bluuebunny/crossref_metadata_2025_split huggingface dataset:
Chemoendocrine Compared With Endocrine Adjuvant Therapies for Node-Negative Breast Cancer: Predictive Value of Centrally Reviewed Expression of Estrogen and Progesterone Receptors—International Breast Cancer Study Group
Authors: Viale Giuseppe , Regan Meredith M. , Maiorano Eugenio , Mastropasqua Mauro G. , Golouh Rastko , Perin Tiziana , Brown Robert W. , Kovács Anikó , Pillay Komala , Öhlschlegel Christian , Braye Stephen , Grigolato Piergiovanni , Rusca Tiziana , Gelber Richard D. , Castiglione-Gertsch Monica , Price Karen N. , Goldhirsch Aron , Gusterson Barry A. , Coates Alan S. 
Published: March 2008

Purpose To centrally assess estrogen receptor (ER) and progesterone receptor (PgR) levels by immunohistochemistry and investigate their predictive value for benefit of chemo-endocrine compared with endocrine adjuvant therapy alone in two randomized clinical trials for node-negative breast cancer. Patients and Methods International Breast Cancer Study Group Trial VIII compared cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy for 6 cycles followed by endocrine therapy with goserelin with either modality alone in pre- and perimenopausal patients. Trial IX compared three cycles of CMF followed by tamoxifen for 5 years versus tamoxifen alone in postmenopausal patients. Central Pathology Office reviewed 883 (83%) of 1,063 patients on Trial VIII and 1,365 (82%) of 1,669 on Trial IX and determined ER and PgR by immunohistochemistry. Disease-free survival (DFS) was compared across the spectrum of expression of each receptor using the Subpopulation Treatment Effect Pattern Plot methodology. Results Both receptors displayed a bimodal distribution, with substantial proportions showing no staining (receptor absent) and most of the remainder showing a high percentage of stained cells. Chemo-endocrine therapy yielded DFS superior to endocrine therapy alone for patients with receptor-absent tumors, and in some cases also for those with low levels of receptor expression. Among patients with ER-expressing tumors, additional prediction of benefit was suggested in absent or low PgR in Trial VIII but not in Trial IX. Conclusion Low levels of ER and PgR are predictive of the benefit of adding chemotherapy to endocrine therapy. Low PgR may add further prediction among pre- and perimenopausal but not postmenopausal patients whose tumors express ER.
Phase II Randomized Controlled Trial of an Epidermal Growth Factor Vaccine in Advanced Non–Small-Cell Lung Cancer
Authors: Vinageras Elia Neninger , de la Torre Ana , Rodríguez Marta Osorio , Ferrer Mauricio Catalá , Bravo Idania , del Pino Mario Mendoza , Abreu Daniel Abreu , Brooks Soraida Acosta , Rives Rolando , del Castillo Carrillo Concepción , Dueñas Marta González , Viada Carmen , Verdecia Beatriz García , Ramos Tania Crombet , Marinello Gisela González , Dávila Agustín Lage 
Published: March 2008

PurposeWe show the result of a randomized phase II clinical trial with an epidermal growth factor (EGF)-based cancer vaccine in advanced non–small-cell lung cancer (NSCLC) patients, evaluating immunogenicity, safety, and effect on survival.Patients and MethodsEighty patients with stage IIIB/IV NSCLC after finishing first-line chemotherapy were randomly assigned to receive best supportive care or EGF vaccinations.ResultsVaccination was safe. Adverse events were observed in less than 25% of cases and were grade 1 or 2 according to National Cancer Institute Common Toxicity Criteria. Good anti-EGF antibody response (GAR) was obtained in 51.3% of vaccinated patients and in none of the control group. Serum EGF concentration showed a major decrease in 64.3% of vaccinated patients. GAR patients survived significantly more than those with poor antibody response (PAR). Also, patients whose serum EGF dropped below 168 pg/mL survived significantly more than the rest. There was a trend to an increased survival for vaccinated patients compared with controls. The survival advantage for vaccinated patients compared with controls was statistically significant in the subgroup of patients with age younger than 60 years.ConclusionVaccination with EGF was safe and provoked an increase in anti-EGF antibody titers and a decrease in serum EGF. There was a direct correlation between antibody response and survival. There was a direct correlation between decrease in serum EGF and survival. In patients younger than 60 years, vaccination was associated with increased survival.
Prognostic Factors for Leukemic Induction Failure in Children With Acute Lymphoblastic Leukemia and Outcome After Salvage Therapy: The FRALLE 93 Study
Authors: Oudot Caroline , Auclerc Marie-Françoise , Levy Vincent , Porcher Raphaël , Piguet Christophe , Perel Yves , Gandemer Virginie , Debre Marianne , Vermylen Christiane , Pautard Brigitte , Berger Claire , Schmitt Claudine , Leblanc Thierry , Cayuela Jean-Michel , Socie Gérard , Michel Gérard , Leverger Guy , Baruchel André 
Published: March 2008

