bluuebunny/crossref_metadata_2025_split huggingface dataset:
Home-Based Physical Activity Intervention for Breast Cancer Patients
Authors: Pinto Bernardine M. , Frierson Georita M. , Rabin Carolyn , Trunzo Joseph J. , Marcus Bess H. 
Published: May 2005

Purpose The efficacy of a home-based physical activity (PA) intervention for early-stage breast cancer patients was evaluated in a randomized controlled trial. Patients and Methods Eighty-six sedentary women (mean age, 53.14 years; standard deviation, 9.70 years) who had completed treatment for stage 0 to II breast cancer were randomly assigned to a PA or contact control group. Participants in the PA group received 12 weeks of PA counseling (based on the Transtheoretical Model) delivered via telephone, as well as weekly exercise tip sheets. Assessments were conducted at baseline, after treatment (12 weeks), and 6 and 9 month after baseline follow-ups. The post-treatment outcomes are reported here. Results Analyses showed that, after treatment, the PA group reported significantly more total minutes of PA, more minutes of moderate-intensity PA, and higher energy expenditure per week than controls. The PA group also out-performed controls on a field test of fitness. Changes in PA were not reflected in objective activity monitoring. The PA group was more likely than controls to progress in motivational readiness for PA and to meet PA guidelines. No significant group differences were found in body mass index and percent body fat. Post-treatment group comparisons revealed significant improvements in vigor and a reduction in fatigue in the PA group. There was a positive trend in intervention effects on overall mood and body esteem. Conclusion The intervention successfully increased PA and improved fitness and specific aspects of psychological well-being among early-stage breast cancer patients. The success of a home-based PA intervention has important implications for promoting recovery in this population.
Phase I Study of 506U78 Administered on a Consecutive 5-Day Schedule in Children and Adults With Refractory Hematologic Malignancies
Authors: Kurtzberg J. , Ernst T.J. , Keating M.J. , Gandhi V. , Hodge J.P. , Kisor D.F. , Lager J.J. , Stephens C. , Levin J. , Krenitsky T. , Elion G. , Mitchell B.S. 
Published: May 2005

Purpose A phase I study was conducted to determine the maximum-tolerated dose (MTD), toxicity profile, and pharmacokinetics of a novel purine nucleoside, nelarabine, a soluble prodrug of 9-beta-D-arabinosylguanine (araG; Nelarabine), in pediatric and adult patients with refractory hematologic malignancies. Patients and Methods Between April 1994 and April 1997, 93 patients with refractory hematologic malignancies were treated with one to 16 cycles of study drug. Nelarabine was administered daily, as a 1-hour intravenous infusion for 5 consecutive days, every 21 to 28 days. First-cycle pharmacokinetic data, including plasma nelarabine and araG levels, were obtained on all patients treated. Intracellular phosphorylation of araG was studied in samples of leukemic blasts from selected patients. Results The MTDs were defined at 60 mg/kg/dose and 40 mg/kg/dose daily × 5 days in children and adults, respectively. Dose-limiting toxicity (DLT) was neurologic in both children and adults. Myelosuppression and other significant organ toxicities did not occur. Pharmacokinetic parameters were similar in children and adults. Accumulation of araGTP in leukemic blasts was correlated with cytotoxic activity. The overall response rate was 31%. Major responses were seen in patients with T-cell malignancies, with 54% of patients with T-lineage acute lymphoblastic leukemia achieving a complete or partial response after one to two courses of drug. Conclusion Nelarabine is a novel nucleoside with significant cytotoxic activity against malignant T cells. DLT is neurologic. Phase II and III trials in patients with T-cell malignancies are encouraged.
Phase II Study of Nelarabine (compound 506U78) in Children and Young Adults With Refractory T-Cell Malignancies: A Report From the Children’s Oncology Group
Authors: Berg Stacey L. , Blaney Susan M. , Devidas Meenakshi , Lampkin Tom A. , Murgo Anthony , Bernstein Mark , Billett Amy , Kurtzberg Joanne , Reaman Greg , Gaynon Paul , Whitlock James , Krailo Mark , Harris Michael B. 
Published: May 2005

