – Alliance - Chicago, IL

2017

  • Feb 9-12 – NRG – Houston, TX
  • May 11-13 – Alliance - Chicago, IL
  • July 13-16 – NRG - Philadelphia, PA
  • Nov 2-4 – Alliance - Chicago, IL

2018

  • Jan 25-28 – NRG - Phoenix, AZ
  • Jul 12-15 – NRG – Philadelphia, PA

 

This article is also posted on ASCO Connection.


Monday, November 23, 2015

A few brief updates from the November meetings of the Alliance for Clinical Trials in Oncology (Alliance) and ECOG-ACRIN Cancer Research Group, as well as upcoming meetings. Both recent meetings conducted individual tumor-specific discussions that I either couldn’t attend simultaneously or are outside the realm of a simple overview.

Alliance

I attended my first Alliance Research Base meeting this November in Rosemont, Illinois. This is a convenient location for many across the country with its proximity to O’Hare Airport. The meeting was well run and attended by some familiar, to me at least, and not-as-familiar National Clinical Trials Network (NCTN) faces. Many of the items from the NCI site NCORP meeting were reiterated and updated, including clinical trial accrual metrics.

The Alliance seems to be doing well in terms of accrual and new concepts in the pipeline. As a result of the Alliance merger, there has been a changeover in staff and integration. Of interest to NCORP sites, Cancer Care Delivery Research (CCDR) studies are in the pipeline, as well as cancer control, prevention, and therapeutic studies. It was noted that Alliance benefits from NCI as well as pharmaceutical sponsor support for continued trial expansion.

I and others have noted in the past in this tweet:

  • #Crowdsourcing #Cancer Clinical Trial Concepts from the General Public – @ALLIANCE_org http://ow.ly/oam2Y HT @FischMD @SWOG 

…that the Alliance encourages and facilitates: “HOW TO SUBMIT A CONCEPT (FOR THE GENERAL PUBLIC).” While this may not be as advanced as some crowdsourcing or crowdfunding efforts, it is a start.

The NCI Molecular Analysis for Therapy CHoice (MATCH) EAY131 study has met the preplanned interim stopping (“pause”) threshold of 500 patients and is on hold for additional arms to be added and additional sample preparation infrastructure and standard operating procedures (SOPs). More information on this trial is presented later in this post.

The Alliance meeting will be held twice yearly (not once yearly as was once anticipated), and the next meeting is May 12-14, 2016, at Loews Chicago O’Hare Hotel.

ECOG-ACRIN

The ECOG-ACRIN meeting was held November 12-14 in Orlando, FL. I discussed social media with groups of radiologists (#oncorad) and nurses (#OncRN), including the use of the Cancer Tag Ontology for sharing information using hashtags for oncology. This information was presented at the 2015 ASCO Annual Meeting and is now published in JAMA Oncology as “Disease-Specific Hashtags for Online Communication About Cancer Care.” We also reviewed use of the @EAOnc handle and #EAOnc hashtag to inform followers about ECOG-ACRIN clinical trials. A series of tweets included:

  • ECOG-ACRIN Active Clinical Trials http://ow.ly/snFqf #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Brain Cancer - #btsm http://ow.ly/snFUX #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Breast Cancer - #bcsm http://ow.ly/snG6o #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Early Detection, Diagnosis, and Prevention Active Trials http://ow.ly/snGkj #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Gastrointestinal (GI) http://ow.ly/Akw56 #EAOnc #ancsm #crcsm #hpbcsm #pancsm #stcsm
  • ECOG-ACRIN Active Clinical Trials - Genitourinary (GU) Cancer - #blcsm #kcsm #tscsm http://ow.ly/snPbQ #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Gynecological Cancer - #gyncsm http://ow.ly/snQ2l #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Head and Neck Cancer - #hncsm http://ow.ly/snQer #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Leukemia - #leusm http://ow.ly/snTwS #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Lymphoma - #lymsm http://ow.ly/snTGD #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Melanoma - #melsm http://ow.ly/snTYL #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Myeloma - #mmsm http://ow.ly/oUgfe #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Patient-centered Outcomes and Survivorship http://ow.ly/snUqi #EAOnc
  • ECOG-ACRIN Active Clinical Trials - Thoracic Cancer - #lcsm http://ow.ly/snULK #EAOnc