Purpose To identify prognostic factors and to evaluate the outcome of children with acute lymphoblastic leukemia (ALL) failure after induction therapy. Patients and Methods Between June 1993 and December 1999, 1,395 leukemic children were included in the French Acute Lymphoblastic Leukemia 93 study. Results Fifty-three patients (3.8%) had a leukemic induction failure (LIF) after three- or four-drug induction therapy. In univariate analysis, high WBC count (P = .001), mediastinal mass (P = .017), T-cell phenotype (T-ALL; P = .001), t(9;22) translocation (P = .001), and a slow early response (at day 8 and/or on day 21, P = .001) were predictive of LIF. The following three prognostic groups for LIF were identified by multivariate analysis: a low-risk group with B-cell progenitor (BCP) ALL without t(9;22) (odds ratio [OR] = 1), an intermediate-risk group with T-ALL and a mediastinal mass (OR = 7.4, P < .0001), and a high-risk group with BCP-ALL and t(9;22) or T-ALL without a mediastinal mass (OR = 28.4, P < .0001). Complete remission (CR) was subsequently obtained in 43 patients (81%). The 5-year overall survival (OS) rate of the 53 patients was 30% ± 6%. The 5-year OS rate among allogeneic graft recipients, autologous graft recipients, and after chemotherapy were 30.4% ± 9.6% (50% ± 26% after genoidentical transplantation), 50% ± 17.7%, and 41.7% ± 14.2%, respectively (P = .18). Fourteen patients (26%) were still in first CR after a median of 83 months (range, 53 to 117 months). Conclusion Three risk categories for LIF in children with ALL were identified. Approximately one third of patients with LIF can be successfully treated with salvage therapy overall. Subsequent CR after LIF is mandatory for cure.
Pharmacogenetic Profiling for Cetuximab Plus Irinotecan Therapy in Patients With Refractory Advanced Colorectal Cancer
Authors: Graziano Francesco , Ruzzo Annamaria , Loupakis Fotios , Canestrari Emanuele , Santini Daniele , Catalano Vincenzo , Bisonni Renato , Torresi Umberto , Floriani Irene , Schiavon Gaia , Andreoni Francesca , Maltese Paolo , Rulli Eliana , Humar Bostjan , Falcone Alfredo , Giustini Lucio , Tonini Giuseppe , Fontana Andrea , Masi Gianluca , Magnani Mauro 
Published: March 2008

PurposeRegulation of epidermal growth factor receptor (EGFR) signaling pathways may play a relevant role in determining the activity of cetuximab therapy in patients with metastatic colorectal cancer (MCRC). We investigated possible associations between genetic variants and clinical outcomes of MCRC patients treated with cetuximab-irinotecan salvage therapy.Patients and MethodsPatients who underwent cetuximab-irinotecan salvage therapy after disease progression during or after first-line bolus/infusional fluorouracil, leucovorin, and oxaliplatin chemotherapy and a second-line irinotecan-based regimen were considered eligible for analysis of polymorphisms with putative influence on cetuximab-related pathways. Epidermal growth factor (EGF) 61A>G, EGF receptor (EGFR) 216G>T, EGFR 497G>A, EGFR intron-1 (CA)ndinucleotide short (S)/long (L) variant, cyclin-D1 870A>G, immunoglobulin-G fragment-C receptors RIIIa 158G>T, and RIIa 131G>A were studied for a possible association with overall survival (OS) as the primary end point. Additional analyses were addressed at possible associations among polymorphisms and EGFR expression, toxicity, and response.ResultsIn 110 assessable patients, significant association with favorable OS was observed for EGFR intron-1 S/S and EGF 61 G/G genotypes. In the multivariate model, EGFR intron-1 S/S and EGF 61 G/G genotypes showed a hazard ratio of 0.41 (95% CI, 0.21 to 0.78; P = .006) and 0.44 (95% CI, 0.23 to 0.84; P = .01), respectively. EGFR intron-1 S/S carriers showed more frequent G2-G3 skin toxicity (χ2test = 12.7; P = .001) and treatment response (χ2test = 9.45; P = .008) than EGFR intron-1 L/L carriers.ConclusionAlthough additional studies are required for confirmation, our findings could optimize the use of cetuximab in MCRC patients.
External Validation of a Biomarker-Based Preoperative Nomogram Predicts Biochemical Recurrence After Radical Prostatectomy
Authors: Shariat Shahrokh F. , Walz Jochen , Roehrborn Claus G. , Zlotta Alexandre R. , Perrotte Paul , Suardi Nazareno , Saad Fred , Karakiewicz Pierre I. 
Published: March 2008

