bluuebunny/crossref_metadata_2025_split huggingface dataset:
A national survey of support and information needs of Australian women living with advanced breast cancer.
Authors: Mileshkin Linda R. , Sheeran Lisa , Robins-Browne Kate , Marven Michelle , Gough Karla , Aranda Sanchia 
Published: March 2020

9124 Background: Improved treatments mean women with advanced breast cancer (ABC) are living longer, sometimes for many years. As a result, these women may experience chronic needs that are different from those with early breast cancer. We aimed to assess the support and information needs of women living with ABC. Methods: A national postal survey was sent to 2,345 women with ABC registered as members of the consumer organizations BCNA and/or BreaCan. Women were asked about their disease, treatment, experiences of care, and to complete the Supportive Care Needs Survey. Results: The response rate was 34% (792 valid responses). Mean age was 57 (range 25-99) with 21% living alone and 27% working. 18% reported living with ABC for >7 years. 656 (85%) were having current treatment: chemotherapy (43%), hormonal therapy (46%), bisphosphonates (49%), and/or trastuzumab (Herceptin) (19%) respectively. 49% of women reported having access to a Breast Care Nurse (BCN) since diagnosis of ABC but only 3% cited a BCN or cancer nurse as their main contact. The majority (76%) cited their medical oncologist as their main contact, 8% cited their family doctor. Women wanted information about: treatment options (84.2%), new treatments (79.2%), symptoms/side effects (78.9%), clinical trials (60.8%), managing pain (57.2%) and financial assistance (38%). Women ≤ 65 had significantly higher levels of unmet needs than those >65 for the 7 items below, including all items from the sexual domain. Conclusions: Women with ABC have many unmet needs with younger women particularly needing more support with sexual needs and anxiety. Women are heavily reliant on their medical oncologist, who may not be equipped or best placed to meet these needs. Models of care need to be developed to address the unmet supportive care needs of women living with ABC. [Table: see text]
YOCAS yoga, fatigue, memory difficulty, and quality of life: Results from a URCC CCOP randomized, controlled clinical trial among 358 cancer survivors.
Authors: Janelsins Michelle Christine , Peppone Luke Joseph , Heckler Charles E , Sprod Lisa , Mohile Supriya Gupta , Chandwani Kavita Dayal , Kirshner Jeffrey J. , Reddy Pavan S. , Morrow Gary R. , Mustian Karen Michelle 
Published: March 2020

9142 Background: Memory difficulty is a serious problem for many cancer survivors and can negatively affect quality of life (QOL). Little evidence exists on the effects of physical activity (PA) interventions, such as yoga, on memory in cancer survivors. We previously reported in a nationwide, Phase III RCT that YOCAS Yoga, implemented over 4 weeks (2 x/wk; 75 min/session), significantly improved fatigue and QOL in cancer survivors. The purpose of this study was to assess the effects of YOCAS on memory and to identify moderating and possible mediating effects of memory in YOCAS improvements of fatigue and QOL. Methods: Cancer survivors between 2-24 months post adjuvant therapy with no participation in yoga during the previous 3 months were randomized to standard care (SC) or SC with YOCAS. YOCAS consists of breathing exercises, gentle Hatha and Restorative yoga postures and meditation. This secondary analysis included participants (N=358, mean age = 54, 96% female, 75% breast cancer) who provided pre- and post-intervention data on Difficulty Remembering Things (modified MD Anderson Symptom Inventory with 0 = “Did not Interfere” to 10 = “Interfered Completely”), fatigue and QOL (FACIT-F). ANCOVA was used to assess the effects of YOCAS on memory at post-intervention incorporating baseline memory score. Path Modeling was conducted to assess the moderating and mediating effects of memory on YOCAS changes in fatigue and QOL. Results: ANCOVA revealed a significant group effect of YOCAS on memory at post intervention (mean change: Yoga - Control = -0.44; Cohen’s D= -0.24; p <0.05). Moderation analyses revealed that baseline memory difficulty did not affect how much YOCAS would improve fatigue (p>0.05) or QOL (p>0.05). Mediation analyses identified changes in memory as a significant partial mediator for improved fatigue (p<0.05) and improved QOL (p<0.05). Conclusions: YOCAS yoga significantly reduces perceived memory difficulty in cancer survivors. Improvements in memory due to YOCAS may be a possible mediator for improving fatigue and QOL. More elaborate PA RCTs are needed to confirm these results. Funding: NCIR25CA10618, K07CA120025, and U10CA37420.
Changes in the use of eythropoetin-stimulating agents (ESAs) in cancer patients: Before and after FDA safety advisories.
Authors: Stafkey-Mailey Dana , Dickson Mike , Norris LeAnn B. , Bennett Charles L. 
Published: March 2020

