bluuebunny/crossref_metadata_2025_split huggingface dataset:
ARST1321: Pazopanib neoadjuvant trial in non-rhabdomysarcoma soft tissue sarcomas: A report of major wound complications.
Authors: Scharschmidt Thomas , Chen Yen-Lin , Wang Dian , Chi Yueh-Yun , Kayton Mark , Sorger Joel , Randall R. Lor , Hawkins Douglas S. , Weiss Aaron R. 
Published: March 2020

11059 Background: The care of soft tissue sarcomas is complex and multidisciplinary in nature. Even without radiation or chemotherapy wound complications are common after surgical resection with a reported incidence of 6-42%. Wound complication rates with the use of neoadjuvant chemoradiation for high-grade soft tissue sarcomas has been reported and supported in the literature to be approximately 30%. Relevant to this study, a trial evaluating the use of a VEGF receptor inhibitor (bevacizumab) in combination with radiation pre-operatively in soft tissue sarcomas reported a wound complication rate of 25%. ARST 1321 is a phase II/III study evaluating the tyrosine kinase inhibitor Pazopanib +/- chemotherapy and radiation in select high-grade soft tissue sarcomas. The dose-finding phase has been completed and the objective of this report is to detail the major wound complications observed with this protocol. Methods: Patient enrolled on all arms of the study (Pre-operative radiation, +/- pazopanib, +/- doxorubicin and ifosphamide) were evaluated for wound complications (Grade I/II and Grade III). Patient demographics, tumor characteristics, and complication details were compiled and analyzed. Results: There were a total of 130 evaluable patients (100 patients on chemotherapy arm, 30 on non-chemotherapy arm). There were 38 overall wound complications reported (38/130, 29%). 23/38 (60%) occurred on the chemotherapy arm; therefore that cohort had 23/100 (23%) wound complication rate, while the non-chemotherapy cohort had an overall rate of 50% (15/30). Grade III wound complications represented 23/38 (66%) of all the complications. 30/38 (79%) of the complications were in the lower extremity. 23/38 (60%) patients were aged > 18 years. Conclusions: The overall rate of wound complications observed was 29% (38/130) which remains within the accepted historical rate based upon literature review without the use of a tyrosine kinase inhibitor. The overall major wound complication (grade III) rate was 19% (25/130). Also consistent with the literature is the finding that a majority of the complications occurred in the lower extremity. In conclusion, the addition of a tyrosine kinase inhibitor (pazopanib) has a wound complication toxicity profile comparable to current and historical literature. Clinical trial information: NCT02180867.
Solitary fibrous tumor: A Brazilian cohort analysis.
Authors: Cesca Marcelle Goldner , Mello Celso Lopes , Felismino Tiago , Formiga Maria Nirvana , Nicolau Ulisses Ribaldo , Aguiar Samuel , Maia Joyce Maria L. 