NCI MATCH

As of the November 7, 2015, 720 patients were molecularly screened for the NCI MATCH study out of a planned 3,000. A few hundred had potential molecular matches based on current or future planned arms of MATCH with actionable targets. One patient (others are pending assessment) is on study drug out of a planned 1,000. It was noted that the response to molecular testing has been far more brisk and enthusiastic than anticipated. The MD Anderson Cancer Center (MDACC) was processing tumor tissue at approximately 20 per day instead of the planned 20 per week. Samples submitted were 85% adequate for tissue amount and quality. Overall, this resulted in more patients screened in the first wave of opened subprotocol studies. It is expected that subsequent waves of subprotocols will have more common actionable mutations as shown in the table.

Table. Subprotocol details of NCI MATCH clinical trial

Wave

Date active / planned

Subprotocol arms

Comments

1

8/12/15

10

ALK, ROS1, EGFR, BRAF, HER2, NF2, cKIT

2

1/2016

17

More common frequency mutations (RAS, PIK3CA, etc.)

3

4/2016

22

MET, mTOR, TSC1/2, FGFR, AKT

4

TBA

pending

 

It also was noted that multiple, sequential drugs in the same category may be used to enroll as a certain target/drug arm completes accrual. The NCI-MATCH leadership is working to increase throughput at the tissue processing sites (MDACC) and the molecular laboratories (MDACC, Massachusetts General, NCI, Yale).

There are 150+ NCI and NCTN members involved in the 10 subcommittees as well as patient advocates involved in trial design. So far MATCH has included only single agents; however, combinations are possible in the future for drugs with known recommended phase II doses. RNA and immunohistochemistry are being analyzed for research purposes. The proposed EAQ152 COMET: COMmunication & Education in Tumor Profiling protocol will be an ancillary to NCI-MATCH. The PI for COMET is Dr. Angela Bradbury. NCI has an updated MATCH website.

CCDR

Although there are no active ECOG-ACRIN CCDR studies, there are multiple concepts in the pipeline evaluating systems-based practice and heterogeneity of care in screening episodes, survivorship care planning, biomarker testing, and high-risk screening in the primary care setting. A second area of active concept development is financial health and toxicity in cancer care. These are in a variety of phases of maturation from completion of preliminary or preparatory research data phase to steering committee resubmission. The ECOG-ACRIN CCDR Chair is Ruth Carlos, MD.

Links and Hashtags for NCORP/NCTN Research Bases

NCORP Resources

Upcoming NCORP Research Base Meetings

2016

  • Jan 21-24 – NRG - Atlanta, GA
  • May 12-15 – ECOG-ACRIN - Boston, MA
  • May 12-14 – Alliance - Chicago, IL
  • Jul 14-17 – NRG - Dallas, TX
  • Nov 3-5 – Alliance - Chicago, IL

2017

  • Feb 9-12 – NRG - Location TBD
  • May 11-13 – Alliance - Chicago, IL
  • July 13-16 – NRG - Philadelphia, PA
  • Nov 2-4 – Alliance - Chicago, IL

Acknowledgements

I appreciate Ruth Carlos, MD, for editing the ECOG-ACRIN CCDR section and Joe Grundle from Aurora Research Institute for reviewing this blog post.

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Note: This post is cross-published on ASCO Connection.

Friday, September 11, 2015

The NCI Community Oncology Research Program (NCORP) annual meeting took place August 27-28, 2015, at the National Institutes of Health campus in Bethesda, MD. Themes paralleled those of the ASCO 2015 Annual Meeting ( #ASCO15):

(1)  Precision Medicine;

(2)  Immuno-Oncology; and

(3)  Value, including Cancer Care Delivery Research (CCDR).

 

I didn’t hear anything about “liquid biopsies,” which was an ASCO theme, but there was discussion about molecular cancer diagnostics for precision medicine studies.

 

NCORP is now one year old and was noted to have benefitted from extensive pre-initiation organization. Other themes at the NCORP meeting that were not as prevalent at past ASCO meetings included:

  • Integrating disparity research and capacity with research bases and the broader NCORP network;
  • Underserved/minority mentoring; and
  • Rural telemedicine.

