bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase II Study of Neoadjuvant Chemotherapy and Radiation Therapy in the Management of High-Risk, High-Grade, Soft Tissue Sarcomas of the Extremities and Body Wall: Radiation Therapy Oncology Group Trial 9514
Authors: Kraybill William G. , Harris Jonathon , Spiro Ira J. , Ettinger David S. , DeLaney Thomas F. , Blum Ronald H. , Lucas David R. , Harmon David C. , Letson G. Douglas , Eisenberg Burton 
Published: January 2006

Purpose On the basis of a positive reported single-institution pilot study, the Radiation Therapy Oncology Group initiated phase II trial 9514 to evaluate its neoadjuvant regimen in a multi-institutional Intergroup setting. Patients and Methods Eligibility included a high-grade soft tissue sarcoma ≥ 8 cm in diameter of the extremities and body wall. Patients received three cycles of neoadjuvant chemotherapy (CT; modified mesna, doxorubicin, ifosfamide, and dacarbazine [MAID]), interdigitated preoperative radiation therapy (RT; 44 Gy administered in split courses), and three cycles of postoperative CT (modified MAID). Results Sixty-six patients were enrolled, of whom 64 were analyzed. Seventy-nine percent of patients completed their preoperative CT and 59% completed all planned CT. Three patients (5%) experienced fatal grade 5 toxicities (myelodysplasias, two patients; infection, one patient). Another 53 patients (83%) experienced grade 4 toxicities; 78% experienced grade 4 hematologic toxicity and 19% experienced grade 4 nonhematologic toxicity. Sixty-one patients underwent surgery. Fifty-eight of these were R0 resections, of which five were amputations. There were three R1 resections. The estimated 3-year rate for local-regional failure is 17.6% if amputation is considered a failure and 10.1% if not. Estimated 3-year rates for disease-free, distant–disease-free, and overall survival are 56.6%, 64.5%, and 75.1%, respectively. Conclusion This combined-modality treatment can be delivered successfully in a multi-institutional setting. Efficacy results are consistent with previous single-institution results.
Phase III Trial of Intraperitoneal Therapy With Yttrium-90–Labeled HMFG1 Murine Monoclonal Antibody in Patients With Epithelial Ovarian Cancer After a Surgically Defined Complete Remission
Authors: Verheijen René H. , Massuger Leon F. , Benigno Benedict B. , Epenetos Agamemnon A. , Lopes Alberto , Soper John T. , Markowska Janica , Vyzula Rostislav , Jobling Tom , Stamp Gordon , Spiegel Gregory , Thurston Dennis , Falke Theo , Lambert Joanna , Seiden Michael V. 
Published: January 2006

Purpose This was a multinational, open-label, randomized phase III trial comparing yttrium-90–labeled murine HMFG1 (90Y-muHMFG1) plus standard treatment versus standard treatment alone in patients with epithelial ovarian cancer (EOC) who had attained a complete clinical remission after cytoreductive surgery and platinum-based chemotherapy. Patients and Methods In total, 844 International Federation of Gynecology and Obstetrics stage Ic to IV patients were initially screened, of whom 447 patients with a negative second-look laparoscopy (SLL) were randomly assigned to receive either a single dose of 90Y-muHMFG1 plus standard treatment (224 patients) or standard treatment alone (223 patients). Patients in the active treatment arm received a single intraperitoneal dose of 25 mg of 90Y-muHMFG1 (target dose 666 MBq/m2). The primary end point was length of survival; secondary end points included time to relapse and safety. The study had an 80% power to detect a 15% change in survival. Results After a median follow-up of 3.5 years (range, 1 to 6 years), 70 patients had died in the active treatment arm compared with 61 patients in the control arm. Cox proportional hazards analysis of survival demonstrated no difference between treatment arms. In the study drug arm, 104 patients experienced relapse compared with 98 patients in the standard treatment arm. No difference in time to relapse was observed between the two study arms. Active therapy was associated with occasional grade 3 or 4 thrombocytopenia and neutropenia and grade 1 or 2 GI symptoms, abdominal discomfort, arthralgia, and myalgia. Conclusion A single IP administration of 90Y-muHMFG1 to patients with EOC who had a negative SLL after primary therapy did not extend survival or time to relapse.
Randomized Double-Blind Trial of Estrogen Replacement Therapy Versus Placebo in Stage I or II Endometrial Cancer: A Gynecologic Oncology Group Study
Authors: Barakat Richard R. , Bundy Brian N. , Spirtos Nick M. , Bell Jeffrey , Mannel Robert S. 
Published: January 2006