9143 Background: Benefits of ESAs in the treatment of cancer-induced anemia have been well documented, most importantly reducing the likelihood of patients needing red blood cell transfusions. However, in early 2007, the FDA issued a series of cautions and Black Box Warning (BBW), that ESAs may enhance tumor progression, increase likelihood of a VTE and decrease patient survival. The objective of this study is to elucidate population patterns and trends in ESA use for cancer patients pre- and post- the BBW and examine their associated outcomes. Methods: Data for this analysis was derived from South Carolina Medicaid claims. Patients with a diagnosis of Lung Cancer (162.x), Breast Cancer (174.x) or Non-Hodgkin's Lymphoma (200.x or 202.x) receiving chemotherapy between January 1, 1994 and December 31, 2010 were eligible for inclusion. The main outcome measures were ESA utilization, blood transfusion, and venous thromboembolism. The percentage of patients experiencing these outcomes were plotted over time to allow for visual examination of changes due to the BBW. In addition, we used multivariable logistic regression models to analyze each of the associated outcomes with clinical and demographic variables. Results: Among the 9,280 patients with one of the study cancers, an average of 25.4% received an ESA. The proportion of patients receiving an ESA increased from 6.2% in 1994 to a high of 47.1% in 2005 at which time utilization began to decline. In 2010, only 7.8% of these patients received an ESA. Use was associated with older age, female sex, and receipt of radiation therapy. The rate of blood transfusion varied sporadically throughout the study period from 5.2% (2008) to 11.7% (1994) (p<0.0001). Venous thromboembolisms developed in 12.3% and 8.5% of patients receiving and not receiving an ESA, respectively (OR= 1.31;p<0.001). Conclusions: As the FDA advisory cautioned, we find an increased risk of venous thromboembolisms associated with ESA use. In contrast to our a priori beliefs initial decline in utilization of ESAs began, in 2005, prior to the BBW and was likely due to changes in reimbursement rates. However, the BBW resulted in the largest decline in ESA use, 19.1 percentage points, between 2007 and 2008.
Efficacy of rituximab plus FAB group C chemotherapy without CNS radiation in CNS-positive pediatric Burkitt lymphoma/leukemia: A report from the Children’s Oncology Group.
Authors: Frazer J. Kimble , Goldman Stanton , Smith Lynette , Harrison Lauren , Perkins Sherrie L , Cairo Mitchell S. 
Published: March 2020

9501 Background: Historically, CNS-positive (CNS+) mature B-NHL in children and adolescents has been associated with a dismal outcome (Miles/Cairo, Br J Haematol, 2012). Adding CNS radiation and high-dose MTX and cytarabine to group C therapy for children with CNS+ B-NHL yielded a 77% 5-yr EFS in LMB89 (Patte et al., Blood, 2001). An ensuing FAB/LMB96 trial replaced cranial radiation with further HD-MTX and intrathecal therapy with similar results (75% 4-yr EFS) (Cairo et al., Blood, 2007). Here, patients with marrow and CNS+ disease fared worse than isolated CNS+ (61% vs. 83% 4-yr EFS, p<0.001), with >50% of CNS+ patients who progressed or recurred having systemic, but not CNS, relapse. Rituximab, a chimeric anti-CD20 antibody, improved EFS, PFS, and OS when added to chemotherapy for adults with DLBCL (Coiffier et al., N Engl J Med, 2002; Pfreundschuh et al., Lancet Oncol, 2006). We tested whether adding rituximab to FAB group C chemotherapy in pediatric patients with CNS+ B-NHL was safe and efficacious. Methods: Children and adolescents (<21 yrs.) with CNS+ B-NHL received FAB group C1 therapy (Cairo et al., Blood, 2007). Rituximab (375 mg/m2/dose) was given twice in COPADM courses 1 & 2 and once in CYVE courses (Cairo et al., ASCO, 2010). CSF blasts (>1), cranial nerve palsy (CNP), intra-cerebral mass (ICM), and/or parameningeal extension (PME) defined cases as CNS+. Results: Of 40 eligible Group C patients,15 (38%) were CNS+; all 15 had Burkitt morphology. Eight CNS+ patients were CSF+ [WBC median 35 (range 1-1104)] with 6 cases CNP+, 4 PME+, and 1 ICM+. No adverse events were attributed to rituximab. Fourteen of 15 CNS+ patients (93%) are alive and disease-free. Of 7 BM-/CNS+ patients, 100% are NED. In BM+/CNS+ cases, 7/8 (88%) are NED, with one patient progressing with systemic and CNS disease. Conclusions: Addition of rituximab to group C FAB therapy was well tolerated. Outcomes in this small cohort of 15 children and adolescents with CNS+ BL (93%) suggest that adding rituximab to FAB group C therapy without CNS radiation may reduce systemic relapse. Large randomized studies are warranted to test this hypothesis in this previously high-risk clinical subgroup.
Stanford V chemotherapy and involved field radiotherapy for children and adolescents with unfavorable risk Hodgkin lymphoma: Results of a multi-institutional prospective clinical trial.
Authors: Metzger Monika , Billett Amy , Friedmann Alison M. , Krasin Matthew J. , Howard Scott C. , Weinstein Howard J. , Larsen Eric , Marcus Karen Chayt , Billups Catherine , Wu Jianrong , Donaldson Sarah S. , Link Michael Paul , Hudson Melissa M. 
Published: March 2020