More was discussed in both formal talks and informal information-sharing than can be captured here, but I will report an overview of highlights.

 

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

 

Upcoming 2015 NCORP Research Base Meetings:

  • September 10-12:  University of Rochester Cancer Center;
  • October 7-9:  SWOG;
  • October 15-17:  Wake Forest;
  • November 5-8:  Alliance; and 
  • November 12-14:  ECOG-ACRIN Cancer Research Group

Also, the ASCO Community Research Forum Annual Meeting is scheduled for Sept. 20-21 at ASCO headquarters in Alexandria, VA.

 

If there are others, please comment below to let us know and we’ll add them to the list.

 

Clinical Trials

The NCI/NCORP clinical trials portfolio includes studies for prevention, cancer control, health-related quality of life (HRQoL), comparative effectiveness, and screening. A link to more information is: http://ncorp.cancer.gov/research.

 

A total of 47 active trials, including 30 legacy trials and 17 trials since the launch of the NCORP, are either in review or have received final approval. There was one international collaboration -- the International Breast Cancer Study Group. Breakout sessions discussed accrual heterogeneity both at various sites and among physicians. Various carrot/stick approaches have been employed at sites trying to optimize (or initiate) physician engagement.

 

Additional notes included that, not surprisingly, high-performing (HP) sites (predefined by NCORP) accrued more than standard sites. Minority and underserved (M/U) accruals were noted. In some cases “underserved” can include many different categories (race, rural, etc.). In the future there may be more pragmatic trials. Very large prevention studies are constrained by fiscal issues. There is interest in cancer screening studies, post-treatment surveillance, and evaluations of lifestyle. Evaluating overdiagnosis is a possible future study topic.

 

The NCI Clinical Trials Reporting Program (CTRP) is a comprehensive database on accrual from all NCI-supported interventional trials (www.cancer.gov/about-nci/organization/ccct/ctrp). This database provides standardized abstraction of protocol information and consistent terminology to minimize duplicative entry. It includes not only National Clinical Trials Network (NCTN) studies but also peer-reviewed institutional and industry studies. It is distinct from ClinicalTrials.gov due to its cancer focus and additional data elements such as biomarkers tested. Trials can still be found in ClinicalTrials.gov as well. Future enhancements may include an expansion beyond interventional studies.

 

It was noted that Cancer.gov isn’t a one-stop search engine for sites because it doesn’t include industry- or non-NCI investigator-initiated studies like those found on ClinicalTrials.gov or other non-NCI search engines such as MolecularMatch (https://www.molecularmatch.com).

 

Precision Medicine

Molecularly guided personalized/precision medicine studies are underway. Specifically, ALCHEMIST and Lung MAP (with revision #2 and revision #3 pending) have a high level of interest. These have been discussed in prior updates and in other venues. The newly (8/12/15) activated NCI Molecular Analysis for Therapy Choice (MATCH) study had 344 sites preregistered, 70% (240) of which are NCORP sites. One issue – not specific to NCI or NCORP – was the issue of the “14 day rule” (http://ow.ly/RsplH and http://bit.ly/1gfyOcr), and an audience member suggested a need to educate Centers for Medicare & Medicaid Services about molecular oncology diagnostics.

 

It was noted that the NCI MATCH study requires the use of NCI’s Central IRB. A central coverage analysis (in progress) may help with future studies in all kinds of NCI clinical trials. Certain ambitious trials will need broad community support in order to screen for accrual to these molecularly guided therapies.

 

Immuno-Oncology

Edith Perez, MD (@EdithPerezMD) from Mayo Clinic and more recently a vice president at Genentech, gave a keynote session on immuno-oncology. She noted that patients are very interested in immunotherapy trials and that it makes sense to them. As an oncology community we need to determine how will we be smart enough to know what drugs to combine. This is true not only for immune therapies, but because anything that kills tumor cells can increase the antigenic load--also for cytotoxic chemotherapies and radiation therapy. Dr. Perez also wondered if the inclusion/exclusion criteria could be “opened up.”

 

Other issues such as serial biomarkers, including tumor blocks as well as serum to evaluate for correlative genomic studies, were discussed. Educational issues regarding immunologic toxicities also exist. For immuno-oncology therapies to be generalizable, they need to be able to be performed in the community oncology setting (where 85% of the patients are located).

