bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of female-dominant support networks on end-of-life decision making among women with advanced or recurrent cancer.
Authors: Robison Katina , Stuckey Ashley , Dizon Don S. , Rogers Michelle , Ott Miles , Miller Susan , Politi Mary C. , Clark Melissa 
Published: March 2020

6590 Background: Improved understanding of the factors that influence a woman’s end of life (EOL) decisions while confronting cancer is needed. The objective of this study was to determine if the composition of one’s social network was associated with advance care planning (ACP) among women with metastatic or recurrent gynecologic or breast cancer. Methods: Women were recruited from a program in women’s oncology in the northeast. Women with an established diagnosis of recurrent or metastatic cancer for ≥3 months duration were eligible. We asked women with advanced or recurrent cancer about their support networks and end-of-life decisions. Interviews were conducted by research staff. Clinical characteristics and documentation of EOL decisions of enrolled women were obtained through chart reviews. Multivariable logistic models were computed. The study protocol was approved by the hospital and university Institutional Review Boards. Results: 200 women were enrolled in the study. The majority had gynecologic malignancies (65.5%). Older age was associated with having an advanced directive (AD) (p<.0001) and a health care proxy (HCP) (p=0.002). Additionally, having more females than males in one’s support network was associated with an AD (p=0.005) and a HCP (p=0.012). Women with gynecologic cancer were more likely to self-report a HCP compared to those with breast cancer (p=0.040).A female support person was 1.57 times more likely to be trusted to make a medical decision (p=0.002) and a female support person was 1.33 times more likely to be someone a woman spoke with about her end of life decision than a male support person (p=0.037). Neither naming a HCP or having an AD were associated with number of support persons named, total number of female support persons, number of friends, number of children, or presence of an intimate partner. Conclusions: Women with more females than males in their social network were more likely to have an advance care directive or health care proxy. In addition, women were more likely to trust and talk with a female support person about end of life decisions than a male support person. However, the composition of the network was not associated with the likelihood of having completed ACP.
Human resources allocation in oncologic day hospital: Validation of the Kohen-Gil Deza scale (KGD) for risk assesment.
Authors: Kohen Nelson , Gil Deza Ernesto , Gercovich Natasha , Morgenfeld Eduardo L. , Garcia Gerardi Carlos Fernando , Martin Reinas Gaston , Montiel Monica , Tognelli Flavio , Rivarola Edgardo G. J. , Gercovich Felipe G. 
Published: March 2020

6596 Background: The oncological day hospital (ODH) at IOHM carries out 80 chemotherapies per day with 6 certified oncological nurses as staff. Human resources allocation in oncology has not been formally studied in relation to treatment risks. The objective of this paper is to present a risk assessment model for the rational allocation for human resources in the ODH using the KGD scale. Methods: The KGD scale was designed through a retrospective evaluation of more than 15,000 treatments (Tx). Between November 1st and December 1st, 2012, this instrument was validated with all new patients (Pt) beginning Tx at IOHM. The KGD scale evaluates risk according to: Five Pt characteristics (Elderly, Polymedicated, Without symptom control, Neuropsychiatric problems, Presence or absence of family members); Four Tx characteristics (New drugs, Complex protocol, High risk of acute toxicity, Infrequently used) and workplace context(New personnel, Holiday absences, With or without close medical support). The KGD scale was determined for each Tx and applied as follows: Low Risk (0-3 points): two nurses in the ODH, supervision is at the patient’s request and the chemotherapy can be administered at the beginning or end of the workday; Intermediate Risk (4-5 points): three nurses in the ODH, supervision is mandatory and the treatment can take place at any time in the workday; High Risk(6 or more points): four nurses in the ODH, supervision must be constant and the Tx must take place in the middle of the workday. The chemotherapy outcome was observed. Results: One hundred and thirty patients were admitted. Sex fem 74 (59%), male 56 (41%): age: 49y (range 22-87). Diagnosis: breast 40, colon: 21, lung: 16, ovaries:11, lymphoma: 11, testis:7, sarcoma: 5 ; others: 19 KGD risk assessment: Low Risk 25 pts (19 %); Intermediate Risk 77 pts (59%); High Risk 28 pts (21%). There were no complications in any of the 312 chemotherapy treatments administered to this cohort. Conclusions: 1) The KGD scale has shown to be a useful aid in the treatment risk assessment. 2) Use of the KGD scale allows for an efficient personnel allocation at the ODH according the Tx risk 3) The academic qualification of the nurses staff are mandatory to control the risk.
Has the “ASCO top 5” changed radiologic staging practices among physicians who treat breast cancer?
Authors: Simos Demetrios , Hutton Brian , Fergusson Dean , Clemons Mark 
Published: March 2020