Purpose To determine the effect of estrogen replacement therapy (ERT) on recurrence rate and survival in women who have undergone surgery for stage I or II endometrial cancer. Patients and Methods After surgery, eligible patients were allocated to therapy with ERT or placebo after undergoing hysterectomy with or without pelvic and aortic nodal sampling. Planned duration of hormonal versus placebo treatment was 3 years, with an additional 2 years of follow-up. Results The median follow-up time for all 1,236 eligible and assessable patients was 35.7 months. Stage, grade, histologic subtype, and percentage of patients receiving adjuvant therapy were similarly distributed between the groups. The median age at diagnosis for the 618 patients randomly assigned to ERT was 57 years (range, 26 to 91 years). Two hundred fifty-one patients (41.1%) were compliant with ERT for the entire treatment period. Disease recurrence was experienced in 14 patients (2.3%). Eight patients (1.3%) developed a new malignancy. There were 26 deaths (4.2%), and five deaths (0.8%) were a result of endometrial cancer. The median age at diagnosis for the 618 patients in the placebo group was 57 years (range, 30 to 88 years). Twelve patients (1.9%) experienced disease recurrence. Ten patients (1.6%) developed a new malignancy. There were 9 deaths (3.1%) in the placebo group, and four deaths (0.6%) were a result of endometrial cancer. Conclusion Although this incomplete study cannot conclusively refute or support the safety of exogenous estrogen with regard to risk of endometrial recurrence, it is noteworthy that the absolute recurrence rate (2.1%) and the incidence of new malignancy were low.
Combined-Modality Therapy Versus Radiotherapy Alone for Treatment of Early-Stage Hodgkin's Disease: Cure Balanced Against Complications
Authors: Koontz Bridget F. , Kirkpatrick John P. , Clough Robert W. , Prosnitz Robert G. , Gockerman Jon P. , Moore Joseph O. , Prosnitz Leonard R. 
Published: January 2006

Purpose The treatment of early-stage Hodgkin's disease (HD) has evolved from radiotherapy alone (RT) to combined-modality therapy (CMT) because of concerns about late adverse effects from high-dose subtotal nodal irradiation (STNI). However, there is little information regarding the long-term results of CMT programs that substantially reduce the dose and extent of radiation. In addition, lowering the total radiation dose may reduce the complication rate without compromising cure. This retrospective study compares the long-term results of STNI with CMT using modestly reduced RT dose in the treatment of early-stage HD. Patients and Methods Between 1982 and 2002, 111 patients with stage IA and IIA HD were treated definitively with RT (mean dose, 37.9 Gy); 70 patients were treated with CMT with low-dose involved-field radiotherapy (LDIFRT; mean dose, 25.5 Gy). Median follow-up was 11.7 years for RT patients and 8.1 years for the CMT group. Results There was a trend toward improved 20-year overall survival with CMT (83% v 70%; P = .405). No second cancers were observed in the CMT group; in the RT group the actuarial frequency of a second cancer was 16% at 20 years. There was no difference in the frequency of cardiac complications (9% v 6%, RT v CMT). Conclusion In this retrospective review, CMT with LDIFRT was effective in curing early-stage HD and was not associated with an increase in second malignancies. For RT alone, a moderate dose seemed to reduce cardiac complications but did not lessen second malignancies compared with higher doses used historically.
Cefixime Allows Greater Dose Escalation of Oral Irinotecan: A Phase I Study in Pediatric Patients With Refractory Solid Tumors
Authors: Furman Wayne L. , Crews Kristine R. , Billups Catherine , Wu Jianrong , Gajjar Amar J. , Daw Najat C. , Patrick Christian C. , Rodriguez-Galindo Carlos , Stewart Clinton F. , Dome Jeffrey S. , Panetta John C. , Houghton Peter J. , Santana Victor M. 
Published: January 2006

