bluuebunny/crossref_metadata_2025 huggingface dataset:
Further insights on social determinants of health: Investigating racial disparities and estimated household income in relation to staging of newly diagnosed breast cancer.
Authors: Ghorpade Rina , Tissavirasingham Fiona , Loague Deanne , Escala Perez-Reyes Andrea , Victor Varun , Singla Shivam , Parekh Nitant , Malipeddi Yashaswi Ram , Trehan Shruti
Published: June 2023

e22529

Background: The incidence of breast cancer in high-income countries has risen by over 20% in the past two decades, with higher incomes relating to higher incidence rates of breast cancer. Racial disparities relating to breast cancer have also been observed, with African American women being diagnosed with more aggressive and advanced-stage breast cancer. We aimed to study how racial disparities and household income relate to breast cancer staging at the time of diagnosis. Methods: A retrospective cohort study was conducted on 1000 breast cancer patients in Aultman hospital cancer center in Canton, Ohio. Patients with a diagnosis of breast cancer diagnosed between 2010-2020 were included in the study. Data including age, zip code, race, and tumor stage at the time of diagnosis was collected. Further, zip code information was used to estimate median household income by searching available US income statistics. For statistical analysis, the Pearson correlation and linear regression model were used, with p< 0.05 defining statistical significance. Results: Patients ranged from 25-95 years old. The percentage of patients with breast cancer staging of 0, I, II, III, and IV was 1.9%, 47.7%, 26.2%, 6.1%, and 18.1% respectively. When separated by income bracket, 86.6% of the study population was found to be within the $44,251-$88,450 income bracket. Regarding income and breast cancer stage, a correlation coefficient of -0.019 (p 0.557) was found. Further, the population of study was found to be 51.4% Caucasian, 2% African American, 0% Hispanic, 0.3% Asian, and 46.3% other races. Regarding race and breast cancer stage, a correlation coefficient of -0.174 (p < 0.01) was found. Conclusions: This study found no significant relationship between income and stage at the time of diagnosis. A limitation to our study was the use of estimated household income rather than exact patient reported income. However, a significant relationship was found between race and breast cancer staging, with earlier stage breast cancer detected among Caucasian women, and later stages among other races at the time of diagnosis. These findings emphasize the need to address racial disparities and access to care to improve upon breast cancer screening and early-stage detection.
Clinical implications of universal germline testing in breast cancer patients in an Arab population: The Jordanian Exploratory Cancer Genetics (Jo-ECAG) study.
Authors: Abdel-Razeq Hikmat , Nielsen Sarah M. , Sharaf Baha' , Bani Hani Hira , Russell Emily M , Heald Brandie , Alkyam Mais , Abujamous Lama , Mustafa Rawan Mohammed Mahmoud , Al-Azzam Khansa , Elemian Shatha , Abu-Fares Hala , Hamed Allah Majd , Zeidan Zeidan , Nussbaum Robert Luke , Esplin Edward D.
Published: June 2023

e22535

Background: Germline genetic testing (GGT) for breast cancer (BC) has implications for surgical decision-making, treatment selection, clinical follow-up and cascade testing. As uptake of GGT increases globally, it is important to examine its impact on clinician decision-making, particularly in different ethnic groups. Methods: The Jo-ECAG Study consisted of unselected, newly diagnosed cancer patients (pts) from a single center in Jordan. Pts were classified as meeting (in criteria, IC) or not meeting (out of criteria, OOC) National Comprehensive Cancer Network (NCCN) v.1.2020 GGT criteria. Pts underwent a 84 gene test with clinician-reported outcomes collected >2 months post GGT. Analysis was limited to pts with BC. Pts with one PGV in a gene associated with autosomal recessive inheritance (“carriers”) were excluded from overall PGV count. Blank responses were considered uninformative. Descriptive statistics and Fisher’s exact test were employed. Results: 1648 (21 male) Arabic pts with BC, 36% metastatic, with a mean age at diagnosis of 50.5 were tested; 67% were IC. 212 PGVs were identified in 202 (12%) pts, with a significantly higher rate in IC vs. OOC pts (14% vs. 8%, p=0.0002). PGVs were most common in BRCA1/2 (4%), APC I1307K (4%), and other BC-associated genes such as ATM, CHEK2, PALB2 and TP53 (collectively, 3%). 2% of pts were carriers and 57% had uncertain results. Among pts with PGVs and informative responses (Table), 18% had changes to treatment (11% OOC) and 82% to surveillance/follow up (16% OOC) based on GGT results. Genetic counseling and/or GGT was recommended for relatives of >90% of PGV and carrier pts. No changes to treatment or follow-up were made for pts with negative or uncertain results. Conclusions: 1 in 8 Jordanian BC pts had a PGV identified, with a similar breakdown of PGVs observed in other ethnic cohorts, aside from a higher percentage of APC I1307K. Both treatment and surveillance/follow-up decisions were impacted by GGT results. Appropriately treatment or management was not escalated for pts with negative or uncertain results. [Table: see text]
Clinical synergy of universal paired tumor genomic and germline sequencing in an unselected, pan-cancer cohort of patients: Greater than the sum of the parts.
Authors: Heald Brandie , Nielsen Sarah M. , Ekpoh Idara , Alexander Dana , Pai Rish , Golafshar Michael A. , Kunze Katie , Uson Junior Pedro Luiz Serrano , Bekaii-Saab Tanios S. , Ahn Daniel H. , Wu Christina , Pineda Alvarez Daniel Esteban , Samadder N. Jewel , Esplin Edward D.
Published: June 2023

