Phase II Study of Osimertinib in Patients With Epidermal Growth Factor Receptor Mutations: Results From the NCI-MATCH ECOG-ACRIN (EAY131) Trial Subprotocol E.

PURPOSE: The National Cancer Institute Molecular Analysis for Therapy Choice trial is a signal-finding genomically driven platform trial that assigns patients with any advanced refractory solid tumor, lymphoma, or myeloma to targeted therapies on the basis of next-generation sequencing results. Subprotocol E evaluated osimertinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in patients with EGFR mutations. METHODS: Eligible patients had EGFR mutations (T790M or rare activating) and received osimertinib 80 mg once daily. Patients with lung cancer with EGFR T790M were excluded. The primary end point was objective response rate (ORR), and the secondary end points were 6-month progression-free survival (PFS), overall survival, and toxicity. RESULTS: A total of 19 patients were enrolled: 17 were evaluable for toxicity and 13 for efficacy. The median age of the 13 included in the efficacy analysis was 63 years, 62% had Eastern Cooperative Oncology Group performance status 1, and 31% received >three previous systemic therapies. The most common tumor type was brain cancers (54%). The ORR was 15.4% (n = 2 of 13; 90% CI, 2.8 to 41.0) and 6-month PFS was 16.7% (90% CI, 0 to 34.4). The two confirmed RECIST responses were observed in a patient with neuroendocrine carcinoma not otherwise specified (EGFR exon 20 S768T and exon 18 G719C mutation) and a patient with low-grade epithelial carcinoma of the paranasal sinus (EGFR D770_N771insSVD). The most common (>20%) treatment-related adverse events were diarrhea, thrombocytopenia, and maculopapular rash. CONCLUSION: In this pretreated cohort, osimertinib did not meet the prespecified end point threshold for efficacy, but responses were seen in a neuroendocrine carcinoma with an EGFR exon 20 S768T and exon 18 G719C mutation and an epithelial carcinoma with an EGFR D770_N771insSVD mutation. Osimertinib was well tolerated and had a safety profile consistent with previous studies.

Phase II Study of Erdafitinib in Patients With Tumors With FGFR Amplifications: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol K1.

PURPOSE: Despite fibroblast growth factor receptor (FGFR) inhibitors being approved in tumor types with select FGFR rearrangements or gene mutations, amplifications of FGFR represent the most common FGFR alteration across malignancies. Subprotocol K1 (EAY131-K1) of the National Cancer Institute-MATCH platform trial was designed to evaluate the antitumor efficacy of the oral FGFR1-4 inhibitor, erdafitinib, in patients with tumors harboring FGFR1-4 amplification. METHODS: EAY131-K1 was an open-label, single-arm, phase II study with central confirmation of presence of FGFR1-4 amplification in tumors. Patients with urothelial carcinoma were excluded. Enrolled patients received oral erdafitinib at a starting dose of 8 mg once daily continuously with escalation to 9 mg once daily continuously, on the basis of predefined time point assessments of phosphate levels, until disease progression or intolerable toxicity. The primary end point was centrally assessed objective response rate (ORR), with key secondary end points being 6-month progression-free survival (PFS6), PFS, overall survival (OS), and safety. RESULTS: Thirty-five patients were enrolled into this study with 18 included in the prespecified primary efficacy analysis. The median age of the 18 patients was 60 years, and 78% had received ≥3 previous lines of therapy. There were no confirmed responses to erdafitinib; however, five patients experienced stable disease (SD) as best response. One patient with an FGFR1-amplified breast cancer had a prolonged PFS >168 days (5.5 months). The median PFS was 1.7 months (90% CI, 1.1 to 1.8 months) and the median OS was 4.2 months (90% CI, 2.3 to 9.3 months). The estimated PFS6 rate was 13.8% (90% CI, 3.3 to 31.6). The majority of toxicities were grade 1 to 2 in nature, although there was one grade 5 treatment-related adverse event. CONCLUSION: Erdafitinib did not meet its primary end point of efficacy as determined by ORR in treatment-refractory solid tumors harboring FGFR1-4 amplifications. Our findings support that rearrangements and gene mutations, but not amplifications, of FGFR remain the established FGFR alterations with approved indications for FGFR inhibition.

