bluuebunny/crossref_metadata_2025_split huggingface dataset:
Enrollment of African Americans Onto Clinical Treatment Trials: Study Design Barriers
Authors: Adams-Campbell Lucile L. , Ahaghotu Chiledum , Gaskins Melvin , Dawkins Fitzroy W. , Smoot Duane , Polk Octavius D. , Gooding Robert , DeWitty Robert L. 
Published: February 2004

Purpose African Americans have the highest cancer mortality rates and poorest survival and are more often uninsured and underinsured compared with other ethnic groups. Minority participation in clinical trials has traditionally been low, with reports ranging from 3% to 20%. The present study systematically assesses 235 consecutively diagnosed African American cancer patients regarding recruitment onto cancer treatment clinical trials at Howard University Cancer Center between January 1, 2001, and December 31, 2002. Our intent is to determine the rate-limiting factors associated with enrolling African Americans onto clinical trials at a historically black medical institution. Patients and Methods Two hundred thirty-five consecutively diagnosed African American cancer patients were assessed for participation in clinical trials at Howard University Hospital and Cancer Center. The study population comprised 165 women and 70 men. Results The overall eligibility rate was 8.5% (20 of 235 patients); however, among those eligible, the enrollment rate (ie, enrollment among the eligible population) was 60.0% (12 of 20 patients). Comorbidities rendered 17.1% of the patient population ineligible for the trials. Advanced disease stage, associated with poor performance status, premature death, and short life expectancy, made an additional 10% of the patient population ineligible. Respiratory failure, HIV positivity, and anemia accounted for 37.8% of the comorbidities in this population. Cardiovascular diseases and renal insufficiency represented 16.2% of the comorbidities. Conclusion It was evident that study design exclusion and inclusion criteria rendered the majority of the study population ineligible. Among African Americans, comorbidity is a major issue that warrants considerable attention.
An Assessment of the Utilization of Complementary and Alternative Medication in Women With Gynecologic or Breast Malignancies
Authors: Navo Marisa A. , Phan Julie , Vaughan Christy , Palmer J. Lynn , Michaud Laura , Jones Kellie L. , Bodurka Diane C. , Basen-Engquist Karen , Hortobagyi Gabriel N. , Kavanagh John J. , Smith Judith A. 
Published: February 2004

Purpose To describe and assess the current utilization of complementary and alternative medicines (CAMs) in women with a diagnosis of either gynecologic or breast cancer and evaluate their reasons for use. Patients and Methods This study included 250 female patients from the Multidisciplinary Breast Center and 250 patients from the Gynecologic Oncology Center of The University of Texas M.D. Anderson Cancer Center (Houston, TX). Patients were selected by having an odd-numbered medical record number, and they were contacted before their clinic visit. The goals of the study were explained, and verbal consent was obtained. Patients who agreed to participate were asked to bring a written list and the medication bottles of all over-the-counter prescriptions and CAMs with them to clinic. In clinic, the investigator obtained a written informed consent and administered the survey. All patients and surveys were assessable. Results The most frequently used herbal products and megavitamins/minerals were identified from the patient medication histories. Overall, we found the proportion of patients using CAM to be 48% (95% CI, 44% to 53%; 241 of 500 patients). CAM use was related to patients' educational status: 62% had postgraduate degrees, 50% had college degrees, 56% had some college, and 33% had a high school education or less. Also, among patients using CAMs, only 53.5% had spoken to a healthcare provider regarding CAM therapy. Conclusion The use of CAM is common among women with cancer. Studies need to be conducted to establish if there are any potential drug interactions and/or therapeutic benefit of CAM products. Moreover, there is a need to educate patients and healthcare providers on appropriate and safe use of CAM products.
Human Kallikrein 13 Protein in Ovarian Cancer Cytosols: A New Favorable Prognostic Marker
Authors: Scorilas Andreas , Borgoño Carla A. , Harbeck Nadia , Dorn Julia , Schmalfeldt Barbara , Schmitt Manfred , Diamandis Eleftherios P. 
Published: February 2004