e22537

Background: Germline and tumor next-generation sequencing (NGS) are complementary tests whose benefit in capturing patients (pts) potentially eligible for precision therapies is maximized when the tests are paired, as qualifying pathogenic variants (PVs) are missed if either test was done in isolation (Lincoln et al. 2020). Germline NGS has the additional benefit of informing prevention through surveillance and cascade testing. We highlight the benefits of a universal approach to concurrent testing in a subset of the previously reported cohort of pan-cancer pts who underwent universal germline NGS (Samadder et al. 2020). Methods: Unselected pts with solid tumors underwent an 80+ gene germline panel and 315+ gene tumor panel. Variants in genes unique to the germline or tumor panels, including microsatellite instability (MSI) and tumor mutation burden (TMB), were also evaluated. Results: 104 pts [81.7% White, non-Hispanic, 71.2% male] with 23 cancer types [28% colorectal, 13% lung, 11% prostate, 49% other] were included. Five (5%) pts had no actionable tumor alterations or germline variants identified (Table). 18 pts (17%) had 19 pathogenic germline variants (PGVs) identified, 11 (58%) of which were detected on tumor NGS (Table). 92 pts had >1 tumor alteration identified, of which 12% were confirmed as PGVs (Table). Notably, tumor NGS revealed 81 pts (78%) pts with biomarkers that would could not have been identified with germline testing alone, such as variants in genes not on germline panel (80) or MSI-high (4), or TMB-high (21) status of the tumor. Conclusions: Germline and tumor NGS are complementary tests that often detect different actionable alterations. There is value in confirming both the presence and absence of somatic variants in the germline in order to make appropriate clinical recommendations for the patient and their family members. [Table: see text]
Aligning NCCN criteria with testing workflows using a novel database application (Criterion).
Authors: Sharma Rekha , Vanzo Rena , St. Lewis Tawanna , Reeves Cheryl , Mukund Pranav , Tolley Morgan , Sharma Poonam , Sharma Jivesh
Published: June 2023

e22541

Background: As cost decreases and benefits become more well known, more individuals are seeking genetic testing. Physicians, genetic counselors, and other healthcare professionals play a critical role in explaining the benefits and limitations of genetic testing for hereditary cancer syndromes. Here we discuss our experience creating a web-based application, utilized by a variety of stakeholders, to determine whether patients are likely to meet clinical testing criteria set forth by the National Comprehensive Cancer Network (NCCN). Methods: To address the challenge of efficiently and accurately determining medical necessity for hereditary cancer genetic testing, we developed a pilot study to assess the utility of Criterion beta, a web-based pilot application. A questionnaire was sent to laboratory staff, genetic counselor assistants, genetic counselors, and physicians to assess the accuracy and usability of Criterion beta. 14 respondents each evaluated three mock patient profiles. They were initially asked to determine if the patients met current NCCN criteria for hereditary cancer genetic testing without using any alternative references or resources. Respondents with no prior training using Criterion were then asked to answer the exact same questions using Criterion beta. Results: Results of this pilot study indicate that implementation of Criterion beta leads to more accurate decision-making. Preliminary survey data shows that response accuracy for NCCN criteria determinations improved by 72% with the use of Criterion beta (see Figure 1). In addition, 85% of respondents reported that the application would allow them to routinely make more accurate decisions regarding who meets NCCN criteria for hereditary cancer genetic testing. Conclusions: As the demand for genetic testing increases, accessibility of professional guidelines like NCCN is important for multiple entities involved in the testing process, especially those unfamiliar with the concept of medical necessity. Clinically-based tools like Criteron beta are critical in this process because guidelines can be complex to navigate. In addition, through its ease of use, Criteron beta can better align implementation of genetic testing among high-risk populations. It may also place indirect pressure on industry stakeholders to align their eligibility requirements with clinical standards like NCCN, ultimately serving the best interests of patients in need of preventative care.
Modifiable risk factors and risk of colorectal and endometrial cancer in Lynch syndrome: A systematic review and meta-analysis.
Authors: Power Robert , Doherty Damien , Parker Imelda , Lowery Maeve Aine , Cadoo Karen Anne
Published: June 2023

