bluuebunny/crossref_metadata_2025 huggingface dataset:
Evaluating sociodemographic, behavioral and psychologic disparities in 918 head and neck cancer survivors.
Authors: Day Andrew T , Vasudevan Anupama , Wynings Erin , Balachandra Sanjana , Khan Saad A. , Sumer Baran D. , Murphy Caitlin C.
Published: May 2019

e17541

Background: Minority race, low-income status, tobacco dependence, alcohol abuse, and depression negatively impact overall survival among head and neck cancer (HNC) survivors. Understanding the prevalence and associations of these factors will inform the development of targeted HNC survivorship interventions. Methods: We pooled cross-sectional samples of HNC patients participating in the National Health Interview Survey from 1997-2016. Descriptive statistics were used to compare: 1) HNC survivors to age- and sex-matched adults without cancer (1:4) and 2) behavioral and psychologic conditions in HNC survivors by income status. Results: Mean age of the 918 HNC survivors was 64.8 years and 65.2% were male. Most HNC survivors were non-Hispanic white (85.3%); 7.6% were non-Hispanic black, 4.9% were Hispanic, and 2.2% were of other race and ethnicity. A substantial portion reported income below the poverty threshold (13.9%) and 5.0% consumed > 14 alcoholic drinks per week. Compared to adults without cancer (n = 3,612), a higher proportion (p < 0.05) of HNC survivors (n = 903) exhibited: current tobacco use (21.3% vs 17.4%); serious psychological distress (Kessler-6 score of ≥13; 6.9% vs 3.9%); depressive symptoms most or all of the time (14.1% vs 8.9%). There were particularly striking differences in the prevalence of these factors among HNC survivors by income. Specifically, a higher proportion of HNC survivors with income below the poverty threshold (n = 133) were non-Hispanic black (15.5% vs 5.8%) and exhibited current tobacco use (42.9% vs 18.6%), serious psychological distress (17.4% vs 5.7%) and depressive symptoms most or all of the time (25.3% vs 12.7%) compared to those at or above the poverty threshold (n = 646; all p < 0.05). Conclusions: HNC survivors experience a disproportionate burden of behavioral and psychologic health conditions compared to age- and sex-matched adults without cancer. Low-income status exacerbates these disparities. HNC survivors, especially those in low-income settings, require comprehensive survivorship care targeting these needs.
TCGA data reveal a transcriptomic signature of Sox2 and Nanog targets associated with survival in head and neck cancer.
Authors: Mladkova Nikol , Blakaj Dukagjin
Published: May 2019

e17546

Background: Head and neck cancers represent a diverse group of tumors linked with HPV infection, alcohol and smoking that contribute to cancer morbidity and mortality globally. Sox2 and Nanog are transcription factors that maintain pluripotency in embryonic stem cells, and their individual expression has been associated with prognosis in head and neck tumors previously. Methods: TCGA dataset containing 522 tumor samples with RNAseq data, clinical information (anatomically classified as 133 oral tongue, 117 laryngeal, 73 oral cavity, 63 floor of mouth, 45 tonsillar, 27 base of tongue and 70 other samples) and 44 normal samples with RNAseq data available was used to detect differentially expressed genes in head and neck tumors. The levels of each gene were then transformed to z-score per patient and classified as over- or under-expressed if those were 2 SD away from the mean. The expression levels were then correlated with survival in individual patients for all tumor combined. Subgroup analysis of oral tongue, laryngeal, oral cavity, floor of mouth, tonsillar cancers was carried out separately. Results: A total of 233 genes were significantly correlated with survival in head and neck tumors ( < 0.01). This geneset was subsequently analyzed for enrichment of common pathway dysregulation or for enrichment of shared regulatory elements. The expression level of a set of a total of 15 genes that represent targets of Nanog and Sox2 was shown to either increase or decrease survival directly dependent on either up- or down-regulated expression levels. Of note, neither Nanog nor Sox2 expression levels individually impacted survival. Subgroup analysis revealed individualized prognostic signatures in each anatomic location, with an overlap of individual genes with Nanog and Sox2 targets signature ranging from 6.25-20%. Conclusions: We describe a prognostic signature in head and neck tumors derived from a TCGA data consisting of genes that represent targets of critical stem cell regulators Sox2 and Nanog. On a subgroup analysis, we also derived prognostic signatures for five anatomic locations and head&neck tumors with various ranges of overlap with Sox2 and Nanog targets signature. Pending validation in additional datasets, those represent an attractive target for further mechanistic evaluation in tumorigenesis in this group of tumors.
Mutational profile of dysplastic lesions evolving to laryngeal cancer.
Authors: Cabezas-Camarero Santiago , García-Barberán Vanesa , Hernanpérez-Hidalgo Diana , Saiz-Pardo-Sanz Melchor , De Pablo Velasco David , Lorca Victor , Iglesias Mari Cruz , Pérez-Segura Pedro
Published: May 2019