9502 Background: To evaluate the efficacy of 12 weeks of Stanford V chemotherapy (prednisone, vinblastine, doxorubicine, nitrogen mustard, etoposide, vincristine, and bleomycin) without routine growth factor support plus response-adapted low-dose, involved-field radiotherapy (IFRT) in children and adolescents with unfavorable risk Hodgkin lymphoma (HL). Methods: Multi-institutional (St. Jude Children’s Research Hospital, Stanford University, Children’s Hospital Boston, Massachusetts General Hospital and Maine Children’s Hospital) clinical trial. One hundred forty-one patients with clinical stages IIB (n=43), IIIB (n=19), IVA (n=27), and IVB (n=52) HL were treated with 12 weeks of Stanford V chemotherapy and low dose IFRT between June 2002 and May 2011. Involved nodal sites in complete remission (CR, defined as > 75% shrinkage of the original tumor and PET negative) after 8 weeks of Stanford V received 15 Gy IFRT; those sites that achieved only partial response received 25.5 Gy IFRT after completion of all 12 weeks of chemotherapy. Results: With a median follow-up of 4.6 years, the 3-year overall and event-free survival (EFS) are 97% (SE=2%) and 79% (SE=4%) respectively. There was no significant difference in EFS by stage (IIB vs. IIIB vs. IV; P=0.84). Ten patients developed progessive disease and 18 relapsed, while 5 have died (1 after relapse in an accident and 4 of refractory disease). Most common toxicities were grade 3 hematologic with 234 episodes of neutropenia in 101 patients (72%) and 85 episodes of anemia in 52 patients (37%); Fever and neutropenia occurred 13 times in 12 patients (9%). Conclusions: Risk-adapted, combined-modality therapy using 12 weeks of Stanford V chemotherapy plus IFRT is well tolerated in this population with manageable acute toxicities. Overall survival is comparable to other more intense chemotherapy regimens. Future high-risk front line therapies may consider a Stanford V backbone with targeted intensification and further tailoring of radiation therapy.
The effects of dexrazoxane on cardiac status and second malignant neoplasms (SMN) in doxorubicin-treated patients with osteosarcoma (OS).
Authors: Kopp Lisa M. , Bernstein Mark L. , Schwartz Cindy L. , Ebb David , Krailo Mark D. , Grier Holcombe E. , Meyers Paul A. , Wexler Leonard H. , Marina Neyssa , Womer Richard , Janeway Katherine A. , Gorlick Richard Greg , Lipshultz Steven E. ,   Children's Oncology Group
Published: March 2020