e22544

Background: Lynch syndrome is the most common hereditary cause of colorectal and endometrial cancer. Non-genetic risk factors, including obesity, physical activity, alcohol intake, and smoking are well-established in sporadic cancers but are less studied in Lynch syndrome. A better understanding of these risk factors could directly contribute to cancer prevention. Methods: Searches were conducted on MEDLINE, Embase and Web of Science for retrospective or prospective cohort studies that investigated the association between modifiable risk factors and the risk of colorectal or endometrial cancer in people with Lynch syndrome. Screening, data extraction and quality assessment were completed by 2 reviewers independently. Adjusted hazard ratios (HR) and 95% confidence intervals (CI) for colorectal and endometrial cancer were pooled using a random effects model. The protocol was prospectively registered on PROSPERO (CRD 42022378462) and the meta-analysis conducted in accordance with PRISMA and MOOSE reporting guidelines. Results: A total of 770 citations were reviewed. Twelve cohort studies involving 12685 patients with Lynch syndrome investigated risk of colorectal cancer, while 3 studies including 1865 patients assessed risk factors for endometrial cancer. Eight colorectal cancer studies were eligible for meta-analysis. Obesity (HR 2.38, 95% CI 1.52-3.73) and alcohol intake (HR 1.43, 95% CI 1.05-1.94) increased colorectal cancer risk, physical activity was protective (HR 0.66, 95% CI 0.52-0.83), and smoking had no effect (HR 1.02 95% CI 0.83-1.27). Type 2 diabetes mellitus and low dietary intake of calcium and multivitamins might increase risk of colorectal cancer, although more studies are needed. There is a paucity of data pertaining to endometrial cancer. In a qualitative synthesis of 3 endometrial cancer cohort studies, female hormonal risk factors and type 2 diabetes mellitus may affect the risk of endometrial cancer, but obesity was not associated with an increased risk. Conclusions: Lifestyle recommendations related to weight, physical activity, and alcohol may also be relevant to cancer prevention for individuals with Lynch syndrome and may provide a meaningful adjunct to standard interventions for risk modification. There are very poor data examining modifiable risk factors in endometrial cancer. Further high-quality prospective cohort studies, in particular including endometrial cancer as an endpoint, are needed to inform evidence-based cancer prevention strategies in this high-risk population.
Trends of female representation in ASCO leadership and abstracts authorship: A detailed review.
Authors: Aljaras Razan , Karkash Ahmad , Dandu Vidya Sree , Alhader Ahmad Abdelfattah
Published: June 2023

e23010

Background: Gender inequalities in medicine are ongoing challenges facing health care providers in different fields. Gender bias in medicine is gaining more attention, raising the awareness of this important topic. Per ASCO 2022 snapshot, females represent 35.8% of total oncologists in the United States. This study aims to spot the light on female representation in ASCO abstracts authors and presidents, adding to the continuous efforts aiming to achieve gender equity in the oncology practice. Methods: Data from the ASCO database and conference materials was gathered for analysis in the different categories. These categories included presidents of ASCO since it was founded in 1964 through 2022, and first authors in abstracts accepted over the past 5 years (2018-2022). Statistical analyses on first authors data were conducted, and a P-value of < 0.001 was deemed to be statistically significant. Results: In the 58-year period (1964-2022), ASCO had 49 men (85%) and 9 women (15%) serve as presidents. 7 out of 9 total female presidents were elected in the last 20 years. In the 5 year period (2018-2022), there was a significant increase in the percentage of abstracts accepted for a female author. 37.1% of the presenters in 2018 were females, compared to 41.4% in 2022, with statistically significant results (P value < 0.001), detailed percentages are shown in tables. Conclusions: Gender gap in the field of oncology goes beyond pay differences to include leadership positions and research authorship. But as shown by our analysis, there has been an increase in representation of females in ASCO abstracts authorship and leadership over the past years. Nonetheless, further work is needed to identify factors contributing to lower representation of women in oncology, and suggested solutions. [Table: see text][Table: see text]
Gastric gastrointestinal stromal tumors and overall survival in elderly patients.
Authors: Spitzer Asha , Kwak Hyunjee V. , Chang Amber , Peng Peter D , Kazantsev George , Chang CK
Published: June 2023

e23516

Background: The purpose of this study is to analyze the overall survival (OS) of various age groups of patients diagnosed with gastric gastrointestinal stromal tumors (GIST). Methods: We compared 4 different age groups ( < 50 years old, 50-64 years old, 65-79 years old, and 80 or greater) comprising 230 patients in terms of various clinicopathological parameters and OS from January 2010 to December 2020 within Kaiser Permanente Northern California (KPNC), using Kaplan-Meier curves, and Cox proportional hazard regression model. Results: Univariate analysis showed that mitosis greater 10 HPF was a statistically significant predictor of decreased OS from gastric GIST (p = .032). Although necrosis alone was not significant (p = .271), the combination with higher mitotic rate was significant (p = .025). Octogenarians with gastric GIST were more likely to present with bleeding, with a 5.3% ninety-day surgical mortality rate. Multivariate Cox regression showed that patients 80 years of age or greater had decreased OS when compared to the other age groups ( p= .002). Conclusions: Gastric GIST mitotic rate is significant in term of overall survival across all age groups and the combination with necrosis portends decreased overall survival. Patients over 80 have a decreased overall survival and require additional vigilance in the early peri-operative period.
Preliminary survival outcomes and toxicities in patients with retroperitoneal sarcoma treated with radiotherapy.
Authors: Cheng Hao-shen , Liu Yi-Chun
Published: June 2023

