bluuebunny/crossref_metadata_2025_split huggingface dataset:
A phase II study of anlotinib in the first-line treatment of locally advanced or metastatic soft-tissue sarcoma: Updated results.
Authors: Li Tao , Ye Zhaoming , Wei Yongzhong , Wang Shoufeng , Liu Yunxia , Chen Jia 
Published: June 2022

e23559 Background: Standard treatment for patients with unresectable locally advanced or metastatic soft-tissue sarcoma is chemotherapy based on anthracyclines, while the tolerance of chemotherapy is limited. Anlotinib had demonstrated promising efficacy and favorable tolerance in the first-line treatment of these patients in the previously report ( 2021 ASCO). We updated the latest long-term efficacy and safety data. Methods: This multicenter, open-label, single-arm, phase II clinical trial (NCT03792542) was done at 7 hospitals in China. Patients diagnosed with locally advanced or metastatic soft-tissue sarcoma who had evaluable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 were eligible for inclusion. Additional inclusion criteria were 1) 18-70 years old, 2) ECOG PS 0-2, 3) chemotherapy intolerance judged by investigators, 4) chemotherapy and anti-angiogenesis treatment naïve. All patients received 12mg anlotinib once daily for 14 days every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Safety assessment was done in patients who received at least one dose of anlotinib. Results: 39 patients (24 males and 15 females) were enrolled between April 2019 to October 2021with a median follow-up 13.4 months (IQR 6.55-19.40), and the median age is 58 (range 23-69) years old. Pathological types included liposarcoma (n = 11), fibrosarcoma (n = 8), undifferentiated pleomorphic sarcoma (n = 5), leiomyosarcoma (n = 4), synovial sarcoma (n = 4), malignant peripheral nerve sheath tumor (n = 4), and others (n = 3). At the data cutoff date on December 27, 2021, the median PFS and median overall survival (OS) were 7.1 months [95%CI 5.42-8.77], 24.3 months [95%CI 14.9-33.7], respectively. The PFS at 6 months was 60.0%, and the OS at 12 months was 76.6%. 37 patients were eligible for the evaluation of tumor response.1 achieved confirmed partial response (PR) and the objective response rate (ORR) was 2.7% (1/37). 30 had stale disease (SD) and the disease control rate (DCR) was 83.8% (31/37). The incidence of adverse events of grade 3 was 33.3%, with a higher incidence of hypertension (12.8%), proteinuria (7.7%) and fatigue (5.1%). Conclusions: Anlotinib has shown encouraging anti-tumor activity and well tolerance in the first-line treatment of locally advanced or metastatic soft-tissue sarcoma who were not suitable for chemotherapy. Clinical trial information: NCT03792542.
Clinical benefit of imatinib in patients with relapsed tenosynovial giant cell tumor/pigmented villonodular synovitis (TGCT/PVNS).
Authors: Yu Jeanette Cu , Sidhu Manpreet Kaur , Fang Andrew , Morse Lee Jae , Pan Minggui 
Published: June 2022

e23561 Background: TGCT/PVNS is an uncommon benign but locally aggressive tumor that affects joints and can lead to significant morbidity. It is characterized in most cases by a t(1;2) translocation that leads to overexpression of colony-stimulating factor 1 (CSF-1) and the accumulation of inflammatory cells that express CSF-1 receptor (CSF-1R) in the affected joints. Imatinib inhibits the tyrosine kinase activity of CSF-1R. Methods: We retrospectively reviewed patients with TGCT/PVNS who received treatment with imatinib within Kaiser Permanente Northern California. Results: Nine patients with relapsed TGCT/PVNS were treated with imatinib from 2019 to 2022. Median age was 43 years. 6 patients were female. The imatinib dose was 400 mg daily. All patients had been treated with surgery previously and relapsed, and further surgery was considered not to be beneficial. All patients presented with persistent joint pain that affected joint mobility and walking. After imatinib therapy was initiated, 7 patients (78%) reported significant improvement in their symptoms, while 2 patients (22%) reported no significant changes. Improvement in symptoms occurred soon after starting therapy, ranging from 3 days to 5 weeks. 8 patients (89%) had stable disease by RECIST criteria based on MRI, and 1 patient was not evaluable. 5 patients are still receiving imatinib currently. The longest treatment duration is 27 months. 4 patients required a dose reduction secondary to toxicity, and 3 patients discontinued therapy (2 patients with G3/4 hepatotoxicity and 1 patient self-discontinued treatment). 2 patients who discontinued imatinib continue to experience resolution of joint pain and other symptoms 10 and 24 months later respectively. Conclusions: Our study shows that treatment with imatinib can result in rapid and lasting symptomatic improvement in patients with relapsed TGCT/PVNS, even after treatment discontinuation. This suggests that imatinib can be an effective and safe treatment option for patients with relapsed TGCT/PVNS refractory or not amenable to further surgery.
Evaluation of formulation-associated ifosfamide neurotoxicity.
Authors: Abernathy Karin , McCabe Colleen , Perciavalle Matthew , Cortez Manuel , Miller Ryan , Yelvington Bradley , Keedy Vicki Leigh , Davis Elizabeth J. 
Published: June 2022

