bluuebunny/crossref_metadata_2025 huggingface dataset:
Safety analysis of radioimmunotherapy (RIT) in patients with relapsed or refractory low grade, follicular or transformed non-Hodgkin's lymphoma and mantle cell lymphoma based on age at time of therapy
Authors: Braun E. , Katz D. , Venugopal P. , Larson M. , Shammo J. , Fung H. , Gregory S.
Published: August 2020

e19529

Background: Radioimmunotherapy is a therapeutic option for relapsed or refractory indolent, follicular and transformed non Hodgkin's lymphoma and mantle cell lymphoma. Although prolongued myelotoxicity has been described with use of iodine I 131 tositumomab (TOSI) and yttrium 90 ibritumomab tiuxetan (IBRI), analysis of toxicity according to patients’ age at therapy still lacks. Methods: Utilizing the Rush University Medical Center database 61 subjects who received RIT between November/2003 and June/2008, either with TOSI or IBRI were divided in 2 groups according to age at time of therapy. Group 1 included patients between 33 and 60 (51.8±6.5) years of age (N=29) and group 2 included patients 61 years old or older (70.1±7.8) (N=32). Parameters compared between groups were: Time to nadir of lowest absolute neutrophil count (ANC), time to recovery ANC above 1000/mcL, time to nadir of lowest hemoglobin levels, time to recovery to hemoglobin levels above 8g/dL, time to lowest platelet count and time to recovery to platelet count above 100,000/mcL. Incidence o myelodysplastic syndrome (MDS) was also compared between groups. Groups characteristics such as sex, type of RIT, presence of disease in bone marrow, FLIPI/IPI and use of G-CSF were noted. Results: There was no significant statistical difference between groups in time (number of days) to achieve nadir of ANC (group 1 85.3±208; group 2 50.3±19.9), nadir of hemoglobin levels (group 1 106±60.6; group 2 84±57.0) and time to nadir of platelet level (group 1 53.5±70.7; group 2 41.8±9.6). There was no statistical significant difference between groups in duration of cytopenias, except for time for platelet recovery which was significant longer in group 2 using the Pearson Correlation analysis. (p=0.008). (Days for platelets recovery to levels above 100,000/mcL group 1 29.4±27.7; group 2 108.8 ±207.3). One patient in group 1 and three patients on group 2 were diagnosed with MDS but were also treated with different chemotherapy regimens. Conclusions: RIT should be considered a safe therapeutic modality in patients with refractory or relapsed indolent, follicular, NHL, transformed and Mantle Cell lymphoma regardless of age.

[Table: see text]
Clinical usefulness of PET/CT in initial staging and response evaluation of primary gastric lymphoma
Authors: Yi J. , Kim S. , Lee S. , Park S. , Ko Y. , Choi J. , Kim W.
Published: August 2020

e19541

Background: Positron emission tomography (PET)/computed tomography (CT) scan has a well-established role in the management of non-Hodgkin's lymphoma (NHL). However, in case of the primary gastric lymphoma, which is the most frequent extranodal NHL, the role of PET/CT scan is still controversial. Methods: We retrospectively analyzed 42 patients with primary gastric lymphoma who underwent PET/CT scans; 32 patients with diffuse large B-cell lymphoma (DLBCL) and 10 patients with extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) were analyzed. The PET/CT scans were compared with clinicopathologic features and the results of CT and endoscopy. After corresponding treatment, response was evaluated by conventional CT scans or PET/CT scans and endoscopy with biopsy Results: Nine patients were up-staged based on the results of their PET/CT scan compared to CT (7 DLBCL, 2 MALT lymphomas) while six patients were down-staged by the PET/CT scan. The high SUVmax group, defined as SUVmax ≥ median value, was significantly associated with an advanced Lugano stage (P < 0.001). Three patients with DLBCL, who showed an initially high SUVmax, died of disease progression. Although not statistically significant, there was a tendency of inferior outcome in the group with high SUVmax. Among 24 patients for whom follow-up PET/CT scan with endoscopy was performed, 11 patients with ulcerative or mucosal lesions showed residual FDG uptake. All of these gastric lesions were grossly and pathologically benign lesions without evidence of lymphoma cells. Conclusions: PET/CT scan can help staging patients with primary gastric lymphoma, and the maximum SUV has possibility to have prognostic value. However, the residual FDG uptake observed during follow-up should be interpreted cautiously in association with the results of endoscopy and multiple gastric biopsies.

No significant financial relationships to disclose.
AIDS-related lymphoma (ARL): Efficacy of highly active anti retroviral therapy (HAART) on survival and prognostic factors in a general hospital in Peru
Authors: Reategui R. D. , Beltran B. , Morales D. , Vera L. , Quinones P. , Portugal K. , Desposorio C. , Capellino A. , Castillo J.
Published: August 2020