6597 Background: The American Society of Clinical Oncology (ASCO) recently published its "Top 5" list for fiscal responsibility in oncology. One of the recommendations was to minimize imaging tests looking for metastatic disease in patients (pts) with early stage breast cancer (BC). This recommendation is in close agreement with other published guidelines. The objective of this study was to see whether physician practice patterns have changed following the publication of the "ASCO Top 5" list. Methods: A retrospective review of pts with operable early-stage BC seen at a large Canadian cancer centre was performed. All perioperative (pre- & post-operative) imaging ordered to detect distant metastases (e.g. in the chest, abdomen and bones) was captured. Additional data on demographics, surgical procedure, pathology, prognostic/predictive factors and treatment was also collected. Results: 200 pt charts were reviewed: 100 pre- & 100 post- the "ASCO Top 5" publication. Baseline pt and tumor characteristics were similar in both groups. In the Pre-Top 5 group, 83% had at least 1 staging imaging test. The total number of perioperative tests in this group was 293, for an average of 3.53 tests/pt imaged. In the Post-Top 5 group, 84% had at least 1 staging imaging test. The total number of perioperative tests in this group was 320, for an average of 3.81 tests/pt imaged (p=ns). Further imaging to clarify indeterminate perioperative imaging results was required in 51/167 pts imaged (31%). Radiologically evident metastases were found in only 2/200 pts (both stage 3). None of the clarification imaging showed metastatic disease. Conclusions: This study again highlights the very low yield from imaging in early stage BC. Confirmatory imaging was frequent and did not yield additional metastatic disease. Local practice patterns do not appear to be affected by the recent ASCO publication. Further study is needed to determine how to successfully implement the ASCO recommendation, as excessive imaging is cost prohibitive and can lead to unwanted treatment delays and exacerbate pt anxiety.
Outcomes of rural patients with metastatic colorectal cancer treated in a centralized system compared with their metropolitan counterparts.
Authors: Price Timothy Jay , Broadbridge Vy , Beeke Carol , Padbury Robert , Maddern Guy , Roder David , Karapetis Christos Stelios 
Published: March 2020

6598 Background: Significant geographical variation in survival after diagnosis of colorectal cancer (CRC) has been reported in Australia. Patients residing in rural locations have inferior survival time compared to metropolitan patients. Factors which have an impact on survival include local access to services (investigations, surgery and chemotherapy). Rural patients tend to present with more advanced disease. We analysed data from South Australia (SA) where cancer care has tended to be centralised to determine if rural patients in this setting have inferior outcomes to metropolitan patients. We examined survival of patients with stage 4 CRC. Methods: An analysis of the SA mCRC registry was performed to compare the oncological and surgical management and survival of city (metropolitan postcode) v rural (rest of state) patients. Overall Survival (OS) was calculated using the Kaplan-meier method. Results: Data from 2289 patient with mCRC since February 2006 were analysed. 27% of patients were rural. Patient characteristics did not differ between the 2 groups. There was no difference in chemotherapy use; City v rural, 1st, 2nd and 3rd line respectively-56%v58%, 23%v23%, 10%v9%. Choice of chemotherapy did not differ between city and rural; FU/Oxaliplatin 61%v60%, irinotecan+/-FU 9%v6%, FU alone 28%v31%. When an oxaliplatin doublet was chosen, oral capecitabine was used more frequently 32% in rural v 13% in city (P<0.001) Addition of bevacizumab/anti-EGFR to first line chemotherapy was equivalent: 19.7% v 14.3%/1.6% v 1.4%. Hepatic resection was also similar in 2 groups 14%v12%. Median OS did not differ; 23.4 months city v 23.5 months rural. These outcomes were similar for men and women. Conclusions: The patient characteristics, choice of chemotherapy (drug and single v doublet), hepatic resection rates and importantly, overall survival did not differ between city v rural patients. Oral chemotherapy used was higher in rural patients without affecting outcome.
Prospective study of cognitive function (cog fcn) in women with early-stage breast cancer (ESBC): Predictors of cognitive decline.
Authors: Rugo Hope S. , DeLuca Amy N , Heflin Lara , Fang Sally , Melisko Michelle E. , Moasser Mark M. , Park John W. , Chien Amy Jo , Munster Pamela N. , Esserman Laura , Landau Susan M , Jagust William J , Kramer Joel H 
Published: March 2020

