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:
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.
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).
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.
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.
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.
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?”
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!
Links for the National Clinical Trials Network research bases
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.
This article is also posted on ASCO Connection.