e23562 Background: Ifosfamide, an alkylating agent used commonly in both hematologic and solid tumor malignancies, carries a notable risk for neurotoxicity/encephalopathy. Ifosfamide is available as both a reconstituted powder formulation and a solution for injection. Literature has shown that there may be higher rates of ifosfamide neurotoxicity/encephalopathy (INT/E) with the solution compared to the reconstituted powder. The primary objective of this study was to compare the rates of neurotoxicity/encephalopathy in association with the two available pharmaceutical formulations of ifosfamide. Methods: We performed a retrospective study of adult patients receiving at least one dose of either available pharmaceutical formulation of ifosfamide. The primary outcome was the incidence of formulation-associated INT/E. Secondary outcomes included additional risk factors for development of INT/E. Results: Of 218 patients evaluated, 212 were included in the study with 56 patients receiving the reconstituted powder formulation and 156 patients receiving the solution for injection formulation of ifosfamide. Baseline characteristics were similar between the two groups, including dose of ifosfamide received, use of INT/E prophylaxis, and renal and hepatic function. INT/E occurred in 4 patients (7.1%) receiving the reconstituted powder formulation vs 32 patients (20.5%) receiving the solution for injection (p = 0.022) Evaluation and analysis of additional risk factors for development of INT/E are ongoing, including the impact of baseline demographics, ifosfamide dosing, renal and hepatic function, and concomitant medications. Conclusions: In this study, hematology/oncology patients who were treated with ifosfamide had significantly lower rates of INT/E with the reconstituted powder formulation compared to the solution for injection. Further analysis regarding additional risk factors for INT/E development is ongoing.[Table: see text]
Long-term efficacy and safety of anlotinib in advanced sarcomas.
Authors: Yao Weitao , Du Xinhui , Wang Jiaqiang , Zhang Peng , Niu Xiaohui , Wang Xin 
Published: June 2022

e23564 Background: Treatment of sarcomas has advanced in recent years partly because of the application of multitarget tyrosine kinase inhibitor (TKI) drugs. Anlotinib is an oral TKI with the dual effects of antiproliferation and antiangiogenesis, and it has a therapeutic effect with good tolerance and low side effects. In theory, physicians can gain long-term tumor control with anlotinib in certain advanced sarcomas. Methods: We conducted a retrospective analysis of patients with advanced sarcomas with measurable target lesions who had been treated in our ward since 2018. There were 22 patients who had taken anlotinib regularly for more than 12 months. Their general information, clinical efficacy, and toxicities were statistically analyzed. We used a swimmer plot to observe the efficacy and duration of the drugs and a waterfall plot to express the best treatment effect. Results: There were 14 male and 8 female patients, ranging in age from 14 to 75 (44.77 on average) years. The primary sarcomas were ASPS in five cases; synovial sarcoma (SS) in four cases; LMS in three cases; epithelioid sarcoma (ES) and UPS in two cases each; and clear cell sarcoma, RMS, angiosarcoma (AS), fibrosarcoma (FS), pleomorphic liposarcoma (LS), and osteosarcoma (OS) in one case each. The sites of metastasis were the lung in 15 cases, lymph nodes in 4 cases, and multiple sites in 3 cases. Therapies were as follows: first-line therapy (6 cases), second-line therapy (9 cases), third-line therapy (5 cases), and more than third-line therapy (2 cases). The current therapy protocols were nine cases with oral anlotinib alone, nine cases with combination chemotherapy, and four cases with combination immunotherapy (anti-PD1). The best clinical efficacy of this group was complete response (CR) in four cases (18.18%), partial response (PR) in five cases (22.73%), and stable disease in 13 cases (59.09%), with an overall response rate of 40.91% and the longest lasting time of 26, 16, 38 months in different response groups. The mean of progression-free survival (PFS) was 23.32 months. The main adverse effects included myelosuppression in seven cases (31.82%), hypertension in three cases (13.64%), and hand-foot syndrome and weakness in two cases (9.10%). Severe adverse effects included hypothyroidism with weakness in one case and wound ulceration with pneumothorax formation in another case. Conclusions: Anlotinib monotherapy or combination therapy can be an effective and safe choice for some advanced sarcomas with a longer maintenance time and acceptable side effects. Besides, anlotinib combined with anti-PD1 therapy has better therapeutic efficacy for specific diseases such as ASPS and ES. Anlotinib combined with chemotherapy has therapeutic efficacy for SS, LMS, FS, and RMS. Clinical efficacy such as CR and PR may be a prediction of long-term PFS in some advanced sarcomas.
Prospective comparison between provider’s assessment and geriatric assessment among older adults with gastroesophageal cancer.
Authors: Connors Meghan , Handorf Elizabeth A. , Meeker Caitlin R. , Filchner Kelly A. , Vijayvergia Namrata , Dotan Efrat 
Published: June 2022