6620 Background: Cog complaints are common among women receiving adjuvant therapy (Rx) for ESBC. Longitudinal prospective data is needed to help identify predictors of cog decline. We conducted a prospective trial to evaluate the effects of chemo- (CTX) & hormone therapy (HRx) on brain & cog fcn in pts with ESBC using multiple objective & subjective tests as well as MRI/PET imaging. Here we report evaluation of clinical characteristics that predict decline in cog fcn. Methods: Eligibility included female patients (pts) planning to receive adjuvant Rx for ESBC. Pts were enrolled in 3 Rx groups (grps): CTX, CTX & HRx, and HRx, with a 4thno Rx age/education matched control grp. All pts underwent a battery of objective & subjective cog tests before start of Rx, 1 mo after CTX or 5 mo after start of HRx (FU1), then 9 mo (FU2) & 18 mo (FU3) after CTX. Brain MRI, PET & serum estradiol (E) were performed at baseline, FU1 & FU2. Results: 81 pts were enrolled as follows, 14 CTX, 33 CTX & HRx, 22 HRx, 12 control. 90% completed FU1, 72% FU2, & 62% FU3, with 29 pts waiting to complete testing. Demographics were similar between grps, median age 54, 78% Caucasian. At each FU, ~25% of pts showed decline in cog fcn compared to the prior time point using a reliable change index; 51% showed decline at > 1 time point, primarily in tests measuring executive function & verbal memory. 62% of pts who declined from baseline to FU1 later stabilized or improved; 77% of pts who declined from FU1 to FU2 later stabilized or improved. Compared to controls, receipt of CTX & HRx (OR 3.15, p=.008), or HRx overall (OR 4.94, p=.004) but not serum E, menopausal status, or CTX, were significant predictors of decline at any time point. Rx group did not predict poorer perceived cog fcn (FACT-COG); depression & fatigue did not predict decline in objective cog fcn. Conclusions: Decline in cog fcn is common in pts receiving adjuvant Rx for ESBC. Predictors included CTX & HRx, or HRx overall but not other treatment & pt related factors. Ongoing HRx, particularly after CTX, appears to be a risk factor for worse cog fcn. Pts should be aware that HRx may be a risk factor for cog deficits, & intervention studies should be designed to focus on this group of pts. Funding: NIH R01 1AG025303-01A2. Clinical trial information: NCT00755313.
Validation of PROMIS emotional distress short form scales for cervical cancer trials.
Authors: Wenzel Lari B. , Osann Kathryn , Hsieh Susie , Nelson Edward L. , Cella David 
Published: March 2020

6633 Background: PROMIS is an NIH-sponsored effort to standardize the measurement of common symptoms and functional concerns of people with chronic conditions. The purpose of this study is to validate the PROMIS Emotional Distress (Depression and Anxiety) Short Forms (SFs) for use with cervical cancer patients. Methods: In a randomized psychosocial telephone counseling (PTC) trial, PROMIS measures of depression and anxiety were used alongside more traditional “legacy” measures of the same concepts. Questionnaires were administered to patients prior to randomization, four months post enrollment, and nine months post enrollment. The depression (8-item) and anxiety (7-item) SFs were evaluated in patients participating in this study, for internal consistency, concurrent validity, and responsiveness to change. SF performance results were compared to the Brief Symptom Inventory (BSI-18) subscales. Data were collapsed between PTC and usual care treatment arms for these analyses. Results: Patients showed significant improvement in depression from baseline to 4 months post study enrollment as measured by the Depression SF (p=0.003; effect size = 0.24), and BSI-Dep (p=0.041; effect size = 0.25). Internal consistency of the two PROMIS SFs were ≥0.95 at baseline (N=203), 4 months (N=165), and 9 months (N=151). The average inter-item correlation was 0.71 at the 4 month assessment for both depression and anxiety. The Depression SF T-score correlated well with the BSI-Dep (0.74), and was moderately correlated with the FACT Emotional Well-Being (EWB) subscale (-0.54), and the Perceived Stress Scale (PSS)(0.63). The Anxiety SF T-score was moderately correlated with BSI-Anx (0.60), EWB (-0.53), and PSS (0.60). Conclusions: The PROMIS Depression and Anxiety SFs reliably and validly assess cervical cancer-specific emotional distress, they capture salient features of distress in this population, and they perform as well or better than legacy measures in this gynecologic cancer population. Clinical trial information: NCT00496106.
A randomized study of lenalidomide (LEN) with or without EPO in RBC transfusion dependent (TD) IPSS low and int-1 (lower risk) myelodysplastic syndromes (MDS) without del 5q resistant to EPO.
Authors: Toma Andrea , Chevret Sylvie , Kosmider Olivier , Delaunay Jacques , Stamatoullas Aspasia , Rose Christian , Beyne-Rauzy Odile , Banos Anne , Guercy-Bresler Agnes , Jourdan Eric , Sardnal Veronique , Caillot Denis , Laribi Kamel , De Renzis Benoit , Bordessoule Dominique , Slama Borhane , Sanhes Laurence , Fontenay Michaela , Fenaux Pierre , Dreyfus Francois 
Published: March 2020