Engaging Communities in Cancer Prevention and Control Activity Prioritization through a Statewide Needs Assessment: A Case Study from Nebraska.

Community outreach and engagement (COE) activities are important in identifying catchment area needs, communicating these needs, and facilitating activities relevant to the population. The National Cancer Institute-designated cancer centers are required to conduct catchment-wide cancer needs assessments as part of their COE activities. The University of Nebraska Medical Center Buffett Cancer Center undertook a three-year-long process to conduct a needs assessment, identify priorities, and develop workgroups to implement cancer prevention and control activities. Activities were conducted through collaborations with internal and external partners. The needs assessment focused on prevention, early detection, and treatment of cancer and involved secondary data analysis and focus groups with identified underrepresented priority populations (rural, African American, Hispanic, Native American, and LGBTQ+ populations). Results were tailored and disseminated to specific audiences via internal and external reports, infographics, and presentations. Several workgroups were developed through meetings with the internal and external partners to address identified priorities. COE-specific initiatives and metrics have been incorporated into University of Nebraska Medical Center and Buffett Cancer Center strategic plans. True community engagement takes a focused effort and significant resources. A systemic and long-term approach is needed to develop trusted relationships between the COE team and its local communities.

Variability in expenses related to spine oncology care: comparison of payer-negotiated rates at National Cancer Institute-Designated Cancer Centers.

BACKGROUND: As of 2021, the Centers for Medicare and Medicaid Services (CMS) requires all hospitals to publish their commercially negotiated prices. To our knowledge, price variation of spine oncology diagnosis and treatments has not been previously investigated. PURPOSE: The aim of this study is to characterize the availability and variation of prices for spinal oncology services among National Cancer Institute-Designated Cancer Centers (NCI-DCC). STUDY DESIGN: Cross-sectional analysis. METHODS: Cancer centers were identified; those that did not provide patient care or participate in Medicare's Inpatient Prospective System were excluded. A cross-sectional analysis was conducted to gather commercially negotiated prices by searching online for "[center name] price transparency OR machine-readable file OR chargemaster." Data obtained was queried using 44 current procedural terminology (CPT) codes for imaging, procedures, and surgeries relevant to spine oncology. Comparison of prices was achieved by normalizing the median price for each service at each center to the estimated 2022 Medicare reimbursement for the center's Medicare Administrator Contractor. The ratios between the lowest and highest median commercial negotiated price within a center and across all centers were defined as "within-center ratio" and "across-center ratio" respectively. RESULTS: In total, 49 centers disclosed commercial payer-negotiated rates. Mean rate (±SD) for cervical corpectomy was $9,134 (±$10,034), thoracic laminectomy for neoplasm excision was $5,382 (±$5502), superficial bone biopsy was $1,853 (±$1,717), and single-photon emission computerized tomography (SPECT) was $813 (±$232). Within-center ratios ranged from 5.0 (SPECT scan) to 17.8 (radiofrequency bone ablation). Across-center ratios (for codes with > 10 centers reporting) ranged from 9.0 (corpectomy, thoracic, lateral extra-cavitary) to 418.7 (anterior approach cervical corpectomy). CONCLUSIONS: Price transparency for spinal oncology remains elusive despite recent CMS regulatory oversight, with marked heterogeneity in the quality of published rates complicating patients' ability to "shop" for care. Additionally, there continues to be significant variation in commercial rates for spine oncology diagnosis and treatment. CLINICAL SIGNIFICANCE: Despite regulation by CMS, prices for spinal oncology services are not uniformly available to patients and vary between NCI-DCC. The findings of this manuscript present potential barriers for patients to compare and obtain affordable care.