e24013 Background: Geriatric Assessment (GA) can help oncologists determine fitness of their older patients for cancer therapy. Our objective was to identify gaps that exist in the care of older adults with gastroesophageal cancer (GEC). Methods: Patients age 65 or older with any stage of GEC were consented and completed a self-administered GA. The patient’s provider completed a baseline assessment (PA) and abnormalities detected by both assessments were centrally reviewed and compared. Geriatric domains assessed include functional status, nutrition, comorbidities, psychological distress, cognition, social support, chemotherapy toxicity risk, and financial toxicity. Any abnormalities found within an evaluated domain were considered in the analysis. Providers reviewed patient GA alongside indicated interventions and identified those they would implement. We compared the proportions detected/not detected by PA vs GA using McNemar’s test for paired data, and we measured agreement using Kappa statistics. This is an interim report of an ongoing trial with total accrual goal of 100 older adults with GEC. Results: 33 patients were enrolled at the time of the interim analysis, majority were male (22, 67%), median age 74 (65-91), with stage III (9, 50%) disease treated with combination chemotherapy (12, 36%). Cancer site was distributed between gastric (45%), esophageal (36%), GEJ (18%). 90% of patients had ECOG status 0 or 1. GA detected 164 abnormalities in geriatric domains, mean 5 per patient, and PA detected 104 abnormalities, mean 3 per patient (see Table). Significant difference in abnormality identification between GA and PA were seen in domains of nutrition, chemotherapy toxicity risk, financial toxicity and psychological distress. 37% of patients had abnormal TUG score and those patients were more likely to have other geriatric abnormalities detected by GA (6.2 vs 4.4). Providers for 28 patients (85%) indicated they would make at least one change, with the majority being referral to social work. Conclusions: Among older adults with gastroesophageal cancer, GA identifies more abnormalities as compared to routine provider’s assessment in most cases leading to important clinical interventions.[Table: see text]
The association between perioperative frailty and ability to complete a web-based geriatric assessment in older adults with cancer.
Authors: Cuadra Andrea , Tin Amy L. , Shahrokni Armin 
Published: June 2022

