National Comprehensive Cancer Network Clinical Research Articles

Looking through the same lens - Immunohistochemistry for salivary gland tumors: A narrative review on testing and management strategies

Salivary gland tumors are relatively uncommon neoplasms, presenting a diagnostic challenge for both clinicians and pathologists. When performing a biopsy, there is often an impasse between both specialists, with the clinician trying to remove as little tissue as possible and the pathologist in a perpetual quest for more. While immunohistochemistry (IHC), coupled with hematoxylin-eosin staining greatly helps in reaching a precise diagnosis and framing a management plan, there are no existing guidelines for the implementation of IHC panels in the diagnostic work-up of salivary gland tumors. The main objective of this review is to provide an up-to-date summary of the application of IHC in the diagnosis of salivary gland malignancies and the current treatment strategies. For this narrative review, we identified 50 meta-analyses and systematic reviews published between September 2013 and September 2023 using the PubMed and Google Scholar databases, with the keywords, “IHC in salivary gland tumors” and “immunohistochemistry in salivary gland tumors.” We excluded non-peer-reviewed articles, non-human studies, case reports, and series, and articles that were not in English or those for which the full text was not available; we included the remaining 18 articles in our qualitative data synthesis. To summarize the management strategy, we collated and included the key points from the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (Head and Neck Cancers, Version 1), 2023 and the American Society of Clinical Oncology guidelines. Our findings reflect that IHC markers, in addition to offering significant prognostic insight and guiding surgical strategy, also help plan hormonal and targeted therapies. A thorough understanding of the clinical implications of various IHC markers ensures informed multidisciplinary communication and helps the clinician and pathologist see things from a common perspective, that is, through the same lens.

Increased Utilization of Low-Dose CT for Lung Cancer Screening at an Arkansas Community Oncology Clinic

BackgroundLow-dose CT (LDCT) is underused in Arkansas for lung cancer screening, a rural state with a high incidence of lung cancer. The objective was to determine whether offering free LDCT increased the number of high-risk individuals screened in a rural catchment area. MethodsThere were 5,402 patients enrolled in screening at Highlands Oncology, a community oncology clinic in Northwest Arkansas, from 2013 to 2020. Screenings were separated into time periods: period 1 (10 months for-fee), period 2 (10 months free with targeted advertisements and primary care outreach), and period 3 (62 months free with only primary care outreach). In all, 5,035 high-risk participants were eligible for analysis based on National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Enrollment rates, incidence densities (IDs), Cox proportional hazard models, and Kaplan-Meier curves were performed to investigate differences between enrollment periods and high-risk groups. ResultsPatient volume increased drastically once screenings were offered free of charge (period 1 = 4.6 versus period 2 = 66.0 and period 3 = 69.8 average patients per month). Incidence density per 1,000 person-years increased through each period (IDPeriod 1 = 17.2; IDPeriod 2 = 20.8; IDPeriod 3 = 25.5 cases). Cox models revealed significant differences in lung cancer risk between high-risk groups (P = .012) but not enrollment periods (P = .19). Kaplan-Meier lung cancer-free probabilities differed significantly between high-risk groups (log-rank P = .00068) but not enrollment periods (log-rank P = .18). ConclusionsThis study suggests that eligible patients are more receptive to free LDCT screening, despite most insurances not having a required copay for eligible patients.

Real world US community urology adherence to prostate cancer guidelines.