e17551

Background: Few studies have addressed the carcinogenic process of laryngeal cancer from its premalignant phases. Our aim was to compare mutational status of laryngeal dysplasias (LD) evolving to laryngeal cancer (ELC) and not evolving to LC (NELC). Methods: Retrospective study of LD diagnosed between 2007 and 2011. A customized 15-gene NGS panel (DICER, IRF6, NOTCH1, NOTCH2, NOTCH3, NOTCH2NLA, PIK3CA, PTEN, RB1, RIPK4, SYNE1, SYNE2, TP53, TP63, CASP8) was used for mutational analysis with Truseq Custom Amplicon (Illumina) performed in FFPE LD samples and results compared between LD-ELC and LD-NELC. Results: Sixty-four patients (pts) with LD were identified. LD-ELC (N = 23) and LD-NELC (N = 41) were scored as mild (N = 40; NELC: 32 / ELC:8), moderate (N = 8; NELC: 4/ ELC: 4) and severe (N = 16; NELC:5 / ELC: 11). Prior or current moderate-to-heavy tobacco smoking ( > 10 pack-year): 53/64 (83%). Males: N = 50 (ELC: 21; NELC: 29); Female: N = 14 (ELC: 2; NELC: 12). Median time to cancer among 23 LD-ELC: 8 m (range: 0-46). Forty-seven gene variants were detected in ELC not found in NELC, of which 27 were pathogenic/likely pathogenic: Frameshift: 8 (1 in NOTCH2, 1 in PTEN, 2 in RB1, 2 in SYNE1 y 2 in SYNE2); Stop-gained: 3 (1 in NOTCH2NL, 2 in SYNE2); Splicing: 3 (1 in RB1, 1 in RIPK4 y 1 in TP53); Missense: 12 (1 in IRF6, 2 in NOTCH1, 1 in RB1, 2 in RIPK4, 6 in SYNE1). Conclusions: LD from pts ELC showed a different mutational profile than LD-NELC. These results show promise for identifying pts at higher risk for developing LC and should be validated in a larger, prospective study.
Which treatment strategies are the most promising for locally advanced resectable human papillomavirus-associated oropharyngeal cancers?
Authors: Yokota Tomoya , Iida Yoshiyuki , Kamijo Tomoyuki , Morita Kotaro , Mukaigawa Takashi , Nishiya Yukio , Hamaguchi Noriko , Hamauchi Satoshi , Kawai Sadayuki , Onozawa Yusuke , Shirasu Hiromichi , Ogawa Hirofumi , Onoe Tsuyoshi , Nakagawa Masahiro , Onitsuka Tetsuro
Published: May 2019

e17556

Background: The standard of care for oropharyngeal squamous cell carcinoma (OPSCC) is surgical (S) or non-surgical (NS) approach including chemoradiation (CRT). However, CRT is associated with significant long-term toxicity. Human papillomavirus (HPV) status are associated with improved prognosis for patients (pts) with OPSCC. The aim of this study was to explore the most promising treatment strategy with maintaining survival outcomes while improving QOL for locally advanced resectable HPV-positive OPSCC. Methods: A retrospective analysis of 96 pts with locally advanced resectable HPV-positive OPSCC in Shizuoka Cancer Center between 2004 and 2018 was performed. p16 immunohistochemistry was used to determine HPV tumor status. Clinical characteristics, acute and late toxicities, nutritional support, and survival were compared by treatment modalities. In pts who received S, surgical procedure and histological findings of the surgical specimens were additionally compared between pts who underwent upfront surgery (US) and those who did induction chemotherapy followed by surgery (ICT-S). Results: The median age was 62 years, with the majority having tonsil and base of the tongue as primary site. Thirty-six pts (38%) were current smokers, and 39 (41%) were former smokers. As an initial treatment, 62 (64.6%) and 34 (35.4%) pts underwent S and NS, respectively. Aspiration pneumonia more frequently occurred in NS (41.2%) than in S (8.1%) (p < 0.01). Nutritional support by gastrostomy tube or total parenteral nutrition was required in 20 pts (58.8%) of NS, compared with 15 pts (24.2%) of S (p < 0.01). S showed a trend toward longer overall survival (OS) than NS [HR = 0.204, p = 0.052], while progression free survival (PFS) was comparable between the groups. Of all S, 48 (50.0%) and 14 (14.6%) underwent US and ICT-S, respectively. Transoral surgery was performed in 78.6% of ICT-S, compared with 20.8% of US (p < 0.01). Histological examination of the surgical specimens revealed that positive surgical margins, involvement of ≥ 2 regional lymph nodes, and positive extracapsular extension were present in 7.1, 35.7, and 35.7% of ICT-S, compared with 31.3, 58.3, and 45.8% of US, respectively (N.S.). Pathologic complete response in the primary site and lymph nodes occurred in 43 % of ICT-S. Both OS and PFS was comparable between the groups. Conclusions: Our results suggest the impact of surgical approach on reduced long-term toxicity for HPV-positive OPSCC. ICT followed by surgery might be promising novel treatment strategy.
Outcomes of post-operative treatment with concurrent systemic therapy and radiotherapy (RT) in intermediate (INT) risk resected oral cavity squamous cell carcinoma (OCSCC): A multi-institutional collaboration.
Authors: Geiger Jessica Lyn , Woody Neil McIver , Tsai C. Jillian , Ghanem Ahmed I. , Dunlap Neal , Liu Howard , Burkey Brian B. , Lamarre Eric , Ku Jamie , Scharpf Joseph , Joshi Nikhil Purushottam , Caudell Jimmy J. , Siddiqui Farzan , Porceddu Sandro , Lee Nancy Y. , Koyfman Shlomo A. , Adelstein David J.
Published: May 2019