e23524

Background: To investigate the survival outcomes, the treatment toxicities, and the recurrence pattern of nineteen patients with retroperitoneal sarcoma treated with radiotherapy. Methods: The inclusion criteria for this retrospective study were previously untreated retroperitoneal sarcoma who had received radiotherapy. From March 2016 to June 2022, the chart records and images of 22 eligible patients were reviewed. There were ten males and twelve females, and their ages ranged from 34 to 80 years old (median 55). Sixteen patients (72.7%) had a liposarcoma, four patients (18.3%) had a leiomyosarcoma, one patient (4.5%) had a spindle cell sarcoma, and one patient (4.5%) had a malignant peripheral nerve sheath tumor with heterologous rhabdomyosarcomatous and liposarcomatous differentiation. At diagnosis, four patients (18.1%) had a stage I-II disease, eighteen patients (77.4%) had a stage III disease, and only one patient (4.5%) had a stage IV disease. Twenty one patients (95.5%) received operation, and nineteen of them had a positive or close ( < 1mm) surgical margin. Nineteen patients (86.4%) received adjuvant radiotherapy (median dose 5400cGy, ranging 5000 to 6300cGy), one patient (5.3%) received neoadjuvant radiotherapy (5000cGy), one patient received definitive chemoradiotherapy (7000cGy), and one patient received palliative radiotherapy (3000cGy) to bone metastasis. Results: The medial follow-up was 32 months, and the two-year overall survival rate was 79.8%. Acute toxicities of radiotherapy included gastrointestinal toxicities (grade 1-2: 9 patients), nausea (grade 1-2: 7 patients, grade 3-4: 3 patients), vomiting (grade 1-2: 3 patients, grade 3-4: 2 patients), neutropenia (grade 1-2: 2 patients, grade 3-4: 1 patients), and fatigue (grade 1-2: 5 patients). In patients without metastatic disease at diagnosis, two-year overall survival rate was 84.0%, and two-year disease-free survival rate was 62.9%. There were 8 recurrences (1 local alone, 2 distant metastasis alone, 1 local plus regional, 3 local plus distant metastasis, and 1 local plus regional plus distant metastasis), and 5 deaths. Recurrent metastatic locations included lung (n = 1), liver (n = 1), bone (n = 2), peritoneum (n = 1), distant lymph nodes (n = 1), and soft tissue of thigh (n = 1). One patient with metastatic disease at diagnosis expired due to disease progression with 8 months survival. Conclusions: Radiotherapy in retroperitoneal sarcoma provided an acceptable two-year survival rate with tolerable toxicities, but recurrence rate was still high. About 75.0% of recurrent events consisted of local recurrence, so close follow up of primary tumor area is necessary.
Efficacy and safety of pazopanib in the treatment of pediatric sarcoma: Retrospective cohort study.
Authors: Unal Emel Cabi , Incesoy Ozdemir Sonay , Tacyildiz Nurdan , Dincaslan Handan , Dogrul Caglar , Guven Ezgi , Yaman Ortakoylu Melek , Bozer Asli , Yavuz Gulsan
Published: June 2023

e23526

Background: The presence of frequent genetic alterations activating the tyrosine kinase (TKI) signaling pathway has recently led to a more targeted therapeutic approach. We describe our institutional experience using pazopanib for pediatric sarcomas. Methods: We performed a retrospective, IRB approved, chart review of all patients with sarcoma treated with pazopanib off-study at Ankara University Pediatric Oncology Clinic between 2019–2021. Results: Twenty-five patients were identified. Median age at commencement of pazopanib treatment was 13 years old (range 4 to18 years; 15 male: 10 female). Median duration on treatment with pazopanib was 16 months (range, 2 to 33). The median duration between the diagnosis of sarcoma and the beginning of pazopanib was 17.0 months (range, 1 to 80 months). Twelve of 25 patients due to metastatic disease at diagnosis, pazopanib was started with first-line chemotherapy and/or continued as maintenance therapy (Group 1). In the remaining 13 of 25 patients, received a second-line chemotherapy with pazopanib was administrated due to relapsed disease (Group 2). Nine patients (36.0%) ( 2 patients in group 1 and 7 patients in group 2) had died from progressive disease ranging between 13 and 70 months (median 33 months) after the diagnosis. OS rate was 64,0% in the entire cohort; group 1 and group 2 were 83,3%, and 46,2%, respectively. The overall median OS was 69.4 months. No new pazopanib-related adverse effects were identified. Conclusions: Pazopanib appears to be an effective treatment for pediatric sarcoma. Treatment with pazopanib is well-tolerated and could have a role to maintain response in patients with pediatric sarcoma. Further studies are needed to better define the use of this regimen in the upfront management of those patients.
Analysis of the efficacy and safety of PD-1/PD-L1 inhibitors–based treatment in myxofibrosarcoma: A single-institution retrospective analysis.
Authors: Zhang Chenlu , Zhou Yuhong , Zhuang Rongyuan , Guo Xi , You Yang , Wang Zhiming
Published: June 2023