449 Background: According to a 2010 Surveillance, Epidemiology, and End Results (SEER) Medicare analysis of prostate cancer (PCa) patients between 1992 and 2005, urologists accounted for more health services provided to PCa patients than any other specialty. Our study assessed the concordance of PCa care with two treatment-related Performance Indicators (PIs) derived from National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) in a real-world setting of community urologists. Methods: This retrospective analysis used PPS Analytics (Specialty Networks) Patient Population Health Management Platform, capturing 90 community urology practices with approximately 539,000 PCa patients treated between 7/1/2019-6/30/2022. Two PIs were identified from NCCN Guidelines through consultation with expert urologists to measure the quality of PCa care. PI-1 was defined as the proportion mCSPC patients who initiated an NCCN Category 1 preferred regimen for mCSPC. Guideline changes on 01/01/2020 created a need for two patient stratifications in PI-1. Patients in PI-1.1 had a mCSPC diagnosis between 05/2002 - 12/2019. Patients in PI-1.2 had a mCSPC diagnosis between 01/2020 - 06/2021. PI-2 was defined as the proportion of newly diagnosed intermediate-to-high risk localized PCa (Gleason score ≥ 7 or PSA ≥ 10) who received concurrent ADT with external beam radiation therapy (EBRT) based on the NCCN Guidelines recommendation for concurrent ADT in newly diagnosed intermediate-to-high risk localized PCa (LPC) receiving EBRT. Multi-level multi-variable regression was used to assess factors associated with concordance for each PI. Results: See table. Conclusions: Although changes in NCCN guidelines after 1/2020 led to improved systemic treatment in mCSPC, most patients still did not receive care concordant with recent NCCN recommendations. Our findings highlight opportunities for improving the quality of PCa care in a real-world community urology setting, notably for treatment in mCSPC. Future research should investigate reasons for deviating from NCCN preferred systemic regimens in mCSPC and intervene as appropriate.[Table: see text]

First-line nivolumab plus ipilimumab for unresectable MPM in China: a cost-effectiveness analysis

BackgroundThe regimen of nivolumab plus ipilimumab (NI) has been recommended by the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology-Malignant Pleural Mesothelioma (Version 1.2022) and Chinese Guidelines for the Clinical Diagnosis and Treatment of Malignant Pleural Mesothelioma (2021 edition) as the first-line treatment for Malignant Pleural Mesothelioma (MPM). But whether immunotherapy has a financial advantage over conventional chemotherapy (pemetrexed plus cisplatin/carboplatin, C) is uncertain.MethodsBased on survival and safety data from the CheckMate 743 clinical trial (NCT02899299), a partitioned survival model was constructed using TreeAge Pro2022 software. The model cycle was set to 1 month and the study period was 10 years. The output indicators included total cost, quality-adjusted life year (QALY) and incremental cost-effectiveness ratio (ICER). One-way and probabilistic sensitivity analyses were used to assess the robustness of the results, considering only direct medical costs.Results and discussionThe ICER for group NI versus Group C was $375,656/QALY in all randomized patients, $327,943/QALY in patients with epithelioid histology, and $115,495/QALY in patients with non-epithelioid histology. The ICERs of all three different populations all exceeded the willingness-to-pay threshold (three times the per capita gross domestic product of China in 2021). The results of univariate sensitivity analysis showed that the price of pemetrexed and nivolumab had great influence on the analysis results. The results of the probabilistic sensitivity analysis show that the probability of the NI scheme being more economical in all three different populations was 0.What is new and conclusionFrom the perspective of the Chinese healthcare system, in patients with unresectable MPM, NI has no economic advantage over C.

Time from biopsy to radical prostatectomy by race in an equal-access healthcare system: Results from the SEARCH cohort.

We previously showed that within an equal-access health system, race was not associated with the time between prostate cancer (PC) diagnosis and radical prostatectomy (RP). However, in the more recent time-period of the study (2003-2007), Black men had significantly longer times to RP. We sought to revisit the question in a larger study population with more contemporary patients. We hypothesized that time from diagnosis to treatment would not differ by race, even after accounting for active surveillance (AS) and the exclusion of men at very low to low risk of PC progression. We analyzed data from 5885 men undergoing RP from 1988 to 2017 at eight Veterans Affairs Hospitals from SEARCH. Multiple linear regression was used to compare time from biopsy to RP and to examine the risk of delays (>90 and >180 days) between races. In sensitivity analyses we excluded men deemed to have initially chosen AS based on having >365 days from biopsy to RP and men at very low to low PC risk for progression according to National Comprehensive Cancer Network Clinical Practice Guidelines. At biopsy, Black men (n = 1959) were younger, had lower body mass index, and higher prostate specific antigen levels, (all p < 0.02), compared to White men (n = 3926). Time from biopsy to RP was longer in Black men (mean days: 98 vs. 92; adjusted ratio of mean number of days, 1.07 [95% confidence interval: 1.03-1.11], p < 0.001); however, there were no differences in delays >90 or >180 days after adjusting for confounders (all p ≥ 0.286). Results were similar following the exclusion of men potentially under on AS and at very low and low risk. In an equal-access healthcare system, we did not find evidence of clinically relevant differences in time from biopsy to RP in Black versus White men.

