bluuebunny/crossref_metadata_2025_split huggingface dataset:
Race, subjective social status and metabolic syndrome in women with breast cancer.
Authors: Greco Giampaolo , Gallagher Emily J. , Leroith Derek , Lin Sylvia , Yagnik Radhi , Feldman Sheldon M. , Killelea Brigid K. , Friedman Neil B , Pilewskie Melissa Louise , Choi Lydia , Bickell Nina A. 
Published: June 2021

560 Background: Metabolic syndrome (MS) is associated with worse breast cancer prognosis. Black women have higher rates of advanced breast cancer, as well as MS, diabetes and obesity. As socioeconomic status is associated with MS, we asked whether the subjective perception of social status (SSS), might influence this association in black and white women with a new breast cancer (BC) diagnosis. Methods: We surveyed, obtained serum and conducted anthropometric measures of 1206 women with a new BC diagnosis. Triglycerides, systolic blood pressure (SBP), waist circumference (cm), HDL and glucose were used to calculate a severity index of MS (MS-Zscore: mean=0; sd=1). Women reported their SSS on the 10 rung McArthur US social status ladder, their household income, education attained, diet quality (5 point scale), and exercise measured with metabolic equivalents (METS). Data were analyzed with multivariable generalized linear models. Missing data were imputed with multiple imputation. Results: Average age was 58 yrs of 295 black and 911 white women. BC stage > II was in 11.6% of black and 2.4% of white women. On average black women had higher BMI (31.5 vs 26.6; p<0.001), waist circumference (103 vs 93; p<0.001) glucose (96 vs 92; p<0.001) and SBP (132 vs 126; p<0.001); lower triglycerides (92 vs 104; p<0.001) and HDL (59 vs 68; p<0.001). Black women were more likely than white women to live in poverty (23.7% vs 4.6%; p<.001); report poor diet (32.4% vs 10.4%; p<.001) and less exercise (29.7% v 23.6% in the 25th %ile), and less likely to graduate college (30.3% vs 70.4%). MSZ-score was positively associated with age (.02 per year; p<.001) and black race (0.35; <.001) and negatively with better diet (-.20 per point in 4 point scale); p<.001), exercise (-.11 per quartile increase in METS; p<.001) and SSS (-.04 per ladder rung; p=.004). SSS was lower in black women within the same levels of income and education). Conclusions: Race, age, diet, exercise and subjective social status all impact metabolic syndrome, a risk factor for breast cancer. Of concern, among breast cancer patients, black women are more likely to rate their SSS below white women, within each education or income level. Subjective social status among women with a new breast cancer diagnosis is associated with MS and may be important to address as a risk factor among breast cancer patients.[Table: see text]
Updated report of a phase II randomized trial of transoral surgical resection followed by low-dose or standard postoperative therapy in resectable p16+ locally advanced oropharynx cancer: A trial of the ECOG-ACRIN cancer research group (E3311).
Authors: Ferris Robert L. , Flamand Yael , Weinstein Gregory S. , Li Shuli , Quon Harry , Mehra Ranee , Garcia Joaquin J. , Ringash Jolie , Lewin Jan S. , Duvvuri Umamaheswar , O'Malley Bert W. , Ozer Enver , Thomas Giovana R. , Koch Wayne , Kupferman Michael Elliot , Bell Richard Bryan , Saba Nabil F. , Lango Miriam , Wagner Lynne I. , Burtness Barbara 
Published: June 2021

6010 Background: Definitive or postoperative chemoradiation (CRT) is highly curative for human papillomavirus-associated (HPV+) oropharynx cancer (OPC) but induces significant toxicity. As a potential deintensification strategy, we studied primary transoral surgery (TOS) and, in intermediate pathologic risk patients, reduced dose postoperative RT (PORT). Methods: E3311 is a phase II trial with randomization to reduced- or standard-dose PORT for resected stage III-IVa (AJCC7) intermediate pathologic risk HPV+ OPC, stratified by smoking history. Primary endpoints have been reported; we now present updated 3-year PFS and patient-reported outcomes (PRO), including head and neck-cancer specific quality of life (FACT-H&N) and swallowing perception and performance (MDADI). Results: Of 519 enrolled patients, 495 underwent TOS. The primary oncologic endpoint was 2-year PFS for 50 Gy (Arm B) or 60Gy (Arm C). Among 360 eligible and treated patients (ETP), Arm A (observation, N = 38) enrolled 11%, Arms B (N = 100) or C (N = 109) randomized 58%, and Arm D (66Gy + weekly cisplatin, N = 113) enrolled 31%. With 35.1 months median follow-up, 3-year PFS Kaplan-Meier estimate is 96.9% (90% CI [91.9%, 100%]) for Arm A; 94.9% (90% CI [91.3%, 98.6%]) for Arm B; 93.5% (90% CI [89.4%, 97.9%]) for Arm C; and 90.7% (90% CI [86.2%, 95.4%]) for Arm D. Recurrences and death without recurrence were 4 and 1 in Arm B, and 5 and one in Arm C. Smokers ( > 10 pack-years) did not have worse 3-year PFS in Arms B or C. Treatment arm distribution and outcome for ineligible patients who started adjuvant therapy mirrored the 360 ETP. A comparison combining arms B/C versus arm D in the proportion of patients stable/improved in FACT-H&N total score, from baseline to 6 months post-treatment as a pre-specified endpoint, was 56% vs. 38% (p value = 0.011, one-sided Fisher’s exact test); however, underlying differences in treatment and risk may be confounding. An exploratory comparison between Arms B and C revealed improvement in FACT H&N (63% in Arm B vs. 49% in Arm C had a stable/improved score, p-value = 0.056). Conclusions: Primary TOS and reduced PORT retained outstanding oncologic outcome at 35 months follow up, with favorable QOL and functional outcomes, in intermediate risk HPV+ OPC. Clinical trial information: NCT 01898494.