e19545

Background: Since the introduction of HAART in 1996, the profile of ARL has shifted considerably. The impact of HAART on the survival of ARL in developing countries in the post-HAART era has not been clearly defined. The aims of this study were to evaluate efficacy of HAART on survival and prognostic factors in our population. Methods: The clinical records of 2,502 HIV-infected patients seen in our institution from March 1997 to March 2008 were reviewed. The survival was calculated using the Kaplan-Meier method and the prognostic factors were evaluated by chi square. Results: Forty-eight patients with HIV-associated lymphoma were identified. From the 48 ARL identified 44 were non Hodgkin lymphoma (NHL) and 4 were Hodgkin lymphoma. Two patients with CNS primary were excluded for analysis. From 42 systemic NHL: 38 (90,5%) were of B-cell and 4 (9,5%) were of T-cell. The 5-year overall survival (OS) was 27%. Three groups of patients were included: 13 patients (31%) received HAART previous the diagnosis of ARL, 21 patients (50%) initiated HAART after ARL diagnosis and 8 patients (19%) did not receive HAART. HAART treatment before the diagnosis of NHL increases the survival (54% versus 9,5% versus 25% respectively, p=0.048). Twenty of 42 patients (47,6%) received chemotherapy. This group had a better survival rate than those who did not receive chemotherapy (50% versus 4,5%, p< 0.0001) The overall response to chemotherapy was 80% with CR (n=11, 55%), PR(n=5, 25%) and PD in four (20%). In a multivariate analysis, IPI score > 2, presence of B symptoms and no HAART previous ARL diagnosis were statistically associated to worse survival with p-values of 0.0001, 0.018 and 0.048 respectively. Conclusions: In our study the use of HAART is effective when started before ARL diagnosis. IPI score > 2, B symptoms and no HAART previous the diagnosis were unfavorable prognostic factors. These latest findings are in concordance with prior reports. This is the first Latinamerican report on the impact of HAART on the OS in ARL patients.

No significant financial relationships to disclose.
Primary breast lymphomas: An Argentinian cooperative study
Authors: Gil Deza E. , Dragosky M. , Annetta I. , Marquez M. , Corzo A. , Gercovich N. , Morgenfeld E. , Tognelli F. , Rivarola E. , Gercovich F. G.
Published: August 2020

e19555

Background: Primary Breast Lymphomas are rare tumors (less than 1% of all primary breast tumors). Because of that, the records of two institutions dedicated exclusively to the treatment of cancer (Hospital Municipal de Oncologia “Maria Curie” and Instituto Oncologico Henry Moore) have been working together in a single series. Objective: To make a retrospective study of the clinical onset, treatment and evolution of the patients with Primary Breast Lymphoma (PBL). Methods: Patients from hemato-oncological databases of both institutions, that presented PBL, were studied. A database containing characteristics of the population, clinical onset, treatments, evolution and survival Results: Gender F/M=2/15 pt. Mean age (range)=54.1 years (24–87). Pathology: Hodgkin's Lymphoma = 1 pt, NHL follicular = 8 pt, Large-Cell Diffuse NHL = 6 pt, lymphoplasmocytic NHL = 1 pt, Marginal Zone NHL = 1 pt. Stages: IA = 2 pt, IIA = 8 pt, IIIA = 1 pt, IVA = 6 pt. Radiotherapy: 11 pt. Polychemotherapy: CVP = 7 pt, COPP = 1 pt, CHOP = 2 pt, CNOP = 4 pt, CVP/CHOP = 1 pt, RCHOP = 1 pt, RESHAP = 1 pt. Response: CR16/16 evaluable pt. Evolution: Recurrence = 3 pt, Second tumors = 3 pt (breast cancer = 3 pt), Third tumors = 1 pt (melanoma = 1 pt). Survival. Dead = 4 pt. Alive with no illness = 12 pt, Alive under treatment = 1 pt. Conclusions: 1) Seventeen pt with PBL were identified. 2) Sixteen out of 17 were non-Hodgkin lymphomas. 3) Fifteen of 17 pt were women 4) Fourteen of the 17 cases affected only one breast. 5) Seven out of 17 cases were tumors of less than 5 cm. 6) Response reached 100% of the evaluable pt. 7) There was an important rate of second and third tumors (20%). 8) With a mean follow up time of 82 months, 75% of the population is alive and free of the illness.

No significant financial relationships to disclose.
HIV-associated anaplastic large cell lymphoma
Authors: Castillo J. , Milani C. , Pantanowitz L.
Published: August 2020

e19563

Background: Anaplastic large cell lymphoma (ALCL) is a CD30+ T-cell lymphoma that is generally unrelated to EBV in the non-HIV setting. Based upon anaplastic lymphoma kinase (ALK) expression, the new WHO classification provisionally distinguishes between ALK+ (favorable) and ALK- (unfavorable) ALCL. The characteristics of ALCL, such as ALK expression and EBV coinfection, in individuals with HIV infection have not been adequately evaluated. The aim of this study was to investigate these features in HIV-associated ALCL cases. Methods: A MEDLINE search for all cases of HIV-associated non-cutaneous ALCL was undertaken. Data regarding patient age, gender, HIV status (CD4 count, viral load, opportunistic infections), HAART, lymphoma features (B symptoms, stage, sites of involvement, immunophenotype, ALK expression, molecular studies), EBV coinfection, therapy and outcome (survival, cause of death) were extracted and analyzed. Results: A total of 23 cases were included. Patients were of median age 39 years with a male:female ratio of 7:1. Median CD4+ count was 76 cells/mm3 and HIV viral load 416,500 copies/ml. Most (67%) patients had an opportunistic infection, although only 3 (17%) were on HAART. ALCL was extranodal in 22 cases (96%) affecting most commonly lung, soft tissue and liver. Many (78%) patients had stage IV disease and B symptoms were reported in 9 cases (50%). T-cell receptor gene rearrangement was present in all cases, CD30 was positive in 22 (96%), and the vast majority (90%) were ALK-negative. EBV was identified in 8 (35%) cases. Therapy for ALCL was documented in 15 (67%) cases; 64% received CHOP. In 2 of the 3 patients who were on HAART, long-term survival was achieved. Many (68%) patients died, with a median survival of 9 months. Death was caused by either lymphoma progression (42%) or infection (58%). Conclusions: HIV-associated non-cutaneous ALCL appears to affect younger individuals and is associated with EBV infection in a subset of cases. Apart from marked immunosuppression, the poor prognosis of HIV-associated ALCL appears to be related to the absence of ALK expression, advanced stage at presentation with prominent extranodal disease, inadequate therapy including HAART, and poor response to CHOP. Further research is needed to better understand and treat this unique HIV-associated lymphoma.