Authorship of Publications Supported by NCI-Funded Grants Involving Low- and Middle-Income Countries.

Importance: Scientific publication is an important tool for knowledge dissemination and career advancement, but authors affiliated with institutions in low- and middle-income countries (LMICs) are historically underrepresented on publications. Objective: To assess the country income level distribution of author affiliations for publications resulting from National Cancer Institute (NCI)-supported extramural grants between 2015 and 2019, with international collaborating institutions exclusively in 1 or more LMICs. Design and Setting: This cross-sectional study assessed authorship on publications resulting from NCI-funded grants between October 1, 2015, and September 30, 2019. Grants with collaborators in LMICs were identified in the National Institutes of Health (NIH) Query/View/Report and linked to publications using Dimensions for NIH, published between 2011 and 2020. Statistical analysis was performed from May 2021 to July 2022. Main Outcomes and Measures: Author institutional affiliation was used to classify author country and related income level as defined by the World Bank. Relative citation ratio and Altmetric data from Dimensions for NIH were used to compare citation impact measures using the Wilcoxon rank sum test. Results: In this cross-sectional study, 159 grants were awarded to US institutions with collaborators in LMICs, and 5 grants were awarded directly to foreign institutions. These 164 grants resulted in 2428 publications, of which 1242 (51%) did not include any authors affiliated with an institution in an LMIC. In addition, 1884 (78%) and 2009 (83%) publications had a first or last author, respectively, affiliated with a high-income country (HIC). Publications with HIC-affiliated last authors also demonstrated greater citation impact compared with publications with LMIC-affiliated last authors as measured by relative citation ratios and Altmetric Attention Scores; publications with HIC-affiliated first authors also had higher Altmetric Attention Scores. Conclusions and Relevance: This cross-sectional study suggests that LMIC-affiliated authors were underrepresented on publications resulting from NCI-funded grants involving LMICs. It is critical to promote equitable scientific participation by LMIC institutions in cancer research, including through current and planned programs led by the NCI.

Defining the Role of the Advanced Practice Provider Within the National Cancer Institute Community Oncology Research Program.

PURPOSE: Oncology advanced practice providers (APPs), including nurse practitioners, clinical nurse specialists, physician assistants, and clinical pharmacists, contribute significantly to quality cancer care. Understanding the research-related roles of APPs in the National Cancer Institute's (NCI) Community Oncology Research Program (NCORP) could lead to enhanced protocol development, trial conduct, and accrual. METHODS: The 2022 NCORP Landscape Assessment Survey asked two questions about the utilization and roles of APPs in the NCORP. RESULTS: A total of 271 practice groups completed the 2022 survey, with a response rate of 90%. Of the 259 nonpediatric exclusive practice groups analyzed in this study, 92% used APPs for clinical care activities and 73% used APPs for research activities. APPs most often provided clinical care for patients enrolled in trials (97%), followed by assistance with coordination (65%), presenting/explaining clinical trials (59%), screening patients (49%), ordering investigational drugs (37%), and consenting participants (24%). Some groups reported APPs as an enrolling investigator (18%) and/or participating in institutional oversight/selection of trials (15%). Only 5% of NCORP sites reported APPs as a site primary investigator for trials, and very few (3%) reported APPs participating in protocol development. CONCLUSION: Practice groups report involving APPs in clinical research within the NCORP network; however, opportunities for growth exists. As team-based care has enhanced clinical practice in oncology, this same approach can be used to enhance successful research. Suggested strategies include supporting APP research-related time, recognition, and education. The findings of this survey and subsequent recommendations may be applied to all adult oncology practices that participate in clinical research.

Disparities in National Cancer Institute and Nonprofit Organization Funding Disproportionately Affect Cancers With Higher Incidence Among Black Patients and Higher Mortality Rates.