Evolution in the Presence and Evidence Category of Radiation Therapy Treatment Recommendations in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology

The changes in the recommended use of radiation therapy (RT) in the presence of expanding systemic cancer therapies and technological advances are poorly characterized. We sought to understand the recommended utilization of RT across a broad range of malignancies by examining National Comprehensive Cancer Network (NCCN) Guidelines. We conducted a comprehensive review and categorization of RT recommendations, with their subsequent supporting evidence categories, in 3 versions of NCCN Guidelines, specifically years 2000, 2009, and 2019. These NCCN Guidelines were individually examined for RT-specific recommendations among the 10 most common tumors. The presence of RT as a recommended modality was recorded for each tumor type in each guideline. Recommendation categories including Category 1, 2A, 2B, and 3 were tallied and compared with examine totals and percentage distributions in each tumor type. A total of 3858 NCCN recommendations were individually reviewed. The presence of a recommendation inclusive of RT increased from incidence of 205 in the year 2000 to 992 in the year 2019 (383%). In the 2019 NCCN Guidelines, the most Category 1 RT recommendations were found within small cell lung (13%), non-small cell lung (5%), breast (5%), bladder (2%), rectal (2%), and non-Hodgkin lymphoma (1%). Pancreatic, uterine, prostate, melanoma, kidney, and colon cancer guidelines had no Category 1 RT recommendations. Rectal cancer had 31 (27%) preferred recommendations. The majority (89%) of 2019 RT recommendations were for initial therapy, and 9% were specific to salvage therapy. Tumor sites with the highest proportion of RT Category 1 evidence were small cell lung (29%), non-small cell lung (24%), and breast cancer (24%). The frequency of recommendations for using RT in NCCN Guidelines has increased by >300% in the past 20 years among the 10 most common malignancies. Consideration of the quality of evidence supporting these recommendations by tumor type is useful to identify specific malignancies in need of higher-level evidence supporting the role of RT.

Update and Interpretation of 2022 National Comprehensive Cancer Network Clinical Practice Guidelines for Gastric Cancer

Update and Interpretation of 2022 National Comprehensive Cancer Network Clinical Practice Guidelines for Gastric Cancer

Abstract 2242: Impact of low-dose computed tomography screening for lung cancer at a community oncology clinic on stage of lung cancer diagnosis in the catchment area

Abstract Introduction: Arkansas has the second-highest incidence of lung cancer in the U.S., with a largely rural and medically underserved population. Low-dose computed tomography (LDCT) is a well-established procedure for lung cancer screening in academic medical centers, but few local community oncology centers utilize this technology. Highlands Oncology Group (HOG), located in Northwest Arkansas (NWA), took the initiative to bring LDCT screening to a non-academic medical center and provide routine LDCT screening to a rural population. The objective of this study is to evaluate the benefits of free LDCT screening at a community oncology clinic. Methods: The study compared for-fee and free periods of LDCT screening at HOG and their impact on identifying cancer in NWA. The study population was patients in HOG’s catchment area who fell into the risk categories set by the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology to be eligible for screening between March 2013 and February 2020. Results: A total of 5,402 eligible participants enrolled in the study. During ten months of for-fee screening (n=60), 3.3% of patients diagnosed had Stage I lung cancer, and 1.7% were diagnosed with Stages II-IV. During the first ten months of free screening (n=729), 3% of patients were diagnosed with Stage I lung cancer, 1.8% were diagnosed with Stages II-IV, and 1.1% were diagnosed with other cancers. Over the entire program until February 2020 (n=5,402), a total of 76 patients were diagnosed with Stage I lung cancer, 52 were diagnosed with Stage II-IV, and 35 were diagnosed with other cancers. Conclusion: The result of this study suggests that eligible patients are more receptive to free lung cancer screening, even though most insurance coverage does not have a required co-pay for eligible patients. We also observed an increased diagnosis rate for early-stage lung cancers due to increased patient influx with free LDCT screening. The state central registry data showed a decline in distant lung cancer after the free LDCT screening offered in the northwestern counties in the HOG catchment area. At the same time, no such trend is visible for the entire state, suggesting a stage shift in lung cancer due to free LDCT screening. Citation Format: Edgar T. Ellis, Michael A. Bauer, Thaddeus Beck, Daniel S. Bradford, Joanna Thompson, Margarete C. Kulik, Joseph L. Su. Impact of low-dose computed tomography screening for lung cancer at a community oncology clinic on stage of lung cancer diagnosis in the catchment area [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 2242.