No significant financial relationships to disclose.
sFLC in healthy Indian subjects and myeloma patients
Authors: Kumar R. , Gupta D. , Raina V. , Sharma A. , Kumar L. , Irshad M. , Singh S. , Chopra A.
Published: August 2020

e19565

Background: Serum free light chain (sFLC) analysis for detection and monitoring of monoclonal gammopathies has been validated by several studies but none from India. We report sFLC in Indian healthy subjects and myeloma patients. Methods: Serum samples from 73 healthy subjects and 39 myeloma patients were analyzed using serum protein electrophoresis, immunofixation where appropriate and estimation of sFLC, the latter using FREELITE reagent kit and Hitachi-912 autoanalyzer. Parameters evaluated were κ and λ levels, κ/λ ratio and dFLC (involved-uninvolved chain). Results: Median age of controls (50 males, 23 females) was 40 years (range 20–65 years) and of patients (34 males, 5 females) was 53.5 years (range 35–80 years). In control group, λ levels were significantly higher than κ. There were 26 of kappa- and 13 of lambda- type myeloma as judged by immunofixation. Results were significantly different between myeloma and control group for κ, λ and κ/λ ratio (p=0.00). Only thirteen patients had iFLC >100 mg/L but ratios were abnormal in all (100%) patients (26 κ, 13 λ) when judged by the full range of normal κ/λ (0.51–1.66). dFLC >50 mg/L with abnormal ratio was seen in 28 (70%) patients. All patients had concordance with immunofixation. Conclusions: Healthy Indian subjects have higher κ and λ values than reported, possibly because of greater incidence of subclinical infections. However κ/λ range is comparable and iFLC >100mg/l appears uncommon. The κ/λ ratio is highly sensitive method for myeloma detection. Results need validation in larger cohort of healthy subjects and patients.

No significant financial relationships to disclose.
The prognostic value of FDG-PET measured by standardized uptake value in patients with melanoma stage III evaluated in a prospective study
Authors: Bastiaannet E. , De Jong J. R. , Brouwers A. H. , Suurmeijer A. J. , Hoekstra H. J.
Published: August 2020

e20000

Background: FDG-PET is a sensitive modality to detect melanoma metastases; melanomas are typically FDG-avid and melanoma shows an unpredictable pattern of spread. Furthermore, FDG-PET is able to quantify FDG uptake and the amount of FDG uptake, measured by the standardized uptake value (SUV), might be important for the prediction of disease specific survival (DSS) or disease free survival (DFS). Therefore, aim of this study was to perform a prospective analysis to determine whether SUV is of prognostic value in the DFS and DSS of melanoma patients with palpable lymph node metastases. Methods: From July 2002 until December 2007, all consecutive patients with palpable, histology or cytology proven lymph node metastases of melanoma referred to the University Medical Centre Groningen for examination with FDG-PET were prospectively included. The SUVmean (70% isocontour) and SUVmax in the lymph node metastasis were calculated for patients who showed no distant metastases on chest X-Ray, FDG-PET and CT. Univariate and multivariate survival analysis was performed to determine whether SUV was associated with DFS and DSS (Cox Proportional Hazard analysis). Results: Overall, 70 patients were eligible. High SUV values were present in axillary metastases (p=0.118), in patients who had more than 15 nodes removed (p=0.061) and in patients with a large tumor size in the lymph node (p=0.0001). Patients with a low SUVmean had a 3-years DFS of 54.3% as compared to 28.1% for patients with a high SUVmean (HR 2.02;p=0.051). In multivariate analysis SUVmean seems to be associated with DFS (p=0.063). DSS for patients with a high SUV was decreased, however not statistically significant (HR 1.71; p=0.182). Conclusions: The SUV in the lymph node metastasis seems to be associated with disease-free survival for melanoma patients clinically stage III.

No significant financial relationships to disclose.
Randomized trial of two schedules of palonosetron for the prevention of nausea and vomiting in patients with metastatic melanoma receiving interleukin-2–based concurrent biochemotherapy
Authors: Homsi J. , Bedikian A. Y. , Kim K. B. , Papadopoulos N. E. , Hwu W. , Mahoney S. , Vardeleon A. G. , Davies M. , Hwu P.
Published: August 2020

e20008

Background: Interleukin-2–based biochemotherapy (BCT) is a common therapy for patients (pts) with metastatic melanoma (MM). BCT induced nausea and vomiting (N/V) remains a significant problem (26% grade 3 and 4). Palonosetron (PALO) is a 5-HT3 receptor antagonist indicated for the prevention of N/V associated with chemotherapy. The recommended dosing schedule of PALO for patients on BCT is unknown. Methods: Chemo-naïve MM pts undergoing their first BCT cycle were randomized to receive PALO 0.25 mg as premedication intravenously on days 1 and 4, or the same dose on days 1, 3, and 5. The BCT regimen included: cisplatin (20 mg/m2) and vinblastine (1.6 mg/m2) on days 1–4, dacarbazine (800 mg/m2) on day 1, interleukin-2 (9 MIU/m2/day) by continuous infusion on days 1–4 and interferon alpha (5 MU/m2/day) on days 1–5. A nausea episode was defined as nausea of any severity reported by the patient or documented by the nursing staff at anytime. Pts with N/V due to known central nervous system or gastrointestinal metastases were excluded. The use of additional antiemetics was recorded. Pts were followed for 21 days (days 1–7 as inpatients). The Functional Living Index-Emesis (FLIE), an emesis- and nausea-specific questionnaire, was completed starting on day 1. Results: 30 pts were enrolled. Median age was 53 years (range 23–64). Eighteen (60%) were men. The incidences of BCT related N/V and those of nausea interfering with appetite, sleep, physical activity, social life and enjoyment of life are summarized by schedule of PALO in the table below. Conclusions: PALO administered on alternate days was more effective at controlling BCT-related N/V and reduced the need for PRN antiemetics. Better control of N/V reduced the impact of N/V on patient functioning in this population.