e23531

Background: Myxofibrosarcoma (MFS) is a rare subtype of soft tissue sarcoma (STS), accounting for about 5% of STS. At present, the treatment of advanced or metastatic MFS is limited and the prognosis is poor. PD-1/PD-L1 inhibitors have shown efficacy in some subtypes of STS, but there is no real-world research data of MFS. This study retrospectively analyzed the efficacy and safety of PD-1/PD-L1 inhibitors-based treatment for MFS patients in Department of Oncology, Zhongshan Hospital, Fudan University. Methods: Advanced or metastatic MFS patients who underwent PD-1/PD-L1 inhibitors-based treatment were collected. The primary end point of this study was progress-free survival (PFS), and the secondary end points included objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety. RECIST 1.1 and CTCAE 5.0 were used to evaluate the efficacy and safety. Results: From January 1, 2018 to January 5, 2023, a total of 11 patients were included in the study. The median age was 57 years (27-74 years); 7 males and 4 females; 4 in extremities, 3 in retroperitoneum, each of 1 in pelvic cavity, mediastinum, trunk and head and neck. 3 cases were primarily unresectable or metastatic, and 8 cases were postoperative recurrence or metastasis. Treatment included: 1 case (1/11) with PD-1/PD-L1 inhibitors and chemotherapy, 2 cases (2/11) with PD-1/PD-L1 inhibitors and anti-angiogenesis therapy, and 8 cases (8/11) with PD-1/PD-L1 inhibitors combined with chemotherapy and anti-angiogenesis therapy. 3 patients were administrated with radiotherapy to enhance local control. Chemotherapy drugs included gemcitabine, nab-pacilitaxel, epirubicin/pegylated liposomal doxorubicin, dacarbazine, and eribulin. Anti-angiogenesis drugs included anlotinib and regorafenib. 5 cases were treated in first line, and 6 cases were in second line or above. The median baseline length of target lesion was 12.4 cm (1.7-23.9 cm). Four patients had distant metastasis, including lung, bone, pleura and lymph node. The median follow-up time was 17.6 months. The median PFS was 12.2 months (95% CI: 9-NE), and the median OS was 19.1 months (95% CI: 14.3-NE). The ORR is 27% (3/11) and the DCR is 91% (10/11). The ≥grade 3 adverse events (AEs) were neutropenia (36.4%), fatigue (18.2%) and hand-foot syndrome (9.1%). The most common AEs of grade 1-2 were of neutrophil (45.5%), hypothyrosis (27.3%), nausea (27.3%), numbness (18.2%), fatigue (9.1%), anemia (9.1%), hepatic impairment (9.1%), and arrhythmia (9.1%). No treatment-related death happened. Conclusions: This is the first retrospective study revealed that the PD-1/PD-L1 inhibitors-based treatment had good efficacy and tolerable toxicity in Chinese advanced or metastatic MFS patients. Further prospective clinical trials and biomarker research on forecasting the efficacy of immune checkpoint inhibitors of MFS are warranted.
A phase II study of surufatinib in patients with osteosarcoma and soft tissue sarcoma who have experienced treatment failure with standard chemotherapy.
Authors: Zhang Xing , Pan Qiuzhong , Peng Ruiqing , Xu Bushu , Hong Dongchun , Que Yi
Published: June 2023

e23540

Background: Surufatinib is a multi-targeted, small-molecule tyrosine kinase inhibitor (TKI) that shows strong inhibitory effect on the activity of VEGFR-1, 2, 3, FGFR1 and CSF-1R. Here we conducted this trial to explore the efficacy and safety of surufatinib in the treatment for osteosarcoma and soft tissue sarcoma (STS) patients (pts) who have failed in standard chemotherapy. Methods: Pts with advanced osteosarcoma and STS (unresectable or metastatic), 14-70 years, and ECOG PS 0-1, are eligible. Surufatinib 300 mg q.d. is given in a 21-days schedule. Progression-free rate at 12 weeks (PFR12weeks) was the primary endpoint. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety (NCT05106777). Results: As of December 30, 2022, 19 pts (male, n=12; median age, 44 years [range, 23-67]; median lines of prior therapy, 2 [range, 2-5]) were enrolled. The most common histological subtypes included 3 leiomyosarcoma, 3 liposacroma, 3 epithelioid hemangioendothelioma, 2 fibrosarcoma and other. The interim analysis revealed 7 pts with stable disease (SD) and 1 pt with partial response (PR) at 12 weeks in stage 1. Recruitment was continued in stage 2 as initially planned. With 15 pts for efficacy analysis, PFR12weeks was 60% (9 pts). Best objective response by RECIST 1.1 was complete response (CR) in 1 pt (ORR of 6.7%) and SD in 11 pts (DCR of 80%). With a median follow-up of 6.97 months (95%CI: 5.28-8.65), the median PFS was 5.7 months (95%CI: 1.07-10.30). Treatment emergent adverse events (TEAEs) were mostly mild (grade 1-2), and the most common were hypertension (80%), proteinuria (73%), hypertriglyceridemia (53%), diarrhea (47%) and hyperbilirubinemia (47%). Grade 3-4 TEAEs were recorded in 4 pts including hypertension, proteinuria, hypertriglyceridemia and hypermagnesemia. Conclusions: Surufatinib is well tolerated and have some clinical activity in advanced osteosarcoma and STS who failed standard chemotherapy. Enrollment is ongoing and updated data will be presented in the future. Clinical trial information: NCT05106777 .
A phase ll study on the neoadjuvant treatment of resectable high-risk soft tissue sarcoma with anlotinib and doxorubicin.
Authors: Weitao Yao , Wang Jiaqiang , Zhang Peng , Wang Xin , Liu Zhiyong , Du Xinhui , Wang Bangmin , Li Zhehuang , Liu Guancong
Published: June 2023