Purpose Human kallikrein 13 (hK13; encoded by the KLK13 gene) is a secreted serine protease expressed in endocrine tissues, including the prostate, testis, breast, and ovary. We have previously reported steroid hormone regulation of the KLK13 gene and its clinical value as a marker of favorable prognosis in breast cancer at the mRNA level. We hypothesized that hK13 may represent a potential biomarker for ovarian carcinomas. Patients and Methods Using a newly developed enzyme-linked immunosorbent assay (ELISA), hK13 levels were quantified in 131 ovarian tumor extracts and correlated with various clinicopathological variables and outcome (progression-free survival [PFS], overall survival [OS]), over a median follow-up period of 42 months. Results hK13 concentration in ovarian tumor cytosols ranged from 0 to 18.4 ng/mg of total protein. An optimal cutoff value of 0.13 ng/mg (67th percentile) was selected, based on the ability of hK13 values to predict the PFS of the study population, to categorize tumors as hK13-positive or negative. Women with hK13-positive tumors most often had early stage (stage I/II) disease, no residual tumor after surgery and optimal debulking success (P < .05). Univariate and multivariate Cox regression analyses revealed that patients with hK13-positive tumors had a significantly longer PFS and OS than hK13-negative patients (P < .05). Kaplan-Meier survival curves further confirmed a reduced risk of relapse and death in women with hK13-positive tumors (P = .007 and P = .002, respectively). Conclusion These results indicate that hK13 is an independent marker of favorable prognosis in ovarian cancer.
Change in Neurocognitive Functioning After Treatment With Cranial Radiation in Childhood
Authors: Spiegler Brenda J. , Bouffet Eric , Greenberg Mark L. , Rutka James T. , Mabbott Donald J. 
Published: February 2004

Purpose To evaluate the pattern of stability and change over time across multiple domains of neurocognitive function in radiated survivors of posterior fossa (PF) tumors. Patients and Methods Thirty-four children (25 males) treated for malignant PF tumors were observed with serial clinical neuropsychologic assessments. Thirty patients were treated for medulloblastoma and four patients were treated for ependymoma. Twelve patients were treated with reduced-dose and 21 patients were treated with standard-dose cranial radiation. All patients received an additional boost to the PF. One patient was treated with PF radiation only. Standardized neuropsychologic tests were administered at different times after diagnosis for each child. The rate of change in scores was determined using a mixed model regression. Results Results showed a 2- to 4-point decline per year in intelligence scores. For our relatively young sample, intellectual function declined quickly in the first few years after treatment, and then more gradually. Significant declines in visual-motor integration, visual memory, verbal fluency, and executive functioning were also documented. No decline was evident for verbal memory and receptive vocabulary. Conclusion Cranial radiation is associated with a decline in multiple neurocognitive domains, with a few notable exceptions. Our results must be interpreted in the context of common limitations of clinical research, including patient variability, changes in test versions, small sample size, and clinical referral bias.
NF-κB in the Vascular Progression of Melanoma
Authors: Kashani-Sabet Mohammed , Shaikh Ladan , Miller James R. , Nosrati Mehdi , Ferreira Carlos M.M. , Debs Robert J. , Sagebiel Richard W. 
Published: February 2004

Purpose To examine a model of melanoma progression based on vascular factors and the role of NF-κB in the vascular progression of melanoma. Patients and Methods A data set of 526 patients from the University of California San Francisco Melanoma Center with 2 years of follow-up or first relapse was studied. The impact of the presence or absence of various prognostic factors on overall survival of melanoma patients was assessed using Cox regression and Kaplan-Meier analysis. A matched-pair analysis of NF-κB expression was performed in cases with vascular involvement and increased tumor vascularity versus matched controls lacking these factors. Results Cox regression analysis of factors evaluated by the American Joint Committee on Cancer Melanoma Staging Committee reproduced the powerful impact of tumor thickness and ulceration in this data set. With the inclusion of vascular factors such as tumor vascularity and vascular involvement, ulceration was no longer significant in predicting overall survival. By multivariate analysis, vascular involvement and tumor vascularity were the strongest predictors of melanoma outcome. Tumor vascularity seems to be a precursor of both vascular involvement and ulceration. A matched-pair tissue array analysis demonstrated the significant correlation between overexpression of NF-κB–p65 and the development of vascular factors. Conclusion Vascular factors play an important role in the progression of malignant melanoma. Ulceration may be a surrogate marker for the interactions between melanoma and the tumor vasculature. NF-κB seems to play an important role in the development of these factors.
Measuring Quality of Life in Routine Oncology Practice Improves Communication and Patient Well-Being: A Randomized Controlled Trial
Authors: Velikova Galina , Booth Laura , Smith Adam B. , Brown Paul M. , Lynch Pamela , Brown Julia M. , Selby Peter J. 
Published: February 2004