[Table: see text]

No significant financial relationships to disclose.
Invasive melanoma of the face: Patterns of local and regional disease in 261 patients managed at a single institution
Authors: Chambers A. J. , Murynka T. , Arlette J. P. , Mckinnon J. G.
Published: August 2020

e20015

Background: The face is a common site of melanoma occurrence, and lesions in this location present specific management challenges. The purpose of this study was to examine outcomes associated with invasive melanoma of the face, with respect to local, regional and distant recurrence. Methods: Patients with invasive melanoma of the face managed from 1997–2008 were identified from a large population-based tumor registry and retrospectively reviewed. Details of lesion histopathology, initial management, sentinel node biopsy (SNB), and local, regional or distant recurrences were recorded. Results: 261 patients were reviewed, mean age 68 and median tumor thickness 0.87mm. Three patients (1.1%) had clinically involved nodes at presentation and underwent nodal dissection. Of 108 patients who were eligible for SNB (with tumor thickness >1mm, Clark level ≥IV or ulceration) this was performed in only 29 (27%). SNB was successfully identified in 28 (97%). No facial nerve injuries occurred. A mean of 1.5 nodes were removed; from parotid region in 24, cervical chain in 12, submandibular in 5, submental in 1 and retroauricular in 1. SNB was positive in 3 (11%) who subsequently underwent neck dissection/parotidectomy. Mean follow-up duration was 37 months. Local recurrence occurred in 13 (5%), in-transit recurrence in 4 (1.5%) and distant recurrence in 20 (7.7%). Regional nodal recurrence occurred in 10 (3.8%); after negative SNB in 1 (SNB failure rate 3.7%), after unsuccessful SNB in 1, following neck dissection for nodal disease at presentation in 1, and in 7 who did not undergo SNB (including 6 patients who were eligible). During the study period there were 60 deaths (crude mortality 23%); due to melanoma in 16, unrelated causes in 41, and indeterminate in 3. Conclusions: Facial melanoma is associated with low rates of regional recurrence despite a low rate of SNB for eligible lesions. Sentinel nodes were most commonly found in the parotid region and could be safely removed without nerve injury. Most regional recurrences occurred in patients eligible for SNB not undergoing this procedure. Due to the older age of patients with facial melanoma, most deaths occurring are from unrelated conditions, and distant metastatic disease was seen in only a small percentage of cases.

No significant financial relationships to disclose.
Cervical and colorectal cancer screening among breast cancer (BrCa) survivors followed in either a breast center (BC) or a breast survivorship clinic (SvC) at The University of Texas M.D. Anderson Cancer Center
Authors: Olson A. L. , Bevers T. , Guzman M. , Theriault R. L. , Hortobagyi G. N. , Hahn K. M.
Published: August 2020

e20506

Background: An essential component of cancer survivorship care includes the prevention and early detection of new cancers. We sought to determine if documentation of appropriate cervical and/or colon cancer screening differed between BrCa survivors followed in our BC (patients < 5 yrs from diagnosis of invasive BrCa or with active BrCa issues) and those seen in our SvC (patients with history of DCIS or ≥ 5 yrs from invasive BrCa diagnosis). Methods: IRB approval was obtained for this retrospective study. 5,982 BrCa survivors were seen for follow-up in our BC or SvC between 7/1/05 and 12/31/06. 2,811 BC patients and 1191 SvC patients (total = 4,002) met inclusion criteria: 1) not receiving chemotherapy, radiation, or undergoing surgical evaluation; 2) no evidence of recurrent BrCa; 3) ≥ 12 months from BrCa diagnosis, 4) no active GYN or GI complaints. Results: BrCa survivors followed our SvC were significantly more likely to have provider documentation of both cervical and colon cancer screening than those followed in our BC (72% versus 22.7%, and 68.4% versus 14.5%, respectively; both p values <0.001). Although nursing documentation of cervical cancer screening is required in both centers, SvC patients were more likely to have this documented than those in the BC (95.3% versus 56.5%, respectively; p <0.001). Nursing documentation of colon cancer screening is required in SvC (84.2% documented) but not in the BC (3.5% documented). Conclusions: BrCa survivors receiving care in our survivorship clinic were more likely to have nursing or provider documentation of cervical and/or colon cancer screening. Strategies that trigger documentation of non-BrCa screening take advantage of the “teachable moment” during a routine visit- thereby promoting the long-term health of cancer survivors.