e23542

Background: Anthracycline and ifosfomide-based chemotherapy is the main neoadjuvant treatment option for resectable high-risk STS with severe myelosuppression and other side effects. Anlotinib has been approved as second-line treatment for most of advanced STS by the Chinese agency. This study was conducted to evaluate the efficacy and safety of anlotinib in combination with doxorubicin in the neoadjuvant treatment of patients with resectable high-risk STS to reduce the toxicity of chemotherapy. Methods: This is a single-center, prospective study. Eligible patients were those ≥18years old, ECOG performance state of 0-1, with histologically conﬁrmed locally resectable high-risk STS. All patients received a preoperative combination of anlotinib (12mg once daily, on for 2 weeks, off for 1 week) and doxorubicin (75mg /m2, IV, D1-2, every 3 weeks) .The combination treatment was repeated 2 to 3 cycles before operation. The primary endpoint was objective response rate (ORR), and the second endpoints were Disease control rate (DCR), and side eﬀects. Results: Between December 2020 and December 2022, 13 patients were evaluated, including 4 synovial sarcoma, 3 undifferentiated sarcoma, 3 spindle cell sarcoma, 2 liposarcoma, 1 angiosarcoma. The median age was 35 years. 1 patients (7.69%) achieved a conﬁrmed partial response (PR) and 7 (53.85%) had stable disease (SD). The ORR and DCR were 7.69% and 61.54% respectively. All patients underwent marginal or extensive excision of the tumor and none underwent amputation. Most of Treatment-related adverse events included neutropenia 5 (38.46%), hypothyroidism 3 (23.08%), anemia 2(15.38%). Three patients experienced grade 3 or 4 adverse events, neutropenia (1/13, 7.69%) and tumor hemorrhage (2/13, 15.38%). No wound complications such as infection, delayed healing or haematoma occurred. Conclusions: This study suggested that the combination of anlotinib and doxorubicin might be a option for neoadjuvant therapy for patients with resectable high-risk STS due to the anti-tumor activity and acceptable toxicity.
Demographic analysis of diagnostic patterns in head and neck fibromyxosarcoma.
Authors: Wang Harvey , Hsia Beau , Wu Xinxin , Sinai Erin , Silberstein Peter T. , Keirns Darby
Published: June 2023

e23546

Background: Fibromyxosarcoma (MFS) is a rare form of cancer that originates in connective tissue, starting in the arms and legs, but spreads into healthy tissues elsewhere in the body. 42% of MFS patients succumb to the disease within 5 years of diagnosis, with most cases being fatal in less than 2 years post-diagnosis. Due to the scarcity of literature regarding MFS, with no prior otolaryngological study on MFS, the diagnostic trend of the disease can assist in understanding its epidemiology. To determine diagnostic patterns, demographic factors of head and neck MFS patients in the National Cancer Database (NCDB) were analyzed. Methods: Using the National Cancer Database (NCDB) data from 2004 – 2020, a retrospective analysis was performed that included patients with a histologically-confirmed MFS diagnosis in the head and neck (N = 67). Descriptive statistics were used to analyze demographic factors: age, sex, race, social status, number of surgical procedures, facility type, insurance status, Charleson-Deyo score, and type of palliative care received. Regression analysis was used to interpret incidence trends. Results: 67 total patients were identified in NCDB with head and neck MFS between 2004 – 2020 with a steady amount of diagnoses per year (R2 = 0.093). The top primary site was the maxillary sinuses (22.4%). The average age of diagnosis was 54.1 years (SD = 18.0, range = 10 – 90 years). MFS was more present in males (59.7%) than females (40.3%). The majority of the patients were non-Hispanic White (82.1%). More patients lived in counties of metropolitan areas of a population of 1 million or more (55.2%) than in other urban/rural areas (13.5%). 82.1% of patients underwent surgical procedures at the primary site, with 28.4% being through a primary incision in the nose. More patients were treated in an academic/research program (52.2%) than in a non-academic program (28.4%). Most of the patients were privately insured (59.7%). More patients had a median income in the top quartile (44.8%) compared to patients in the second, third, or fourth quartiles. Most individuals had a Charlson-Deyo score of 0 (82.1%). The majority of the patients did not receive palliative care (97.0%). Conclusions: This is the first analysis of otolaryngological MFS using the NCDB, which expands our knowledge on the sociodemographic factors associated with its diagnosis. From all the years analyzed, MFS remains a rare disease. The majority of patients diagnosed with MFS tend to be non-Hispanic, White males with the primary site in the maxillary sinus. MFS patients are mostly treated in academic/research programs and live in densely-populated areas. This analysis provides an initial overview of the impact of demographic factors in patients with MFS, but examination into the impact of these variables on the prognosis and outcome of MFS patients would be valuable in understanding the social inequity surrounding this malignancy.
Income level as a prognostic factor in non-dedifferentiated liposarcoma.
Authors: Bine Christopher Reese , Braaten Marco , Nielsen Eric , Czaplicki Alec , Silberstein Peter T.
Published: June 2023