Purpose To examine the effects on process of care and patient well-being, of the regular collection and use of health-related quality-of-life (HRQL) data in oncology practice. Patients and Methods In a prospective study with repeated measures involving 28 oncologists, 286 cancer patients were randomly assigned to either the intervention group (regular completion of European Organization for Research and Treatment of Cancer-Core Quality of Life Questionnaire version 3.0, and Hospital Anxiety and Depression Scale on touch-screen computers in clinic and feedback of results to physicians); attention-control group (completion of questionnaires, but no feedback); or control group (no HRQL measurement in clinic before encounters). Primary outcomes were patient HRQL over time, measured by the Functional Assessment of Cancer Therapy-General questionnaire, physician-patient communication, and clinical management, measured by content analysis of tape-recorded encounters. Analysis employed mixed-effects modeling and multiple regression. Results Patients in the intervention and attention-control groups had better HRQL than the control group (P = .006 and P = .01, respectively), but the intervention and attention-control groups were not significantly different (P = .80). A positive effect on emotional well-being was associated with feedback of data (P = .008), but not with instrument completion (P = .12). A larger proportion of intervention patients showed clinically meaningful improvement in HRQL. More frequent discussion of chronic nonspecific symptoms (P = .03) was found in the intervention group, without prolonging encounters. There was no detectable effect on patient management (P = .60). In the intervention patients, HRQL improvement was associated with explicit use of HRQL data (P = .016), discussion of pain, and role function (P = .046). Conclusion Routine assessment of cancer patients' HRQL had an impact on physician-patient communication and resulted in benefits for some patients, who had better HRQL and emotional functioning.
Phase II Trial of Biweekly Infusional Fluorouracil, Folinic Acid, and Oxaliplatin in Patients With Advanced Gastric Cancer
Authors: Al-Batran Salah-Eddin , Atmaca Akin , Hegewisch-Becker Susanna , Jaeger Dirk , Hahnfeld Sabine , Rummel Mathias J , Seipelt Gernot , Rost Andreas , Orth Jacqueline , Knuth Alexander , Jaeger Elke 
Published: February 2004

Purpose To evaluate the toxicity and activity of infusional fluorouracil (FU), folinic acid (FA), and oxaliplatin, administered every 2 weeks in patients with metastatic gastric cancer. Patients and Methods Forty-one previously untreated patients with measurable adenocarcinoma of the stomach were eligible for the study. Patients received FU 2.6 g/m2 (24-hour continuous infusion), FA 500 mg/m2 (2-hour intravenous infusion), and oxaliplatin 85 mg/m2 (2-hour intravenous infusion) every 2 weeks for 6 weeks. Treatment was continued until progression of disease was observed. Results All patients were assessable for toxicity and 37 of 41 patients were assessable for response. Patient characteristics were: sex (male, 28; female,13), median age 60 years (range, 20 to 77 years), and median Eastern Cooperative Oncology Group performance status of 1. Response was evaluated every 6 weeks. Of 37 assessable patients, one complete and 15 partial remissions were observed (overall response rate, 43%). Stable disease was observed in 12 patients (32%) and progressive disease in nine patients (24%). The median overall survival was 9.6 months. WHO grade 3 or 4 hematologic toxicities included neutropenia in two patients (4.9%) and thrombocytopenia in one patient (2.4%). Other WHO grade 3 or 4 toxicities included diarrhea in three patients (7.3%) and vomiting in two patients (4.9%). There were no cases of grade 3 peripheral neuropathy and no treatment-related deaths. Conclusion Biweekly fluorouracil, folinic acid, and oxaliplatin is active and well-tolerated in patients with advanced gastric cancer. Response rates, time to progression, and overall survival were comparable to those achieved with other combination chemotherapy regimens, including FOLFOX6, with significantly less toxicity.
Prognosis of Premenopausal Breast Cancer and Childbirth Prior to Diagnosis
Authors: Phillips Kelly-Anne , Milne Roger L. , Friedlander Michael L. , Jenkins Mark A. , McCredie Margaret R.E. , Giles Graham G. , Hopper John L. 
Published: February 2004