Avelumab First-Line Maintenance Treatment in Advanced Bladder Cancer: Practical Implementation Steps for Infusion Nurses.

Immune checkpoint inhibitors, such as programmed cell death ligand 1 inhibitors pembrolizumab, nivolumab, atezolizumab, and avelumab, are used to treat patients with advanced urothelial carcinoma (UC). Based on data from the phase 3 JAVELIN Bladder 100 trial, avelumab first-line (1L) maintenance is now considered the standard-of-care treatment for patients with locally advanced or metastatic UC who responded or experienced disease stabilization after 1L platinum-containing chemotherapy, and it is the only category 1 preferred checkpoint inhibitor maintenance option in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for patients with cisplatin-eligible and cisplatin-ineligible locally advanced or metastatic UC. This article reviews key considerations related to avelumab 1L maintenance therapy that infusion nurses should be familiar with, including dosing, administration, and immune-related adverse event recognition and management, to ensure safe and appropriate use of this important and impactful therapy.

Basal cell carcinoma: An updated review of pathogenesis and treatment options.

Basal cell carcinoma (BCC) remains the most common malignancy worldwide. BCC pathogenesis is a result of the interplay between one's environment, genetics, and phenotypic factors. BCC has a low mortality but given its increasing incidence and potential to cause local destruction thus resulting in significant morbidity, it is vital for dermatologists to remain up to date with recent updates in this malignancy's pathogenesis and treatment. This article provides a comprehensive review of the pathogenesis of BCC as well as the current treatments available and clinical trials underway. We also touch upon the updated National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology in respect to BCC's recommended treatment modalities.

Dermatology representation on National Comprehensive Cancer Network Guideline Committees

To the Editor: National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) are the most used practice guidelines for the clinical management of malignancies, applying to over 97% of cancers diagnosed in the United States. The NCCN is comprised of 31 member institutions. To date, practice guidelines have been developed for 59 cancer types and 12 supportive care topics.1 Current clinical guidelines for melanoma, squamous cell carcinoma, and basal cell carcinoma released by the American Academy of Dermatology use NCCN guidelines.

Merkel cell carcinoma: An updated review of pathogenesis, diagnosis, and treatment options.

Merkel cell carcinoma is a rare neuroendocrine carcinoma that typically appears in sun-exposed areas of the elderly. It has a poor prognosis and with its incidence projected to increase, it is vital for dermatologists to remain up to date with recent updates in this malignancy's pathogenesis and treatment. In the past few decades Merkel cell carcinoma's pathogenesis, more specifically its relation to the Merkel cell polyomavirus, has sparked further interest in the study of this carcinoma. Most cases are attributed to malignant transformation secondary to the Merkel cell polyomavirus, with a minority derived from DNA damage resulting from ultraviolet radiation. Investigators have also determined that there are immunologic influences in the development and prognosis of Merkel cell carcinoma, as individuals with HIV, solid organ transplants, and lymphoproliferative malignancies are at a greater risk of developing this carcinoma. In addition, this immunologic link carries treatment value, as immunologic therapies are currently being investigated. This article provides a comprehensive review of the epidemiology and pathogenesis of Merkel cell carcinoma as well as the current treatments available and clinical trials underway. We also touch upon the updated National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology in respect to its diagnosis and recommended treatment modalities.