e17567

Background: Patients (pts) with adverse pathologic factors in resected OCSCC excluding positive surgical margins or extranodal extension represent a group of INT risk disease. Though not standard of care, adjuvant CRT is often used in INT pts. We conducted a multi-institutional study to evaluate factors associated with improved outcomes in INT pts treated with or without chemotherapy. Methods: An IRB-approved collaborative database of patients with primary OCSCC (Stage I-IVB AJCC 7th edition) treated with primary surgical resection between 1/1/2005 and 1/1/2015 with or without adjuvant therapy was established from 6 academic institutions. Pts were categorized by pathologic features and adjuvant therapy. Kaplan Meier curves, log-rank p-values and multivariate analysis (MVA) were used to describe outcomes by treatment including locoregional control (LRC) and disease free survival (DFS). Results: From a total sample size of 1270 patients, 455 INT risk pts were treated with primary surgical resection and adjuvant therapy; 95 received CRT, 274 received RT alone, and 86 received RT without recorded chemotherapy. 49% of pts had perineural invasion (PNI), 24.8% lymphovascular space invasion, 21.5% poorly differentiated histology, 47.3% with pT3/4 disease, and 27.9% with > 2 lymph node positive (LN+). 55.8% of CRT pts were treated with cisplatin. > 2 LN+ was the only significant predictor of LRC (HR 1.49, p= 0.049). PNI and > 2 LN+ were significant predictors of DFS (HR 1.52, p= 0.003 and HR 1.76, p< 0.001). On MVA, after adjusting for > 2 LN+, treatment with cisplatin-RT was borderline significant for LRC (HR 0.52, p= 0.08). 3 year LRC in pts with > 2 LN+ was 84.4% in pts treated with cisplatin-RT compared with 64.9% for RT alone. Conclusions: The addition of cisplatin-based CRT to INT risk pts is controversial but among pts with > 2 LN+ there was a trend toward benefit. This study is limited by small numbers of pts treated with CRT, though these results highlight the need for further investigation in this population to identify INT pts who would benefit from adjuvant therapy intensification.
Diagnostic value of cytokeratin-1, survivin and TG expression in circulating tumor cells in the differentiation of benign and malignant thyroid nodules.
Authors: Liu Jie , Xu Siyuan , Luo Jinghua , Wang Yan , Liu Xia , Du Rong , Tang Yu , Wang Jianwei , Fang Nan , Wu Qixi
Published: May 2019

e17575

Background: Fine needle aspiration cytology (FNAB) has the advantages of minimal trauma, speed and accuracy, and is currently considered to be the most predictive screening technique before thyroid nodule surgery. However, there are several drawbacks to this method, including certain complications, a relatively high false negative rate, a low acceptance of invasive surgery among patients, and the fact that about 20% of the lesions cannot be clearly defined as benign or malignant. Blood-based noninvasive testing can be used to analyze circulating cancer cells (CTCs) for clinical testing. Here, we investigated the performance of CTCs in thyroid cancer screening. Methods: We established a multi-marker real-time quantitative PCR (CK-19/surviving/Tg) to detect and quantify CTCs in peripheral blood samples. 100 subjects who were diagnosed by ultrasound imaging as having thyroid nodules were enrolled. FNAB or surgical specimens were subjected to pathological tests to differentiate between the benign nodules and thyroid cancer. Meanwhile the CTCs in the blood were isolated and quantified by multi-marker qPCR. Results: Among 100 patients, 50 were diagnosed as Papillary Thyroid Carcinoma (PTC) by pathological test. The sensitivity of each single marker of CK19, Survivin and Tg were only 48%, 44%, and 50% respectively, with the specificity of 94%, 100% and 94%. However, the combination of these three markers results in the highest sensitivity and specificity of 86% and 90%. Thus, the combined marker could achieve the best diagnostic value. Conclusions: Compared with FNAB, CTC is minimally invasive. The performance of the multi-marker real-time quantitative PCR showed that CTC could be used as an adjunctive test after ultrasound evaluation. Our results indicated that CTCs have potential clinical value in the identification of benign and malignant thyroid nodules.
Association between radiotherapy and obstructive sleep apnea in cancer patients: A systematic review and meta-analysis.
Authors: Tawfik Gehad Mohamed , Alshareef Abdulmueti , Mostafa Esraa Mahmoud , Khaled Samar , Hmeda AlMotsim Ben , Abdelwahed Khloud Amr , Amer Ahmed Esmail , Agage Hesham , Emara Nehad Samy , Mahran Saleh Adel , Ebied Amr , Huy Nguyen Tien
Published: May 2019

e17576

Background: With the increase in survival of cancer patients, consequently, increasing their quality of life is mandatory as well. Sleep disturbances, particularly Obstructive Sleep Apnea (OSA), is one of the main complaints of cancer patients in which patients face frequent episodes of upper airway closure during sleep. Possible causes for OSA include either the specific cancer or its treatment whether sedatives, narcotics, radiotherapy, or chemotherapy, but the primary cause is still hard to prove. Our aim was to investigate the association between the occurrence of OSA and radiotherapy in cancer patients. Methods: On the 9th of September, 2018, we have searched comprehensively 12 electronic databases to retrieve relevant studies. All eligible studies that assess the association between OSA and radiotherapy in cancer patients were included in our meta-analysis. Quality assessment of included studies was done using the NIH tool for cohort and cross-sectional studies. Results: Fourteen studies met our selection criteria, eight studies were eligible for our meta-analysis. There was a positive association between the occurrence of OSA and radiotherapy in cancer patients (OR 1.16, 95% CI [0.52–2.56]; P = 0.718). OSA was noted in 103 of 181 cancer patients who received radiotherapy, yielding a remarkable overall prevalence of 63% (95% CI [0.36–0.85]; P = 0.343). A positive risk ratio for the development of OSA in cancer patients treated with radiotherapy was detected (RRs 1.27, 95% CI [0.81–2.00]; P = 0.297). The overall mean of apnea hypopnea index (AHI) for patients with OSA in six studies was 22.45. Conclusions: These findings point to a striking association between OSA risk and radiotherapy in cancer patients. Since the early recognition and management of OSA in such patients may play an important role in improving their quality of life, we recommend screening all cancer patients treated with radiation for early signs of OSA to further improve their survival.
Next Generation Sequencing in Salivary Gland Carcinomas: Do Actionable Mutations Lead to a Therapeutic Advantage? A Multicenter Experience.
Authors: Moore Assaf , Gutfeld Orit , Billan Salem , Bar Yael , Maurice Dror Corinne , Ospovat Inna , Gordon Noa , Popovitzer Aron
Published: May 2019