e23558

Background: Liposarcoma is the most common soft tissue sarcoma and primarily arises in subcutaneous fat of the lower extremities. Previous research has shown socioeconomic factors (eg. Income, insurance status, facility type) to be strongly associated with patterns of care as well as overall survival in bone and soft tissue sarcoma patients. Using the NCDB, this study analyzed the association between income and survival in patients with non-dedifferentiated liposarcoma. Methods: The National Cancer Database (NCDB) was used to identify patients diagnosed with Liposarcoma from 2004 to 2019 using the histology codes 8850, 8851, 8852, 8853, 8855, and 8857 as assigned by the Commission on Cancer Accreditation program. Kaplan-Meier, ANOVA Chi-Square, and Cox Proportional Hazards tests were performed. Data was analyzed using SPSS version 27 and statistical significance was set at α = 0.05. Results: Of 4631 patients included in the sample, 1508 (32.5%) were from the highest income ( > $46,000) bracket. High-income patients experienced longer mean overall survival (149 months) compared to middle (136.5 months) and low (130 months) income patients (p < 0.001). After controlling for age, tumor size, stage, and surgery of primary site, low-income patients experienced higher hazard ratios relative to the middle- and high-income groups (HR1.56; p < 0.001). On presentation, higher income patients had less co-morbidities, and tumors which were less aggressive (grade) and advanced (NCDB stage & metastasis) (p < 0.001). Furthermore, they were more likely to undergo surgery (90.3%) and had the shortest interval between diagnosis and definitive surgical procedure (p < 0.001). No differences were seen in surgical margins, palliative care, tumor size, or radiation dose. Conclusions: This study found that high-income patients with non-dedifferentiated liposarcoma experience improved overall survival and expedited surgery compared to middle- and low-income groups. Further research could elucidate the true cause of this disparity.
Evaluating embedded geriatric care in gastrointestinal (GI) oncology program for older adults (OA): Feasibility and key learnings.
Authors: McCleary Nadine Jackson , Hshieh Tammy , Weitzner Rachel , Rostamnjad Leila , Brais Lauren K. , Horick Nora K. , Gray Tamryn , Wang Jiping , Meyerhardt Jeffrey A
Published: June 2023

e24015

Background: Older adults with GI cancers experience frequent interruptions to life-improving care due to emergency department (ED) or unplanned hospital visits (UHV), with estimates ranging from 34-84% for advanced disease. Geriatric assessment can predict survival, toxicity, and completion of planned therapy but has been considered cumbersome for use in oncology practice. Geriatric co-management is now standard within certain primary care and subspecialty practices at the Brigham and Women’s Hospital (BWH), and has resulted in reduced mortality at 1-year, lower incidence of delirium, and improved provider/patient satisfaction. The REACH study (Resilience and Equity in Aging, Cancer, and Health) is a type III hybrid implementation mixed methods study that evaluates the ability of geriatric consultation to improve quality of life and reduce ED/UHV for pre-frail and frail OA diagnosed with GI cancer. Methods: We reviewed early data from the REACH study based in the Gastrointestinal Cancer Center at Dana-Farber Cancer Institute (DFCI) between Jan. 2022–Jan. 2023. Data included REACH-eligible patients scheduled for a new consult visit, OA patients continuing care at DFCI, percentage of patients consented to participate, and percentage of consented patients who completed the frailty questionnaire (EFA). Results: As of 1/31/2023, a total of 815 OA patients age 70+ were screened initially eligible. Consented patients completed the REACH EFA. Among the 815 patients initially eligible, 73.8% of OA patients aged 70-74 continued care at DFCI, along with 74.7% of patients age 75-79, and 73.5% of patients age 80-84. For patients 85 or older, 82.7% of patients continued their oncology care at DFCI. Patients who screened ineligible or declined to participate were due to either not continuing care at DFCI, preferred language other than English/Spanish, or initiating hospice care. From Jan. 2022 to Jan. 2023, n = 30 consented to participate with a 90% completion rate of the full EFA questionnaire (n = 27/30). Conclusions: Data for the REACH study is ongoing. We are now transitioning to a clinical program where consent is no longer needed to complete the REACH EFA questionnaire. DFCI has pivoted to EFA questionnaire being standard of care for OA patients due to its acceptability and importance. Future program efforts will improve patient language access and expand to additional DFCI regional sites around New England to ensure a more diverse population and provide tailored support for those patients who have a higher level of frailty and more complex needs throughout their cancer care journey. Clinical trial information: NCT04674267 .
A retrospective single-centre analysis of the prevalence of statin use in geriatric oncology: Is there a role for cessation?
Authors: O'Sullivan Darragh Thomas , Horgan Anne , Clarke Rachel , Ronan Karine , Cronin Chris , Besalaar Zelmarie
Published: June 2023

e24016

Background: Statins have become ubiquitous in medicine. There is a myriad of indications, and the duration of treatment required for efficacy is measured in years. There is a need for clarity on their role in geriatric oncology and when to de-prescribe. Within a sample of Irish patients in 1987, 8% would have been eligible for a statin. By 2016, this had climbed to 61%. During this time, the number needed to treat increased from 40 to 400. In terms of benefit, a meta-analysis concluded that 100 patients need treatment for 2.5 years to prevent one major adverse cardiovascular event (MACE) in the primary preventative setting. It is not clear whether this benefit is derived in later life. As a result, the United States preventive service task force concluded that evidence is insufficient to recommend initiating a statin for primary prevention in adults over 75. The aim of our study was to assess the prevalence of statin use in older adults with cancer, and the evidence for de-prescribing. Methods: Data was retrospectively collected from a prospectively maintained database of patients attending the Geriatric Oncology Assessment and Liaision (GOAL) clinic in the South East Cancer Centre, University Hospital Waterford, Ireland. Data collected includes age at cancer diagnosis, stage, co-morbidities, and medications. We determined how many patients were taking statins (or ezetimibe) prior to first oncology review, their indication and overall survival. Indications for statins were categorised using a hierarchy of indications, as described by Wallach Kildemoes et al. Results: 138 of 233 patients were taking statins at the time of their review (59%). The average age at cancer diagnosis was 78.6 years. Seventy-nine were taking statins for primary prevention (58%). 15 of 79 whom had diabetes. Stage 3 or 4 disease accounted for 78% of this group. Overall survival in this group was 1.59 years. Within the group with stage 4 disease (n = 100), 53 were taking a statin. Twenty-eight (52.8%) were for primary prevention. Within this group, 6 had diabetes. Overall survival in this group was 1.44 years. Conclusions: Overall survival of patients was short of the 2.5 years required to provide benefit. Therefore, there is evidence to stop this medication in the primary preventative group, once diagnosed with advanced cancer. The stage 4 disease group included patients undergoing secondary prevention, so treatment is more efficacious. However, with an overall survival of 1.44 years, the window for benefit is small.[Table: see text]
Feasibility of integrating geriatric oncology and palliative care assessment into the routine care of older adults in a community setting.
Authors: Sedhom Ramy , Goldman Noah A. , Celaya Kerri , Mastro Kari A , Ortiz Paul , Dougherty David W.
Published: June 2023