Published: March 2020

11068 Background: Solitary fibrous tumor (SFT) is a rare mesenchymal tumor that account for less than 2% of all soft tissue sarcomas. SFT has been identified in multiple anatomic locations and can arise anywhere in the body. Surgical management is the mainstay of treatment for localized disease. However, about 20% will develop locoregional recurrences or distant metastasis with a role for systemic treatment. Methods: A retrospective analysis was carried out in a large cancer center in Brazil. Our primary objective was to evaluate clinical and treatment aspects of metastatic/ locally advanced (Mtx/LA) SFT cohort and secondary to describe clinical characteristics of entire population diagnosed with SFT. Descriptive statistics was used for main results. Survival curves were estimated using Kaplan-Meier. Data were retrieved from electronic patient medical records. Results: From April, 1971 to October, 2017, 82 patients with SFT were treated. Median follow-up was 45.5 months. 67 (81.7%) were alive on the cut-off date. Median age at diagnosis was 51 (14-78). 40.2% men. Most common primary sites (PS) were pleura (19.8%), central nervous system (CNS - 11%) and pelvis (11%). 18 (21.9%) underwent chemotherapy for Mtx/LA disease. In this subgroup, 61.1% were men; PS retroperitoneal (22.2%), extremities (16.7%), CNS (16.7%). 66.7% had pulmonary, 44.4% hepatic, 27.8% bone metastasis and one (5.5%) local recurrence. All patients had at least one adverse prognostic factor (tumor size ≥ 10cm, positive margins, necrosis, ≥ 4/10 mitosis). One (5,5%) had Doege-Potter syndrome. 7 (38.9%) did one, 5 (27.8%) two and 6 (33.3%) ≥ 3 lines of treatment. First line was temozolomide/bevacizumab (TMZ/Bev) in 55.6%, followed by chemotherapy (Ch) in 27.8% and tyrosine kinase inhibitors (TKI) in 16.7%. Median progression-free survival was 3.5 months (95% IC: 0.0-7.4) and overall survival 27.3 months (95% IC: 18.7-36.0). Response rate using RECIST criteria was 12.5% for TMZ/Bev and 62.5% had stable disease. TKI and Ch had no response. Conclusions: SFT is rare and with heterogeneous clinical presentation. In our analysis, patients received a wide range of therapy, reflecting the lack of well-established systemic treatment option. TMZ/Bev showed consistent activity in Mtx/LA scenario.
Sarcopenia (SMI(+)) in patients (pts) with advanced or metastatic soft tissue sarcoma (a/mSTS): Potential parameter for risk prediction during multimodal therapy (MT)?
Authors: Strassmann Dennis , Hensen Bennet , Gruenwald Viktor , Stange Katharina , Eggers Hendik , Länger Florain , Panzica Martin , Zardo Patrick , Christiansen Hans , Reuter Christoph W. , Wacker Frank , Ganser Arnold , Ivanyi Philipp 
Published: March 2020

11069 Background: Objective parameters identifying ideal pts for MT from pts with a/mSTS remain scarce. Here, we analysed the impact of sacropenia in a/mSTS pts on treatment outcome of MT, retrospectively. Methods: Pts. with a/m STS treated at our centre (12/98-5/16ere identified. 89/181 pts were evaluable for analysis (CT-scans: -14 days before MT onset). Lumbar skeletal muscle index (SMI) was measured with MeVisLab 2.7 by manually segmentation of preinterventional CTs. SMI cut-off were defined through optimal fitting method (sarcopenia = SMI(+) in male: < 44 , in female: 38). Progression was defined by clinical or radiological judgment. Descriptive statistics, Kaplan-Meier-analysis and Cox-regression were administered. Results: At MT onset 28/89 pts (31%) suffered from sarcopenia, and SMI(+) pts were older than SMI(-) pts (p = 0.025). SMI(+) pts tends to receive lower numbers of medical treatments, received less often surgery, and more frequently radiotherapy, although differences were not significant. Further on, SMI(+) pts tends to profit less from first line medical treatment, compared to SMI(-) pts (objective responses: 14,3% vs. 27.9%, p = .161, clinical benefit rate: 25% vs. 65.6%, p = .032, PFS: 1 (95%-CI:.35-1.65) vs. 16 (95%CI:8.8-23.2) months, p = .002). OS was inferior in SMI(+) compared to SMI(-) pts. (4 (95%CI:2-6) vs. 16 (95%CI:8.8-23.2), p = .002). Multivariable analysis showed a trend for SMI(+) to be associated with PFS (HR: 1.7 (95%CI: 0.9-2.8), p = .067) and were independently associated with OS (HR: 2.53 (95%CI: 1.5-4.2), p < .001). Conclusions: In our cohort sarcopenia tends to be associated with less aggressive therapy in a/mSTS pts. However, sarcopenia tends to be associated with inferior PFS and was identified as independent risk factor for inferior OS. Although this analysis is limited due to its sample size sarcopenia might offer an attractive tool as guidance for treatment intensity modulation in a/mSTS patients, avoiding overtreatment in this cohort with dismal prognosis.