PurposeIrinotecan is active against a variety of malignancies; however, severe diarrhea limits its usefulness. In our phase I study, the intravenous formulation of irinotecan was administered orally daily for 5 days for 2 consecutive weeks (repeated every 21 days) to children with refractory solid tumors. Our objectives were to determine the maximum-tolerated dose (MTD), dose-limiting toxicity, and pharmacokinetics of oral irinotecan and to evaluate whether coadministration of cefixime (8 mg/kg/d beginning 5 days before irinotecan and continuing throughout the course) ameliorates irinotecan-induced diarrhea.Patients and MethodsIn separate cohorts, irinotecan doses were escalated from 15 to 45 mg/m2/d without cefixime and then from 45 to 60 and 75 mg/m2/d with cefixime.ResultsWithout cefixime, diarrhea was dose limiting at irinotecan 45 mg/m2/d. Myelotoxicity was not significant at any dose. The MTD was 40 mg/m2/d without cefixime but 60 mg/m2/d with cefixime. Systemic exposure to SN-38 at the MTD was significantly higher with cefixime than without cefixime (mean SN-38 area under the curve: 19.5 ng×h/mL; standard deviation [SD], 6.8 ng × h/mL v 10.4 ng × h/mL; SD, 4.3 ng × h/mL, respectively; P = .030).ConclusionCefixime administered with oral irinotecan is well tolerated in children and allows greater dose escalation of irinotecan. Because diarrhea is a major adverse effect of both intravenous and oral irinotecan, further evaluation of the use of cefixime to ameliorate this adverse effect is warranted.
Short-Term Treatment-Related Symptoms and Quality of Life: Results From an International Randomized Phase III Study of Cisplatin With or Without Raltitrexed in Patients With Malignant Pleural Mesothelioma: An EORTC Lung-Cancer Group and National Cancer Institute, Canada, Intergroup Study
Authors: Bottomley Andrew , Gaafa Rabab , Manegold Christian , Burgers Sjaak , Coens Corneel , Legrand Catherine , Vincent Mark , Giaccone Giuseppe , Van Meerbeeck Jan 
Published: January 2006

Purpose For malignant pleural mesothelioma (MPM) patients with a poor prognosis, maintaining health-related quality of life (HRQOL) is important. This article compares the impact on HRQOL of first-line treatment with cisplatin versus raltitrexed and cisplatin. Patients and Methods Patients with histologically-proven unresectable MPM, not pretreated with chemotherapy were randomly assigned to receive cisplatin 80 mg/m2 intravenously on day 1, with or without preceding infusion of raltitrexed 3 mg/m2. HRQOL was assessed with the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (EORTC QLQ-C30) and EORTC Lung Cancer Module (QLQ-LC13) tools. Assessments were conducted at baseline, immediately before every treatment cycle, at the end of treatment, and every six weeks for 12 months. Results Two hundred fifty patients were randomly assigned, 80% were male with a median age of 58 years, WHO performance status 0, 1, and 2, in 25%, 62%, and 13% of cases. The clinical results found raltitrexed and cisplatin to be superior to cisplatin with regard to overall survival (P = .048). The global HRQOL scale was comparable at baseline on both treatment arms (P = .848); at no point was any significant difference apparent on this end point. Both treatments led to an improvement, over time, in dyspnoea. This effect is an important clinically meaningful reduction from baseline in the cisplatin/raltitrexed arm. However, the majority of scales of the EORTC QLQ-C30 or LC13 showed stabilization of HRQOL with few clinically significant differences between the treatment arms. Conclusion This study provides important information about the HRQOL of chemotherapy-treated MPM patients.
Randomized Phase II Study of Neoadjuvant Combined-Modality Chemoradiation for Distal Rectal Cancer: Radiation Therapy Oncology Group Trial 0012
Authors: Mohiuddin Mohammed , Winter Kathryn , Mitchell Edith , Hanna Nader , Yuen Albert , Nichols Charles , Shane Robert , Hayostek Cherie , Willett Christopher 
Published: January 2006

