Symptom science research conducted in community programs funded by the US National Cancer Institute: a 12-year review, 2008 to 2019.

PURPOSE: This study was conducted to describe the portfolio of symptom science research conducted through the community oncology network supported by the US National Cancer Institute during the 12-year period 2008 to 2019. METHODS: The National Cancer Institute conducted a retrospective review of the National Cancer Institute database to identify pediatric and adult symptom management studies that were opened between 2008 and 2019 in the community oncology network and to determine types of studies, accrual patterns, completed studies, and number of publications reporting clinical trial results. RESULTS: The NCI community oncology network conducted 109 symptom studies between 2008 and 2019. The majority of these studies were phase II and III clinical trials. Neurotoxicities were the most frequently occurring symptom studied, with the majority of those focused on neurocognitive impairments. Gastrointestinal symptoms, pain, and fatigue were the next most frequently studied. A variety of interventions were utilized including pharmacologic, behavioral, complementary and alternative medicines, and radiation therapy. Accrual to symptom studies ranged from a low of 896 participants in 2008 to a high of 3468 participants in 2012. The number of open studies ranged from 8 in 2008 to 35 in 2012. CONCLUSIONS: Examining the symptom science portfolio of the NCI community oncology network has identified research gaps and has highlighted the need to focus on a mechanistic understanding of symptoms and phenotyping of patients experiencing cancer and treatment-related symptoms. Subsequently, targeted interventions can be developed to prevent or treat these symptoms.

Use of tamoxifen and raloxifene for breast cancer chemoprevention in 2010.

Two selective estrogen receptor modulators, tamoxifen and raloxifene, have been shown in randomized clinical trials to reduce the risk of developing primary invasive breast cancer in high-risk women. In 1998, the U.S. Food and Drug Administration (FDA) used these studies as a basis for approving tamoxifen for primary breast chemoprevention in both premenopausal and postmenopausal women at high risk. In 2007, the FDA approved raloxifene for primary breast cancer chemoprevention for postmenopausal women. Data from the year 2010 National Health Interview Survey were analyzed to estimate the prevalence of tamoxifen and raloxifene use for chemoprevention of primary breast cancers among U.S. women. Prevalence of use of chemopreventive agents for primary tumors was 20,598 (95 % CI, 518-114,864) for U.S. women aged 35-79 for tamoxifen. Prevalence was 96,890 (95 % CI, 41,277-192,391) for U.S. women aged 50-79 for raloxifene. Use of tamoxifen and raloxifene for prevention of primary breast cancers continues to be low. In 2010, women reporting medication use for breast cancer chemoprevention were primarily using the more recently FDA approved drug raloxifene. Multiple possible explanations for the low use exist, including lack of awareness and/or concern about side effects among primary care physicians and patients.

The National Cancer Institute Clinical Trials Planning Meeting for Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy.

Although recent scientific advances have improved our understanding of basic biological mechanisms underlying chemotherapy-induced peripheral neuropathy (CIPN), few interventions are available to prevent or treat CIPN. Although some biological targets from preclinical studies show promise in nonhuman animal models, few targets have been translated to successful clinical trials. To address this problem, the National Cancer Institute's Symptom Management and Health-Related Quality of Life Steering Committee convened a meeting of experts in the CIPN and oncology symptom management fields to participate in a Clinical Trials Planning Meeting (CTPM). Investigators presented data from preclinical and translational studies for possible CIPN interventions; these were evaluated for readiness of randomized clinical trial testing by experts, and recommendations were provided. Breakout sessions were convened to discuss and develop future studies. The CTPM experts concluded that there is compelling evidence to move forward with selected pharmacological and nonpharmacological clinical trials for the prevention and treatment of CIPN. Several key feasibility issues need to be addressed, however. These include identification of optimal outcome measures to define the CIPN phenotype, establishment of parameters that guide the evaluation of clinically meaningful effects, and adoption of approaches for inclusion of translational and biomarker and/or genetic measures. The results of the CTPM provide support for conducting clinical trials that include both pharmacological and nonpharmacological approaches, alone or in combination, with biomarkers, genetics, or other measures designed to inform underlying CIPN mechanisms. Several working groups were formed to design rigorous CIPN clinical trials, the results of which are ongoing.