Purpose Nelarabine (compound 506U78), a water soluble prodrug of 9-b-d-arabinofuranosylguanine, is converted to ara-GTP in T lymphoblasts. We sought to define the response rate of nelarabine in children and young adults with refractory or recurrent T-cell disease. Patients and Methods We performed a phase II study with patients stratified as follows: stratum 1: ≥ 25% bone marrow blasts in first relapse; stratum 2: ≥ 25% bone marrow blasts in ≥ second relapse; stratum 3: positive CSF; stratum 4: extramedullary (non-CNS) relapse. The initial nelarabine dose was 1.2 g/m2 daily for 5 consecutive days every 3 weeks. There were two dose de-escalations due to neurotoxicity on this or other studies. The final dose was 650 mg/m2/d for strata 1 and two patients and 400 mg/m2/d for strata 3 and four patients. Results We enrolled 121 patients (106 assessable for response) at the final dose levels. Complete plus partial response rates at the final dose levels were: 55% in stratum 1; 27% in stratum 2; 33% in stratum 3; and 14% in stratum 4. There were 31 episodes of ≥ grade 3 neurologic adverse events in 27 patients (18% of patients). Conclusion Nelarabine is active as a single agent in recurrent T-cell leukemia, with a response rate more than 50% in first bone marrow relapse. The most significant adverse events associated with nelarabine administration are neurologic. Further studies are planned to determine whether the addition of nelarabine to front-line therapy for T-cell leukemia in children will improve survival.
Randomized Comparison of Group Versus Individual Genetic Education and Counseling for Familial Breast and/or Ovarian Cancer
Authors: Calzone Kathleen A. , Prindiville Sheila A. , Jourkiv Oxana , Jenkins Jean , DeCarvalho Maria , Wallerstedt Dawn B. , Liewehr David J. , Steinberg Seth M. , Soballe Peter W. , Lipkowitz Stan , Klein Pamela , Kirsch Ilan R. 
Published: May 2005

Purpose An efficient approach to education and counseling before BRCA1 and BRCA2 mutation testing is necessary for effective utilization of testing in the community. Education and counseling, when delivered individually, are limited by a shortage of trained health care providers as well as by financial and time constraints. The purpose of this study was to determine whether pretest education and counseling for breast cancer genetics in a group setting is equivalent to that provided on an individual basis. Patients and Methods One hundred forty-two patients at high risk for harboring a BRCA mutation were randomly assigned to group or individual education and counseling sessions. Group education was followed by brief individual counseling. Knowledge and Impact of Events Scales (IES) were administered at baseline and after education and counseling and at 1 week and 3, 6, and 12 months. Satisfaction with education and counseling was measured at completion of the session. Preferred method of education and counseling was solicited at 3 months. Results There was no difference in knowledge or IES scores between groups. When stratified by genetic test results, knowledge scores showed no difference. Regardless of group, post-test IES scores in patients with positive results were higher than patients with negative or uninformative results but returned to baseline by 12 months. Participants were equally satisfied with either method they were assigned. Significantly more time was spent per patient in individual sessions (1.25 hours) than in group education (0.74 hours). Conclusion Our data suggest that group education and counseling may confer similar benefits compared with traditional individual sessions. Additional investigation of this approach in larger numbers of patients is warranted.
Patient Online Self-Reporting of Toxicity Symptoms During Chemotherapy
Authors: Basch Ethan , Artz David , Dulko Dorothy , Scher Kevin , Sabbatini Paul , Hensley Martee , Mitra Nandita , Speakman John , McCabe Mary , Schrag Deborah 
Published: May 2005

Purpose Tracking symptoms related to treatment toxicity is standard practice in routine care and during clinical trials. Currently, clinicians collect symptom information via complex and often inefficient mechanisms, but there is growing interest in collecting outcome information directly from patients. Patients and Methods The National Cancer Institute Common Terminology Criteria for Adverse Events schema for seven common symptoms was adapted into a Web-based patient-reporting system, accessible from desktop computers in outpatient clinics and from home computers. Eighty patients with gynecologic malignancies beginning standard chemotherapy regimens were enrolled between April and September 2004. During an 8-week observation period, participants were encouraged to log in and report symptoms at each follow-up visit, or alternatively, to access the system from home. Results All patients completed an initial log in. At each subsequent appointment, most enrollees (80% to 85%) reported symptoms using the online system, with a mean of three follow-up visits per patient during the observation period (range, one to six). Sixty of 80 patients (75%) logged in at least once from home. Use was significantly associated with prior Internet experience. Forty-two severe toxicities (grade 3 to 4) entered from home prompted seven clinician interventions. Most patients (96%) found the system useful and would recommend it to others. Conclusion Patients are capable of reporting symptoms experienced during chemotherapy using a Web-based interface. Assessment in the clinical trial setting and comparison of direct patient- versus clinician-based approaches for reporting symptoms and their severity are warranted.
Evaluation of Five Radiation Schedules and Prognostic Factors for Metastatic Spinal Cord Compression
Authors: Rades Dirk , Stalpers Lukas J.A. , Veninga Theo , Schulte Rainer , Hoskin Peter J. , Obralic Nermina , Bajrovic Amira , Rudat Volker , Schwarz Rudolf , Hulshof Maarten C. , Poortmans Philip , Schild Steven E. 
Published: May 2005