IMPACT OF NUTRITIONAL STATUS ON INDUCTION MORTALITY IN PAEDIATRIC ACUTE LYMPHOBLASTIC LEUKAEMIA

OBJECTIVE: To study the impact of nutritional status on induction mortality among pediatric patients suffering from acute lymphoblastic leukemia (ALL). METHODS: This descriptive analytical study was conducted on pediatric ALL patients who completed induction chemotherapy in Pediatric Oncology Department Combined Military Hospital, Rawalpindi, Pakistan from 1st January 2012 to 30th June 2021. All patients of ALL diagnosed on basis of National Comprehensive Cancer Network Clinical Practice Guidelines, aged 1-18 years were included. Patients who left before completion of induction chemotherapy or refused to participate were excluded. Cases were divided into three groups based on nutritional status. Induction chemotherapy was given as per UKALL 2011 protocol. RESULTS: Out of 926 patients diagnosed with ALL, 586 (63.3%) were males and 340 (46.7%) were females. Mean age of patients was a 5.83±3.627 years. Majority of the patients (n=679, 73.3%) were well-nourished; and 161 (17.4%) and 86 (9.3%) were moderately and severely malnourished, respectively. About 49.8% (n=461) patients received standard risk chemotherapy protocol with three-drug induction and 50.2% (n=465) received four-drug induction chemotherapy. Infection was the most common complication in 742 (80.1%) patients. Overall induction mortality was 12.9% (n=119/926) in all patients including 9.54% (n=44/461) in standard-risk and 16.12% (n=75/465) in high-risk patients (p=0.003). Induction mortality was significantly high in malnourished-group (17.8%) and 12.2% in normally-nourished children (p=0.008). CONCLUSION: Nutritional status and risk group at time of diagnosis emerged as predictors of induction mortality among ALL patients. Considerable number of patients died during induction phase of treatment. Malnourished children have a high mortality rate.

Racial disparities in biomarker testing and clinical trial enrollment in non-small cell lung cancer (NSCLC).

9005 Background: Cancer racial disparities may exist at many levels in the health care system, from screening to timely diagnosis and treatments received, as well as clinical trial enrollment. This study investigated differences in black versus white race among patients with NSCLC undergoing biomarker testing and clinical trial enrollment in the US. Methods: This retrospective observational study utilized the Flatiron Health database, which includes longitudinal data of patients with advanced/metastatic NSCLC. Patients were eligible if they had evidence of systemic therapy in the database from 1/1/2017 through 10/30/2020. Descriptive analyses summarized differences by race in biomarker testing and trial enrollment. Multivariable regression examined the relationship between these factors. Results: A total of 14,768 patients were eligible: 9,793 (66.3%) were white and 1,288 (8.7%) were black. 76.4% of white patients and 73.6% of black patients underwent at least one single molecular test or comprehensive genomic analysis (p = 0.03). Next-generation sequencing (NGS) was performed among 50.1% of white patients and 39.8% of black patients (p &lt; 0.0001. Trial participation was observed among 3.9% of white and 1.9% of black patients (p = 0.0002). There was a statistically significant association between race (white vs black) and both biomarker testing (ever vs never) and trial participation (yes vs no) (both p &lt; 0.001, unadjusted chi square). Differences in NGS testing, baseline biomarker testing, and race were retained as statistically significant (p &lt; 0.01) in adjusted regression analyses. The receipt of first-line targeted therapy was comparable between white and black patients (10.2% and 9.2%, respectively, p = 0.24); however, this summary did not consider biomarker test results. First line use of pembrolizumab+carboplatin+pemetrexed was observed among 19.8% of white and 22.6% of black patients; carboplatin+paclitaxel was observed among 16.5% and 18.6%, and single-agent pembrolizumab was observed among 14.8% and 11.5%, respectively. Conclusions: The use of NGS-based testing, which is recommended by the National Comprehensive Cancer Network Clinical Guidelines in Oncology for patients with advanced/metastatic NSCLC, is the most notable disparity among black patients, with more than a 10 percentage-point difference in receipt of this testing versus white counterparts. This may in part contribute to the more than double the rate of participation in clinical trials observed among white patients, as many second line and beyond trials utilize molecular targets as inclusion criteria. While multiple factors are known to impact health care disparities, access to and receipt of appropriate biomarker testing may be an attenable goal in order to ensure equal access to quality care.