e17582

Background: Salivary gland cancers (SGCs) are rare tumors. The approach to recurrent or metastatic patients is histology dependent, as the clinical course is highly variable. Response rates to chemotherapy are modest and no second-line therapies have proven to be effective. The rarity and heterogeneity of SGCs make conducting clinical trials challenging. Recent reports of Next Generation Sequencing (NGS) in SGCs have identified unique genetic attributes of certain histological classes. However, despite the elaborate work done with genetic characterization, there is very little evidence on whether these findings translate to tumor control. In this study, we aimed to explore the treatment outcomes of patients with advanced SGCs who underwent a commercially available NGS. Methods: A retrospective analysis of all patients with histologically confirmed SGC treated in three major Israeli cancer centers who underwent NGS. Results: Twenty-seven patients were included. Eighteen patients were male (66.6%). The median age was 59 (range 38-81). Histologic type was adenoid cystic carcinoma in 11 (40.7%) patients, 8 (29.6%) mucoepidermoid carcinomas, 5 (18.5%) adenocarcinomas, 2 (7.4%) salivary duct carcinomas and 1 (3.7%) acinic cell carcinoma. Twenty-five (92.6%) had recurrent disease after initial curative treatment and 2 were initially diagnosed with metastatic disease. Median time to recurrence was 24.3 months. The median number of systemic treatment lines was 1 (range 0-5). Thirteen patients (48%) had targetable findings in NGS, including: 5 ERBB2 amplifications, 3 PIK3CA mutation, 1 TRIM33-RET fusion, 1 FGFR3-TACC3 fusion, 1 MSI-high and 2 high mutational burden. Nine patients were treated accordingly; 5 in the second-line and 4 as first-line treatment. Median progression-free survival for targeted treatment was 8.4 months. Of 4 patients who achieved durable responses to anti-RET/HER2 agents and immunotherapy of 8.4 – 31.1 months, two are ongoing. The median overall survival for all patients was 101.75 months, was not reached for patients receiving targeted treatment and was 40.4 months for patients treated conventionally (p = 0.26). Conclusions: In the absence of a well-established therapeutic approach, NGS may detect clinically significant genetic alterations and benefit patients with advanced SGCs.
Comparison of mortality trends in patients with non-salivary gland and salivary gland adenoid cystic carcinoma in the United States population.
Authors: Raval Girindra Ghanshyam , Ajebo Germame Hailegiorgis , Bryan Locke Johnson , Guddati Achuta Kumar
Published: May 2019

e17584

Background: Adenoid cystic carcinoma is the most common histological subtype of malignancy seen in major and minor salivary glands. Although indolent they tend to recur and progress. Adenoid cystic carcinoma also arises from other structures such as lacrimal glands and trachea. This study compares the incidence-based mortality between patients who have salivary and no-salivary origin adenoid cystic carcinomas of the head and neck region over the period of 2000 to 2014. Methods: A nation-wide analysis was conducted utilizing the Surveillance, Epidemiology, and End Results (SEER) Database from the years 2000 to 2014. Incidence-based mortality for all stages of adenoid cystic carcinoma was queried and the results were grouped by race (Caucasian/White, African American/Black, American Indian/Alaskan native and Asian/Pacific Islander) and gender. All stages were included in the analysis. T-test was used to determine statistically significance difference between various subgroups. Linearized trend lines were used to visualize the mortality trends of all sub groups. Results: Incidence-based mortality for salivary gland adenoid cystic carcinomas in African American/Black patients is comparable to Caucasian/White patients despite a higher incidence in Caucasian/White patients (no statistically significant difference was noted). Also, the incidence-based mortality for non-salivary gland adenoid cystic carcinomas of the head and neck region in African American/Black patients was similar to Caucasian/White patients. Essentially no racial difference in mortality was noted between salivary and non-salivary gland tumors. Comparison of mortality between genders in both races in salivary and non-salivary gland tumors also did not show any statistically significant difference. Conclusions: This study showed that adenoid cystic carcinoma of non-salivary gland origin have the same mortality trends as that from salivary gland origin in both Caucasian/White and American/Black patients and in both genders. Given such uniformity, genetic and environmental factors may not play significant role in the progression and outcomes of this disease. Hence, adenoid cystic carcinoma may be treated with similar therapeutic approaches regardless of the origin, gender and race of the patient.
Efficacy and prognostic factors of systemic therapies for metastatic adenoid cystic carcinoma.
Authors: Roussel-Simonin Cyril , Riet Francois , Hervé Geneviève , Bertolus Chloe , Maingon Philippe , Spano Jean-Philippe , Gobert Aurelien
Published: May 2019