Results of the dose-finding phase of ARST 1321 from the Children's Oncology Group and NRG Oncology: Neoadjuvant chemoradiation or radiation therapy +/- pazopanib in non-rhabdomyosarcoma soft tissue sarcomas.
Authors: Chen Yen-Lin , Weiss Aaron R. , Scharschmidt Thomas , Chi Yueh-Yun , Black Jennifer M. , Choy Edwin , Kao Simon C. , Kayton Mark , Okuno Scott H. , Ostrenga Andrew , Randall R , Terezakis Stephanie Alicia , Zambrano Eduardo , Spunt Sheri L. , Hawkins Douglas S. , Wang Dian 
Published: March 2020

11070 Background: Pazopanib is a tyrosine kinase inhibitor approved globally for advanced soft tissue sarcomas. The dose finding phase of this cooperative group trial assessed the dose limiting toxicities (DLT) and the maximally tolerated dose (MTD) of adding pazopanib to neoadjuvant chemoradiation or radiation therapy in children and adults with unresected intermediate/high-risk trunk and extremity non-rhabdomyosarcoma soft tissue sarcomas (NRSTS). Methods: ARST1321, a jointly designed intergroup study lead by Children's Oncology Group and NRG Oncology opened for enrollment in July 2014. Eligible adult and pediatric patients with newly diagnosed, unresected trunk/extremity NRSTS with plans for primary tumor resection were enrolled into either the Chemotherapy Cohort (those with chemosensitive NRSTS > 5 cm, grade 3, including all synovial sarcoma) or the Non-Chemotherapy Cohort (those with chemotherapy insensitive NRSTS of any size, grade 2/3, or any chemosensitive NRSTS for whom no chemotherapy was planned per discretion of patients and treatment teams). In the Chemotherapy Cohort, pazopanib was given with ifosfamide (7.5 grams/m2) and doxorubicin (75 mg/m2) plus 45 Gy preoperative RT starting after cycle 2. Primary tumor was resected at week 13, followed by chemotherapy and pazopanib to week 25. In the Non-Chemotherapy Cohort, pazopanib was given with 50 Gy preoperative RT, primary tumor was resected at week 10, and pazopanib continued to week 25. Feasibility was assessed through week 6 of therapy to determine pazopanib dose escalation/de-escalation based on DLT, total doses of pazopanib, and overall adverse event profile. Results: In the Chemotherapy Cohort, MTD was reached at Dose Level 1 (350 mg/m2 peds; 600 mg adults) with two DLTs (1 grade 3 ALT rise, 1 intolerability to therapy) in 10 patients. In the Non-Chemotherapy Cohort, 11 patients enrolled at Dose Level 1 (350 mg/m2 peds; 600 mg adults) without any observed DLTs and all received ≥75% of prescribed total pazopanib dose; MTD was reached at Dose Level 2 (450 mg/m2 peds; 800 mg adults) with 2 DLTs in ten patients enrolled (1 grade 3 dermatitis and 1 intolerability to therapy) and 9/10 receiving ≥75% of full dose. Conclusions: Pazopanib in combination with chemoradiation or radiation therapy alone was found to be safe in children and adults with NRSTS. Following this finding, ARST1321 opened in both arms using the newly determined pazopanib MTDs. Clinical trial information: NCT02180867.
A phase II RCT of high-dose vitamin D supplementation and exercise for cancer treatment-induced bone loss in breast cancer patients on aromatase inhibitors.
Authors: Peppone Luke Joseph , Reschke Jennifer E , Janelsins Michelle Christine , Inglis Julia Ellen , Mustian Karen Michelle , Culakova Eva , Kleckner Amber , Kamen Charles Stewart , Lin Po-Ju , Dunne Richard Francis , Kleckner Ian , Huston Alissa , Shayne Michelle , Morrow Gary R. 
