bluuebunny/crossref_metadata_2025_split huggingface dataset:
Symptom identification and management in epithelial ovarian cancer.
Authors: Hickman Ashley , Ruddy Kathryn Jean , Pachman Deirdre R. , Fischer Kristin , Rahman Parvez , Goergen Krista M. , Lee Minji , Cheville Andrea L. , Wahner Hendrickson Andrea Elisabeth 
Published: June 2021

5554 Background: A better understanding regarding the burden of treatment side effects in patients with gynecological malignancies could help guide symptom interventions and oncologic therapy decision-making. We aim to inform understanding of symptom burden in epithelial ovarian cancer (EOC) by analyzing patient-reported symptom data from patients treated for this condition over a 16-month period. Methods: Patients receiving medical oncology care at Mayo Clinic Rochester and at Midwest Mayo Clinic Health System community sites have received symptom-focused surveys prior to each medical oncology visit since March 28, 2019 through the Enhanced Electronic Health Record Facilitated Cancer Symptom Control Study (E2C2). These surveys, administered either through the electronic medical record portal or on a clinic tablet prior to each oncology office visit, no more frequently than every 2 weeks, include six linear analogue scales measuring sleep disturbance, pain, anxiety, emotional distress, and fatigue (SPADE), as well as physical dysfunction on a scale of 0 (none) to 10 (as bad as you can imagine). Scores of 0-3 were considered mild symptoms, 4-6 moderate symptoms, and 7-10 severe symptoms. We collected survey results from March 28, 2019 to July 20, 2020 for patients with EOC and reviewed the number of surveys per patient in addition to the average symptom scores. Results: From March 2019 to July 2020, for patients with EOC, there were 2974 encounter-based surveys from 762 patients. The number of surveys completed by each patient ranged from 1-20. The following number of patients returned the correlating number of surveys: 1 survey:240 patients; 2 surveys:145; 3 surveys:79; 4 surveys:56; 5 surveys:58; 6 surveys:45; 7 surveys:38; 8 surveys:27; 9 surveys:22; ≥10 surveys:52. The average score from all surveys for each symptom was: 2.41 for sleep disturbance, 2.03 for pain, 2.32 for anxiety, 1.97 for emotional distress, 3.26 for fatigue, and 2.50 for physical dysfunction. Please see the table for the proportion of surveys that reported symptoms as mild, moderate, or severe. Conclusions: Fatigue and physical dysfunction were reported most frequently in patients with EOC, while emotional distress and pain were reported least frequently. 20% of surveys reported moderate to severe emotional distress, while 40% reported moderate to severe fatigue. A targeted approach to symptom management is needed for patients undergoing EOC evaluation and treatment. Our next steps in this analysis include an assessment of potential predictors of greater symptom burden (e.g., specific treatments, age, and other clinical and sociodemographic characteristics). Clinical trial information: NCT03892967. [Table: see text]
Real-life data of niraparib maintenance treatment in patients with recurrent platinum-sensitive ovarian cancer.
Authors: Vilming Bente , Fallås-Dahl Jørgen , Bentzen Anne-Gry , Ingebrigtsen Vibeke Anett , Berge Nilsen Elisabeth , Vistad Ingvild , Dørum Anne , Solheim Olesya , Bjørge Line , Aune Guro , Lindemann Kristina 
Published: June 2021

5560 Background: PARP (poly adenosine diphosphate [ADP]–ribose polymerase) inhibitors are the new standard for maintenance treatment in platinum sensitive recurrent ovarian cancer (PSROC), independent of germline (g-BRCA) or somatic BRCA mutation status. Real-life data after the introduction of new anti-neoplastic agents are needed to evaluate whether the benefit observed in phase III trials can be translated into clinical practice. The aim of this study was to provide real-life data on efficacy and safety of niraparib in non-gBRCA PSROC. Methods: This retrospective multi-center cohort study included patients with PSROC who were enrolled in a national individual patient access program in Norway. Efficacy and safety data were collected from the patients´ electronic medical records. The primary outcome was time from start of niraparib treatment to first subsequent treatment (TFST). Secondary endpoints included prevalence of dose interruption and -reduction, as well as adverse events. Results: The study included 106 patients with median age of 64 years (range 38-81). After median follow up of 15.3 months (95% CI 12.1-18.5), 71 patients (67%) had progressed, 64 (60%) had started a new line of