No significant financial relationships to disclose.
Correlates of clinically significant fatigue in women with newly diagnosed breast cancer
Authors: Gerber N. L. , Diao G. , Stout N. , Soballe P. , McGarvey C. , Pfalzer L. , Springer B. , Shieh C.
Published: August 2020

e20517

Background: Cancer related fatigue (CRF) is common in cancer survivors. CRF has been reported to be one of the most distressing symptoms associated with cancer and its treatment. Activity and biological profiles of those who suffer from CRF, have been poorly characterized. This IRB approved prospective, natural history study reports fatigue and associated findings in women newly diagnosed with breast cancer (BrCa), receiving standard treatment. Methods: All women were evaluated pre-operatively and at >9 months after diagnosis. Variables measured: Age, height, marital status, presence of children, menopausal status, tumor size, node status, estrogen receptor (ER+), hemoglobin, white blood cell count, fasting blood glucose, and BMI. Patient reported outcomes included visual analog scale (VAS) of fatigue (F), SF-36 version2, Physical Activity Questionnaire (PAQ, Harvard Alumni Health Study) and Sleep Questionnaire. Some variables were dichotomized to maximize the statistical power for the relatively small sample size. Bivariate correlations, and logistic regression analyses were performed using two fatigue conditions: presence of any F, or presence of clinically significant fatigue (CSF) defined as >=4 on the VAS. Results: 61 women, mean age of 51y, 39% had BMI >=25, 85% had >= 1 child, 52% were post-menopause, 92% ER+. Increased F at follow-up was statistically significant when compared to baseline (p=<0.0001, using paired t-test). Significant correlations (p<0.1) are reported between CSF and the following: node+, BMI>=25; inverse correlations with amount of vigorous activity (PAQ), physical function and vitality on SF-36. Physical function (SF-36) had significant inverse correlations with: age, menopause, and BMI. Low vitality was associated with: large tumor size, high WBC, longer time sleeping. Node+, BMI>=25, low physical function and vitality levels retained statistically significant relationships to CSF in the regression analyses. Conclusions: Node+ BrCa, BMI>=25, low level of physical activity and vitality (SF-36) are correlated with CSF. Except node status, each is treatable and may reduce CSF

No significant financial relationships to disclose.
Significance of MTHFR gene mutation with normal homocysteine level in vascular events
Authors: Gadiyaram V. K. , Khan M. A. , Hogan T. , Altaha R. , Crowell E. , Hobbs G. , Perrota P.
Published: August 2020

e20520

Background: Hyperhomocysteinemia, due to a combination of genetic and environmental factors, is considered to be a risk factor for vascular disease. Two common variations of the MTHFR gene (C677T and A1298C) result in amino acid substitutions and enhanced thermolability of the enzyme. Individuals with MTHFR gene mutations appear to have raised plasma level of homocysteine which may lead to increased risk of vascular events. However, significance of MTHFR gene mutations with normal homocysteine levels is unknown. Objective: To assess the relation of MTHFR gene mutations with normal homocysteine level and risk of Vascular events (deep venous thrombosis (DVT), pulmonary embolism (PE), Ischemic Heart disease (IHD), cerebrovascular accidents (CVA),recurrent fetal loss). Methods: We reviewed the records of 90 patients referred to our benign hematology clinic for thrombophilia evaluation between 2006 and 2008. All available medical history for risk factors and laboratory test results, obtained from first vascular event through time of consultation, including genetic testing, were reviewed. Anti-cardiolipin antibody, MTHFR genotyping and Protein C and Protein S assays were performed at Warde Medical Laboratory, Ann Arbor, MI. Results: 61 patients with documented vascular events were tested for MTHFR gene mutations. Forty one of these patients also had homocysteine levels available. Thirty-eight of these 41 (92 %) patients had an MTHFR gene mutation with normal homocysteine levels. Eighteen (47%) of these 38 patients had only an MTHFR gene mutation with normal homocysteine level and no other congenital or acquired risk factors for vascular events identified. Conclusions: In our clinic population, many patients with documented vascular events had MTHFR gene polymorphisms with normal homocysteine levels with no other thrombophilia risk factors identified, raising the question of whether MTHFR gene polymorphisms alone, without hyperhomocysteinemia, may somehow contribute to thrombophilia.

[Table: see text]

No significant financial relationships to disclose.
Coping styles and psychological outcomes in men with advanced cancer
Authors: Schmidt K. , Monahan P. , Tong Y. , Rawl S. , Rand K. , Cripe L. D.
Published: August 2020

e20521

Background: The psychological outcomes of men with advanced cancer may vary based upon their appraisal and response to the threat of cancer. Coping styles in other illnesses are influenced by gender and stage of disease, but little is known specifically about men with advanced cancer. Methods: We recruited 81 men with advanced cancer to complete surveys assessing coping (Mini-MAC), post-traumatic growth (PTGI), and psychological outcomes (Hospital Anxiety and Depression Scale). Psychological outcomes and coping styles were determined with means, and percentages above established cutoff points. Relationships were assessed using Pearson correlation coefficients. Results: The mean HADS anxiety and depression scores were 5.4 and 4.0, respectively. Fourteen men (17%) scored 8–10 and 8 (10%) scored ≥11 suggesting an anxiety state and disorder, respectively. Eight men (10%) had scores suggesting a depressive state and 4 (5%) a depressive disorder. Greater helplessness/hopelessness and anxious preoccupation scores were correlated with greater anxiety (r =.54, p<.0001; r =.66, p<.0001) and depression scores (r =.43, p<.0001; r=.47, p<.0001). Greater fighting spirit correlated with less anxiety (r =-.26, p=.018) and less depression (r = -.42, p < .0001) and with increased post-traumatic growth in the form of new possibilities (r = .26, p = .020), personal strength (r = .33, p = .003), and the total PTGI score (r = .23, p = .043). Greater fatalism was associated with lower total distress measured by the total HADS score (r = -.24, p = .032), and marginally so when assessed separately for anxiety (r = -.22, p = .052) and depression (r = -.21, p = .056). In addition, greater fatalism was significantly associated with greater post-traumatic growth in all five areas assessed by the PTGI subscales (.27 < r < .36; .001 p < .032). Conclusions: As expected men with advanced cancer report anxiety and depression. Coping styles were significantly associated with anxiety, depression, and post-traumatic growth.