e17587

Background: Metastatic cystic adenoid carcinoma (mCCA) is a rare entity of cancer associated with a poor prognostic. Only limited efficacy data based on case-reports and retrospective analysis are available and there is currently no standard for treatment. The aim of our study is to evaluate the efficacy and prognostic factors in recently diagnosed mCCA. Methods: We retrospectively collected demographic and efficacy data from patients treated for mCCA between September 2012 and January 2019 at the Pitié-Salpêtrière Hospital. Univariate analysis of prognostic factors was performed using the Cox model. Survival was estimated using the Kaplan-Meier method and long rank analysis. Results: Fifteen patients were included: 8 women and 7 men with a median age at diagnosis of 57 years (range 32-71). The primitive sites were accessory salivary glands in 9 patients, major salivary glands in 3 patients, lung, cervix and lacrimal glands in each of the 3 other patients. Histology of the primary tumor was available for 7 patients with 4 cribriform and 3 solid types respectively, an intermediate grade in 5 patients, a high in 2 patients, and a median of Ki67 at 35% (range 8.5-40%). Thirteen patients received a first line therapy, including 10 with platinum – LV5FU2, 2 with cisplatine anthracycline and cyclophosphamide association (CAP) and 1 with sunitinib. A stable disease was found in 7 patients (54%), a partial response in 4 patients (31%) and 2 patients had progression at first evaluation. The median 1st line PFS was 5.8 months (range 2.0-12.7). With a median time of follow-up at 12.9 months (range 4.0-61.3), 5 patients (33%) were dead, 8 patients (53%) were still receiving systemic therapy and 4 patients (27%) received 4 lines. A patient with partial response after 6 CAP cycles,received a liposomal anthracycline combined with carboplatin for 8 cycles with a response time of 12.7 months. In univariate analysis, no statistically significant prognostic factors were found. Conclusions: In our retrospective study, 1st line of systemic therapy is efficient in mACC with a 31% response rate. Furthermore, here we report the first patient treated with liposomal anthracycline associated with duration of response for 12.7 months. These preliminary results should be confirmed before becoming a new option for treatment in mACC.
External validation of the COMPASS-Cancer Associated Thrombosis Study: A predictive score to identify patients with solid tumors on treatment who are at risk for venous thromboembolism.
Authors: Anand Lalitha N , Spyropoulos Alex C , Eldredge Joanna B , Nourabadi Soheila , Zhang Meng , Qiu Michael , Rosenberg David
Published: May 2019

e18005

Background: A predictive model to identify patients on active treatment for solid tumors at risk for venous thromboembolism (VTE) remains an important clinical need. The COMPASS-CAT Risk Assessment Model (RAM) for VTE in a Eurasian patient population with solid tumors undergoing active treatment displayed good discrimination to identify patients into low/intermediate versus high VTE risk groups. We sought to externally validate this RAM in a North American cancer population. Methods: Patients age > 17 years who presented to the Monter Cancer Center between 1/12014 to 12/31/2016 with breast, ovarian, lung, or colorectal cancers were included. The COMPASS CAT RAM included 8 scored variables that were identified by ICD-9 and -10 codes and chart review. The primary endpoint at 6-month study follow-up was symptomatic VTE. Area under the ROC Curve (AUC) was calculated. We calculated a binary cut off to define VTE risk groups into low/intermediate and high VTE risk categories and calculated sensitivity, specificity, and negative and positive predictive values (NPV, PPV). Results: 3814 patients were included with a mean age of 64, of whom 49%, 5%, 29%, and 17% had breast, ovarian, lung, and colorectal cancer, and 52% had localized and 48% had advanced stage disease. In 94% of patients, cancer was diagnosed within the last 6 months prior to inclusion and 46% of patients were on active therapy when evaluated. Symptomatic VTE at 6-month follow-up occurred in 5.85% of patients. The AUC was 0.62. Using model cut-offs of 0-6 or > 7 points, patients stratified into low/intermediate and high-risk groups had VTE rates of 2.27% and 6.31%, respectively. The sensitivity, specificity, NPV, and PPV of the RAM were 95%,12%, 97.73%, and 6.31%, respectively. Conclusions: In this large retrospective external validation study of the COMPASS-CAT RAM for VTE in cancer patients undergoing active treatment, model discrimination and calibration was fair. Further prospective validation studies are needed before the model can be implemented into routine clinical practice for primary thromboprophylaxis of high VTE risk cancer patients with solid tumors.
Contemporary use of inpatient antineoplastic (IP) treatment (Rx): Who is getting care and why?
Authors: Hachem Hilal , Levitz David , Dima Danai , Dower Joshua R. , Fresco Rabiah B. , Weidner Ruth Ann , Buchsbaum Rachel J. , Erban John Kalil , Parsons Susan K.
Published: May 2019

e18015

Background: The steady trend towards outpatient antineoplastic medication delivery has been spurred by improvements in supportive care, innovations in drug delivery, and financial considerations. Despite these trends, a significant number of patients (pts) continue to receive IP Rx for both hematological (HM) and solid cancers (ST). The purpose of this study is to describe a single center’s experience with IP Rx between 01/01/2015 and 12/31/2017. Methods: All pts ( > 18yo) who received IP Rx for a cancer diagnosis, exclusive of stem cell transplantation, were identified from hospital pharmacy records. Patient and disease characteristics were collected at the index (initial) admission. All pts were followed for 1 year after index admission for 30-day readmission and subsequent admissions for IP Rx. Reasons for IP Rx included: urgent/emergent initiation of Rx; high acuity inpatient management for ST (e.g., intraperitoneal, intra-arterial, intravesical therapy) or complex HM regimen; ongoing Rx; palliation. Results: A total of 266 index admissions were identified with 66.2% of pts having a HM (n = 176) and 33.8% having a ST (n = 90). IP Rx was classified as urgent for 48.1% of pts (n = 128); 70.3% (n = 90) of these admissions were new diagnoses of which 91.4% (n = 86) were HM. High acuity IP management was required for 37.5% of pts (n = 100) (47% for ST (n = 47) and 53% for HM (n = 53)). The remaining index admissions were classified as ongoing Rx for 4.5% of pts (n = 12) and palliation for 9.8% (n = 26). Pts with ST required intensive care significantly more often than pts with HM (57.8% vs. 15.9%, p < 0.001) but with no difference in inpatient mortality (4.4% vs. 5.7%, p = 0.891). The 30-day readmission rate was 32.2% for ST and 25.6% for HM (p = 0.515). After the index admission, 10% of ST pts and 60.2% of HM pts had at least 1 subsequent admission for IP Rx (p < 0.001). Conclusions: In this 3-year retrospective review, the vast majority of pts receiving IP Rx required either urgent initiation of care or high acuity care, currently only available in the inpatient setting. While there is little evidence of routine IP Rx or opportunity, at present, to transition further care to the outpatient setting, the high rates of 30-day readmission warrant further evaluation.
The Children’s Oncology Group (COG) Adolescent and Young Adult (AYA) Responsible Investigator (RI) Network: An initiative for advancing AYA cancer research in the National Clinical Trials Network (NCTN).
Authors: Mittal Nupur , Saha Aniket , Freyer David Robert , Roth Michael
Published: May 2019