9503 Background: Anthracyclines are highly efficacious in OS but associated with risk of cardiotoxicity. We conducted two studies using dexrazoxane as a cardioprotectant: i) AOST0121, a phase II study for metastatic OS and ii) P9754, a series of pilot studies including doxorubicin dose intensification in patients with localized OS. Methods: Patients on AOST0121 received methotrexate, doxorubicin (375 mg/m2), cisplatin, ifosfamide and etoposide (MAPIE). Those with HER2-positive tumors also received trastuzumab (4 mg/kg loading dose, 2 mg/kg weekly). On P9754, patients received MAP in Pilot 1, MAPI or MAPIE in Pilots 2 and 3. Total doxorubicin was 450 mg/m2 or 600 mg/m2 with each dose preceded by dexrazoxane (10:1 ratio). Etoposide was never given simultaneously with dexrazoxane. Measurements of left ventricular systolic function by echocardiography, serum troponin-T (cTnT, a myocardial injury marker) and N-terminal pro-brain natriuretic peptide (NT-proBNP, a cardiomyopathy marker) were obtained at baseline and repeated during therapy. Secondary malignancies were reported to the NCI. Results: None of the 47 patients (17 receiving trastuzumab) evaluated for cardiac toxicity on AOST0121 had significant changes in left ventricular fractional shortening, measurable cTnT, elevation of NT-proBNP or clinical evidence of cardiotoxicity (CTCv2.0). In P9754, 242 patients were evaluated for cardiotoxicity. Only 1 patient had CTCv2.0 grade 3 toxicity and 1 patient had a measurable cTnT. Three of 96 patients treated on AOST0121 and two of 272 patients on P9754 developed AML. Combining both studies: 5/398 or 1.4%. Conclusions: This large group of OS patients demonstrates that dexrazoxane is an effective cardioprotectant for doxorubicin alone (375-600 mg/m2), and in combination with trastuzumab. Dexrazoxane did not lead to an increase in secondary malignancies in OS patients treated with these regimens as compared to historical rates of 1-2%. Our results do not support the findings of a recent European Medicines Agency safety review that concluded dexrazoxane was unsafe for use in children and adolescents due to risk of SMN.
Cardioprotection and safety of dexrazoxane (DRZ) in children treated for newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) or advanced stage lymphoblastic leukemia (T-LL).
Authors: Asselin Barbara , Devidas Meenakshi , Zhou Tianni , Camitta Bruce M. , Lipshultz Steven E. ,   Children's Oncology Group ALL Committee
Published: March 2020

9504 Background: POG 9404 evaluated the efficacy of DRZ as a cardioprotectant and its side effects in children receiving doxorubicin (DOX) as part of chemotherapy for T-ALL/T-LL. Methods: Between 6/1996 and 9/2001, 537 T-ALL/T-LL patients were treated with multi-agent chemotherapy that included 12 DOX doses of 30 mg/m2. Patients were randomized at diagnosis to treatment with or without DRZ (300 mg/m2 IV immediately prior to each DOX dose). Cardiac effects were assessed by serial echocardiograph measurements of left ventricular (LV) function (fractional shortening) and structure (end-diastolic dimension, wall thickness, and mass). Adverse events, grades 3-5 were recorded using CTCAE version 2.0. Results: Five-year EFS was similar for the DRZ (0.77±0.03%) and no-DRZ (0.76±0.03%) groups (p=0.9). Acute cardiac toxicity occurred in 1 patient (arrhythmia) on DRZ and 4 patients treated without DRZ (1-arrhythmia, 3-decreased LV fractional shortening). At each of the three time-points post-baseline (end-induction, after the last DOX dose and two years post study entry) LV dimensions were larger from baseline for patients who did not receive DRZ. In univariate analyses, change in LV end-diastolic dimension from baseline was the only variable that was significantly different between DRZ and no-DRZ arms. This was true at each of the three time points (p=0.005-0.02). The frequencies of grade 3 or 4 toxicity (hematologic, infection, CNS events, mucositis) or death were similar in groups with or without DRZ (p<0.24). There were 13 second malignancies, 10 patients had received DRZ and 3 had not (p=0.07). Conclusions: Our LV dimension measurements suggest that DRZ may protect against the early LV remodeling and enlargement that is seen with DOX cardiotoxicity. Addition of DRZ did not interfere with the anti-tumor efficacy of this DOX-containing, multi-agent regimen, and there was no significant increase in toxicities. An increased rate of second malignancies with DRZ did not reach conventional levels of statistical significance. The study was not powered to assess second malignancy rates and this trend is of unknown clinical significance.
Increasing risk of chronic health conditions in aging survivors of childhood cancer: A report from the Childhood Cancer Survivor Study.
Authors: Armstrong Gregory T. , Kawashima Toana , Leisenring Wendy M. , Stovall Marilyn , Sklar Charles A , Robison Leslie L. , Oeffinger Kevin C. 
Published: March 2020