e24022 Background: With expansion of web-based geriatric assessment (GA), the aim of our study is to assess whether patients’ independency and time to complete electronic Rapid Fitness Assessment (eRFA), a web-based GA at our institution, is associated with frailty. Methods: Retrospective study of 3456 patients with cancer who underwent cancer surgery in 2015-2020 with hospital length of stay of 1+ days and completed the eRFA prior to surgery. Frailty was assessed by two methods: Memorial Sloan Kettering Frailty Index (MSK-FI, score 0-11) and accumulative geriatric deficits (AGD, score 0-13). In both measures, higher score is reflective of higher degree of frailty. Patient’s independency to complete the eRFA was self-reported (no help, some help, someone else). Time to complete the eRFA was captured by the system based on survey start time and submission time. Association between characteristics and patient’s independency to complete the eRFA were assessed using Kruskal Wallis test for continuous variable and Chi-square test for categorical variables. Analysis into time to complete the eRFA excluded surveys completed by someone else (n = 407), those completed in < 2 min (n = 1) or > 40 min (n = 82). Association between time to complete the eRFA and frailty was assessed using two separate linear regression models with frailty—MSK-FI and AGD, separately—as the outcome, and minutes to complete the eRFA as the predictor, in surveys completed with no help and some help, separately. Time to complete the eRFA was included in the model as a non-linear term with restricted cubic splines with knots at the tertiles. Results: Among our cohort, the median age at the time of survey completion was 78 (quartiles 75, 82), just under half (49%) of patients were male. Survey completion corresponded to 58% with no help, 30% with some help, and 12% by someone else. Independency in completing the eRFA was associated with younger age (median ages: no help 77, some help 80, someone else 80), and lower frailty (median AGD: no help 4, some help 6, someone else 8; median MSK-FI: no help 2, some help 3, someone else 3) (all p < 0.001). Longer time to complete the eRFA was associated with higher degree of frailty measured by MSK-FI and AGD (all non-linear association p < 0.001). For example, for surveys completed with no help in 5, 10, and 15 minutes, the estimated MSK-FI is 1.4 (95% CI 1.3, 1.6); 2.3 (95% CI 2.2, 2.4); and 2.3 (95% CI 2.1, 2.6), and the estimated AGD is 3.1 (95% CI 2.9, 3.3); 5.1 (95% CI 4.9, 5.4), and 5.1 (95% CI 4.7, 5.5). Conclusions: Patients who needed assistance or took a longer time to complete the assessment were more likely to have a higher degree of frailty. To avoid burdening the hospital, placing undue stress on patients, and possibly inaccurate responses, we should test solutions that may enhance the ability of frail patients to complete the eRFA faster and without assistance from others, such as by using voice assistants.
Factors associated to hospitalizations in older cancer patients treated with chemotherapy.
Authors: Bordignon Claudia , Rosa Daniela Dornelles 
Published: June 2022

e24025 Background: Chemotherapy toxicity (CT) is higher in elderly cancer patients, mainly due to fragilities identified in this subgroup. Hospitalization can be an adverse outcome of cancer treatment, which is disruptive in older patients, leading to worse functional status and cognitive disfunction, as well as increased costs for the health system. We evaluated patients treated with chemotherapy to identify hospitalizations related to oncological treatment and factors associated with this outcome. Methods: A retrospective study was conducted in a Brazilian Oncology Center. Patients ≥65 years old who started chemotherapy for solid tumors as curative or first-line therapy in 2019 were included and data was collected of the entire treatment until suspension or change in therapy (because of progression, completion, toxicity, or death). Those treated concomitantly with immunotherapy and radiotherapy were excluded. Characteristics of patients and their treatments were analyzed as risk factors for hospitalization through univariate analysis (UVA) with Fisher’s Exact Test and Mann-Whitney Test, and those variables considered significant (p < 0.05) were submitted to a multivariate analysis (MVA) with Logistic Regression. Results: We included 124 patients with a median of 70 (65-93) years old and a median of 6 (1-26) cycles of chemotherapy completed. There were 67% of women, 42.8% had Charlson Comorbidity Index (CCI) ≥1; polypharmacy (≥5 medications) was present in 38.7%; the main cancer treated were gastrointestinal (34.7%), breast (21%) and pancreas/biliary tract (20.2%). Most patients had metastatic disease (54%) and received polychemotherapy (80.6%) as primary treatment ;body index measure was ≥25 in 50.8% and 24.2% lost 5% or more of body weight during the time analyzed. Unplanned hospitalizations occurred in 40 patients and 25 were considered associated with CT (febrile neutropenia, infections, gastrointestinal adverse events, worse renal function). In UVA, age, pancreas/ biliary tract cancers, CCI≥1 and polypharmacy were factors associated to hospitalization due to CT. After MVA, only CCI≥1 (OR 3.23, CI95%1.12 – 10.05) continued as an independent factor associated to CT. Conclusions: Evaluation of comorbidities with CCI can identify older patients at higher risk of hospitalization due to toxicity during treatment with chemotherapy. Comprehensive geriatric assessment should be offered to high-risk patients in order to develop strategies to prevent this adverse outcome.
More than just “vaginal dryness”: Addressing an unmet need for sexual health intervention in female cancer survivors.
Authors: Pon Fay , Satish Sanjana , Penedo Frank J. , Rojas Kristin E. 
Published: June 2022