PURPOSE: National Cancer Institute (NCI) and nonprofit organization (NPO) funding is critical for research and advocacy but may not be equitable across cancers. METHODS: This study evaluated funding from the NCI and NPOs supporting lung, breast, colorectal, pancreatic, hepatobiliary, prostate, ovarian, cervical and endometrial cancers, leukemia, lymphoma, and melanoma from 2015 to 2018. The primary objectives were to assess for funding disparities across different cancers compared with their incidence and mortality and across racial groups. We also determined if underfunding correlates with fewer clinical trials. Correlations between funding for each cancer and its incidence, mortality, and number of clinical trials were analyzed using descriptive statistics and Pearson correlation coefficients (CCs). RESULTS: Diseases with the largest combined NCI and NPO funding were breast cancer ($3.75 billion in US dollars [USD]) and leukemia ($1.99 billion USD). Those with the least funding were endometrial ($94 million USD), cervical ($292 million USD), and hepatobiliary cancers ($348 million USD). Disease-specific funding correlated well with incidence but correlated poorly with mortality (Pearson CCs, 0.74; P = .006 and .30, P = .346, respectively). Breast cancer, leukemia, and lymphoma were well-funded while colorectal, lung, hepatobiliary and uterine cancers were underfunded. Higher incidence among Black patients correlated with underfunding. The amount of funding for a particular cancer correlated strongly with the number of clinical trials for that disease (Pearson CC, 0.91; P < .0001). CONCLUSION: Many cancers with high incidence and mortality rates are underfunded. Cancers that affect Black patients at higher rates are also underfunded. Underfunding strongly correlates with fewer clinical trials, which could impede future advances in underfunded cancers.

Pulmonary metastatectomy in pediatric cancer patients at National Cancer Institute, Egypt: prognostic factors and outcome.

BACKGROUND: Metastatic tumors account for 80% of all lung tumors in children. Wilms tumour and osteosarcoma are the most tumors of childhood that produce lung metastases. The aim of the current study is to assess the prognostic factors of pulmonary metastatectomy in pediatric solid tumours as age, number, size, site,laterality, resectability of pulmonary nodules, and number of Thoracotomies. Calculate overall survival among patients who underwent pulmonary metastatectomy. METHODS: It is a retrospective study including all pediatric patients with metastatic solid tumors to lungs treated at pediatric oncology department, National Cancer Institute, Cairo University from 2008 to 2014. Fifty-five patients were included, 43 (78.2℅) patients of them had Osteosarcoma. RESULTS: Thirty (54.5℅)patients were male. The mean age was 15 years ranging from (4.5- 23) years. The site of primary disease was at lower limbs in 43 (78.2%) patients. All patients underwent complete surgical resection of the primary disease with negative margin, 22(51.1%) of the osteosarcoma patients did amputation with tumor necrosis less than 90%. All patients received chemotherapy and only 9 received radiation therapy. The patients were classified into four groups according to time of diagnosis of pulmonary metastasis: at time of diagnosis in 13 (21.8%) patients, within treatment in 16 (30.9%) patients, within first year follow up in 18 (32.7%) patients and detected late in 8 (14.5%) patients. Bilateral lung metastasis diagnosed by CT chest were detected in 42 (76.4%) patients. Size of metastatic nodules was ranging from (0.5 to 10 cm) with mean 3.4 cm. Number of metastatic nodules was ranging from (1 to 28) median 4.Metastatic complications were detected in 19 patients. 5-year OS was 74.8% in the study group, and 68% in osteosarcoma patients. Effect of prognostic factors as sex, time of respectability, laterality, tumor necrosis of the 1ry disease, Timing of lung metastasis, size and site of the primary, Surgical approach of metastatectomy, postoperative complications on overall survival of the studied patients was done with significant P-value of tumor necrosis of the 1ry disease and Timing of lung metastasis 0.017, 0.001 respectively. CONCLUSION: Resection of pulmonary metastases of pediatric solid tumours is a safe and effective treatment that offers better survival.