Efficacy and toxicity of weekly paclitaxel, carboplatin, and cetuximab as induction chemotherapy or in cases of metastases or relapse for head and neck cancer in elderly or frail patients.
Authors: Forman Rebecca , Bhatia Aarti K. , Burtness Barbara 
Published: June 2021

6042 Background: Standard of care treatments for locally advanced and metastatic head and neck squamous cell carcinoma (HNSCC) are not well tolerated, particularly in elderly or frail patients. One combination that has been studied in recent years is paclitaxel, carboplatin and cetuximab (PCC). Studies have shown this regimen yields promising results when used as an induction chemotherapy for locally advanced disease. PCC has also been studied in patients with metastatic or recurrent incurable disease, and has shown good response with tolerable toxicity rates, but there is a relative dearth of evidence surrounding its use. Methods: This retrospective observational study utilized EMR data analysis software to generate the cohort of adult patients that received PCC for HNSCC in 2014-2019 as well as demographic data. Chart review was used to gather details about the patients’ tumors and clinical course. Modified RECIST response rates (MRRR), progression free survival (PFS) and overall survival (OS) were the primary end points calculated for the metastatic/recurrent group, and percentage of successful inductions (e.g., patients went on to definitive treatment, avoided surgery) and MRRR were used for the induction group. Results: There were 80 patients in the cohort. The average age was 65 (range 33-84) and the patients were 81% male. The most common tumor site was the tongue (25 patients), followed by tonsil (15), oropharynx (9), and larynx (7). 13 patients had p16 positive disease. Most patients had Stage IVA (36 patients), followed by IVB (20), and IVC (15); the remainder had stage III or below or unknown stage. The most common reasons patients did not receive cisplatin were performance status (13 patients), hearing loss (11), concern for nephrotoxicity (6) and age (5). 97.5% of patients experienced at least one adverse effect. The most common adverse effect was dermatologic (69%), followed by hematologic (51%), fatigue (41%) and gastrointestinal symptoms (41%). 53 patients (66%) experienced at least one dose interruption due to adverse effects. 11 patients (14%) stopped treatment due to toxicities. 58 patients received PCC for metastatic or recurrent disease. They had received a median of 1 line of systemic treatment prior; 72% had prior radiation, and 26% had prior salvage surgery. The MRRR was 22% (5 patients with complete response, 8 partial response, 15 stable, 27 progression). There was a 7.0 month mean PFS, and 17.3 month mean OS. Of the 22 patients who received PCC as induction, 86% (19) successfully reached their induction endpoint. The MRRR was 64% (8 patients with complete response, 6 partial response). Conclusions: PCC is a relatively well-tolerated combination with a very good induction success rate. More research is needed around alternate options for frail and elderly patients with HNSCC.
Inductive camrelizumab and apatinib for patients with locally advanced and resectable oral squamous cell carcinoma: A single-arm trial (Icemelting trial).