Purpose
To evaluate the rate of pathologic complete response and toxicity of neoadjuvant chemoradiation for advanced T3/T4 distal rectal cancers in a randomized phase II study

Patients and Methods

Patients with clinical T3/T4 distal rectal cancers were randomly assigned in a phase II study to receive combined neoadjuvant chemoradiotherapy followed by surgical resection. Patients were randomly assigned to receive continuous venous infusion (CVI) fluorouracil (FU) 225 mg/m
2
per day, 7 days per week, plus pelvic hyperfractionated radiation 55.2 to 60 Gy at 1.2 Gy bid (arm 1) or CVI FU 225 mg/m
2
per day Monday to Friday, 120 hours per week plus irinotecan 50 mg/m
2
once weekly for 4 weeks plus pelvic radiation therapy 50.4 to 54 Gy at 1.8 Gy per day (arm 2). Surgery was performed 4 to 10 weeks after completion of neoadjuvant therapy. The primary end point of this study was pathologic complete response (pCR). Secondary end points included acute and late normal tissue morbidity.

Results
A total of 106 patients were entered onto the study, with 103 assessable for response. The overall resectability rate was 93%. The median time to surgery was 7 weeks. Tumor downstaging was observed in 78% of patients in both arms. The pCR rate for all assessable patients was 26% in each arm. For patients who had surgery, the pCR rate was also the same (28%) in both arms. Acute and late toxicity was also similar. Grade 3 and 4 acute hematologic and nonhematologic toxicity occurred in 13% and 38% in arm 1 and 12% and 45% in arm 2, respectively.

Conclusion
Although the overall complete response rate and toxicity seems similar in both arms, this is the first multi-institutional study to establish a relatively high (28%) pCR rate after neoadjuvant therapy.
Randomized Phase II Trial Comparing Nitroglycerin Plus Vinorelbine and Cisplatin With Vinorelbine and Cisplatin Alone in Previously Untreated Stage IIIB/IV Non–Small-Cell Lung Cancer
Authors: Yasuda Hiroyasu , Yamaya Mutsuo , Nakayama Katsutoshi , Sasaki Takahiko , Ebihara Satoru , Kanda Akio , Asada Masanori , Inoue Daisuke , Suzuki Tomoko , Okazaki Tatsuma , Takahashi Hidenori , Yoshida Motoki , Kaneta Tomohiro , Ishizawa Kota , Yamanda Shinsuke , Tomita Naoki , Yamasaki Miyako , Kikuchi Akiko , Kubo Hiroshi , Sasaki Hidetada 
Published: January 2006