Availability of cancer survivorship support services across the National Cancer Institute Community Oncology Research Program network.

BACKGROUND: National cancer organizations recommend provision of nutrition, physical activity, and mental health supportive services to cancer survivors. However, the availability of these services across diverse community oncology settings remains unclear. METHODS: The National Cancer Institute Community Oncology Research Program (NCORP) is a national network of community oncology practices engaged in cancer research. The 2022 NCORP Landscape Assessment (5UG1CA189824) assessed individual practices' establishment of survivorship clinics and nutrition, physical activity, and mental health services, resources, and/or referrals. Descriptive statistics summarized and logistic regression quantified the association between services, practice, and patient characteristics. RESULTS: Of 46 NCORP community sites, 45 (98%) responded to the survey, representing 259 adult practice groups. A total of 41% had a survivorship clinic; 96% offered mental health, 94% nutrition, and 53% physical activity services, resources, and/or referrals. All 3 services were offered in various formats (eg, in-house, referrals, education) by 51% and in-house only by 25% of practices. Practices with advanced practice providers were more likely to have a survivorship clinic (odds ratio [OR] = 3.19, 95% confidence interval [CI] = 1.04 to 9.76). Practices with at least 30% Medicare patients (OR = 2.54, 95% CI = 1.39 to 4.66) and more oncology providers (OR = 1.02, 95% CI = 1.01 to 1.04) were more likely to have all 3 services in any format. Practices with at least 30% Medicare patients (OR = 3.41, 95% CI = 1.50 to 7.77) and a survivorship clinic (OR = 2.84, 95% CI = 1.57 to 5.14) were more likely to have all 3 services in-house. CONCLUSIONS: Larger oncology practices and those caring for more survivors on Medicare provided more supportive services, resources, and/or referrals. Smaller practices and those without survivorship clinics may need strategies to address potential gaps in supportive services.

Access to Care for Adolescents and Young Adults With Cancer in the United States: State of the Literature.

Access to care remains a persistent challenge for adolescents and young adults (AYAs) with cancer. We review key findings in the science to date. (1) Location of care matters. There is survival benefit for AYAs treated either at a pediatric center or site with special status (eg, Children's Oncology Group, National Cancer Institute [NCI]-designated Comprehensive Cancer Center). (2) Socioeconomic status and insurance require further investigation. Medicaid expansion has had a moderate effect on AYA outcomes. The dependent care expansion benefit has come largely from improvements in coverage for younger populations whose parents have insurance, while some subgroups likely still face insurance gaps. (3) Clinical trial enrollment remains poor, but access may be improving. Numerous barriers and facilitators of clinical trial enrollment include those that are system level and patient level. NCI has established several initiatives over the past decade to improve enrollment, and newer collaboratives have recently brought together multidisciplinary US teams to increase clinical trial enrollment. (4) Effective AYA programs require provider and system flexibility and program reflection. With flexibility comes a need for metrics to assess program effectiveness in the context of the program model. Centers treating AYAs with cancer could submit a subset of metrics (appropriate to their program and/or services) to maintain their status; persistence would require an entity with staying power committed to overseeing the metrics and the system. Substantial clinical and biological advances are anticipated over the next 20 years that will benefit all patients with cancer. In parallel, it is crucial to prioritize research regarding access to health care and cancer care delivery; only with equitable access to care for AYAs can they, too, benefit from these advances.

Classical Hematology Referrals at an National Cancer Institute-Designated Cancer Center: Lessons Learned.