treatment, and 25 (24%) had died. 25 (24%) patients were still receiving niraparib. Median duration of niraparib treatment was 7.6 months (0.4 to 27.3 months). Median TFST was 11.7 months (95% CI 9.2 -14.2). Patients with elevated CA125 after chemotherapy prior to start of niraparib had shorter progression-free survival (PFS) compared to patients with complete serological response (6.5 months (95% CI 5.7 – 7.3) vs 12 months (95% CI 6.2 – 17.9, (p < 0.001)). Grade 3-4 hematologic and non-hematologic events occurred in 25% and 17% of the patients, respectively. The most common grade 3/4 hematologic events were anemia (15%), thrombocytopenia (11%) and neutropenia (8%). Adverse events led to dose interruption in 38% and dose reduction in 44% of the patients. Patients with individualized dosing based on baseline weight and platelet counts had fewer dose reductions (p < 0.001) and -interruptions (p = 0.042) than patients whose dose was not adjusted to those baseline values. Conclusions: In a real-life setting, niraparib maintenance treatment in patients with non-gBRCA PSROC showed efficacy comparable with the published phase III data and an acceptable safety profile. Individualized dosing at start of treatment minimized adverse events. The prolonged PFS in patients with CA125 normalization after last chemotherapy, suggests that these patients in particular benefit from maintenance treatment but warrants confirmation in a larger sample.[Table: see text]
Anlotinib plus sintilimab in patients with recurrent advanced endometrial cancer: A prospective open-label, single-arm, phase II clinical trial.
Authors: Wei Wei , Ban Xiaohua , Yang Fan , Huang Yongwen , Li Jibin , Qiu Ya , Cheng Xiaqin , Li Jundong , Zheng Min 
Published: June 2021

5583 Background: Endometrial cancer is one of the most common gynecologic malignancies in the world. however, the effects of systemic chemotherapy are limited. The combination of targeted therapy with immunotherapy is a new research field in the treatment of malignant tumors. Anlotinib is a novel tyrosine kinase inhibitor with highly selective inhibition effects on multi-targets, especially on vascular endothelial growth factor receptor, Platelet-derived growth factor receptor and Fibroblast growth factor receptor. Sintilimab is a highly selective, fully humanized, monoclonal antibody, which blocks the interaction between Programmed death 1 and its ligands. This research aimed to evaluate the efficacy and safety of the combination of anotinib and sintilimab in patients with recurrent advanced endometrial cancer. Methods: Patients who received at least one platinum-based systemic chemotherapy, had an Eastern Cooperative Oncology Group performance status of 0 or 1 were considered eligible for enrollment. Sintilimab was administered intravenously (200mg，q3w); anlotinib was taken orally (12mg qd, d1-14, 21 days per cycle). The treatment was continued until disease progression, death or intolerant toxicity. The primary endpoint was objective response rate (ORR) and the secondary endpoints included duration of response, disease control rate (DCR), progression-free survival (PFS), overall survival and safety. Results: From November 2019 to to September 2020, 23 patients with a median age of 56 years (range: 37-70), FIGO stage IA (21.7%), IB (8.7%), II (4.4%), IIIA (13.1%)，IIIC (30.4%), IVB (21.7%) were enrolled. Among these participants, 22 patients were evaluable. The therapeutic evaluation showed the incidence of complete response, partial response, stable disease and progression disease was 13.6%, 63.7%, 13.6% and 9.1% respectively, yielding the ORR of 77.3% (95%CI: 58.3%-96.3%) and the DCR of 91.7% (95%CI: 79.8%-100%). ≥1 and ＜1 Combined Positive Score of PD-L1 expression were observed in 66.7% (14/21) and 33.3% (7/21) patients respectively, and the ORR was 92.9% (95%CI: 77.4%-100%) and 57.1% (95%CI: 18.4%-90.1%) in the two groups. The median time of the first response was 1.5 months (range, 0.7-12.8). The median PFS was not reached. Most of the occurring adverse events (AEs) were grade 1 or 2. Grade 3 AEs included ileus (4.3%), immune myocarditis (4.3%) immune peritonitis (4.3%), hand-foot syndrome (8.7%), neutropenia (4.3%), neutrophils decrease (4.3%), and hypertension (4.3%); Grade 4 AE was lymphocytosis (4.3%). Neither unexpected safety signals nor treatment-related death occurred. Conclusions: Anlotinib plus sintilimab showed a promising antitumor activity with a favorable toxicity profile for patients with recurrent advanced endometrial cancer. We will report more data in the future. Clinical trial information: NCT04157491.