Level of Scientific Evidence Underlying the National Comprehensive Cancer Network Clinical Practice Guidelines for Hematologic Malignancies: Are We Moving Forward?

Background: The level of scientific evidence in National Comprehensive Cancer Network (NCCN) guidelines for malignant hematological conditions haven't been recently investigated. We describe the distribution of categories of evidence and consensus (EC) among the 10 most common hematologic malignancies with regard to recommendations for staging, initial and salvage therapy, and surveillance. Methods: We reviewed the level of evidence for the 10 most common hematological malignancies by incidence in the United States as of 2020. The NCCN definitions for EC are: category 1, high level of evidence, such as randomized controlled trials, with uniform consensus; category 2A, lower level of evidence with uniform consensus; category 2B, lower level of evidence without a uniform consensus but with no major disagreement; and category 3, any level of evidence but with major disagreement. We compared our results with previously published results from 2011. Results: Of 1353 recommendations, 5%, 91%, 4%, and 1% fell into EC categories 1, 2A, 2B, and 3, respectively, while in 2011 the comparable percentages were 3%, 93%, 4%, and 0%, respectively. Recommendations with category 1 EC were found in all guidelines, except for Burkitt lymphoma. Of all therapeutic recommendations, 6.3% were category 1 EC, with the majority of these (56.4%) pertaining to initial therapy. Guidelines with highest proportions of therapeutic recommendations with category 1 EC were multiple myeloma (12.4%), chronic lymphocytic leukemia/small lymphocytic lymphoma (6.9%), and acute myeloid leukemia (5.6%). Conclusions: Recommendations in the 2020 NCCN guidelines are largely developed from lower levels of evidence but with uniform expert opinion, underscoring the urgent need and available opportunities to expand the current evidence base in malignant hematological disorders.

Prognostic Role of Mismatch Repair Status, Histotype and High-Risk Pathologic Features in Stage II Small Bowel Adenocarcinomas

BackgroundSmall bowel adenocarcinoma is a relatively rare cancer, often diagnosed in an advanced stage. In localized and resectable disease, surgery alone or in combination with adjuvant chemotherapy is the mainstay of treatment. In the recently published National Comprehensive Cancer Network Clinical Practice guidelines, criteria for selecting patients with stage II small bowel adenocarcinoma to receive adjuvant chemotherapy are provided, and they are mainly extrapolated from studies on colorectal cancer.Patients and MethodsIn the present study, we aimed to verify whether mismatch repair deficiency phenotype, high-risk pathologic features (including T4, positive resection margins and a low number of lymph nodes harvested), as well as tumor histologic subtype, were associated with cancer-specific survival in 66 stage II non-ampullary small bowel adenocarcinoma patients, collected through the Small Bowel Cancer Italian Consortium. A central histopathology review was performed. Mismatch repair deficiency was tested by immunohistochemistry for MLH1, MSH2, MSH6 and PMS2, and confirmed by polymerase chain reaction for microsatellite instability.ResultsWe identified mismatch repair deficiency, glandular/medullary histologic subtype, and celiac disease as significant predictors of favorable cancer-specific survival using univariable analysis with retained significance in bivariable models adjusted for pT stage. Among the high-risk features, only T4 showed a significant association with an increased risk of death; however, its prognostic value was not independent of mismatch repair status.ConclusionsMismatch repair protein expression, histologic subtype, association with celiac disease, and, in the mismatch repair proficient subset only, T stage, may help identify patients who may benefit from adjuvant chemotherapy.Graphic

Evaluation of the Use of Cancer Registry Data for Comparative Effectiveness Research