PURPOSE: To understand the spectrum and volume of classical hematology (CH) referrals to hematology clinics at a National Cancer Institute (NCI)-designated cancer center (CC) to plan for the delivery of effective and equitable care for this population. METHODS: One referral office at the Academic CC located in Bexar County, TX, handles all adult hematology referrals. From October 1, 2021, to September 30, 2022, all nonmalignant hematology (MH) referrals were triaged daily to define the category of CH problem. Declined referrals (confirmed at triage that no CH problem was evident) are included as part of this analysis. Electronic consultation (opinion rendered without patient seen) at our CC is available and is not part of this analysis. RESULTS: One thousand nine hundred forty-five CH referrals were received in the 12-month period. Seventy-six referrals (3.9%) were declined. During the study period, there were 2,289 medical oncology referrals and 779 referrals for MH. CH referrals therefore comprise 39% of all hematology-oncology referrals and 71% of all hematology referrals at the CC. Anemia and thrombotic disorders were the most common categories of the accepted CH referrals at 487 (26%) and 393 (21%), respectively. Video visits were used for 447 of all CH referrals (23%), and the rest were in person. CONCLUSION: Nearly 40% of all referrals to hematology and medical oncology at our NCI-designated CC are for CH. Effective management of the CH population of patients will allow ideal care for CH problems and also allow cancer-focused care to improve.

State of the science and future directions for research on HIV and cancer: Summary of a joint workshop sponsored by IARC and NCI.

An estimated 38 million people live with human immunodeficiency virus (HIV) worldwide and are at excess risk for multiple cancer types. Elevated cancer risks in people living with HIV (PLWH) are driven primarily by increased exposure to carcinogens, most notably oncogenic viruses acquired through shared transmission routes, plus acceleration of viral carcinogenesis by HIV-related immunosuppression. In the era of widespread antiretroviral therapy (ART), life expectancy of PLWH has increased, with cancer now a leading cause of co-morbidity and death. Furthermore, the types of cancers occurring among PLWH are shifting over time and vary in their relative burden in different parts of the world. In this context, the International Agency for Research on Cancer (IARC) and the US National Cancer Institute (NCI) convened a meeting in September 2022 of multinational and multidisciplinary experts to focus on cancer in PLWH. This report summarizes the proceedings, including a review of the state of the science of cancer descriptive epidemiology, etiology, molecular tumor characterization, primary and secondary prevention, treatment disparities and survival in PLWH around the world. A consensus of key research priorities and recommendations in these domains is also presented.

mHealth Apps Use and Their Associations With Healthcare Decision-Making and Health Communication Among Informal Caregivers: Evidence From the National Cancer Institute's Health Information National Trends Survey.

PURPOSE: The current study investigates associations between mHealth apps and healthcare decision-making and health communication among informal caregivers in the US. DESIGN: Cross-sectional study employing secondary data. SETTING: The Health Information National Trends Survey (HINTS5, Cycles 2 through 4, 2018 - 2020). SAMPLE: Self-identified informal caregivers (n = 1386; had mHealth apps = 61.3%, female = 63.2%, some college or more in education = 80.3%) who reported owning at least a smartphone or a tablet computer (i.e., ownership of a "smart device"). MEASURES: Sociodemographic characteristics, reports of having mHealth apps, smart device utilization in healthcare decision-making and health communication. ANALYSIS: Accounting for the complex design features of the HINTS data, we constructed multiple hierarchical logistic regressions to compute adjusted odds ratios (aOR) and their 95% confidence intervals (CI). RESULTS: Compared to caregivers without mHealth apps, those with the apps had higher odds of utilizing their smart devices to make a health-related decision, such as how to treat a disease or a medical condition (aOR = 1.65; 95% CI: 1.13-2.39, P < .01), or engage in health-related discussions with a healthcare provider (aOR = 2.36; 95% CI: 1.54-3.61, P < .001). CONCLUSION: Having mHealth apps was associated with a higher likelihood of using smart devices in healthcare decision-making and health communication by informal caregivers. Empowering caregivers to make informed health-related decisions and communicate effectively with healthcare providers are both crucial to health promotion and well-being. Future studies should investigate facilitators as well as barriers to using mHealth apps and smart devices in health-promoting strategies involving informal caregivers.