Authors: Zhong Lai-Ping , Ju Wu-tong , Xia Rong-hui , Zhu Qi , Zhu Guopei , Dou Shengjin , Li Jiang , Dong Min-jun 
Published: June 2021

6052 Background: In patients with locally advanced oral squamous cell carcinoma (LAOSCC), major pathologic response (MPR) to induction therapy may translate into improved survival. The induction therapy using chemo-free drugs, such as the combination of anti-PD1 and anti-VEGFR drugs, has not been well issued in LAOSCC. Methods: A prospective single arm trial (NCT04393506) has been performed to evaluate the induction therapy of anti-PD1 and anti-VEGFR protocol in LAOSCC patients at clinical stage III and IVA. The patients received three cycles of intravenous Camrelizumab (PD-1 antibody, 200mg) on d1, d15, d29; and oral Apatinib (anti-VEGFR inhibitor, 250mg) daily, initiating on d1, ending on the 5th day before surgery. Radical surgery was planned on d42-d45. Post-operative radiotherapy was planned within 1.5 months after surgery, based on clinical and pathological stage. The primary endpoints were MPR and safety; primary tumors were assessed for the percentage of residual viable tumor that was identified on HE staining, and tumors with no more than 10% viable tumor cells were considered as MPR. This study has been approved by institutional ethics committee at Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine. Results: From April to December 2020, 21 patients were enrolled in this trial, and one patient withdraw from the trial at the beginning of treatment. The induction therapy was well-tolerated with no grade 3-4 toxicity or serve induction therapy-related AEs. One patient required surgery delay for 7 days due to unexplainable cTnI elevation. One patient put off Camrelizumab for 14 days due to grade 2 thrombocytopenia. One patient suspended Apatinib for 21 days due to grade 2 Hyperbilirubinemia. The induction therapy did not effect on the subsequent standard treatment. MPR rate was 40% (8/20), including 5% (1/20) pCR. Radiological evaluation of response to induction therapy showed 3 PR, 10 SD, 5 PD and 2 NA. Weak correlation was found between pathologic and radiological evaluation on induction therapy. Combined positive score (CPS) of PD-L1 expression in biopsy was evaluated in 19 patients; all 4 patients with CPS≥ 20 had MPR, 3 out of 11 patients with 1≤CPS < 20 had MPR, and 1 out of 4 patients with CPS < 1 had MPR. Conclusions: The chemo-free protocol of induction therapy using Camrelizumab and Apatinib is safe and well-tolerated for the patients with LAOSCC. The MPR rate is much higher using the anti-PD1 and anti-VEGFR protocol than the traditional induction chemotherapy protocol in LAOSCC. Clinical trial information: NCT04393506.
Quality of life analysis of HPV-positive oropharyngeal cancer patients in a randomized trial of reduced-dose (rdCRT) versus standard (sdCRT) chemoradiotherapy: Five-year follow-up.
Authors: Takahashi Mai , Hwang Michael , Misiukiewicz Krzysztof , Bakst Richard Lorne , Miles Brett A. , Gupta Vishal , Bonomi Marcelo Raul , Sharma Sonam , Botzler John , Genden Eric Michael , Moshier Erin , Selkridge Isaiah , Posner Marshall R. 
Published: June 2021

6062 Background: Human papillomavirus-positive oropharyngeal cancer (HPV OPC) portends a more favorable prognosis compared to HPV-negative cases. To prevent overtreatment, long-term morbidity and deterioration in functionality and quality of life (QoL), multiple studies have focused on de-intensification techniques for HPV OPC treatment. To this end, we prospectively assessed differences in patient reported QoL in locally advanced HPV OPC patients receiving rdCRTversus sdCRT)in a randomized trial using a sequential therapy plan. Methods: Patients were enrolled between December 2012 and February 2016; received 3 cycles of induction docetaxel, cisplatin, and 5-FU; and were randomized to sdCRT (70 Gy) or rdCRT (56 Gy) with weekly carboplatin. Patients were followed for Progression Free Survival (PFS), Overall Survival (OS), and changes in QoL as assessed by the MD Anderson Dysphagia Inventory (MDADI), MD Anderson Symptom Inventory (MDASI Head and Neck), Xerostomia Questionnaire (XQ), and the European Organization for Research and Treatment of Cancer Questionnaire (EORTC QLQ-C30) with the head and neck module (EORTC HN). A mixed model ANOVA was used to estimate changes from baseline QoL to that at each follow-up timepoint and to compare the difference in QoL changes between the treatment arms. Results: We randomized 20 HPV+ locally advanced (LA) patients (median age: 56.5 yrs) to rdCRT (12 subjects) or sdCRT (8 subjects). 70% had high risk features. At a median follow-up of 81.5 mos, PFS and OS were 87.5% and 83.3% for sdCRT and rdCRT, respectively with a median OS of 76 mos in both arms. One patient in the sdCRT arm developed an HPV negative retromolar trigone squamous cell cancer in the radiation field 7 yrs after therapy. Baseline QoL was identical in the 15 patients who completed the QoL modules. Patients receiving rdCRT hadsignificantly lower declines in QoL scores at 3-6 month follow-up. At 5 yrs, differences in QoL changes all favored the rdCRT arm (Table) and two QoL scales reached statistical significance (P<0.05). Conclusions: In HPV OPC patients, rdCRT resulted in comparable long-term survival and greater improvement in specific domains of QoL when compared to sdCRT. Our results support the need for a larger, long-term Phase 3 study in LA HPVOPC to assess these two treatments with respect to survival, QoL, and safety. Clinical trial information: NCT02945631. [Table: see text]
Selpercatinib efficacy and safety in patients with RET-altered thyroid cancer: A clinical trial update.