No significant financial relationships to disclose.
Impact of pegylated liposomal doxorubicin (PLD) plus docetaxel (D) versus single-agent D on health-related quality of life (HRQOL) of patients with advanced breast cancer (BC) previously treated with neoadjuvant-adjuvant anthracycline
Authors: Tjulandin S. A. , Bondarenko I. N. , Semiglazov V. F. , Balashova O. I. , Makhson A. N. , Bogdanova N. V. , Wu Y. , Chatikhine V. A. , Yuan Z. , Sparano J. A.
Published: August 2020

e20522

Background: A randomized, multicenter phase 3 trial of PLD+D showed a significant improvement in the primary endpoint of time to progression (TTP) compared with D alone but with increased Grade 3/4 hand-foot syndrome (HFS: 24% vs. 0%) and mucositis/stomatitis (M/S: 12% vs. 1%) in patients (pts) with advanced breast cancer (BC). (Sparano JA et al. SABCS 2008. #80) This analysis evaluated HRQOL in these pts. Methods: Pts were randomized to D 75 mg/m2 (N=373) or PLD 30 mg/m2 + D 60 mg/m2 (N=378) on Day 1 every 21 days until progression or unacceptable toxicity. HRQOL was assessed using the Functional Assessment of Cancer Therapy - Breast (FACT-B) at baseline and at every cycle during treatment. FACT-B has 4 primary domains: physical, social/family, emotional, and functional, plus a BC-specific subscale. The primary analysis was a t-test comparison of change in the trial outcome index (TOI) from baseline to the last evaluation. TOI combined physical/functional domain scores with BC-specific scores. Other FACT-B endpoints analyzed included FACT-B total score and individual subscales. Also, % pts meeting an established minimally important difference (MID) of HRQOL improvement in TOI was assessed. Results: Median number of cycles was 6 for both arms. TOI was available for 97.9% of all scheduled assessments for both treatment groups. At baseline, mean FACT-B and TOI scores were similar for PLD+D vs D arms (94.2±18.6 vs 95.3±18.7 and 59.7±13.8 vs 60.2±13.4, respectively); other FACT-B domains were also similar. PLD+D vs D arms showed similar mean change from baseline to last evaluation in TOI (-4.6±12.2 vs -6.0±12.4; P=0.13). Other FACT-B subscales showed 1–2 point differences across domains over time. Likewise, % pts reaching MID was similar across arms. Pts in both arms experienced similar FACT-B declines as disease progressed. Conclusions: Despite increased HFS and M/S with PLD+D vs D alone, HRQOL was comparable for both arms.

[Table: see text]
The better bisphosphonate in patients with bone metastasis: Zoledronic acid or ibandronic acid? A study from Eastern India
Authors: Pandey R. , Dey S. , Mukhopadhyay A.
Published: August 2020

e20524

Background: Ibandronic acid is a third generation bisphosphonate which acts by inhibition of osteoclasts. Zoledronic acid also has a similar mechanism of action. This study was designed to study superiority or inferiority of either agent over other in terms of efficacy in reducing bone pain and complications in patients with bone metastases. Methods: From Jan 2005 to Dec 2008, 240 patients of various malignancies with bone metatstasis were enrolled and were randomized on a 1:1 basis to receive monthly IV infusions of ibandronate or zoledronate and were analysed for pain relief, skeletal related events and adverse events. Results: Patients in both the arms were well matched for their diagnosis, stage of disease, burden of skeletal disease and performance status. Different diagnoses were, carcinoma breast (n=99), carcinoma prostate (n=54), myeloma (n=48), carcinoma lung (n=23), others (n=20). Median follow up was 18 months. At 18 months, mean increases in British Pain Inventory pain scores were lower with zoledronate compared to ibandronate (0.43 vs 0.88 [p=0.02]). Analgesic use as defined by 4 point analgesic scale was less with zoledronate as compared to ibandronate. Incidence of skeletal related events was not significantly different between two arms (33% for zoledronate vs 39% for ibandronate [p=0.2]). Median time to first skeletal related event was not reached in either arm. At 18 months of median follow up, percentage of patients with skeletal related events were 39% in zoledronate arm vs 43% in ibandronate arm (p=0.06). Zoledronate caused fever in 30 (12.5%) patients and hypocalcemia in 10 patients. Ibandronte caused hypocalcemia in 3 patients. No cases of osteonecrosis of jaw were observed. Conclusions: Zoledronate is the preferred bisphosphonate in developing countries for its shorter infusion time and availability of cheaper generic brands. This study also indicates that it may be slightly better than ibandronate in reducing bone pain and preventing skeletal related events.

No significant financial relationships to disclose.
The effect and safety of Clino-san on vaginal symptoms in breast cancer survivors: A randomized, controlled study
Authors: Kim J. , Lee Y. , Park N. , Song Y. , Kang S.
Published: August 2020

e20525

Background: The purpose of this study was to determine the effect of Clino-san on vaginal symptoms and atrophy in breast cancer survivors treated with chemotherapy or endocrine therapy. Methods: A randomized, double-blind, placebo-controlled study. Breast cancer survivors who experienced menopause after chemotherapy or endocrine therapy were enrolled voluntarily and randomly applied vaginal topical lactic acid, Clino-san or placebo three times per week for 12 weeks. Vaginal dryness and dyspareunia measured by visual analogue scale, vaginal health index, vaginal pH, and the effect on endometrium or ovary were evaluated. Results: Among 89 enrolled women, 81 were evaluated. Forty-two received Clino-san treatment, and the remaining 39 received placebo. Vaginal dryness and dyspareunia in Clino-san treatment group improved compared with placebo group (p=0.012). Clino-san increased vaginal health index, however it is not statistically significant (p=0.058). Vaginal pH decreased more in Clino-san treatment group (p=0.025). There was no significant difference of adverse effects between two groups other than mild irritation at the early time of Clino-san use. Conclusions: Vaginal topical Clino-san could relieve the vaginal symptoms and improve the vaginal health in breast cancer survivors who experienced menopause after cancer treatment.