The role of community outreach and engagement in evaluation of NCI Cancer Center Support Grants.

PURPOSE: National Cancer Institute (NCI)-designated cancer centers are required to consider their impact on the catchment area they serve. These activities are facilitated by community outreach and engagement (COE) activities as specified in the Cancer Center Support Grant (CCSG) request for applications. While the critical importance of COE activities to NCI-designated cancer centers is well known, it is less clear what impact the COE component has on the overall CCSG merit descriptor and score. METHODS: We undertook an online survey of all 62 NCI-designated Comprehensive and Clinical centers who reported their COE merit descriptor and overall CCSG priority score as of Fall 2021. RESULTS: Of 48 (77%) of responding centers, we identified a strong correlation between the COE merit descriptor and the overall numerical CCSG score received by the center (Spearman's rank correlation coefficient r = 0.360, p = 0.0053). When stratifying this relationship by center type, we observed a very strong correlation between COE and CCSG ratings for comprehensive cancer centers (n = 40; r = 0.544; p = 0.0003) but not for non-comprehensive cancer centers (n = 8; r = 0.073; p = 0.864). CONCLUSION: COE component merit descriptors for comprehensive cancer center CCSG evaluations are strongly correlated with the overall cancer center review score.

Efficacy of Sunitinib in Patients With Favorable and Intermediate Risk Metastatic Renal Cell Carcinoma - Lithuanian National Cancer Institute Experience.

BACKGROUND/AIM: According to the European Society for Medical Oncology (ESMO) and National Comprehensive Cancer Network (NCCN) recommendations, sunitinib is one of the recommended regimens for favorable and intermediate-risk metastatic renal cell carcinoma (mRCC) patients. The objective of this study was to evaluate sunitinib efficacy as a first-line treatment for mRCC patients with favorable/intermediate prognostic risk in a real-world setting. PATIENTS AND METHODS: Patients diagnosed with mRCC and confirmed as appropriate candidates for the first-line systemic treatment were included in this retrospective study. The prognostic risk was evaluated according to the model of the International Metastatic RCC Database Consortium (IMDC). RESULTS: Patients received sunitinib as a first-line treatment. A total of 94 patients were enrolled from 2019 to the 2020and 67 of them were included in the detailed analysis. Median progression-free survival (PFS) was 23.4 (95%CI=17.3-29.5), and median overall survival (OS) was 66 months (95%CI=44.9-87.1). The age over 60 years was a significant negative predictor for PFS and OS. Regarding the IMDC model for disease risk prediction, the number of two risk factors in the intermediate risk group was a significant predictor for a shorter response to the first-line therapy. CONCLUSION: Sunitinib is an effective tyrosine kinase inhibitor, which can be used as a first-line treatment in favorable/intermediate-risk groups of patients with mRCC, especially in countries where novel systemic treatment modalities are not yet available.

Rationale, Procedures, and Response Rates for a Pilot Study to Sample Cancer Survivors for NCI's Health Information National Trends Survey: HINTS-SEER 2021.

The National Cancer Institute's (NCI) Health Information National Trends Survey (HINTS) is a nationally representative survey of U.S. adults in which 12-17% of respondents report a cancer history. To increase representation from adult cancer survivors, in 2021, NCI sampled survivors from three Surveillance, Epidemiology, and End Results (SEER) program cancer registries: Iowa, New Mexico, and the Greater Bay Area. Sampling frames were stratified by time since diagnosis and race/ethnicity, with nonmalignant tumors and non-melanoma skin cancers excluded. Participants completed a self-administered postal questionnaire. The overall response rate for HINTS-SEER (N = 1,234) was 12.6%; a non-response bias analysis indicated few demographic differences between respondents and the pool of sampled patients in each registry. Most of the sample was 10+ years since diagnosis (n = 722; 60.2%); 392 respondents were 5 to < 10 years since diagnosis (29.6%); and 120 were < 5 years since diagnosis (10.2%). Common cancers included male reproductive (n = 304; 24.6%), female breast (n = 284; 23.0%), melanoma (n = 119; 9.6%), and gastrointestinal (n = 106; 8.6%). Tumors were mostly localized (67.8%; n = 833), with 22.4% (n = 282) regional, 6.2% (n = 72) distant, and 3.7% (n = 47) unknown. HINTS-SEER data are available by request and may be used for secondary analyses to examine a range of social, behavioral, and healthcare outcomes among cancer survivors.