Purpose Biomarker signatures currently are used in several malignancies to guide clinical decision making. Recently, preoperative plasma levels of transforming growth factor-β1 (TGF-β1) and interleukin-6 soluble receptor (IL6-SR) have improved the accuracy of a clinical nomogram that predicted biochemical recurrence after radical prostatectomy. However, this model was never externally validated. We tested the accuracy of this nomogram in an independent, external cohort. Patients and Methods Preoperative plasma levels of TGF-β1 and IL6-SR were measured in 423 consecutive men who underwent radical prostatectomy and bilateral lymphadenectomy and were used, along with preoperative prostate-specific antigen levels, biopsy Gleason sum, and clinical stage to determine nomogram-derived probabilities of biochemical recurrence–free survival at 5 years after radical prostatectomy. The accuracy of predictions was quantified with the area under the curve (AUC) and calibration plots that graphically displayed the nomogram's performance characteristics. The statistical significance of the difference between the biomarker nomogram and a model designed on the basis of clinical variables alone was tested by using the Mantel-Haenszel statistic. Results Biochemical recurrence–free survival at 5 years was 77.0% (95% CI, 72.0% to 82.0%). The biomarker-based nomogram was 87.9% accurate versus 71.1% for the nomogram designed on the basis of clinical variables alone (16.8% difference; P < .001). The performance characteristics of the biomarker-based nomogram were superior to those of the clinical nomogram. Conclusion We confirm that plasma levels of TGF-β1 and IL6-SR considerably enhance the accuracy of the standard preoperative nomogram for the prediction of biochemical recurrence after radical prostatectomy. This model further refines our ability to identify patients at a high risk of biochemical recurrence after radical prostatectomy.
Ontario Cancer Research Ethics Board: Lessons Learned From Developing a Multicenter Regional Institutional Review Board
Authors: Saginur Raphael , Dent Susan F. , Schwartz Lisa , Heslegrave Ronald , Stacey Sid , Manzo Janet 
Published: March 2008

Purpose We describe issues and outcomes in the development of a specialized, central institutional review board (IRB) for multicenter oncology protocols. Numerous authoritative bodies have called for a change to the ethics review system to better manage multicenter trials in terms of quality, timeliness, and efficiency. In 2003, the American Society of Clinical Oncology proposed a network of regional IRBs for cancer. Previous experience with central IRBs has been met with mixed success. Methods We took a bottom-up approach to organizing a province-wide IRB, which was led by an IRB chair and a clinical investigator at one cancer center. Participation on the part of institutions was voluntary. Results Uptake in the first 2 years was modest and increased from 11 clinical trials in year 1 to 21 in year 2. In the third year, there was an apparent upsurge in the number of involved centers (14) and in the number of submitted clinical protocols (54). Conclusion Sponsors and investigators are loath to risk development of a novel IRB until there is a clear demonstration of quality, efficiency, and timeliness of decision. Development of a regional, specialized IRB requires considerable efforts to develop and maintain the trust of sponsors, investigators, and institutions despite prior demands for more efficient and timely ethics review. Voluntary institutional participation, clear delineation of roles and responsibilities, and effective execution promote development of this trust.
Phase III Trial in Metastatic Gastroesophageal Adenocarcinoma with Fluorouracil, Leucovorin Plus Either Oxaliplatin or Cisplatin: A Study of the Arbeitsgemeinschaft Internistische Onkologie
Authors: Al-Batran Salah-Eddin , Hartmann Joerg Thomas , Probst Stephan , Schmalenberg Harald , Hollerbach Stephan , Hofheinz Ralf , Rethwisch Volker , Seipelt Gernot , Homann Nils , Wilhelm Gerhard , Schuch Gunter , Stoehlmacher Jan , Derigs Hans Günter , Hegewisch-Becker Susanna , Grossmann Johannes , Pauligk Claudia , Atmaca Akin , Bokemeyer Carsten , Knuth Alexander , Jäger Elke 
Published: March 2008