e18016

Background: The COG has previously developed a successful model in which institutional RIs are identified to champion site-level research activities and trial enrollment. In response to low participation of AYAs in COG clinical trials, the COG AYA RI Network was developed. Methods: In January 2018, the COG AYA Committee solicited nominations of AYA RIs by site Principal Investigators. The AYA RI role is focused on the following site-level activities: 1. Working with the local IRB to prioritize AYA relevant studies; 2. Developing systems for screening AYAs for enrollment; 3. Serving as a liaison with medical oncology; 4. Educating staff on disparities in AYA outcomes. Increased site-level interaction with adult NCTN groups is a goal of this initiative. Results: The network was launched in February 2018. Subsequently, 144 RIs (physicians, research staff, psychologists, administrators) from 118 demographically and geographically diverse sites have joined the initiative. To date, there have been 9 interactive webinars, with 18 presenters from diverse institutions, each attended by 60-90 RIs. Two symposia on addressing barriers to enrollment were held at COG meetings. Shared site-level barriers and facilitators to enrollment have been identified. The most common recommendations for improving AYA accrual are: 1. Increase the number and diversity of AYA trials; 2. Increase collaboration between pediatric and medical oncology; 3. Increase support and resources from institutional leadership; and 4. Overcome logistical constraints to accruing AYAs to COG trials. Recently, the COG AYA RI Network joined with the SWOG AYA Committee to identify site-level dyads involving an AYA RI representing each group. Conclusions: To our knowledge, the COG AYA RI network is a novel model for enhancing AYA-focused cooperative group research at the site level, including enrollment on clinical trials. Next steps include conducting a formal survey to gather site-level data and establishing metrics to assess impact of this initiative, as well as continuing to work closely with SWOG to improve cross-group trial enrollment of AYAs.
Using a video to introduce fertility preservation to women with cancer.
Authors: Gupta Abha A. , Lenton-Brym Talia , Charow Rebecca , Paulo Chelsea , Samadi Mahsa , Forcina Victoria , Chen Shian Li , Thavaratnam Adrian , Mitchell Laura , Lorenzo Armando J. , Papadakos Janet
Published: May 2019

e18021

Background: Women with cancer risk premature ovarian insufficiency with implications for future fertility due to chemotherapy and radiotherapy. Still, infertility discussions are inconsistently provided. Options for egg cryopreservation exist for females, but discussing these topics can be overwhelming for patients and families. This paper aims to assess the understandability, actionability, and readability of a fertility preservation (FP) educational video, as well as patient (pt) and caregiver pre- and post-video perceptions and knowledge. Methods: A video was created by the institution's Adolescent and Young Adult Program to explain relevant anatomy, pathophysiology of ovulation and process of cryopreservation. Understandability and actionability were evaluated using the Patient Education Materials Assessment Tool for Audiovisual Materials (PEMAT-AV) and readability using the SMOG and Flesch-Kincaid indices. Pt perceptions and knowledge growth were captured using pre-post questionnaires. Female pts (n = 108) were recruited in oncology clinics over 2 months, using a convenience sample. Questionnaire responses were analyzed using SPSS to calculate descriptive statistics to conduct correlation analyses. Results: The median age of the participants was 28 (range 14-39 yrs). The average PEMAT-A/V score was 79% (±11.3%) for understandability and 72% (±13.1%) for actionability. A score of 70% is regarded as acceptable. The readability assessment determined that the video script was, on average, at a grade 8 reading level. Pts’ interest in learning about FP increased, with 14% of those initially uninterested or unsure wanting to learn more after viewing the video. Pts’ general knowledge on FP increased from the pre- to post-video questionnaire, from a mean score of 75% initially (±17.9%), to a mean score of 84% (±14.5%) after watching the video (t = -5.972, p = 0.000). On average, overall satisfaction with the video was 85% (±8.5%). Conclusions: Women commonly use online tools for researching health questions. This study demonstrates that the video is understandable and provides guidance for future discussion. It shows that videos can spark interest in sensitive discussions and can improve fertility knowledge. This video may encourage providers to more consistently initiate discussions about infertility. Furthermore, the video can be translated for related topics to help provide accurate information in a patient-friendly medium.
Follow-up of cancer patients at the Colorectal Multidisciplinary Clinic: The University of the Philippines - Philippine General Hospital (UP-PGH) experience.
Authors: Ting Frederic Ivan Leong , Sacdalan Danielle Benedict Leoncio , Sacdalan Josephine Anne Lucero , Sacdalan Dennis Lee
Published: May 2019