Purpose To study five radiotherapy (RT) schedules and potential prognostic factors for functional outcome in metastatic spinal cord compression (MSCC). Patients and Methods One thousand three hundred four patients who were irradiated from January 1992 to December 2003 were included in this retrospective review. The schedules of 1 × 8 Gy in 1 day (n = 261), 5 × 4 Gy in 1 week (n = 279), 10 × 3 Gy in 2 weeks (n = 274), 15 × 2.5 Gy in 3 weeks (n = 233), and 20 × 2 Gy in 4 weeks (n = 257) were compared for motor function, ambulatory status, and in-field recurrences. The following potential prognostic factors were investigated: age, sex, performance status, histology, number of involved vertebra, interval from cancer diagnosis to MSCC, pretreatment ambulatory status, and time of developing motor deficits before RT. A multivariate analysis was performed with the ordered logit model. Results Motor function improved in 26% (1 × 8 Gy), 28% (5 × 4 Gy), 27% (10 × 3 Gy), 31% (15 × 2.5 Gy), and 28% (20 × 2 Gy); and posttreatment ambulatory rates were 69%, 68%, 63%, 66%, and 74% (P = .578), respectively. On multivariate analysis, age, performance status, primary tumor, involved vertebra, interval from cancer diagnosis to MSCC, pretreatment ambulatory status, and time of developing motor deficits were significantly associated with functional outcome, whereas the RT schedule was not. Acute toxicity was mild, and late toxicity was not observed. In-field recurrence rates at 2 years were 24% (1 × 8 Gy), 26% (5 × 4 Gy), 14% (10 × 3 Gy), 9% (15 × 2.5 Gy), and 7% (20 × 2 Gy) (P < .001). Neither the difference between 1 × 8 Gy and 5 × 4 Gy (P = .44) nor between 10 × 3 Gy, 15 × 2.5 Gy, and 20 × 2 Gy (P = .71) was significant. Conclusion The five RT schedules provided similar functional outcome. The three more protracted schedules seemed to result in fewer in-field recurrences. To minimize treatment time, the following two schedules are recommended: 1 × 8 Gy for patients with poor predicted survival and 10 × 3 Gy for other patients. Results should be confirmed in a prospective randomized trial.
Quality of Life Among Younger Women With Breast Cancer
Authors: Avis Nancy E. , Crawford Sybil , Manuel Janeen 
Published: May 2005

Purpose To describe quality of life (QOL) of younger women 4 to 42 months after breast cancer diagnosis and to identify factors associated with impaired QOL. Methods A total of 202 women diagnosed with stage I to III breast cancer at age 50 or younger from 4 to 42 months after breast cancer diagnosis previously completed a mailed survey. Global QOL; health-related QOL as measured by the Functional Assessment of Cancer Therapy–Breast Cancer (FACT-B); medical history; symptoms; days of work/activity missed after diagnosis; relationship, sexual, and body image problems; coping strategies; and feelings of preparedness were measured. Results General aches and pains and unhappiness with appearance were reported by more than 70% of women. Hot flashes (P = .0007), pain with sexual intercourse (P = .02), and difficulty with bladder control (P = .002) all significantly increased with age. Global QOL was significantly lower than for a nonpatient sample of younger women (P < .0001). In general, few sociodemographic and medical factors were related to QOL. In multivariate analyses, days of work/usual activity missed immediately after diagnosis; relationship, sexual, or body image problems after diagnosis; and coping strategies were related to almost all QOL domains. Ongoing treatment, vaginal dryness, and feeling unprepared for the impact of breast cancer were related to some domains. Conclusion Younger breast cancer survivors are at risk for impaired QOL up to several years after diagnosis. Younger women, especially those at high risk for lower QOL, may need interventions that specifically target their needs related to menopausal symptoms and problems with relationships, sexual functioning, and body image. Preparing younger woman for the impact of breast cancer may also prove beneficial.
Neoadjuvant Immunotherapy of Oral Squamous Cell Carcinoma Modulates Intratumoral CD4/CD8 Ratio and Tumor Microenvironment: A Multicenter Phase II Clinical Trial
Authors: Tímár József , Ladányi Andrea , Forster-Horváth Csaba , Lukits Júlia , Döme Balázs , Remenár Éva , Gődény Mária , Kásler Miklós , Bencsik Beáta , Répássy Gábor , Szabó György , Velich Norbert , Suba Zsuzsa , Élő János , Balatoni Zsuzsa , Pócza Károly , Zemplén Béla , Chretien Paul , Talor Eyal 
Published: May 2005