No significant financial relationships to disclose.
The predictors of information needs and different views of patients and relatives on disclosure and treatment participation: A multicentric survey study
Authors: Ozdogan M. , Bozcuk H. , Er O. , Abali H. , Coskun H. S. , Zengin N. , Artac M. , Savas B.
Published: August 2020

e20526

Background: We wanted to explain if the views of patients and their relatives differed on disclosure and treatment participation or not, and if so, to evaluate the predictors of this difference. Methods: The survey aimed to unveil the attitude of patients and their relatives in 3 domains; disclosure of diagnosis, prognosis and participation to treatment. Multinomial logistic regression models with forward selection procedure were constructed for the multivariate analysis to explain the origins of discordance in these domains. Results: A total of 1,052 consecutive cases (526 patients and their 526 relatives) were interviewed. The relatives, when they were asked to imagine themselves with a new diagnosis of cancer, opted for disclosure of diagnosis, prognosis, and participation to treatment in 92.4%, 84.6%, and 86.3% of cases. When patients were asked for their information needs in disclosure of diagnosis, prognosis, and participation to treatment, 83.8%, 70.2%, and 70% wanted disclosure, whereas, their relatives wanted disclosure for their patients in these 3 domains in 32.9%, 40.5%, and 60.3% of cases, respectively. The multivariate predictors of discordance for disclosure of diagnosis between patients and relatives were patient age, social insurance, and oncology centers (P=0.003, 0.007, and <0.001, respectively). The associates of discordance for disclosure of prognosis were again oncology centers and relatives’ relationship with the patients (P<0.001 and 0.012). Likewise, the correlates of discordance for treatment participation were again oncology centers and patient age (P<0.001 and 0.016). Conclusions: Information needs of patients and their relatives, when they imagine themselves as cancer patients, are quite similar. However, relatives are not in favor of disclosure to their patients of diagnosis and prognosis, moreover, in spite of this, they want their patients to actively participate in treatment decisions. We believe this paradox represents a desire of the relatives to escape from responsibility and emotional burden of the care of the cancer patients. This paradox, in addition, is a threat to a healthy patient and physician communication.

No significant financial relationships to disclose.
Single- versus multiple-item assessment of quality of life in patients with advanced cancer
Authors: Bush S. H. , Parsons H. A. , Palmer J. L. , Chacko R. , Li Z. , Scott C. , Bruera E.
Published: August 2020

e20528

Background: The main objective of palliative cancer care is to improve quality of life (QOL). As multiple dimensions impact on the construct of QOL, multi-dimensional instruments are usually used in its measurement. These are time consuming and burdensome for repeated use. Recent authors have suggested that brief single-item global assessments can provide a reliable measure of QOL. We assessed the performance of the Edmonton Symptom Assessment System ‘feeling of well-being’ item (ESAS WB) using the Functional Assessment of Cancer Therapy - General (FACT-G) instrument as a gold standard. Methods: After obtaining IRB approval, we reviewed the data from 213 advanced cancer patients who had participated in six studies from March 2006 to June 2008 and determined the level of association between baseline ESAS WB and FACT-G total score and subscale domains (Physical (Pwb), Social/Family (Swb), Emotional (Ewb), and Functional (Fwb) Well-Being) and also the 9 ESAS symptom intensity scores using Spearman correlation coefficients. We also calculated the change between the baseline (T1) and second (T2) observations of ESAS WB and of FACT-G total score and determined their level of association using a Pearson correlation coefficient. In addition, we predicted the change in FACT-G as predicted by the change in ESAS WB score using regression analysis. Results: Mean age was 60 (SD 12) years and 48% were female. At T1, the Spearman correlation coefficient of ESAS WB and FACT-G was -0.48 (p<0.0001). Spearman correlation coefficients for ESAS WB and FACT-G subscale domains and ESAS symptom intensity scores were also highly significant (p<0.0001) for all physical and emotional symptoms (other than p=0.003 for nausea) except for FACT Swb (p=0.08). The Pearson correlation coefficient for difference between T1 and T2 in ESAS WB and FACT-G for 146 patients was -0.36 (p<0.0001). The regression analysis was highly significant (p<0.0001). The change in ESAS WB corresponding to FACT-G published minimally important difference (MID) was -0.24 for 3, -1.55 for 5, and -2.87 for 7, respectively. Conclusions: ESAS WB is a practical instrument for clinical use and best reflects the Pwb, Ewb and Fwb domains of FACT-G as compared to Swb.