Researchers often analyze cancer registry data to assess for differences in survival among cancer treatments. However, the retrospective, nonrandomized design of these analyses raises questions about study validity. To examine the extent to which comparative effectiveness analyses using observational cancer registry data produce results concordant with those of randomized clinical trials. In this comparative effectiveness study, a total of 141 randomized clinical trials referenced in the National Comprehensive Cancer Network Clinical Practice Guidelines for 8 common solid tumor types were identified. Data on participants within the National Cancer Database (NCDB) diagnosed between 2004 and 2014, matching the eligibility criteria of the randomized clinical trial, were obtained. The present study was conducted from August 1, 2017, to September 10, 2019. The trials included 85 118 patients, and the corresponding NCDB analyses included 1 344 536 patients. Three Cox proportional hazards regression models were used to determine hazard ratios (HRs) for overall survival, including univariable, multivariable, and propensity score-adjusted models. Multivariable and propensity score analyses controlled for potential confounders, including demographic, comorbidity, clinical, treatment, and tumor-related variables. The main outcome was concordance between the results of randomized clinical trials and observational cancer registry data. Hazard ratios with an NCDB analysis were considered concordant if the NDCB HR fell within the 95% CI of the randomized clinical trial HR. An NCDB analysis was considered concordant if both the NCDB and clinical trial P values for survival were nonsignificant (P ≥ .05) or if they were both significant (P < .05) with survival favoring the same treatment arm in the NCDB and in the randomized clinical trial. Analyses using the NCDB-produced HRs for survival were concordant with those of 141 randomized clinical trials in 79 univariable analyses (56%), 98 multivariable analyses (70%), and 90 propensity score models (64%). The NCDB analyses produced P values concordant with randomized clinical trials in 58 univariable analyses (41%), 65 multivariable analyses (46%), and 63 propensity score models (45%). No clinical trial characteristics were associated with concordance between NCDB analyses and randomized clinical trials, including disease site, type of clinical intervention, or severity of cancer. The findings of this study suggest that comparative effectiveness research using cancer registry data often produces survival outcomes discordant with those of randomized clinical trial data. These findings may help provide context for clinicians and policy makers interpreting observational comparative effectiveness research in oncology.

Oral management strategies for radiotherapy of head and neck cancer.

SummaryRadiotherapy, often with concomitant chemotherapy, has a significant role in the management of head and neck cancer, however, radiotherapy induces adverse events include oral mucositis, hyposalivation, loss of taste, dental caries, osteoradionecrosis, and trismus, all of which have an impact on patients’ quality of life. Therefore, it is necessary to implement oral management strategies prior to the initiation of radiotherapy in patients with head and neck cancer. Since 2014, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) have enumerated the “Principles of Dental Evaluation and Management (DENT-A)” in the section on head and neck cancers, however, oral management was not explained in detail. Oral management has not been achieved a consensus protocol. The aim of this literature is to show that oral management strategy include removal infected teeth before the start of radiotherapy to prevent osteoradionecrosis, oral care for preventing severe oral mucositis to support patient complete radiotherapy during radiotherapy, and prevent of dental caries followed by osteoradionecrosis after radiotherapy.

Sentinel Lymph Nodes and Precision Surgery in Gynecologic Cancer.

Besides histologic features, the presence of nodal metastasis is the most crucial prognostic factor for recurrence and survival for patients with gynecologic cancer. Conventionally, lymphadenectomy has been performed routinely to assess lymphatic metastasis. However, lymphadenectomy may be unnecessary in early-stage gynecologic cancer, because the percentage of patients with lymph node involvement is very low. The recent use of sentinel lymph node mapping has provided high feasibility, safety, and accuracy in the assessment of nodal metastasis. The National Comprehensive Cancer Network Clinical Practice Guidelines have incorporated the sentinel lymph node for nodal evaluation in vulvar, endometrial, and cervical cancers.