Published: March 2020

11500 Background: Cancer-treatment-induced bone loss (CTIBL) is a side effect of aromatase inhibitors (AIs) and can result in osteoporotic fractures. Vitamin D (VITD) protects against postmenopausal bone loss but it is unclear if the recommended daily allowance (RDA: 600 IU/day) of VITD is sufficient to prevent CTIBL. This phase II RCT aimed to assess the feasibility, safety, and preliminary efficacy of high-dose VITD (with and without exercise) on bone mineral density (BMD) compared to the RDA. Methods: Non-metastatic breast cancer patients starting AIs with low VITD (<32 ng/ml) were randomized 1:1:1 into 3 arms: 1) placebo 2) high-dose VITD (50,000 IU/week) or 3) high-dose VITD + Exercise for Cancer Patients (EXCAP): a home-based, personalized walking and resistance band training program for 24 weeks. All subjects received the RDA of VITD 600 IU/day. Serum VITD and calcium levels were assessed at baseline, weeks 6, 12, 18, and 24. BMD was assessed at the hip via DXA at baseline and week 24. Results: Of the 116 subjects randomized (mean age = 60; 94% white; mean baseline VITD = 24.6 ng/mL), 90 provided fully evaluable data. Compliance (≥ 80% of instructed doses) exceeded 95% in all 3 arms with no between-group difference. ANCOVA showed significant differences between groups on final VITD levels (high-dose = 63.6 vs high-dose + EXCAP = 60.3 vs placebo = 32.0 ng/mL; p<0.001) without severe calcium toxicities, as indicated by final calcium level (high-dose = 9.4 vs high-dose + EXCAP = 9.5 vs placebo = 9.4 ng/mL; p = 0.78). The placebo group lost a significant amount of hip BMD (−1.7%; p < 0.01) while hip BMD was maintained in the high-dose (−0.1%; p = 0.77) and high-dose + EXCAP (−0.2%; p = 0.74) resulting in significant between-group differences for high-dose + EXCAP vs placebo (p = 0.04) and high-dose vs placebo (p = 0.05). Conclusions: This is one of the first studies to show our novel high-dose VITD intervention, with and without exercise, significantly reduced hip BMD loss in breast cancer patients on AIs. Moreover, high-dose VITD supplementation is safe and feasible in this population. A phase III RCT is needed to confirm these findings. Funding: K07CA168911. Clinical trial information: NCT01419730.
Candidate SNPs enhance prediction of cognitive impairment after blood or marrow transplantation (BMT) for hematologic malignancy (HM).
Authors: Sharafeldin Noha , Richman Joshua , Bosworth Alysia , Chen Yanjun , Singh Purnima , Patel Sunita K. , Wang Xuexia , Morse Emily , Mather Molly , Sun Can-Lan , Francisco Liton , Forman Stephen J. , Wong F. Lennie , Bhatia Smita 
Published: March 2020

11520 Background: We tested the hypothesis that candidate genetic variants are associated with cognitive impairment in BMT recipients for HM, and that inclusion of genetic variants improves the performance of a risk prediction model that includes only clinical and demographic characteristics. Methods: We used standardized tests to assess cognitive function in 277 adult BMT recipients at City of Hope (COH). Global Deficit Score (GDS) ≥0.50 was used as indicator of cognitive impairment. Generalized estimating equation models and logic regression were used to identify single-SNP and gene-level associations with cognitive impairment post-BMT. Three risk prediction models were developed in the COH cohort using elastic net regression: Base Model (sociodemographics); Clinical Model (Base Model + clinical characteristics, therapeutic exposures and baseline cognitive reserve); Combined Model (Clinical + Genetic Model). The Genetic Model included significant SNPs in blood brain barrier, telomere homeostasis and DNA repair identified from single- and gene-level analyses. Models were validated in an independent cohort of long-term BMT survivors (BMTSS) with (n = 141) and without (n = 258) memory problems. Results: Training set (COH): The cohort included 58.5% males; 68.6% non-Hispanic whites; 46.6% allogeneic BMT recipients; median age at BMT: 51.6y. The mean area under the receiver operating characteristic curve (AUC) was: Base Model: 0.69 (95%CI: 0.63-0.75); Clinical Model: 0.77 (95%CI: 0.71-0.83); Combined Model: 0.89 (95%CI: 0.84-0.92). Test set (BMTSS): Median age at BMT was 45y; 53.5% were males; 88.4% non-Hispanic whites. Testing the models in BMTSS yielded mean AUC of 0.57 (95%CI: 0.49-0.63) in the Clinical Model and 0.72, (95%CI: 0.65-0.78) in the Combined Model. Conclusions: These findings provide evidence on the utility of a validated risk prediction tool that incorporates genetic factors that could identify BMT recipients at risk for cognitive impairment, providing opportunities for targeted interventions.