Purpose To investigate the efficacy and safety of nitroglycerin plus vinorelbine and cisplatin in patients with previously untreated stage IIIB/IV non–small-cell lung cancer (NSCLC) as the experimental arm for the next phase III trial. Patients and Methods One hundred twenty patients with stage IIIB/IV NSCLC were randomly assigned to vinorelbine 25 mg/m2 on days 1 and 8 and cisplatin 80 mg/m2 on day 1, with transdermally applied nitroglycerin (25 mg/patient daily for 5 days; arm A) or with placebo patch (arm B) every 3 weeks for a maximum of four cycles in a double-blind and controlled trial. Primary efficacy end points were the best confirmed response rate and time to disease progression (TTP). Results The response rate in arm A (72%; 43 of 60 patients) was significantly higher than that for patients in arm B (42%; 25 of 60 patients; P < .001). Median TTP in arm A was longer than that in arm B (327 v 185 days). No severe adverse effect was recognized for either arm. The rate of grade 1 to 2 headache in arm A (30%; 18 of 60 patients) was significantly higher than that in arm B (2%; one of 60 patients; P < .001, χ2 test). Conclusion Use of nitroglycerin combined with vinorelbine and cisplatin may improve overall response and TTP in patients with stage IIIB/IV NSCLC. The arm A regimen is being evaluated in a large phase III trial.
Anatomically diverse butterfly scales all produce structural colours by coherent scattering
Authors: Prum Richard O. , Quinn Tim , Torres Rodolfo H. 
Published: January 2006

SUMMARYThe structural colours of butterflies and moths (Lepidoptera) have been attributed to a diversity of physical mechanisms, including multilayer interference, diffraction, Bragg scattering, Tyndall scattering and Rayleigh scattering. We used fibre optic spectrophotometry, transmission electron microscopy (TEM) and 2D Fourier analysis to investigate the physical mechanisms of structural colour production in twelve lepidopteran species from four families, representing all of the previously proposed anatomical and optical classes of butterfly nanostructure. The 2D Fourier analyses of TEMs of colour producing butterfly scales document that all species are appropriately nanostructured to produce visible colours by coherent scattering, i.e. differential interference and reinforcement of scattered, visible wavelengths. Previously hypothesized to produce a blue colour by incoherent, Tyndall scattering, the scales of Papilio zalmoxis are not appropriately nanostructured for incoherent scattering. Rather, available data indicate that the blue of P. zalmoxis is a fluorescent pigmentary colour. Despite their nanoscale anatomical diversity, all structurally coloured butterfly scales share a single fundamental physical color production mechanism -coherent scattering. Recognition of this commonality provides a new perspective on how the nanostructure and optical properties of structurally coloured butterfly scales evolved and diversified among and within lepidopteran clades.
Local mechanical properties of the head articulation cuticle in the beetlePachnoda marginata(Coleoptera, Scarabaeidae)
Authors: Barbakadze N. , Enders S. , Gorb S. , Arzt E. 
Published: January 2006

SUMMARYInsect exoskeleton (cuticle) has a broad range of mechanical properties depending on the function of a particular structure of the skeleton. Structure and mechanical properties of the specialised cuticle of insect joints remain largely unknown to date. We used scanning (SEM) and transmission electron microscopy (TEM) to obtain information about the material structure of the gula plate, the head part of the head-to-neck articulation system in the beetle Pachnoda marginata. The surface of this cuticle appears rather smooth in SEM. The fibers of the exocuticle are partly oriented almost perpendicular to the surface, which is rather unusual for arthropod cuticle. Nanoindentation experiments were performed to determine the local mechanical properties (hardness and elastic modulus) of the gula material. To understand the effect of desiccation and the influence of an outer wax layer on the mechanical behavior of the material, the samples were tested in fresh, dry and chemically treated (lipid extraction in organic solvents) conditions. Nanoindentation results were found to be strongly influenced by desiccation but only slightly by lipid extraction. Decreasing water content (∼15-20%of the cuticle mass) led to an increase in hardness (from 0.1 to 0.49 GPa) and elastic modulus (from 1.5 to 7.5 GPa). The lipid extraction caused a slight further hardening (to 0.52 GPa) as well as stiffening (to 7.7 GPa) of the material. The results are discussed in relation to the mechanical function of the gula plate.
Recent Development of Multireference Density Functional Theory
Authors: Yamanaka Shusuke , Nakata Kazuto , Takada Toshikazu , Kusakabe Koichi , Ugalde Jesus M , Yamaguchi Kizashi 
Published: January 2006