Authors: Sherman Eric Jeffrey , Wirth Lori J. , Shah Manisha H. , Cabanillas Maria E. , Robinson Bruce , Laskin Janessa J. , Kroiss Matthias , Subbiah Vivek , Drilon Alexander E. , Wright Jennifer , Soldatenkova Victoria , French Pearl Plernjit , Italiano Antoine , Weiler Daniela 
Published: June 2021

6073 Background: Selpercatinib, is a first-in-class, highly selective, CNS active and potent RET inhibitor approved in multiple countries for treatment of RET-fusion positive lung or thyroid cancers. Reported is an update of efficacy and safety results in RET-altered thyroid cancer, with a longer follow up (30 Mar 2020 data cutoff vs 16 Dec 2019) and additional enrolment. Methods: Patients (pts) with RET-mutant medullary thyroid cancer (MTC) and RET-fusion positive thyroid cancer (TC) were enrolled in the global (16 countries, 89 sites) Phase 1/2 LIBRETTO-001 trial (NCT03157128). The primary endpoint was objective response rate (ORR) per RECIST 1.1 by independent review committee (IRC). Secondary endpoints included duration of response (DoR), progression-free survival (PFS), clinical benefit rate (CBR; CR+PR+SD ≥16 weeks), and safety. The integrated analysis set (IAS, n = 143) includes efficacy evaluable MTC pts previously treated with cabozantinib and/or vandetanib (cabo/vande). The primary analysis set (PAS), a subset of IAS, is the first 55 enrolled pts. Cabo/vande naïve MTC pts (N = 112) and TC pts with prior systemic treatment (N = 22) were also analyzed. Safety population includes all pts who received ≥1 dose of selpercatinib (MTC N = 315; TC N = 42) by data cutoff. Results: For MTC patients, the ORR for IAS was 69.2%, in the PAS it was 69.1%, and 71.4% for cabo/vande naïve MTC pts. The ORR for TC pts (n = 22) was 77.3% (see table). Most treatment-emergent adverse events (TEAEs) were low grade; the most common (≥25% of MTC and/or TC pts treated with selpercatinib) were dry mouth, diarrhea, hypertension, fatigue and constipation for both MTC and TC pts, increased ALT/AST, peripheral edema and headache in MTC pts and nausea in TC pts. 4.8% of MTC and TC pts discontinued selpercatinib due to TEAEs but only 1.9% with MTC and none with TC discontinued due to treatment-related adverse events. Conclusions: In this updated analysis, selpercatinib continued to show marked and durable antitumor activity in pts with RET-altered thyroid cancers. Selpercatinib was well tolerated and no new safety concerns were identified. A global, randomized, phase 3 trial (LIBRETTO-531) evaluating selpercatinib compared to cabo/vande in kinase inhibitor naïve MTC pts is ongoing. Clinical trial information: NCT03157128. [Table: see text]
NTRK, RET, BRAF, and ALK fusions in thyroid fine-needle aspirates (FNAs).