9514 Background: Survivors of childhood cancer are at an increased risk for treatment-related chronic health conditions during early adulthood. However, the incidence, severity, and spectrum of chronic health conditions in the fourth and fifth decades of life have not been well studied. Methods: Analyses included 14,358 > 5 yr survivors of childhood cancer (median age at last follow-up 32.3 yrs, range 8.0-58.0; 21.4% > 40 years) and a sibling comparison group (n = 4,031). Self-reported health conditions were classified using NCI CTCAE 4.0 grading system. Analyses focused on two primary outcomes: severe/life-threatening/fatal conditions (grades 3-5), and multiple (≥ 2) conditions. Cumulative incidence of a new chronic health condition was calculated from age 26 yrs. Cox proportional hazards models adjusted for gender and race, were evaluated using age as the time scale. Results: Among survivors with no previous health conditions through age 25, the cumulative incidence for a new grade 3-5 condition by age 50 compared to siblings was 45.9% (95% CI 45.9-45.9) vs. 13.9%, (95% CI 13.9-14.0) and for new onset of ≥ 2 conditions 33.0% (95% CI 33.0-33.1) vs. 24.9% (95% CI 24.8-24.9) . Survivors ≥ 40 yrs of age had a 5.8-fold (95% CI 5.3 – 6.5) increased risk of a grade 3-5 condition compared to same age siblings, in contrast to those < 40 years of age (HR 2.7, 95% CI 2.5-3.0). A similar magnitude of difference was present for risk of >2 conditions (HR 2.7 vs. 1.2). In comparison to siblings, survivors > 40 years of age had a significantly increased risk for: congestive heart failure (HR 15.7, 95% CI 9.2-26.7), myocardial infarction (HR 8.8, 95% CI 6.0-12.9), stroke (HR 8.6, 95% CI 5.6-13.2),joint replacement (HR 6.8, 95% CI 4.1-11.4), renal failure (HR 5.1, 95% CI 2.2-11.9) among other serious conditions. Conclusions: As they age, adult survivors of childhood cancer continue to develop new and serious health conditions at substantially higher rates than siblings. These data emphasize the importance of placing a greater focus on investigations of premature aging and organ senescence in this high risk population.
Family history of cancer and clinical outcome in pediatric oncology.
Authors: Schiffman Joshua David , Smith Ken R , Burningham Zachary , Kohlmann Wendy , Curtin Karen 
Published: March 2020

9525 Background: We previously reported in a small study (n=363) that children diagnosed with cancer who have a family history of cancer (FHC) may have worse prognosis than those without FHC, specifically children diagnosed with Hodgkin Disease (HD) and acute lymphoblastic leukemia (ALL) (Eichstadt et al., ASCO 2009). The Utah Population Database (UPDB), a unique resource, includes a Surveillance Epidemiology and End Results (SEER) registry (the Utah Cancer Registry) record-linked to extensive genealogies for 6.5 million people in which most Utah families are represented. A majority of pedigrees include ≥3 generations and several span 7+ generations. The UPDB provides an accurate, objective assessment of FHC. We expanded our original study by examining cancer mortality of 4,482 pediatric cases (age ≤18) diagnosed from 1966-2009 with adequate follow-up (median 9.5 years) and family information. Methods: We compared survival from cancer-caused mortality for pediatric cases diagnosed from 1966-2009 with FHC of any cancer diagnosed <80 yo in 1st-degree, 2nd-degree, or 3rd-degree relatives to pediatric cases without FHC. Nonparametric estimates of survivor function were determined by the life-table method and a log-rank test of homogeneity was used to test for differences between pediatric probands with FHC compared to no FHC. Results: Overall survival was significantly lower in children with positive FHC (n=1,128) than in children with no FHC (n=3,354) independent of stage (p<0.0001; 10yr survival, 69% with FHC vs.78% with no FHC). We observed lower survival in children with any leukemia and FHC (n=279) compared to children with leukemia and no FHC (n=871; p<0.0001). In particular, cases with ALL and FHC had lower survival (p<0.0001; 10yr survival, 61% vs. 75%). Pediatric lymphoma cases had lower survival when positive for FHC (n=150) vs. no FHC (n=428; p<0.0001), specifically for an HD diagnosis (p=0.0004; 10yr survival, 83% vs. 94%). Conclusions: Pediatric cancer cases with FHC of any cancer (children or adults) have decreased survival compared to cases with no FHC, specifically in children diagnosed with ALL or HD, thus validating our earlier findings. Familial factors likely contribute to increased pediatric cancer mortality.