Tumor-Specific Activity of Precision Medicines in the NCI-MATCH Trial.

PURPOSE: National Cancer Institute Molecular Analysis for Therapy Choice (NCI-MATCH) is a precision medicine basket trial designed to test the effectiveness of treating cancers based on specific genetic changes in patients' tumors, regardless of cancer type. Multiple subprotocols have each tested different targeted therapies matched to specific genetic aberrations. Most subprotocols exhibited low rates of tumor shrinkage as evaluated across all tumor types enrolled. We hypothesized that these results may arise because these precision cancer therapies have tumor type-specific efficacy, as is common among other cancer therapies. EXPERIMENTAL DESIGN: To test the hypothesis that certain tumor types are more sensitive to specific therapies than other tumor types, we applied permutation testing to tumor volume change and progression-free survival data from 10 published NCI-MATCH subprotocols (together n = 435 patients). FDR was controlled by the Benjamini-Hochberg procedure. RESULTS: Six of ten subprotocols exhibited statistically significant evidence of tumor-specific drug sensitivity, four of which were previously considered negative based on response rate across all tumors. This signal-finding analysis highlights potential uses of FGFR tyrosine kinase inhibition in urothelial carcinomas with actionable FGFR aberrations and MEK inhibition in lung cancers with BRAF non-V600E mutations. In addition, it identifies low-grade serious ovarian carcinoma with BRAF v600E mutation as especially sensitive to BRAF and MEK co-inhibition (dabrafenib plus trametinib), a treatment that received accelerated FDA approval for advanced solid tumors with BRAF v600E mutation. CONCLUSIONS: These findings support the value of basket trials because even when precision medicines do not have tumor-agnostic activity, basket trials can identify tumor-specific activity for future study.

Incidence Trends of Melanoma of the Lower Limbs and Hips in the United States: A Surveillance, Epidemiology, and End Results Analysis 2000-2019.

BACKGROUND/AIM: No specific studies on the changes in the incidence of melanoma in the lower limbs and hips have been performed. This article aimed to examine trends in incidence rates of melanoma of the lower extremities in the U.S. PATIENTS AND METHODS: Data from the SEER program provided by the National Cancer Institute were used to examine trends in melanoma incidence from 2000 to 2019. Data analysis was performed from October to December 2022. RESULTS: A total of 192,327 cases of melanoma of the lower limbs and hips were diagnosed from 2000 to 2019 and included in our study. The incidence rate increased from 9.78 to 13.65 cases per 100,000 person-year and by an average annual percent change (AAPC) of 2% (95%CI=1.4-2.9%). The incidence increased by an AAPC of 2.1% in men and 1.7% in women. The incidence among people under 50 remained stable but increased among those over 50 years. Localized stage disease was the only stage where a continuously increasing incidence was observed, with an AAPC of 1.7% (95%CI=0.9-2.5%). Lentiginous melanoma showed the highest incidence trend rate with an AAPC of 2.3% (95%CI=1.0-3.5%). CONCLUSION: The incidence rate of melanoma in the lower limbs and hips increased between 2000 and 2019, with a higher incidence in men, reversing the previously described trend of higher incidence among women. However, incidence among people under 50 remained stable, suggesting the efficacy of prevention campaigns in this population.