Metabolic and bariatric surgery among endometrial cancer survivors: Are we missing an opportunity to help?
Authors: Gray Justin , Myneni Ajay A , Towle-Miller Lorin M , Simmonds Iman , Burnstein Matthew , Schwaitzberg Steven , Hoffman Aaron B , Zsiros Emese , Noyes Katia 
Published: June 2021

5591 Background: Multiple studies have delineated a clear link between the estrogenic effects of obesity and the incidence of endometrial cancer (EC). Obese EC patients are less likely to receive guideline-recommended surgical treatment (ST) relying instead on chemotherapy and radiation therapy. Furthermore, EC patients are more likely to die from obesity-related complications than from cancer-related causes. Several small-scale studies have demonstrated that metabolic and bariatric surgery (MBS) could offer EC patients fast, safe and effective weight loss, which provides an opportunity to improve survival. This is the first population-based study that examines uptake and outcomes of MBS among EC survivors in New York State (NYS). Methods: This study was based on the all-payer longitudinal data from the NYS’s Statewide Planning and Research Cooperative System and included inpatient and ambulatory surgeries performed between 2006 and 2012. Using ICD and CPT diagnostic and procedure codes, we identified patients diagnosed with EC for the first time, and we further examined whether they received ST within one year of their initial EC diagnosis. We followed EC patients with ST for 4 years to examine the rates of MBS, and we assessed long-term patient outcomes through 2019. We conducted bivariate and multivariate analyses to evaluate all-cause mortality and identify risk factors for poor surgical outcomes and readmissions. Results: Among 24,950 EC patients (2006-2012), 16,156 (65%) of them underwent ST within 1 year of EC diagnosis. Compared to those who did not receive ST, patients who underwent ST were younger, less likely to be White and more likely to be from urban counties, had private insurance, diagnosed with diabetes and hypertension, and had lower Elixhauser scores for readmission and mortality ( p < 0.01 for all). Within 4 years following ST, 136 (0.8%) EC patients underwent MBS. Those who underwent MBS were younger ( p < 0.01), predominantly white, privately insured, morbidly obese ( p < 0.01) and diabetic ( p = 0.01) compared to those who did not undergo MBS. Conclusions: Despite having higher risk of mortality from obesity-related complications such as diabetes and cardiovascular disease, the proportion of EC patients obtaining MBS (0.8%) was similar to that seen among the US population eligible for MBS (1.0%). More research is needed to understand barriers to MBS among eligible women with EC.
Pyrotinib as neoadjuvant therapy for HER2+ breast cancer: A multicenter, randomized, controlled, phase II trial.
Authors: Ding Xiaowen , Mo Wenju , Xie Xiaohong , Wang Ouchen , Ding Yuqin , Zhao Shuai , He Xiangming , Feng Weiliang , Zou Dehong , Yang Hongjian 
Published: June 2021

574 Background: Pyrotinib is a new irreversible tyrosine kinase inhibitor (TKI) which significantly improved the progression-free survival (PFS) of patients with HER2+ metastatic breast cancer (MBC). In this study we aim to investigate the efficacy and safety of pyrotinib in neoadjuvant therapy. Methods: This is an open-label, multicenter, randomized controlled trial. Eligible patients (pts) aged 18–70 years with invasive carcinoma, cT2-3N0-3M0 stage, HER2-positive breast cancer were included. We randomized 34 pts into the treatment group and 33 into the controlled group from 2019-2021. Pts in the treatment group received 6 cycles of pyrotinib 400mg + trastuzumab 6mg/kg (LD 8mg/kg) + docetaxel 75mg/m2 + carboplatin (AUC = 6mg/ml·min) (TCbH+Py) treatment while the controlled group received 6 cycles of trastuzumab 6mg/kg (LD 8mg/kg) + docetaxel 75mg/m2 + carboplatin (AUC = 6mg/ml·min) (TCbH). Total pathologic complete response (tpCR) was defined as no invasive or in situ disease in the breast or axilla (ypT0/Tis, ypN0) and was assigned to be the primary outcome (NCT03756064). Results: 51 cases had completed 6 cycles of neoadjuvant therapy and successfully underwent operation (21 in the treatment group and 30 in the controlled group). In the treatment group, 6 cases have not complete neoadjuvant therapy, 6 cases quitted because of poor compliance and 1 patient has not receive operation yet. For controlled group, 3 patients have not complete neoadjuvant therapy. The tpCR rate in the treatment group is 71.4% (15/21) versus 36.7% (11/30) in the controlled group. A significant difference was determined between the two groups (p < 0.05). All pts achieved an objective response in the treatment group while in the controlled group for about 83.3% (25/30). 4 cases showed stable disease (SD) and 1 case was evaluated as progressive disease (PD) in the controlled group. The most common AE in the treatment group is diarrhoea with grade 3 occurred in 6 cases (28.6%), most of this event limited in the first treatment cycle. In the controlled group 3 pts (10%) occurred grade 3 diarrhoea. Conclusions: In this study TCbH+Py neoadjuvant therapy significantly improved the tpCR rate of HER2+ breast cancer pts for about twice higher than TCbH with a manageable safety. Clinical trial information: NCT03756064.