Geriatric Assessment Identifies Impairments in Younger Candidates for Allogeneic Hematopoietic Stem Cell Transplantation

Introduction: Geriatric assessment (GA) is a multidimensional evaluation of patient health and function that may detect impairments not identified as part of routine care, predict treatment-related morbidity and mortality, and inform treatment plans. Given evidence of these benefits, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend GA for older candidates of hematopoietic stem cell transplantation (HCT). However, both older and younger HCT candidates will often receive multiple rounds of chemotherapy before HCT, leading to functional impairments in all age groups. Furthermore, HCT patients often experience a significant gap between when they are first evaluated and actually proceed to transplant (e.g., while a donor search is conducted), creating an opportunity to identify impairments and optimize function prior to transplant. Methods: To address this opportunity, we created a clinical pre-HCT optimization program (C-POP) to evaluate physical function, cognitive function, nutritional status, and mental health in all adults who were deemed potential candidates for allogeneic HCT by a HCT physician. We applied this standard of care program to all adult candidates for HCT, regardless of age, with the goal of identifying functional impairments and then referring patients to services to optimize those impairments prior to HCT. We defined impairments using validated measures and compared results to established norms or scoring, controlling for age and gender where appropriate (e.g., the cut-off for six-minute walk distance was adjusted for age, gender, height, and weight, while the cut-off for falls was any fall regardless of characteristics). Patients with impairments were referred to the appropriate supportive care (e.g., physical function impairment -&gt; referral to physical therapy). Results were prospectively analyzed at new patient evaluation (NPE), which was the first time the patient met a HCT physician and sign-off, which occurred within a week before starting transplant. While the program is ongoing, we present here the results of patients evaluated between October 16th, 2017 and July 1st, 2019. Patients are divided into three pre-specified age groups: &lt;40 years old, 40-59 years old, and &gt;=60 years old, with results compared using a chi-squared test. Results: We evaluated 115 patients: 21 (18%) &lt;40 years, 40 (35%) 40-59 years, and 54 (47%) &gt;=60 years). There were no differences between the age groups in other demographics (gender, race, and ethnicity). At NPE, 93 (81%) met criteria for at least 1 impairment in physical function, cognitive function, nutritional status, or mental health; 62 (54%) met criteria for impairments in 2 or more areas. Surprisingly, patients &lt;40 years were more likely to screen positive for physical function (20/21, 95%) than patients 40-59 years (26/40, 65%) and patients &gt;=60 years (36/54, 67%) (p=0.03). Of those 115 patients, 52 (45%) proceeded to HCT, including 12 (57%) &lt;40 years, 18 (45%) 40-59 years, and 22 (41%) &gt;=60 years (p=0.75); of those patients who have not proceeded to HCT, 40 (35%) will never proceed to HCT (e.g., deemed not a candidate after functional evaluation or died of disease prior to HCT) while 23 (20%) are still awaiting HCT (e.g., donor search ongoing). Patients who proceeded to HCT were less likely to have mental health impairments (2/52, 4% vs. 9/40, 23%, p=0.006). Of the 52 who were seen at new patient evaluation and proceeded to transplant, 40 (77%) were seen at sign off. Of those who had impairments at NPE, 12/23 (52%) improved their physical function to normal limits, 4/9 (44%) improved their cognitive function, and 9/13 (69%) improved their nutritional status by the time of sign-off (of those who were seen at sign-off, none had mental health impairments at NPE). Discussion: These results demonstrate that younger as well as older candidates for HCT exhibit a high degree of functional impairment. However, this impairment could be amenable to improvement prior to HCT. These findings support application of GA to all HCT candidates regardless of age. We will investigate the effect of referred interventions (e.g., physical therapy, seeing a dietician) in improving functional impairments in future studies, as well as look at the effect of these findings on HCT outcomes. Disclosures Wiggins: Incyte, Inc.: Speakers Bureau. Gasparetto:Janssen: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; Celgene: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; BMS: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed . Rizzieri:Millennium: Speakers Bureau; Novartis: Consultancy; AbbVie: Consultancy; Pfizer: Consultancy; Amgen: Consultancy; Incyte: Consultancy, Speakers Bureau; TEVA: Consultancy; Spectrum: Consultancy; Kite Pharma: Consultancy; Gilead Sciences: Consultancy, Speakers Bureau; Seattle Genetics: Consultancy, Speakers Bureau; Jazz Pharmaceuticals: Speakers Bureau. Horwitz:Abbvie Inc: Membership on an entity's Board of Directors or advisory committees. Sung:Novartis: Research Funding; Merck: Research Funding; Seres: Research Funding.