 

Cancer Care Delivery Research

CCDR is a research component within NCORP and has been the subject of numerous discussions within NCORP. There are currently no activated studies. However, there are approved concepts in the review process.

 

The NCORP committees discussed CCDR priorities, evaluation of multidisciplinary conference planning, cancer care delivery models, patient support services including supportive or palliative care, outreach to minority/underserved patients, communications between patient and caregivers, survivorship, and genomic implementation.

 

Study types suggested were:

(1)  Descriptive observational studies;

(2)  Analytic observational studies; and

(3)  Iintervention studies including randomized designs.

 

Geriatric Oncology

The Friday Keynote Address was on “Cancer and the Elderly” by Hyman Muss, MD. He discussed an NCTN Alliance model for geriatric oncology and shared references about the disparities between FDA approval data and real-world use scenarios. He suggested that elderly pharmacokinetic and pharmacogenetic studies are needed and that more attention to this population is needed in all clinical trial development and publication strategies.

 

Symptom Science

The Translational Research Working Group submitted a white paper to the NCI titled “Knowledge and Resource Gaps in NCORP Cancer Control Research and Symptom Science: A Call for Critical Resources.” This white paper led to a number of funding supplements, including the 2015 Translational Science Supplements.

 

One area of focus is the NCI Provocative Question #9: “What are the molecular and/or cellular mechanisms that underlie the development of cancer therapy-induced severe adverse sequelae?”

(provocativequestions.nci.nih.gov/rfa/mainquestions_listview).

The Symptom Management and Quality of Life (SxQOL) Steering Committee engaged in a process to identify research priorities. The first tier of priorities include: cognitive impairment, neurotoxicity, cardiovascular toxicity (#CardioOnc), fatigue, and cancer-specific pain. The second tier includes sleep disorders, bone health toxicity, metabolic toxicity, and psychological distress.

 

Behind the Scenes

For the first year of NCORP, a number of “behind the scenes” activities took place. These included the development of resources such as an NCORP Portal website, NCORP interactive map, guideline webinars specific to clinical trials, and NCORP badges.

 

Development of infrastructure included systems integration, utilizing NCI’s CIRB, trial-stopping rules for “languishing studies,” and cancer control biobanks.

 

Sheila Prindiville, MD, MPH, discussed “Clinical Trials Reporting Program and ClinicalTrials.gov.”

 

Connie Szczepanek, RN, BSN, the ASCO Community Research Forum Billing Compliance Working Group Chair and the Director of the Cancer Research Consortium of West Michigan, reviewed “Progress/Plans for Coverage Analysis.” This includes plans to create a coverage analysis document for MATCH to outline in detail study-related costs and entities responsible for covering costs (e.g., covered by insurance, covered by the trial, etc.). She also discussed the NCI-ASCO partnership to create coverage analysis documents for NCTN and NCORP trials.

 

There is currently a lack of clarity regarding who is responsible for covering NCTN and NCORP trial costs, which could be an obstacle for patients. This is also a challenge for clinical practices, to ensure that billing and managing the costs of conducting clinical trials is completed accurately.

 

NCI and ASCO held a joint meeting in August 2015 with representatives from each of the seven NCORP research bases as well as from NCORP Community sites. Consensus was reached at this meeting that coverage analysis documents for NCTN and NCORP trials are needed. Plans are underway to develop resources through the CTSU as a centralized resource for the development and dissemination of coverage analysis documents.

 

“NCI CRCHD Disparities Initiatives and Opportunities for Collaboration” was reviewed by Mary Ann Van Duyn, PhD, MPH, Chanita Hughes-Halbert, PhD, MS, and Jennifer Roye, RN.

 

The concept of an “NCORP Clinical Trial Screening Tool” was discussed by Worta McCaskill-Stevens, MD, MS. This idea was previously implemented on a smaller scale as “Use of the National Cancer Institute Community Cancer Centers Program (NCCCP) Screening and Accrual Log to Address Cancer Clinical Trial Accrual” -- http://ow.ly/sAkZN

 

It has been a busy first year!

 

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Links for the National Clinical Trials Network research bases

NCORP Resources:

Acknowledgements:  I appreciate Joe Grundle from the Aurora Research Institute for reviewing this blog post and Lynne Wagner, PhD for her notes on symptom management and quality of life.