Effect of neoadjuvant systemic therapy given during window trials on quality metrics in resectable head and neck squamous cell carcinoma.
Authors: Mascarella Marco Antonio , Vendra Varun , Kubik Mark , Sridharan Shaum , Kim Seungwon , Ferris Robert L. , Fenton Moon Jung , Ohr James , Zandberg Dan Paul , Duvvuri Umamaheswar 
Published: June 2021

6033 Background: Quality oncologic care, including negative surgical margin status, adequate lymph node yield and prompt initiation of adjuvant treatment, impacts disease control and overall survival in patients with mucosal head and neck squamous cell carcinoma (HNSCC). The aim of this study was to ascertain the effect of neoadjuvant systemic therapy given during window trials on oncologic quality metrics in patients with delayed definitive surgery for a HNSCC. Methods: Treatment-naïve patients with HNSCC participating in one of two window of opportunity clinical trials at UPMC from 2009-2019 were included. Neoadjuvant regimens consisted of one dose of cetuximab (n = 33) or anti-ErbB3 antibody (n = 9) within 28 days of surgery. Sociodemographic, clinical and tumor staging were recorded. The primary outcome was overall oncologic quality, as defined as a composite measure of negative margin status, adequate lymph node yield, completion of adjuvant therapy (if indicated) and time to initiation of adjuvant therapy within 6 weeks of surgery. Secondary outcomes were difference in clinical and pathologic stages and overall survival (OS). Results: A total of 42 patients with a mean age of 57.1 (±10.2) years and median follow-up of 58 months were analyzed. 29 patients had clinical stage IVA disease with 43% (18/42) oral cavity, 36% (15/42) larynx/hypopharynx and 21% (9/42) oropharynx primaries. All patients underwent surgery following neoadjuvant systemic therapy. In 30 patients (71%), all oncologic quality markers were achieved. Pathological downstaging occurred in 21% (9/42) of patients with 4 patients no longer meeting criteria for adjuvant treatment and were observed. 3 patients showed pathological upstaging. The 3-year OS were 76% (95% CI of 63.6-88.4), respectively. Patients with a pathologic downstage migration (64.9%, 95% CI of 49.9-79.8) had higher 5-year OS compared to those without (57.8%, 95% CI of 40.1-76.4, P = 0.046). Conclusions: Most patients receiving neoadjuvant systemic therapy on window trials prior to surgery met all oncologic quality markers. Importantly, even with brief window trial therapy pathologic downstaging was achieved and associated with significantly better overall survival.
Radiomics-based prediction of response to multikinase inhibitors in radioiodine-refractory differentiated thyroid cancer patients.