Purpose To investigate the clinicopathologic effects of local neoadjuvant Leukocyte Interleukin Injection (LI) regimen in oral squamous cell carcinoma (OSCC) patients. Treatment regimen included LI 800 IU/d as interleukin-2 (IL-2), administered half peritumorally and half perilymphatically five times per week for 3 weeks; low-dose cyclophosphamide; indomethacin; zinc; and multivitamins. Patients and Methods Thirty-nine patients diagnosed with T2-3N0-2M0 OSCC participated in the pathology portion of this phase II multicenter study (19 LI-treated patients and 20 historical controls). Clinical responses were determined by imaging. Paraffin-embedded tumor samples were obtained at surgery for all patients. Surgery for the LI-treated group was performed between days 14 and 54 after the end of treatment. Histologic evaluation, pathologic staging, necrosis, and American Joint Committee on Cancer grading were performed from hematoxylin and eosin sections. Immunohistochemistry and morphometry determined cellular infiltrate. Results Two pathologically complete, two major (> 50%), and four minor responses (> 30% but < 50%) resulted from LI treatment (overall response rate, 42%). Histopathology showed that the intratumoral CD4+:CD8+ ratio was low (< 1) in patients not treated with LI (controls). An increase in tumor-infiltrating CD4+ and a decrease of CD8+ T cells was observed in LI-treated patients, leading to a significantly (P < .05) higher intratumoral CD4+:CD8+ ratio (> 2.5). This was paralleled by dendritic cell transition from tumor surface toward stromal interface (P < .05), with macrophage decrease and neutrophil accumulation, multifocal microscopic necrosis, and significant (P < .05) increase in tumor stroma of LI-treated patients compared with controls. Conclusion LI-treated OSCC patients were characterized by a markedly altered composition of tumor-infiltrating mononuclear cells, increased CD4+:CD8+ ratio, and increased tumor stroma to epithelial ratio, all of which were distinct from controls.
Gemcitabine in Combination With Oxaliplatin Compared With Gemcitabine Alone in Locally Advanced or Metastatic Pancreatic Cancer: Results of a GERCOR and GISCAD Phase III Trial
Authors: Louvet C. , Labianca R. , Hammel P. , Lledo G. , Zampino M.G. , André T. , Zaniboni A. , Ducreux M. , Aitini E. , Taïeb J. , Faroux R. , Lepere C. , de Gramont A. 
Published: May 2005

Purpose Gemcitabine (Gem) is the standard treatment for advanced pancreatic cancer. Given the promising phase II results obtained with the Gem-oxaliplatin (GemOx) combination, we conducted a phase III study comparing GemOx with Gem alone in advanced pancreatic cancer. Patients and Methods Patients with advanced pancreatic cancer were stratified according to center, performance status, and type of disease (locally advanced v metastatic) and randomly assigned to either GemOx (gemcitabine 1 g/m2 as a 100-minute infusion on day 1 and oxaliplatin 100 mg/m2 as a 2-hour infusion on day 2 every 2 weeks) or Gem (gemcitabine 1 g/m2 as a weekly 30-minute infusion). Results Three hundred twenty-six patients were enrolled; 313 were eligible, and 157 and 156 were allocated to the GemOx and Gem arms, respectively. GemOx was superior to Gem in terms of response rate (26.8% v 17.3%, respectively; P = .04), progression-free survival (5.8 v 3.7 months, respectively; P = .04), and clinical benefit (38.2% v 26.9%, respectively; P = .03). Median overall survival (OS) for GemOx and Gem was 9.0 and 7.1 months, respectively (P = .13). GemOx was well tolerated overall, although a higher incidence of National Cancer Institute Common Toxicity Criteria grade 3 and 4 toxicity per patient was observed for platelets (14.0% for GemOx v 3.2% for Gem), vomiting (8.9% for GemOx v 3.2% for Gem), and neurosensory symptoms (19.1% for GemOx v 0% for Gem). Conclusion These results confirm the efficacy and safety of GemOx, but this study failed to demonstrate a statistically significant advantage in terms of OS compared with Gem. Because GemOx is the first combined treatment to be superior to Gem alone in terms of clinical benefit, this promising regimen deserves further development.
Clinical Examination Following Preoperative Chemoradiation for Rectal Cancer Is Not a Reliable Surrogate End Point
Authors: Guillem Jose G. , Chessin David B. , Shia Jinru , Moore Harvey G. , Mazumdar Madhu , Bernard Bianca , Paty Philip B. , Saltz Leonard , Minsky Bruce D. , Weiser Martin R. , Temple Larissa K.F. , Cohen Alfred M. , Wong W. Douglas 
Published: May 2005