e18022

Background: The University of the Philippines - Philippine General Hospital (UP-PGH) Colorectal Multidisciplinary Team is composed of colorectal surgeons, radiation oncologists, and medical oncologists tasked with the care of patients with colon and rectal cancers in a multidisciplinary clinic. Patients that have been lost to follow-up after initial work-up and treatment return later with more advanced disease if at all they come back for treatment. This is a concern because cancers of the colon and rectum are potentially curable if addressed in a timely manner by patient and physician. Moreover, aggressive follow-up of potentially curable colon and rectal cancers has been shown to improve patient outcomes. Identifying factors that contribute to poor patient follow-up will allow the team to design strategies that will lead to more patients completing treatment. This study aimed to identify the different factors that influence follow-up among Filipino cancer patients presenting at the UP-PGH Colorectal multidisciplinary clinic. Methods: This is a 6 month prospective cross-sectional pilot study where a questionnaire was designed to evaluate patient views regarding factors that contribute to continued follow-up as well as factors associated with poor follow-up at the colorectal multidisciplinary clinic. Patients were allowed to state multiple factors as they see fit. Descriptive statistics were employed in the analysis of data. Results: Of the 97 responders, 39 (40%) patients identified belief in the effectiveness of the treatment and trust in their physicians, 33 (34%) stated adequacy of family support , and 31 (32%) noted affordability of treatment as factors contributing to patient follow-up. In contrast, 44 (45%) patients identified financial constraints, and 7 (7%) stated the far distance of their home to the treatment center as potential causes of poor follow-up. Other potential causes of poor follow-up identified were fear and anxiety about treatment, intolerable side-effects, and long lines at the clinic -all with 2 (2%) responses each. Conclusions: Healthcare decisions in the Philippines are affected by an interplay of factors. This study has identified belief in treatment efficacy, trust in their attending physician, financial factors, and clinic accessibility as influencing continued patient follow-up. Future endeavors may be directed towards these factors to improve follow-up and care at the colorectal multidisciplinary clinic.
The impact of a digital solution on case discussion time at tumor boards.
Authors: Fowler Donna , Sheets Lincoln R , Prime Matthew S , Siadimas Athanasios , Levy Yariv Z , Hammer Richard D
Published: May 2019

e18028

Background: A multidisciplinary tumor board (MTB) provides an interdisciplinary approach for decision-making in cancer care. Information factors such as, multiple data sources, incomplete or missing information and teleconferencing failures, have been identified as issues contributing to variability in MTB conduction and impact. Little is known about how digital tumor board solutions can optimize MTB meeting conduction. Methods: A prospective IRB approved cohort study was undertaken to evaluate the time for patient case discussions,before and after the implementation of the NAVIFY Tumor Board (NTB) solution, at University of Missouri Health Care. Data was collected using a digital time-tracking application. The NTB manual version was implemented via a phased roll-out (Breast May 18, 2018; Gastrointestinal (GI) Jul 11, 2018; ENT Oct 30, 2018 – no manual version phase). Subsequently, the integrated version was introduced (Oct 4, 2018) whereby automated electronic medical record (EMR) data extraction was enabled. Results: Patient case discussion time was recorded at 138 MTBs (1109 patient cases) during 2018 (Breast 40 MTB; 236cases / GI 49 MTB; 389 cases / ENT 49 MTBs; 484 cases). Case discussion time significantly reduced at the Breast MTB (6.6mins to 5.3 mins; p-value = 0.01). Case discussion time at ENT MTB and GI MTB showed no significant change (Table 1). Time variance in case discussions significantly decreased post-NTB implementation at the Breast MTB (p-value = 0.008). For the GI & ENT MTBs, there was no significant difference post-NTB implementation (GI p-value =0.199; ENT p-value = 0.511), however, variance was already sma Conclusions: Introduction of the NTB reduced the time spent discussing cases for the Breast MTB, but showed no change forGI MTB and ENT MTB. Interestingly, case discussion times converged to between 5.5 - 6.5 minutesirrespective of the MTB type. Furthermore, variance decreased or was already small, for all MTB types. Both observations suggest that NTB standardized the case discussion process, perhaps because it created a common format for case presentation. A common workflow tool for MTB meeting conduction could ensure availability of all required data, increase efficiency of therapy decision-making, and lead to higher throughput of cases resulting in shorter time-to-treatment.
A systematic analysis of off-label drug use in real-world data (RWD) across more than 145,000 cancer patients.
Authors: McCafferty Jonathan , Grover Kartikey , Li Li , Li Zhiqiang , Fink Marc Y. , Goldsweig Howard , Ma Meng , Zhou Xiang , Mullaney Tommy , Redfern Arielle , Jappe Whitney , Zimmerman Michelle , Prentice Tony , Pan Qi , Oh William K. , Schadt Eric , Li Dan , Chen Rong
Published: May 2019