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This article is also posted on ASCO Connection.

 

 


Thursday, April 30, 2015

Overview

The NCI Community Oncology Research Program (NCORP) is a national network of cancer care investigators, providers, academia, and other organizations that care for diverse populations in the health system. 

 

There has been a consolidation of NCI (@theNCI) cooperative groups into the new NCTN including ECOG-ACRIN (@EAOnc, #EAOnc), SWOG (@SWOG, #SWOGOnc), Alliance (@ALLIANCE_org, #AllianceNCTN), NRG (@NRGOnc, #NRGOncology), COG, as well as the University of Rochester and Wake Forest (ref: http://ow.ly/zScPb). The NCORP integrates prior networks (NCCCP & CCOP) into one new program.

 

Current NCORP sites are shown here: http://ncorp.cancer.gov/about/sites.html

 

Links for the NCTN research bases are as follows:

-- Alliance for Clinical Trials in Oncology: http://www.allianceforclinicaltrialsinoncology.org/main/

-- COG: http://www.childrensoncologygroup.org/

-- ECOG-ACRIN: http://ecog-acrin.org/

-- NRG: http://www.nrgoncology.org/

-- SWOG: http://www.swog.org/

 

A few short updates since my last post:

 

NCORP resources

Twitter hashtags: #CCDR, #NCORP

#NCORP Hashtag Influencers, Transcript & Analytics via @symplur http://ow.ly/AdIMM

New NCORP Link: http://ncorp.cancer.gov/

 

 

Upcoming NCTN/NCORP 2015 meetings

OT Full listing of conferences:  http://bit.ly/OTMeetings

4/29-5/2 - SWOG 

4/30-5/2 - ECOG-ACRIN

5/13-16 - Alliance    

7/15-19 - NRG (combined NSABP, RTOG, GOG)

8/27-28 - NCORP Annual Meeting at NCI

9/10-12 - URCC (University of Rochester Cancer Center)

10/6-9 - COG 

10/15-17 Wake Forest 

 

If there are others, please comment below to let us know and we’ll add them to the list.

 

Technology to Share Information

ECOG-ACRIN has introduced a free Mobile Conferencing App for the Spring 2015 meeting, via the EventPilot Conference App. As described from the notice: 

 

Special features:

·   View the current schedule of sessions and receive automatic updates of changes

·   Browse sessions by Day, Track or Session Chair

·   Locate your session room on the interactive map

·   Connect directly to our Group Meeting website for additional info.

 

Additional features available after logging into the app (by creating a username and password of your choice):

·   Create your own customized schedule

·   Take personal notes on sessions

·   Post public comments about each session

·   And more.

 

To install the free app on your iPhone, iPad, Android Phone, or Android Tablet:

·    Search the Apple App store or the Google Play store for  “EventPilot”

·    Install “EventPilot Conference App”

·    When prompted, enter the following as the event code: ECOG-ACRIN Spring 2015

 

Contact information:  Infotech@ecog-acrin.org

 

NCI MATCH Study

The EAY131-NCI MATCH--Molecular Analysis for Therapy Choice--is not yet activated, but is anticipated to start soon. This study, headed by Peter O'Dwyer, MD, may eventually involve more than 40 drugs from a variety of sponsors. At study activation approximately nine drugs would be available. This study covers solid tumors and lymphoma. The NCI central IRB will be utilized. NCI MATCH includes in parallel 31 Phase II clinical trials, with response rate as the primary endpoint (5% vs. 25%).

 

Cancer Care Delivery Research (CCDR)

CCDR was discussed in a previous post.

There are currently no CCDR activated in the NCORP.

They are under development and are highly anticipated including from the research bases such as URCC and Wake Forest. The NCI CCDR Steering Committee is operative and has completed its first concept review. It meets once per month and is designed to provide robust scientific peer review for CCDR studies and to set strategic scientific priorities for CCDR. It is the new Steering Committee -- one of 17 disease and non-disease peer view committees.
 

NCI CIRB

The launching of the NCI Division of Cancer Prevention's Central IRB (CIRB) has launched. This will cover NCORP studies. That should improve efficiency and hopefully decrease the heterogeneity of IRB reviews (REF: ow.ly/q5OBr).