NCORP Year in Review
Posted: November 17, 2016
The NCI Community Oncology Research Program (NCORP) achieved numerous successes through research and collaborations in its second year, NCORP director Worta McCaskill-Stevens told the group’s annual meeting October 17-18, 2016 in Bethesda, Maryland.
The network’s research portfolio and participating sites are as diverse as the four seasons, McCaskill-Stevens said. NCORP, which launched in 2014, operates as an academic/community partnership focused on conducting clinical trials for prevention, cancer control, health-related quality of life, comparative effectiveness and screening. The network also accrues to National Clinical Trials Network (NCTN) treatment and imaging trials.
NCORP’s current portfolio comprises 45 clinical trials that are active and accruing, 50 clinical trials in active follow-up, and 19 trials since the launch of NCORP either in review or with final approval. In the first and second program years combined, 7,527 patients were accrued to NCORP trials (including enrollment to quality-of-life sub-studies for treatment trials); and 6,742 patients were accrued to NCTN trials.
In the new area of cancer care delivery research (CCDR), which is focused on patient-provider and organization-level influences on cancer outcomes, four protocols have been approved; one concept is approved and moving toward protocol submission; and two abstracts on CCDR were presented at national meetings. The approved studies are investigating a prospective financial impact assessment tool in patients with metastatic colorectal cancer; a guideline-based colony stimulating factor standing order intervention; evidence-based supportive care clinical practice guidelines in pediatric oncology; and decision aids to improve prostate cancer decisions for minority men.
"We’re a network of goals, dreams and deadlines," McCaskill-Stevens said to the principal investigators, site administrators, CCDR leads, clinical research coordinators, and NCI staff who gathered to review the program and look ahead at the third year and beyond. She highlighted the following:
- Symptom science progressed with approval to use integrated biomarkers to focus on mechanisms of toxicities;
- Reinvigoration of cancer prevention research was a key focus of the meeting of the seven NCORP Research Base Committee Chairs, whose groups design and conduct the multi-center studies, and of the Cancer Prevention Think Tank of experts and stakeholders which convened in late 2015;
- The NCI Cancer Prevention and Control Central Institutional Review Board (CPC CIRB) was expanded to handle review of cancer care delivery research;
- A Memorandum of Understanding between NCI and the Veterans Administration was signed to allow the VA to utilize the NCI CIRB for their IRB of record for NCORP and NCTN studies and trials;
- Enrollment by community NCORP sites in the NCTN precision medicine initiative trials;
- Tissue acquisition for genomic studies; and
- NCORP representation in the Cancer Moonshot Initiative.
A total of 58 NCORP representatives sit on multiple NCI Steering Committees and Task Forces that oversee the network. A lot of community participation was evident in the research reviews and the input was extremely valuable, McCaskill-Stevens said. Fifteen NCI Steering committees are involved in reviewing concepts. In the 2016 NCORP network election, approximately 50 nominations were received and there was an 80% participation rate by the NCORP sites. Among the results, nine positions on eight steering committees were filled (breast cancer, gastrointestinal, genitourinary, gynecologic, leukemia, lymphoma, myeloma, thoracic malignancy); and nine positions on eight task forces were filled.
Incorporation of cancer disparities research into clinical trials and cancer care delivery research was notable in minority enrollment across the network as well in two specific studies. One, to improve resection rates among African Americans with early stage lung cancer, is evaluating the impact of a nurse-led patient navigation intervention. The rate of surgical resection has been estimated to be 12.7% lower in African Americans compared with whites in a study of Medicare patients with early-stage lung cancer. The second study will conduct molecular profiling of early onset malignancies among racially and ethnically diverse populations diagnosed with one of six cancer types.
Two other successes since the launch of NCORP were noted by the program director. A clinical trial with 362 participants is studying the combination of magnetic resonance imaging (MRI) with gene expression studies in the diagnosis of patients with ductal carcinoma in situ (DCIS), abnormal cells in the breast duct that have not spread outside the duct. The primary foci are the proportion of patients judged to be breast conservation candidates based on standard imaging and physical examination who convert to mastectomy based on MRI findings, and the proportion of patients judged to be breast conservation candidates based on standard imaging and physical examination who have a mastectomy. The study also looks at several other factors associated with DCIS such as tumor grade, necrosis, histologic type, and lesion size; diagnostic accuracy of MRI in DCIS evaluation; decision quality and level of decision involvement; patient-reported quality of life; and patient-reported diagnostic testing burden.
A second clinical trial, with 272 patients completed in May 2016, affirmed the efficacy of doxepin mouthwash rinse for the treatment of pain caused by mouth sores resulting from radiation therapy. The study, which was presented at the American Society for Radiation Oncology (ASTRO), evaluated the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.
The Cancer Prevention Think Tank identified six potential opportunities/priorities for reinvigorating cancer prevention in the community setting: immunoprevention for cancers of noninfectious origin; one versus two doses of the HPV vaccine; overdiagnosis and annotating methods of diagnosis; a prevention tumor cancer genome atlas (PreTCGA) aimed at single cell analysis and underlying risk; tomosynthesis (3D) vs. digital (2D) mammography; and surveillance colonoscopy focused on screening intervals.
The first Harry Hynes Award since the inception of NCORP was awarded to James D. Bearden, III, MD, of the Southeast Clinical Oncology Research NCORP. The award recognizes physicians who demonstrate excellence in community-based research. It has been awarded intermittently since 2002 to honor its namesake, who exemplified the importance of clinical trials and community-based research.
Another special segment of the meeting was the showing of 53 images, one from each of the seven NCORP Research Bases, 34 Community Sites and 12 Minority/Underserved Community Sites. The images are part of a weekly NCI Instagram quiz that asks: Where's the National Cancer Institute?
Themes around community site administration encompassed topics such as credentialing for radiation therapy and imaging; costs not covered by health insurance; centralized data systems for meeting the needs of Food and Drug Administration regulations; and the future of remote monitoring of site-generated data. Discussion sessions covered mentoring future cancer care leaders; CCDR study implementation; challenges to meeting accrual goals for cancer control trials; bridging silos between pediatric and adult oncologists to address the suboptimal accrual of adolescent and young adult cancer patients to clinical trials; and developing and leveraging teams and teamwork within the network.
Moving forward, newly established NCORP working groups will focus on: cancer prevention, radiation oncology, adolescents and young adults, non-oncology specialty group, integrating cancer disparities research (trans-research base), symptom science and quality of life, and chemotherapy induced peripheral neuropathy.