7002 Background: ESAs, the first line treatments of anemia in non del 5q lower risk MDS, yield only 40-50% responses. LEN gives RBC transfusion independence (TI) in about 25% of ESA resistant (or relapsing) TD lower risk MDS without del 5q (Raza, Blood, 2008), and a gene expression signature can predict response (Ebert, Plos Med 2008). We randomized in this patient population LEN alone and LEN+EPO. Methods: In this prospective multicenter open-label phase II study (NCT01718379), lower risk MDS patients without del 5q, with TD (≥4 RBC units during the previous 8 weeks (w)) with ESA resistance or relapse after a response were randomized between LEN alone, 10mg/d x 21 d/4 w (L arm) or LEN (same schedule) + EPO beta, 60 000 U/w (LE arm). The primary endpoint was erythroid response (HI-E, IWG 2006 criteria) after 4 treatment cycles. Secondary objectives included identification of biomarkers of response. Results: Between July 2010 and June 2012, 132 patients (pts, 66 / arm), median age 73 (range 46-88), M/F: 88/44 were enrolled. Median TD was 6 RBC units/8w (range 2-18). IPSS was Low in 45% and Int-1 in 55% pts. Pretreatment characteristics did not differ between the 2 groups. All but 3 pts, who withdrew consent (2L+1LE), were evaluable for response. In this ITT population, HI-E was obtained in 15 pts (23.4%) in L arm and 26 (40.0%) in LE arm (RR= 1.7, p= 0.043, chi2 test), and TI in 9 (14.1%) versus 16 (24.6%) pts (RR=1.7, p= 0.13). In the 99 pts who completed 4 treatment cycles, 41 achieved HI-E, including 15/49 (30.6%) in L arm versus 26/50 (52.0%) in LE arm (p= 0.03), and TI in 9 (18.4%) versus 16 (32.0%) pts (RR= 1.7, p=0.12). Side effects (cytopenias and 1 DVT/arm) were similar in the 2 arms. A 29-gene expression profile signature predicting HI-E to L or LE, different from that previously published, was identified and a polymorphism in the CRBN gene (Kosmider, submitted) was significantly associated with HI-E in the entire cohort (p=0.034). Conclusions: LEN + EPO yielded a significantly better erythroid response than LEN alone in lower risk MDS patients with anemia resistant to ESA alone. A gene expression signature and a CRBN gene polymorphism correlated with the erythroid response. Clinical trial information: NCT01718379.
Final results of a phase I study of idelalisib (GSE1101) a selective inhibitor of PI3Kδ, in patients with relapsed or refractory CLL.
Authors: Brown Jennifer R. , Furman Richard R. , Flinn Ian , Coutre Steven E. , Wagner-Johnston Nina D. , Kahl Brad S. , Spurgeon Stephen Edward Forbes , Benson Don M. , Peterman Sissy , Johnson David Michael , Li Daniel , Dansey Roger D. , Jahn Thomas Michael , Byrd John C. 
Published: March 2020