End-of-life care and immune checkpoint inhibitors.
Authors: O'Sullivan Hazel , Collins Dearbhaile , O'Mahony Deirdre , Power Derek , Bambury Richard , O'Reilly Seamus 
Published: March 2020

11531 Background: In the era of cytotoxic chemotherapy, aggressive cancer treatment and hospitalization at the end of life (EOL) has been associated with a worse quality of death. Meanwhile, in the era of immunotherapy (IO), little is known of the impact of these novel agents on EOL care. The aim of this study was to evaluate the EOL care of metastatic cancer patients treated with immune checkpoint inhibitors. Methods: We conducted a retrospective analysis of patients prescribedPD1/L1 or CTLA-4 antibodies in Cork University Hospital (CUH) and Mercy University Hospital (MUH) between January 2013 to December 2018. Patients treated on a clinical trial were excluded. Results: We identified 224 patients treated with immune checkpoint inhibitors (outside of a clinical trial) in CUH and MUH over the described 6 year period. 108 of these patients were deceased, 102 electronic files were available for analysis. Of the 102 patients, 57 had metastatic melanoma, 33 non small cell lung cancer, 8 renal cell carcinoma, 4 had other advanced malignancies. 43% were female and 57% were male. 6% of patients had an ECOG performance status (PS) of 0 at diagnosis, 80% PS of 1 and 10% PS of 2. Median age at death was 62 years. 47 patients were treated with pembrolizumab, 26 nivolumab, 25 ipilimumab, 2 nivolumab/ipilimumab and 2 received atezolizumab. 29 patients received IO as first line treatment, 50 as second line, 17 as third line and 6 as fourth line. Median number of IO cycles received was 4 (range 1 - 41). Progression of disease (62%) and declining performance status (14%) were the most common reasons for discontinuation of IO treatment. 16 of the 102 patients received a further line of systemic therapy. Median time from last dose of IO to death was 57 days. 20 patients (20%) died within 30 days of last dose of IO. Of these 20 patients, the median number of cycles of IO received was 2 (range 1-7), 8 of these 20 patients received one cycle of IO only. 39 patients (38%) attended the ED in the last month of life. 47 (46%) patients had at least one hospital admission in the last month of life, the median hospital length of stay was 6 days (range 1-30) and 22 patients died in hospital. 94% of patients were referred to palliative care, the median time from palliative care referral to death was 64 days (range 1- 1010), 62% of patients died in hospice. Conclusions: Patients with advanced cancer treated with immunotherapy have high rates of hospital admissions and ED attendances despite early palliative care involvement. 20% of patients died within 30 days of IO. More research is needed to help physicians identify patients who are least likely to benefit from IO so as not to treat futile cases.
Immune checkpoint inhibitor use near the end of life.