No significant financial relationships to disclose.
Management of cancer-related vertebral compression fracture: Comparison of treatment options: A literature meta-analysis
Authors: Bhargava A. , Trivedi D. , Kalva L. , Tumas M. , Hooks M. , Speth J.
Published: August 2020

e20529

Objective: The objective of this review was to compare the efficacy and safety of treatment options for management of vertebral compression fractures (VCF) secondary to multiple myeloma and/or metastatic tumors based on a meta-analysis of the literature. Methods: A search was performed of published literature through November 2008. All articles reporting at least one clinical outcome were included. VAS pain scores and cement extravasation were the most common efficacy and safety outcomes reported in the included studies and were considered for analysis. The mean weighted difference in VAS scores or the effect size was calculated using the number of patients in each study as the weights. The paired t-test was used to assess significance of these differences. A 95% confidence interval (CI) was computed around these differences. The significance of difference (VAS and % cement extravasations) between different modes of treatment was assessed using a two sample t-test. Results: A total of 59 studies met the inclusion criteria and were included in the meta-analysis. The majority of the included studies (56 studies) were case series. No randomized controlled study was identified. The total sample size from the included study was 4,460 patients - 73% of patients had a diagnosis of tumor metastasis to the vertebral column; 18% had a diagnosis of multiple myeloma. Percutaneous vertebroplasty (VP) was described in 57.6% studies; balloon kyphoplasty (BKP) in 20.3%; conservative/combined (CC) therapy in 22%. Results are shown in the Table . Conclusions: This meta-analysis indicates that BKP is more effective than either VP or conservative therapy in relieving pain secondary to cancer-related VCF and that BKP is a safer intervention than VP based on the analysis of the rates of cement extravasation.

[Table: see text]

No significant financial relationships to disclose.
The association between autonomic dysfunction and survival in advanced cancer: A preliminary report
Authors: Fadul N. A. , Strasser F. , Palmer J. L. , Dalal S. , Allo J. , Bruera E.
Published: August 2020

e20534

Background: Autonomic nervous system dysfunction (AD) is a common syndrome in patients with advanced cancer. It is associated with decreased survival in several patient populations including diabetes mellitus, heart failure and neurological diseases. Based on this available evidence, we hypothesized that autonomic dysfunction is associated with reduced survival in patients with advanced cancer. The objective of this preliminary study was to test the association between AD as measured by the standardized Ewing test and Heart Variability (HRV) measures and survival in patients with advanced cancer. Methods: We examined the relationship between survival and parameters of AD in male patients with advanced cancer who participated in a prospective study of autonomic dysfunction and hypogonadism. Eligibility criteria were defined based on the prospective study protocol. We collected demographic information, date of study entry and Ewing and HRV scores. Date of death was obtained from the online Social Security Death Index database. We defined survival as the interval between study entry and date of death. A survival analysis was used to test the association between survival (days) and Ewing test (0–5) and measures of heart rate variability (HRV), including time domain (SDNN) and frequency domain (Ultra low, Very low, Low, and High frequency) parameters.A spearman correlation test was also performed. Results: 47 male patients were included in this study. Median age was 59 (20–79) and 63% were caucasians. Autonomic dysfunction (AD), defined as Ewing score >2, was present in 80% (38/47) of the patients. Median Ewing score was 3 (1–5), indicating moderate to severe AD. Spearman correlation for Ewing and SDNN HRV was 0.44 (p=0.002). There was a significant association between abnormal Ewing score and survival (p<0.0001), and abnormal SDNN HRV and survival (p=0.056). Spearman correlation for Ewing score and survival and SDNN HRV and survival were r = -0.27620 (p=0.0602) and r =0.24198 (p= 0.1013) respectively. Conclusions: Autonomic dysfunction is associated with shorter survival in male patients with advanced cancer. Further longitudinal research in a larger cohort is justified based on these findings.

No significant financial relationships to disclose.
Functional recovery after surgery in patients with breast cancer
Authors: Springer B. , Danoff J. , Levy E. , Stout N. , Pfalzer L. , McGarvey C. , Gerber L. , Soballe P.
Published: August 2020

e20539

Background: Upper extremity dysfunction and decreased quality of life are frequently reported sequelae of the treatment for early stage breast cancer (BC). Surgical trauma and/or radiation therapy may lead to upper extremity (UE) impairments, functional limitations and disabilities including pain, stiffness, lymphedema, decreased strength and range of motion (ROM) and decreased activity tolerance. In this study we examined specific functional characteristics of shoulder impairments and associated limitations. Methods: Women (n=88, mean age = 53y [SD=11.81]) newly diagnosed with unilateral, Stage I to III BC were screened pre-operatively for this prospective trial. Patient data and physical therapy based assessments were recorded at the pre-operative visit (baseline) and at 1, 3, and 12+ months (BA, M1, M3, M12) after surgical treatment including pain (VAS on 10 point scale), bilateral shoulder ROM and strength (MMT). Volumes for upper extremities were taken using an optoelectric device (Perometer®). During post BC treatment visits, appropriate physical therapy was provided, and if there was a diagnosis of lymphedema, a light-grade compression garment was fitted. ROMs (shoulder Abd, ER, Flex, IR), a composite MMT value, and volume were analyzed with one-way repeated ANOVA including Greenhouse-Geisser correction for non-normal data where necessary. Post hoc testing was done using Within-Subjects Contrasts. Limited range of values for pain resulted in a highly skewed distribution, inappropriate for statistical testing. Results: For the variables Abd, ER, Flex, and sumMMT there was a decrease in function from BA to M1, improvement from M1 to M3, and further improvement from M3 to M12 (all p < 0.0001). For IR there was a decrease from BA to M1, no difference between M1 and M3, and an improvement from M1 and M3 to M12 (p < 0.3). Pain remained relatively low with 60–80% of the women reporting ≤2/10. Conclusions: After surgery for breast cancer, a decrement in shoulder function may be expected around 1 month after the procedure. Most subjects demonstrated significant improvement in function by 3 months after the procedure, and by 12 months, subjects achieved near complete recovery of shoulder impairment.

No significant financial relationships to disclose.