Purpose The time interval between last childbirth and subsequent breast cancer diagnosis is emerging as an important prognostic factor for premenopausal women. Patients and Methods We studied, prospectively, 750 women diagnosed with primary invasive breast cancer before age 45 years who participated in the population-based Australian Breast Cancer Family Study (ABCFS). Results Median follow-up time was 4.9 years (range, 0.8 to 10.8 years). Compared with nulliparous women, women who gave birth within 2 years prior to diagnosis were more likely to have axillary node-positive (58% v 41%; P = .01), and estrogen receptor-negative (58% v 39%; P = .005) tumors. The unadjusted hazard ratios for death were 2.3 (95% CI, 1.3 to 3.8; P = .002), 1.7 (95% CI, 1.1 to 2.6; P = .03), and 0.9 (95% CI, 0.6 to 1.5; P = .8) for patients who gave birth less than 2 years, 2 to 5 years, and 5 or more years before diagnosis, respectively. After adjusting for tumor characteristics, these hazard ratios were reduced to 1.9 (95%CI, 1.1 to 3.2; P = .02), 1.3 (95% CI, 0.8 to 2.1; P = .3), and 0.9 (95%CI, 0.5 to 1.4; P = .5). Modeling showed that, compared with nulliparous women, the mortality hazard ratio in parous women was 1.9, decreasing by 8% (95%CI, 4% to 13%; P < .001) for each year between last birth and breast cancer diagnosis. Conclusion Proximity of last childbirth to subsequent breast cancer diagnosis is a predictor of mortality independent of histopathological tumor characteristics. Clinicians should be aware that women diagnosed with breast cancer within a few years following childbirth may have a worse outcome than that suggested solely by the standard histopathological prognostic factors of their cancer.
Impact of Body Mass Index on Outcomes and Treatment-Related Toxicity in Patients With Stage II and III Rectal Cancer: Findings From Intergroup Trial 0114
Authors: Meyerhardt Jeffrey A. , Tepper Joel E. , Niedzwiecki Donna , Hollis Donna R. , McCollum A. David , Brady Denise , O'Connell Michael J. , Mayer Robert J. , Cummings Bernard , Willett Christopher , Macdonald John S. , Benson Al B. , Fuchs Charles S. 
Published: February 2004

Purpose To study the relationship between body mass index (BMI) and rates of sphincter-preserving operations, overall survival, cancer recurrence, and treatment-related toxicities in patients with rectal cancer. Patients and Methods We evaluated a nested cohort of 1,688 patients with stage II and III rectal cancer participating in a randomized trial of postoperative fluorouracil-based chemotherapy and radiation therapy. Results Obese patients were more likely to undergo an abdominoperineal resection (APR) than normal-weight patients (odds ratio, 1.77; 95% CI, 1.27 to 2.46). When analyzed by sex, increasing adiposity in men was a strong predictor of having an APR (P < .0001). Obese men with rectal cancer were also more likely than normal-weight men to have a local recurrence (hazard ratio [HR], 1.61; 95% CI, 1.00 to 2.59). In contrast, obesity was not predictive of cancer recurrence in women, nor was BMI predictive of overall mortality in either men or women. Underweight patients had an increased risk of death (HR, 1.43; 95% CI, 1.08 to 1.89) compared with normal-weight patients but no increase in cancer recurrences. Among all study participants, obese patients had a significantly lower rate of grade 3 to 4 leukopenia, neutropenia, and stomatitis and a lower rate of any grade 3 or worse toxicity when compared with normal-weight individuals. Conclusion Increasing BMI in male patients with rectal cancer is associated with a decreased likelihood of sphincter preservation and a higher chance of local recurrence. For both men and women, overweight and obese patients experience less toxicity associated with adjuvant chemoradiotherapy, suggesting that actual body weight dosing of fluorouracil for obese patients is justified.
Primary Cutaneous B-Cell Lymphoma Treated With Radiotherapy: A Comparison of the European Organization for Research and Treatment of Cancer and the WHO Classification Systems
Authors: Smith Benjamin D. , Glusac Earl J. , McNiff Jennifer M. , Smith Grace L. , Heald Peter W. , Cooper Dennis L. , Wilson Lynn D. 
Published: February 2004