Authors: Corino Valentina , Colombo Elena , Bologna Marco , Calareso Giuseppina , Mainardi Luca , Cavalieri Stefano , Filippini Daria Maria , Resteghini Carlo , Bergamini Cristiana , Licitra Lisa F. , Locati Laura Deborah 
Published: June 2021

6077 Background: Antiangiogenic tyrosine kinase inhibitors (TKIs) represent the first-line treatment for radioiodine-refractory differentiated thyroid cancer (RR-DTC). Currently, no predictive factors for the activity of these drugs are available. We investigated whether radiomics may have a predictive role in this setting. Methods: We retrospectively identified patients (pts) affected by metastatic RR-DTC, treated with TKIs between July 2008 and January 2020 at our Institution, with availability of computed tomography (CT) scans at baseline and after at least 2 courses of TKI. Response to TKIs was evaluated according to RECIST v1.1. Pts with complete or partial response at the first radiological evaluation were considered responders (R), pts with stable or progressive disease non-responders (NR). A dedicated radiologist segmented the target lesions as regions of interest (ROIs). Radiomic features related to multiple categories (shape and size, first order statistics, textural features) were extracted from each ROI and computed using the PyRadiomics library v. 3.0. A semi-supervised form of principal component analysis estimated principal components that were then used for response classification through a k nearest neighbors (kNN) classifier. The quality of the model was assessed through train-validation-test split (55% of the data used as training set, 25% as validation set, 20% as test set), repeated 100 times. Performance of the predictive models was quantified with the mean Area Under the ROC Curve (AUC) obtained in the test set. Results: A total of 51 pts with metastatic RR-DTC who had received lenvatinib (n=37), sorafenib (n=4), axitinib (n=3), or vandetanib (n=7) were analyzed. Median age was 64.6 years, with a male prevalence (72.5%). Metastatic sites were lung (84.3%), bone (35.3%), brain (9.9%). Median time from TKI treatment start to the first radiological evaluation was 2.77 months, 24 pts (47%) were R (all partial responses) and 27 (52.9%) NR. In the radiomic analysis, 851 features were computed and 4-19 principal components were selected. Models’ performance of prediction of early response to TKIs is presented in Table. For each value of AUC, the corresponding 95% confidence interval is reported in brackets. Conclusions: Radiomics predicted the response to TKIs of RR-DTC pts with an accuracy of 71%. Radiomics technique has the potential to enable clinicians to anticipate the probability of response to TKIs at baseline, directing toward the most suitable patient-tailored therapeutic path. Prospective studies may further validate these preliminary findings.[Table: see text]
Patient-reported outcomes (PROs) from a phase II trial of pembrolizumab for HPV-associated papilloma patients with laryngeal, tracheal and/or pulmonary involvement.
Authors: Pai Sara I. , Franco Ramon , Muniappan Ashok , Friedman Aaron D , Park Jong Chul , Campbell Nicholas Paul , Krantz Seth B. , Song Phillip C , Nocon Cheryl , Carroll Thomas L , Faquin William C , Shin Kee-Young , O'Neill Anne M. , Wirth Lori J. 
Published: June 2021

6080 Background: Recurrent respiratory papillomatosis (RRP) is caused by human papillomavirus (HPV) types 6 & 11. RRP proliferates in the respiratory tract impacting breathing, swallowing, and voice and carries a 1-4% risk of malignant transformation.There is no curative therapy for RRP. Given the tolerized host immune response against HPV, the safety and efficacy of pembrolizumab (pembro) as an alternative treatment for this patient population was evaluated in a phase II clinical trial. Patient reported outcomes (PROs) were assessed during the trial to capture the patient perspective of pembro as an alternative to surgery or in office procedures, both standard of care (SOC). Methods: RRP patients who had previously undergone >3 procedures in any year, or with known tracheal or pulmonary involvement prior to study entry were treated with pembro 200mg every 3 weeks. The primary endpoint of the trial was best ‘overall response rate’ (ORR) measured by an endoscopic-based disease burden score (lower score reflects better ‘response’) and/or RECIST 1.1, secondary endpoint included PROs. Twenty-one patients were required to assess the primary endpoint. Most of the QoL surveys used Likert scale to assess PROs (‘never, sometimes, often, most of the time, always’). The percentage reporting ’never’ having an issue with symptom or activity at baseline, 6 months, and at time of ORR (nadir disease burden score) is reported here. Results: Twenty-one patients were accrued. Median age (range) was 45 (19-68), 57% (12/21) were male and 67% (14/21) were white. Questionnaire completion rates were 100% at baseline, 90% at 6 months, and 85% at ORR. Improvement in: social interactions (less difficulty with: physical intimacy [38%,56%,65% reporting ‘never’ at baseline, 6 months, and at ORR respectively]), discussing disease diagnosis [19%,21%,39%]); personal feelings (less depression [14%,32%,33%], less anxiety [5%,16%,22%], less embarrassment [19%,37%,50%]), and work-related absences (less frequently fabricating reasons for work absence due to disease-related treatment [57%,78%,56%] and less utilization of family vacation or FMLA for disease treatment [29%,53%,56%]) were reported. At ORR, 72% (13/18) patients reported that IV infusion was not emotionally burdensome and 78% (14/18) reported it as the preferred treatment relative to their perceived experience with SOC surgery or in office procedures. Conclusions: PRO results show consistent benefit in key aspects of the patient experience with pembro over procedure based SOC further supporting its overall clinical benefit in patients with HPV-associated RRP. Clinical trial information: NCT02632344.