Purpose Clinical assessment of rectal cancer response to preoperative combined-modality therapy (CMT) using digital rectal examination (DRE) has been proposed as a means of assessing efficacy of therapy. However, because the accuracy of this approach has not been established, we conducted a prospective analysis to determine the operating surgeon's ability to assess response using DRE. Patients and Methods Ninety-four prospectively accrued patients with locally advanced rectal cancer (T3/4 or N1) were evaluated with DRE and sigmoidoscopy in order to determine the following tumor characteristics: size, location, mobility, morphology, and circumference. Following preoperative CMT (50.40 Gy with fluorouracil-based chemotherapy) and under general anesthesia, the same surgeon estimated tumor response based on changes in these tumor characteristics, assessed via DRE. Percent pathologic tumor response was determined prospectively by a single pathologist using whole mount sections of the resected cancer. Results Clinical assessment using DRE underestimated pathologic response in 73 cases (78%). In addition, DRE was able to identify only 3 of 14 cases (21%) with a pathologic complete response. There were no clinical overestimates of response. None of the clinicopathologic tumor characteristics examined had a significant impact on DRE estimation of response. Conclusion Clinical examination underestimates the extent of rectal cancer response to preoperative CMT. Given the inaccuracy of DRE following preoperative CMT, it should not be used as a sole means of assessing efficacy of therapy nor for selecting patients following CMT for local surgical therapies.
Clinical Value of Mitochondrial Mutations in Colorectal Cancer
Authors: Lièvre Astrid , Chapusot Caroline , Bouvier Anne-Marie , Zinzindohoué Franck , Piard Françoise , Roignot Patrick , Arnould Laurent , Beaune Philippe , Faivre Jean , Laurent-Puig Pierre 
Published: May 2005

Purpose Prognostic factors that could select high-risk recurrence colorectal cancer patients and predict chemosensitivity are needed. Since mutations of mitochondrial DNA (mtDNA) have been described in different types of cancers and since they may play a role in response to anticancer agents, we investigated in a population-based series of colorectal cancer patients the clinical value of mtDNA mutations. Patients and Methods The displacement loop (D-loop) region of mtDNA was sequenced on a series of 365 patients recorded in the Digestive Cancer Registry of Côte-d'Or (France) between 1998 and 2000. Clinicopathologic characteristics were correlated to the presence of a D-loop mutation. Survival rates were compared with the log-rank test. A multivariate survival analysis was performed. Results D-loop mutations were found in 38.3% of the tumors. The 3-year survival rate was 53.5% in patients with D-loop mutation versus 62.1% in patients without (P = .05). After adjustment for age, stage, and microsatellite instability status, the relative risk of death in patients with D-loop mutation was 1.40 (95% CI, 1.02 to 1.93; P = .034) as compared with those without. In stage III colon cancers, adjuvant chemotherapy was beneficial only for patients without D-loop mutation (3-year survival, 78.3% v 45.4%, P < .02). In those with D-loop mutation who received adjuvant chemotherapy, the relative risk of death was 4.30 (95% CI, 1.23 to 15.00; P < .02). Conclusion The D-loop region is a hotspot for somatic mutations in colorectal tumors. Moreover, presence of tumor D-loop mutation appears to be a factor of poor prognosis in colorectal patients and a factor of resistance to fluorouracil-based adjuvant chemotherapy in stage III colon cancers.