e24050 Background: Female sexual dysfunction (FSD) in cancer survivors is underreported and therefore undertreated. This study aims to describe the population of female cancer survivors seeking treatment for sexual dysfunction through a novel sexual health after cancer program. Methods: We conducted a retrospective analysis to characterize patients presenting to the MUSIC (Menopause, Urogenital, Sexual Health and Intimacy Clinic) Program at a NCI-designated cancer center in South Florida. Patients received a baseline Female Sexual Function Index (FSFI) and underwent a physical, including abdominopelvic, exam. The FSFI is a 19-item survey previously validated for use in female cancer survivors. Severity of dysfunction (by presenting symptom, physical exam, and FSFI) was correlated to demographic and cancer characteristics. Sexual dysfunction was defined as ≤26.55. Results: Between 2020-2021, 104 female cis-gender women with a median age of 46 (range 19-75) at diagnosis were seen. 56% identified as Hispanic/Latinx. Most were treated for breast (80%) or gynecologic (10%) cancer. Common presenting symptoms included vaginal dryness (55%), painful sex (45%), low desire (36%) and hot flashes (22%). Patients who disclosed details about pain (n = 62) reported penetration was possible but uncomfortable (16%), possible but painful (66%) or impossible due to pain (18%). Those who disclosed changes with orgasm (n = 43) reported it was more difficult (26%), or impossible (23%). Of those completing the FSFI (n = 66), median Desire Domain score was 1.2 (IQR 1.2-2.4), and median Total Score was 8.1 (IQR 2.9-16.4), with 97% of patients meeting criteria for FSD (Table). Conclusions: The present study highlights a continued unmet need to address severe sexual health concerns in the growing female cancer survivor population. Future work will describe treatment strategies employed and their effectiveness at symptom resolution and quality-of-life improvement.[Table: see text]
A cross sectional study on female sexual function following pelvic radiotherapy.
Authors: Joseph Deepa , Singh Pragya , Abraham Bruzily , Nair Sharanya , Gupta Manoj Kumar 
Published: June 2022

e24051 Background: Pelvic radiotherapy (PRT) is an integral part of treatment in many pelvic cancers. PRT is associated with multiple organic changes in the genital area that have the potential to negatively impact female sexuality and quality of life. Fear of cancer transmission and stigma associated can result in lack of sexual activity and many women get abandoned by their partners. Often this topic is neglected and limited studies are available assessing female sexual function (FSF) especially from Indian subcontinent. This study was an attempt to assess the FSF in patients who had received PRT as part of their curative treatment for pelvic malignancy. Methods: This was an observational cross-sectional study conducted in January 2022. Study included female patients who received RT for pelvic malignancy. Patients with a minimum of 6 months follow up after RT with clinical complete response, sexually active before start of treatment & living with their partners at time of study were included. Demographic profile was collected from treatment records. Socioeconomic status calculated using updated B J Prasad’s scale. Female Sexual Function Index (FSFI) questionnaire was used with score ≤ 26 indicating female sexual dysfunction (FSD). Questionnaire was filled by patients under supervision of a trained staff. 6 domains of sexual function i.e. desire, arousal, lubrication, orgasm satisfaction & pain were studied. Patients reporting zero score in any of the domain indicating no sexual activity in the last 4 weeks were also included. Results: 38 eligible patients with age range from 34-69 years, mean age 51 years, 37% patients were > 60 years. All were house wives, 40% illiterate, 50% high school & below, 10% were above high school. 70% were from rural area. 13% belonged to upper class, 35% upper middle & middle class, 52% to lower middle and lower class. Commonest diagnosis was carcinoma cervix (86%) followed by endometrium (10%) & anorectum (4%). All patients with carcinoma cervix received radical chemoRT. Patients with Ca Endometrium were postoperative. 92% of all patients received pelvic EBRT & 3% only vault brachytherapy. The mean duration from completion of RT was 17 months (range 6 – 41 months). FSD was found in 89%. Age wise mean scores in six domains of FSFI & overall score is illustrated in the table. 0 score in at least one of the domain was reported by 65% patients. Conclusions: Study showed a very high incidence of FSD among pelvic cancer survivors after RT. Since there are limited data in this domain from Indian patients, this can become baseline data for further studies. Our data is limited by lack of comparison of FSD from age adjusted healthy females of this region.[Table: see text]