Authors: Wirth Lori J. , Hu Mimi I-Nan , Waguespack Steven G. , Dosiou Chrysoula , Ladenson Paul , Livhits Masha J. , Sadow Peter M. , Krane Jeffrey , Stack Brendan C. , Zafereo Mark , Ali Syed Z. , Weitzman Steven P , Hao Yangyang , Babiarz Joshua , Kennedy Giulia , Kloos Richard 
Published: June 2021

6083 Background: Receptor tyrosine kinase (RTK) fusions may be targeted by small molecule inhibitors to treat various advanced tumors, including thyroid cancer. Clinical trials have studied selective inhibitors of ALK, BRAF, NTRK and RET, leading to several FDA-approved therapies. The Afirma Genomic Sequencing Classifier (GSC) classifies cytologically indeterminate thyroid nodules as molecularly benign or suspicious. The Xpression Atlas reports 905 genomic variants and 235 fusion pairs on GSC Suspicious, Suspicious for Malignancy (SFM), and Malignant FNA samples at the time of diagnosis. Here we report the prevalence of these fusion genes in real-world clinical practice. Methods: We analyzed anonymized data from 50,644 consecutive Bethesda III-VI nodule FNA samples submitted to the Veracyte CLIA laboratory for molecular testing using whole transcriptome RNA sequencing (RNA-Seq). Gene pairs are listed alphabetically. Results: 32,080 Bethesda III/IV nodules were classified as GSC Benign and 278 were Parathyroid Classifier positive. No ALK, BRAF, NTRK1/3, or RET fusions were identified among these samples. Among 16,594 Bethesda III/IV GSC Suspicious FNAs, 3% (n = 529) were positive for ALK, BRAF, NTRK1/3 or RET fusions. Among the 1,692 Bethesda V/VI FNAs, the proportion of positive nodules was 8% (n = 135). Among these combined cohorts of Bethesda III/IV GSC Suspicious and Bethesda V/VI, the most common gene fusions observed for each of the 5 studied RTK genes was: ETV6/NTRK3 (n = 164, 72% of NTRK3 fusions), CCDC6/RET (n = 104, 55% of RET), BRAF/SND1 (n = 32, 20% of BRAF), ALK/STRN (n = 20, 37% of ALK), and NTRK1/TPM3 (n = 14, 50% of NTRK1). BRAF showed the highest diversity of fusions, with 80 gene partners. Different gene partners with RET, ALK, NTRK1, and NTRK3 numbered 25, 11, 9, and 5 , respectively . Conclusions: Whole-transcriptome RNA-seq on small sample thyroid FNA specimens can identify clinically relevant ALK, BRAF, NTRK, and RET fusions across Bethesda categories. The prevalence ranges from 3% in Bethesda III/IV Afirma GSC Suspicious specimens to 8% among Bethesda V/VI specimens. Future studies need to determine if detection of precision medicine candidates by pre-operative FNA can optimize initial treatment, predict response to treatment, and prioritize selective targeted therapy should systemic treatment be needed.[Table: see text]
Cancer diagnosis and adverse financial events: Evidence from credit reports.
Authors: Shankaran Veena , Li Li , Fedorenko Catherine R. , Sanchez Hayley , Du Yuxian , Khor Sara , Kreizenbeck Karma L. , Ramsey Scott David 
Published: June 2021

6504 Background: Increasing evidence shows that cancer patients (pts) experience financial hardships after diagnosis. Few studies, however, have used objective financial data to estimate the relative risk of adverse financial events (AFEs) in cancer pts versus individuals without cancer. Using a retrospective case-control design, we investigated whether cancer pts are at increased risk of new AFEs, as measured by their credit reports. Methods: Western Washington Surveillance Epidemiology and End Results (SEER) cancer registry (cases) and voter registry (controls) records from 2013 to 2018 were linked to quarterly credit records from TransUnion (2012-2020), one of the 3 largest national credit agencies. Controls were age and sex matched to cases and assigned an index date corresponding to the diagnosis (dx) date of the matched case. Individuals with evidence of any AFE in the credit report closest to index/dx date or did not survive to 24 months were excluded. Cases and controls experiencing any of the following AFEs within 24 months were compared, using two-sample z tests: severe (3rd party collections, charge-offs), more severe (tax liens, delinquent mortgage payments), and most severe (foreclosures, repossessions). Multivariate logistic regression models were used to evaluate the association between cancer dx and AFE, adjusting for age, sex, dx year, and available credit 6 months before the index/dx date. Results: A total of 332,825 individuals (84,185 cases and 248,640 controls, mean age 66 (SD 13), 52.7% female) were included. The mean available line of credit in the year before index/dx date was $12,303. AFEs were more common in cases versus controls (Table). After adjusting for age, sex, available credit above or below $12,303, and dx year, cancer dx was significantly associated with any AFE (OR 1.77, 95% CI 1.7-1.85, p<0.0001), severe AFEs (OR 1.94, 95% CI 1.85-2.03, p<0.0001), more severe AFEs (OR 1.23, 95% CI 1.12-1.36, p<0.0001), and most severe AFEs (OR 1.46, 95% CI 1.16-1.86, p=0.0016). Age >65 and higher available baseline credit were associated with decreased risk of any and each category of AFE. Conclusions: Within 24 months from dx, significantly higher proportions of cancer pts experienced AFEs relative to controls. Such events on credit reports have serious and long-lasting consequences on financial status. Studies that link clinical and financial data to investigate the impacts of these events on treatment decisions, quality of life, and clinical outcomes are needed.[Table: see text]