7003 Background: Signals through PI3K-delta regulate activation, proliferation and survival of B cells, critically influence homing and retention of B cells in lymphoid tissues, and are hyperactive in many BEcell malignancies. Idelalisib (GS-1101) is a first-in-class, selective, oral inhibitor of PI3Kδ that reduces proliferation, enhances apoptosis, and inhibits homing and retention of malignant B cells. Methods: Pts with relapsed/refractory CLL were treated continuously with single-agent oral idelalisib from 50E350 mg/dose (QD or BID). Response evaluated by investigators per Hallek (2008) and Cheson (2012). Results: 54 pts (9F/45M) median (range) age 63 (37E82) years enrolled with: bulky lymphadenopathy (80%), refractory disease (70%), extensive prior therapies (median: 5, range: 2E14), unmutated IgHV (91%), del17p and/or TP53 mutation (24%), del11q (28%), NOTCH1 mutation (17%). The median (range) exposure was 9 (0E41+) months. 25 (46%) pts completed the primary study, 23 (43%) enrolled into an extension study. ORR was 30/54 (56%, 2 CR, 28 PR). Of the 28 PR, 22 met Hallek (2008) and 6 met PR with lymphocytosis Cheson (2012). 44/54 (81%) showed a lymph node response (≥50% reduction in the nodal SPD). 21/54 were SD and 3/54 NE. The median (range) time to first response was 1.9 (0.9-12.9) months. Median PFS was 17 months and median DOR was 18 months. Idelalisib treatment resulted in resolution of splenomegaly (14/20, 70%) and normalization of cytopenias: anemia (17/25, 68%); thrombocytopenia (27/34 79%), neutropenia (15/15, 100%). Most common AEs independent of causality (any Grade/≥Gr 3) included fatigue (31%/2%), diarrhea (30%/6%), pyrexia (30%/4%), rash (22%/0%), upper respiratory tract infection (22%/0%), pneumonia (20%/19%). 2% of pts had ≥Gr 3 ALT/AST elevation. 15% of pts discontinued due to AEs, 7% potentially treatment-related. There were no dose-limiting toxicities. Conclusions: Idelalisib shows substantial clinical activity and a favorable safety profile in heavily pretreated, refractory and highErisk pts with CLL. Phase 3 trials with idelalisib in combination with rituximab or bendamustine/rituximab are ongoing. Clinical trial information: NCT01539512, NCT01569295.
Obinutuzumab (GA101) plus chlorambucil (Clb) or rituximab (R) plus Clb versus Clb alone in patients with chronic lymphocytic leukemia (CLL) and preexisting medical conditions (comorbidities): Final stage 1 results of the CLL11 (BO21004) phase III trial.
Authors: Goede Valentin , Fischer Kirsten , Humphrey Kathryn , Asikanius Elina , Busch Raymonde , Engelke Anja , Wendtner Clemens M. , Samoylova Olga , Chagorova Tatiana , Dilhuydy Marie-Sarah , De La Serna Torroba Javier , Illmer Thomas , Opat Stephen , Owen Carolyn , Kreuzer Karl A , Langerak Anton W , Ritgen Matthias , Stilgenbauer Stephan , Wenger Michael , Hallek Michael 
Published: March 2020

7004 Background: Chemoimmunotherapy (CIT) is standard of care in young and physically fit patients (pts) with CLL. Development of CIT for older and less fit CLL pts is ongoing, but data from phase III trials are sparse. CLL11 is the largest trial to evaluate three treatments in previously untreated CLL pts with comorbidities: Clb alone, GA101 + Clb (GClb), R + Clb (RClb). The final analysis of CLL11 stage 1 efficacy and safety results is presented here. Methods: Treatment-naïve CLL pts with a Cumulative Illness Rating Scale (CIRS) total score >6 and/or an estimated creatinine clearance (CrCl) <70 mL/min were eligible. Pts received Clb alone (0.5 mg/kg po d1, d15 q28 days, 6 cycles), GClb (100 mg iv d1, 900 mg d2, 1000 mg d8, d15 of cycle 1, 1000 mg d1 cycles 2-6), or RClb (375 mg/m2 iv d1 cycle 1, 500 mg/m2 d1 cycles 2-6). Primary endpoint was investigator-assessed progression-free survival (PFS). Results: Median age, CIRS score, and CrCl at baseline were 73 years, 8, and 61.1 mL/min for stage 1a (Clb vs GClb, 356 pts) and 73 years, 8, and 62.1 mL/min for stage 1b (Clb vs RClb, 351 pts, triggered by a different event rate). Key efficacy and safety results are shown in the Table.Grade 3-4 infusion-related reactions with GClb occurred at first infusion only. Management required splitting the first dose over 2 days. Conclusions: CIT with GClb or RClb significantly prolongs PFS vs Clb alone. The results demonstrate that GClb and RClb are very active in CLL and superior treament options in this population. GClb vs RClb will be compared in stage 2 analysis with more follow-up available. Clinical trial information: NCT01010061. [Table: see text]