Purpose To determine the relationship between the WHO and European Organization for Research and Treatment of Cancer (EORTC) pathologic classifications for primary cutaneous B-cell lymphoma (CBCL) and the implication of this relationship on initial treatment. Patients and Methods Patients with primary CBCL treated with radiotherapy were identified retrospectively. Initial biopsy specimens were reviewed by two dermatopathologists and classified according to the EORTC and WHO systems. Primary outcomes were recurrence-free and overall survival. Results Thirty-four patients were identified; initial biopsy specimens were adequate for classification in 32 patients. Four different composite histopathologic subtypes of lymphoma were identified: 53% (17 of 32) follicle center cell by EORTC and diffuse large B-cell by WHO (FCC/DLB), 25% (eight of 32) follicle center cell by EORTC and follicular by WHO (FCC/Fol), 13% (four of 32) marginal zone by EORTC and WHO (MZ/MZ), and 9% (three of 32) large B-cell of the leg by EORTC and diffuse large B-cell by WHO (Leg/DLB). Five-year relapse-free survival ranged from 62% to 73% for FCC/DLB, FCC/Fol, and MZ/MZ but was 33% for Leg/DLB (P = .6). Five-year overall survival was 100% for FCC/DLB, FCC/Fol, and MZ/MZ but was 67% for Leg/DLB (P = .07). At 5 years, 21% of all patients had developed extracutaneous disease. Conclusion Two-thirds of primary cutaneous FCC lymphomas by EORTC criteria satisfy WHO criteria for DLB lymphoma. Unlike DLB lymphoma presenting in nodal or noncutaneous sites, these lesions are associated with an indolent course and may be treated with local radiotherapy alone.
EBV-Positive Gastric Adenocarcinomas: A Distinct Clinicopathologic Entity With a Low Frequency of Lymph Node Involvement
Authors: van Beek Josine , zur Hausen Axel , Klein Kranenbarg Elma , van de Velde Cornelis J.H. , Middeldorp Jaap M. , van den Brule Adriaan J.C. , Meijer Chris J.L.M. , Bloemena Elisabeth 
Published: February 2004

Purpose Epstein-Barr virus (EBV) is detected in a substantial subgroup of gastric adenocarcinomas worldwide. We have previously reported that these EBV-positive gastric carcinomas carry distinct genomic aberrations. In the present study, we analyzed a large cohort of EBV-positive and EBV-negative gastric adenocarcinomas for their clinicopathologic features to determine whether they constitute a different clinical entity. Patients and Methods Using a validated polymerase chain reaction/enzyme immunoassay–based prescreening method in combination with EBER1/2-RNA in situ hybridization, EBV was detected in the tumor cells of 7.2% (n = 41) of the gastric carcinomas from the Dutch D1D2 trial (N = 566; mean follow-up, 9 years). EBV status was correlated with clinicopathologic features collected for the Dutch D1D2 trial. Results EBV-positive gastric carcinomas occurred significantly more frequently in males (P < .0001) and in younger patients (P = .012). Most were of the intestinal type according to the Laurén classification (P = .047) or tubular according to the WHO classification (P = .006) and located in the proximal part of the stomach (P < .0001). A significantly lower tumor-node-metastasis system-stage (P = .026) was observed in the patients with EBV-carrying carcinomas, which was solely explained by less lymph node (LN) involvement (P = .034) in these cases. In addition, a better prognosis, as reflected by a longer disease-free period (P = .04) and a significant better cancer-related survival (P = .02), was observed for these patients, which could be explained by less LN involvement, less residual disease, and younger patient age. Conclusion EBV-carrying gastric adenocarcinomas are a distinct entity of carcinomas, characterized not only by unique genomic aberrations, but also by distinct clinicopathologic features associated with significantly better prognosis.