Abstract
We review a recently developed ab initio multireference (MR)-density functional theory (DFT) approach based on the partially interacting reference systems. Instead of Kohn–Sham equations, we introduce the auxiliary CI equation with the effective DFT potential field. For practice, we classify electrons of the target system into valence electrons and other electrons. The former plays the quantum resonating feature of electronic structure of molecular species, while the latter affects the electronic properties via the effective correlation potential for the former electrons. The theoretical devices in our MR-DFT are introduced to avoid the double counting problem for any combination of a wavefunction and a correlation functional. Some numerical examples are presented.
Performance Evaluation and Subsequent Clinical Experience with the Abbott Automated Architect STAT Troponin-I Assay
Authors: Lam Que , Black Marion , Youdell Odette , Spilsbury Heather , Schneider Hans-Gerhard 
Published: January 2006

AbstractBackground: Cardiac troponins are specific biochemical markers of myocardial injury used in the diagnosis of acute myocardial disease and cardiac risk stratification. To avoid misclassification of patients, troponin assays must demonstrate precision at the low end of the measuring range. We report our evaluation of the Architect STAT Troponin-I assay (Abbott Diagnostics), comparison of low-positive results with 2 other assays, and occurrence of heterophile antibody interference in the assay.Methods: We assessed analytical performance on the ci8200 according to CLSI protocols, using quality-control and patient samples. Our healthy reference population included 480 blood donors. For correlation studies against the AxSYM first-generation cTnI (Abbott Diagnostics) and Access second-generation AccuTnI (Beckman Coulter) assays, we used 339 samples from hospital patients.Results: The CV of the Architect STAT Troponin-I assay was 10% near the 99th percentile for the reference population (0.03 μg/L). Comparison with the AxSYM first-generation cTnI assay showed good correlation at higher concentrations, but better sensitivity of the Architect cTnI assay at low concentrations, which were clinically relevant as shown by review of patient histories. Correlation was good at the low end of the measuring range with the Access second-generation AccuTnI. Over the last 12 months we have identified 6 patients with heterophile antibodies causing positive interference.Conclusions: The Architect STAT Troponin-I assay provides highly sensitive measurement of cTnI with a CV of 10% near the upper limit of a reference population; however, heterophile antibodies can interfere with this assay.
Point-of-Care i-STAT Cardiac Troponin I for Assessment of Patients with Symptoms Suggestive of Acute Coronary Syndrome,
Authors: Apple Fred S , Ler Ranka , Chung Adrine Y , Berger Michael J , Murakami MaryAnn M 
Published: January 2006

Abstract
Background: Few studies have investigated the role of cardiac troponin point-of-care (POC) testing for predicting adverse outcomes in acute coronary syndrome (ACS) patients. We investigated the use of a POC cTnI assay in ACS patients.
Methods: We studied consecutive patients (n = 367) presenting with symptoms suggestive of ACS who were admitted through the emergency department. We measured plasma cTnI with the i-STAT assay. Patients were risk-stratified based on cTnI concentrations defined by the predetermined 99th percentile reference limit for plasma (0.04 μg/L). Patients were followed for 60 days. We computed survival and event curves with the Kaplan–Meier method and compared risk stratification groups with the log-rank test.
Results: Acute myocardial infarction (MI) was diagnosed in 8.1% of patients. Odds ratios and 95% confidence intervals for all-cause death (ACD), MI or ACD, MI or cardiac death, and cardiac death at 60 days were all statistically significant after adjustment for age, diabetes, hypertension, and history of renal failure as follows: 2.54 (1.24–5.20), P = 0.009; 2.76 (1.37–5.58), P = 0.003; 5.98 (1.65–21.7), P = 0.008; and 2.54 (1.24–5.20), P = 0.009. Kaplan–Meier curves showed early separation between patients with increased vs. reference concentrations before 30 days for ACD, MI or ACD, and MI or cardiac death.
Conclusion: The i-STAT POC cTnI assay can be added to the list of assays for risk stratification.