Authors: Glisch Chad , Snyders Travis , Gilbertson-White Stephanie , Hagiwara Yuya , Milhem Mohammed M. , Lyckholm Laurel 
Published: March 2020

11533 Background: Studies of chemotherapy near the end of life reveal increased costs, adverse effects and minimal clinical benefit. Immune Checkpoint Inhibitor (ICI) use near the end of life has not been described. We studied factors related to ICI use near the end of life. Methods: We conducted a single-institution retrospective chart review of patients who received ICI and died between August 2014 and December 2018. End of life ICI (EOL-ICI) was defined as treatment within the last 30 days of life and comparisons were made to patients who received treatment > 30 days from end of life (non EOL-ICI). Results: 441 patients were reviewed. Mean age was 64 and 182 (41%) were female. 294 (67%) received ICI within the last 90 days of life and 117 (27%) within the last 30 days of life. At time of last ICI, 145 (33%) had brain metastases and 416 (94%) were stage 4. The most common cancers were melanoma (124, 28%), NSCLC (118, 27%) and urothelial carcinoma (34, 8%). The EOL-ICI group had a higher proportion of patients with ECOG ≥3 at time of last treatment (22% vs. 7%, p = < .001), higher rate of death in hospital (32% vs. 18%, p = 0.003) and lower hospice enrollment (52% vs. 76%, p = < .001). The EOL-ICI group received fewer ICI doses (mean 5.1 vs 6.7, p = 0.016). A higher proportion of patients in the EOL-ICI group were just beginning treatment and received ≤ 3 doses (60% vs 40%, p < .001). There was no difference in mean age or presence of brain metastases between the groups. Even when the cutoff for EOL-ICI is extended from 30 to 90 days, there remain significant differences in ECOG, hospice enrollment and starting ICI but no difference in rate of dying in the hospital. Conclusions: One out of four patients studied received ICI within the last 30 days of life. EOL-ICI treatment is associated with higher rates of death in the hospital and lower hospice enrollment. Our results suggest that performance status is important when considering treatment with ICI. Use of ICI in the last 30 days of life had minimal clinical benefit and high cost.
Write to recover: The impact of group led creative writing on behavioral health outcomes in cancer patients.
Authors: Nesterova Darya , Zhu Junjia , Kramer Courtney , Vasekar Monali K. , Collins Jolene , Truica Cristina I. , Joshi Aditya , Hayes Michael , Saunders Erika , Drabick Joseph J. , Joshi Monika 
Published: March 2020

11536 Background: The diagnosis of cancer can adversely affect mental wellbeing. In addition to treating cancer, the emotional wellbeing of patients must simultaneously be addressed. A previous pilot exploring the feasibility of creative writing workshop (CWW) in cancer patients showed apositive effect on patients’ mental health. Methods: To longitudinally evaluate the efficacy of CWW on mood, we conducted a phase II study with cancer patients (any stage, any cancer type); randomized 2:1 to CWW vs. active control (AC). Patients in the CWW arm attended at least 4, 1.5-hour bi-monthly CWW x 8 wks, whereas AC patients completed independent writing at home with the help of a book (bi-monthly x 8wks). We used validated tools, [Emotional Thermometer Scales (ETS), PHQ-9, GAD-7] to assess changes in overall mood, depression, and anxiety. Primary end point: a) ETS scores before and after intervention b) Changes in depression and anxiety based on PHQ-9 and GAD-7 scores. We present results from ETS scores. Descriptive statistics were generated for these quantitative scales measured in each group, pre and post intervention. Comparisons between groups (gp) were made using Wilcoxon Rank-sum tests. All tests were two sided and the statistical significance level used was 0.05. Results: Amongst evaluable patients, N of 50 (demographics in table below), twenty-six patients in the CWW gp attended at least one class and 19 attended at least 4 classes. Patients in CWW showed significant mood improvement vs. AC when comparing the final overall ETS (p=0.0063). Three of the five sub-scale ETS scores were significantly lower for the CWW vs. AC gp: anxiety (p=0.0027), depression (p=0.0009), and anger (p=0.0027). Conclusions: Group led CWW have a positive effect on mood. Our results suggest potential therapeutic benefit of this intervention on the emotional wellbeing of cancer patients. Larger studies are needed to evaluate the effect of CWW in cancer patients. Clinical trial information: NCT03536702. [Table: see text]