e18031

Background: Off-label drug use is common in cancer treatment (tx) due to limited approved tx options. Systematic analysis of RWD for off-label drug use facilitates hypothesis generation and design of clinical studies for new indications. Methods: We analyzed systemic tx data of > 145,000 cancer patients at Mount Sinai hospitals for 60 chemotherapy, 80 targeted, 16 hormonal therapy drugs, and 6 immune checkpoint inhibitors (CPIs). Off-label use was determined when patients received a drug for cancer indications that had not received regulatory approval, and the tx was not in a clinical trial setting. Clinical response to off-label tx was assessed using time to treatment discontinuation (TTD) as a surrogate endpoint. Results: Chemotherapy drugs were used off-label more frequently than targeted and hormonal agents. Across all cancer tx regimens involving a chemotherapy drug , 31% were off-label. In contrast, for tx regimens involving targeted and hormonal therapy drugs, only 11% and 6.7%, respectively, were used off-label. Further investigation revealed that chemotherapy often combines multiple drugs, where the combinations may include one or more drugs not approved for the disease. For example, cisplatin is approved only for bladder, ovarian and testicular cancers, but is widely used in combination to treat other cancers. Consequently, we observed an 84% off-label use of cisplatin. Several targeted drugs and CPIs were used off-label at high frequencies. 53% of nivolumab tx was off-label, primarily for treating hepatocellular carcinoma (before FDA approval) and relapsed/refractory multiple myelomas (RRMM). Trametinib targeting MEK and venetoclax targeting Bcl-2 were used off-label at a frequency of 84% and 89%, respectively, mainly in RRMM. In MM patients treated with trametinib (n = 91) and venetoclax (n = 121), 14 (15%) and 42 (35%), respectively, had TTD > 120 days. Conclusions: Off-label uses of novel targeted and immunotherapy drugs are likely based on disease mechanisms and when clinical trials deliver early, encouraging results. A thorough chart review would help us better understand clinical response as well as adverse events in these patients and potentially guide future clinical studies.
Use of a theoretical framework to examine declines in clinical trial enrollment.
Authors: Mackay Christine B. , Hepler Kerry , Daley Christine Makosky , Brooks Joanna Veazey
Published: May 2019

e18037

Background: Clinical trial enrollment at a group of community oncology sites dropped significantly surrounding acquisition by an academic medical center. While previous research used empirical data to identify enrollment barriers, this study used a theoretical framework to investigate research site personnel behavior associated with enrollment, and to further explore clinical trial enrollment barriers. Methods: Data from focus groups and interviews were analyzed using the integrated TDF and COM-B theoretical framework [1] . [1] Theoretical Domains Framework with Capability, Opportunity, Motivation Behavior Wheel. Results: Fifty-six community personnel [2] participated in focus groups and interviews about enrollment experiences before and after the acquisition. Participants described how changes in the workplace and resources affected their Opportunity to enroll: "It's kind of hard to put somebody on a study when you don't have one available." -cs "You can't grow a research department by cutting staff. What message does it send to the organization as far as the importance of research? …it makes you wonder whether the organization truly backs the research effort." -m Physician participants specifically shared that the lack of time and staff devoted to research hampered enrollment efforts, consequently affecting their Motivation: “Current road block is that doc doesn't have time to go through the patient records, so if [the study coordinator] could determine eligibility before the patient visit, that would be helpful.” -p Participants expressed frustration in not knowing the processes for opening trials, therefore their Capability was affected. “I think [in the past], we knew more about what was out there, where I don't see as much of that here now. I don't know if it's because we don't have a research nurse or we are not getting a list [of trials] anymore or what is going on." -cs [2] Quotes from personnel cs = clinic staff, m = manager, p = provider. Conclusions: Participants perceived many barriers to clinical trial enrollment after the acquisition. To optimally continue providing services as expected, support systems need to be maintained. This study provided evidence of using the TDF for exploring enrollment barriers.
Evaluation of cancer patients’ perspectives on weight management counseling at a comprehensive cancer center.
Authors: Hansra Damien Mikael , Daniels Cynthia , Alvarez Ricardo H.
Published: May 2019

e18041

Background: Over 2/3 of Americans are Overweight (OW) or obese (OB). Being OW or OB is a risk factor for a variety of cancers & denotes a worse prognosis for some. Evidenced based strategies on management of OW & OB patients (pts) are lacking. Data shows the majority of physicians are OW & OB and confidence in obesity counseling in these individuals is less compared with normal weight (NW) counterparts. Here we report the results of a survey on cancer pt’s opinions weight management counseling. Methods: An HRPP exemption was obtained. Pts asked to complete a 20-question (Q) survey. Clinical info collected: age, race, cancer type, weight class (underweight, NW, OW, OB, unsure but likely overweight). Survey Qs asked about optimal timing, type of weight counseling preferences. Also, Qs regarding importance of their oncologists (ONCO) BMI assessed. Secondary Qs about pt risk factors for obesity, pt willingness, & pt preferred modalities to change dietary & exercise habits also assessed. Statistical analysis: One-way ANOVA used to compare mean responses. P-values reported α = 0.05. Results: 245 cancer pts completed the survey. Demographics: 53% white, 37% black, 8% multiracial, 1% American Indian, 1% Asian. Majority of pts 51-65 years old (55%) and female ( > 75%). 71% (175/245) of pts were OW or OB vs. 29% (70/245) of pts with normal weight. 78% (191/245) of pts had breast cancer vs. 22% (54/245) other cancers. Main results: The best time for an ONCO to address weight reduction with pts is? “Anytime” = 45% (111/245), “First visit” = 27% (65/245), “After primary treatment” = 27% (65/245), “Never” = 1% (2/245) (p < 0.01). The approach pts prefer ONCO use to counsel on weight reduction is? “Educational approach” = 26% (65/245), “Direct approach” = 24% (59/245), “Passive approach” = 8% (20/245), “Passive & educational” = 18% (44/245), “Direct & educational” = 18% (43/245), “Other approaches” = 5% (12/245), “No approach, I don’t want counseling” = 1% (2/245) (p < 0.01). Who would you listen to MOST about weight loss advice? “Normal weight ONCO” = 41% (101/245), “The BMI of my ONCO does not matter” = 53% (131/245), “OB or OW” 5% (13/245) (p < 0.01). Results of secondary Qs included in presentation. Conclusions: Almost all pts would like to discuss weight loss with their oncologist on the first visit or after primary treatment has been completed. Also, most pts would like to receive counseling by their oncologist regardless of their oncologist’s weight. Furthermore, pts seem to prefer education about why weight loss is important be included in their weight loss counseling.