e24024

Background: Emerging data support the value of geriatric assessment (GA) and palliative care (PC) domains in determining treatment for older adults with cancer. Limited data exist on the ability to integrate GA and PC in a community oncology clinic. The objective of this study was to determine the feasibility of integrating GA and PC screening in the community. Methods: Patients ≥ 75 were eligible. The GA included a health care provider assessment of performance status, cognitive function, functional status, psychological state, social support, and nutritional status. PC assessment included ESAS questionnaire, patient goals and values, advance care plans, and caregiver distress. Results: From September 2021 to Jan 2023, 131 consecutive older adults were assessed in one community clinic in the State of New Jersey, a satellite of the University of Pennsylvania. The median age was 82 (range 75-97). Using the VES-13 survey, 11% of patients were fit, 60% vulnerable and 29% frail. Issues were noted in cognition (11%), psychological state (27%), social support (38%), and nutrition (26%). The majority of patients prioritized quality of life over time (73%) and maintenance of independence was often cited as the most important goal (62%). Fewer than half of patients had formal advance directives (42%). 32% of the time, the final plan deviated from standard of care to align with patient/caregiver values. Conclusions: Integration of GA and PC is feasible in the community oncology setting. Further study is planned to evaluate the impact on patient and caregiver outcomes, and to standardize assessment for routine care across all Penn Medicine clinics.
Comparison of glomerular filtration rate estimating equations in Indian geriatric patients with cancer.
Authors: Gota Vikram , Gandhi Khushboo A , Castelino Renita , Kumar Sharath , Chavan Ashish , Shirsat Aditi , Rao Abhijith Rajaram , Gattani Shreya , Kumar Anita , Pillai Anupa , Sehgal Arshiya , Ramaswamy Anant , Dhekale Ratan , Krishnamurthy Jyoti , Banavali Shripad Dinanath , Badwe Rajendra A. , Prabhash Kumar , Noronha Vanita
Published: June 2023

e24025

Background: Accurate estimation of glomerular filtration rate (eGFR) is essential for dose calculation of certain anticancer drugs. It is particularly important in older cancer patients because of age-related compromise in renal function. 99mTc-DTPA plasma clearance for GFR measurement poses practical difficulties in the elderly and is expensive. Therefore, we investigated the predictive accuracy of eight commonly used eGFR equations against 99mTc-DTPA plasma clearance as the gold standard in Indian geriatric oncology population. Methods: A cross-sectional study was conducted in the geriatric oncology clinic of Tata Memorial Hospital, India, from June 2021 to November 2022. Age, sex, weight, BUN and serum creatinine were obtained from the hospital records. Serum cystatin C was estimated using sandwich ELISA (Sigma, Germany). GFR was estimated using Cockcroft-Gault (CG); 6 variable MDRD; 4 variable MDRD; CKD-EPI creatinine; CKD-EPI cystatin; CKD-EPI creatinine-cystatin; BIS 1; and BIS 2 equations. GFR was also measured by 99mTc-DTPA plasma technique (Gates’ method). The agreement between different eGFR methods and the measured GFR was analyzed using Bland-Altman test. Results: Out of 311 enrolled patients, 276 patients having full covariate data required for estimation of eGFR by all eight equations were included in the analysis. Majority were males (N = 214). Median age (range) of the patients was 68 (60 – 88) years. Median of measured GFR using 99mTc-DTPA was 71 (17 – 141) ml/min. The performance i.e., bias and 95% Limit of Agreement (LoA) of eGFR equations against measured GFR is shown in table 1. Overall, the BIS 2 equation with least bias of 0.854 and narrowest 95% LoA (-31.23 to 32.94) had the highest agreement with ‘gold standard’. In fact, BIS 2 performed consistently well across age (60-70, 71-80, 81-90) and BMI (≤18.5, 18.6-24.9, ≥25) groups (data not shown). BIS 2 was followed by CKD-EPIcr-cys and CKD-EPIcys with best estimates of bias and 95% LoA (Table 1). Interestingly, all three equations have cystatin C as a covariate. 4vMDRD had the highest bias (-24.08) and least agreement with DTPA (-86.52 – 38.36). Post hoc analysis showed that 59/115 (51.3%) patients who were cisplatin-ineligible (GFR < 60) based on CG were cisplatin-eligible based on BIS 2, while 19/161 (11.8%) patients who were cisplatin-eligible based on CG were actually ineligible as per BIS 2. Conclusions: Equations derived using cystatin C in general, and BIS 2 in particular, have highest predictive accuracy for GFR estimation in older cancer patients. [Table: see text]