Purpose This study was designed to compare fluorouracil, leucovorin, and oxaliplatin with fluorouracil, leucovorin, and cisplatin in patients with advanced gastric cancer. Patients and Methods Patients with previously untreated advanced adenocarcinoma of the stomach or esophagogastric junction were randomly assigned to receive either fluorouracil 2,600 mg/m2 via 24-hour infusion, leucovorin 200 mg/m2, and oxaliplatin 85 mg/m2 (FLO) every 2 weeks or fluorouracil 2,000 mg/m2 via 24-hour infusion, leucovorin 200 mg/m2 weekly, and cisplatin 50 mg/m2 every 2 weeks (FLP). The primary end point was progression-free survival (PFS). Results Two hundred twenty patients (median age, 64 years; metastatic, 94%) were randomly assigned. FLO was associated with significantly less (any grade) anemia (54% v 72%), nausea (53% v 70%), vomiting (31% v 52%), alopecia (22% v 39%), fatigue (19% v 34%), renal toxicity (11% v 34%), thromboembolic events (0.9% v 7.8%), and serious adverse events related to the treatment (9% v 19%). FLP was associated with significantly less peripheral neuropathy (22% v 63%). There was a trend toward improved median PFS with FLO versus FLP (5.8 v 3.9 months, respectively; P = .077) and no significant difference in median overall survival (10.7 v 8.8 months, respectively). However, in patients older than 65 years (n = 94), treatment with FLO resulted in significantly superior response rates (41.3% v 16.7%; P = .012), time to treatment failure (5.4 v 2.3 months; P < .001), and PFS (6.0 v 3.1 month; P = .029) and an improved OS (13.9 v 7.2 months) as compared with FLP, respectively. Conclusion FLO reduced toxicity as compared with FLP. In older adult patients, FLO also seemed to be associated with improved efficacy.
Risk of Subsequent Solid Tumors After Non-Hodgkin's Lymphoma: Effect of Diagnostic Age and Time Since Diagnosis
Authors: Hemminki Kari , Lenner Per , Sundquist Jan , Lorenzo Bermejo Justo 
Published: March 2008

Purpose Quantitative data on subsequent cancers after primary cancers provide information on treatment-related risks on second cancers, with implications for therapeutic adverse effects and human susceptibility in general. Quantitative data on solid tumors are limited. We focus on survivors of non-Hodgkin's lymphoma (NHL) because the disease is diagnosed at a wide range of ages and treated uniformly primarily with chemotherapy. Patients and Methods The nationwide Swedish Family-Cancer Database included 11.5 million individuals whose cancers were retrieved from the Swedish Cancer Registry. Standardized incidence ratios (SIRs) were calculated for subsequent neoplasms among 28,131 patients with NHL. Results The SIR for solid tumors after NHL was 1.65 (2,290 patients) and that for lymphohematopoietic neoplasms was 5.36 (369 patients). Among the 25 most common solid tumors, the SIRs were increased for all but nine sites; the highest SIR (40.8) was observed for spinal meningioma. The SIRs for solid tumors declined in an age-dependent manner from 4.52 in diagnostic age younger than 20 years to 1.12 in diagnostic age 70+ years. In the most common patient groups, the SIRs for solid tumors increased up to 30 years after NHL diagnosis. Because of the high incidence of solid tumors in these age groups, they contributed the largest numbers of therapy-related cases. Conclusion These data indicate that age at treatment determines both the magnitude of the initial relative risk and the time-dependent modulation of the response. Therapy-related damage persists at least 30 years and its toll of solid tumors is largest 21 to 30 years after diagnosis.
Immunoglobulin G Fragment C Receptor Polymorphisms and Clinical Efficacy of Trastuzumab-Based Therapy in Patients With HER-2/neu–Positive Metastatic Breast Cancer
Authors: Musolino Antonino , Naldi Nadia , Bortesi Beatrice , Pezzuolo Debora , Capelletti Marzia , Missale Gabriele , Laccabue Diletta , Zerbini Alessandro , Camisa Roberta , Bisagni Giancarlo , Neri Tauro Maria , Ardizzoni Andrea 
Published: March 2008

PurposeThe anti–HER-2/neu monoclonal antibody trastuzumab has been shown to engage both activatory (fragment C receptor [FcγR]IIIa; FcγRIIa) and inhibitory (FcγRIIb) antibody receptors and FcγR polymorphisms have been identified that may affect the antibody-dependent cell-mediated cytotoxicity (ADCC) of natural-killer cells/monocytes. In this study, we tested whether FcγR polymorphisms are associated with clinical outcome of patients with breast cancer who received trastuzumab.Patients and MethodsFifty-four consecutive patients with HER-2/neu–amplified breast cancer receiving trastuzumab plus taxane for metastatic disease were evaluated for genotype for the FcγRIIIa-158 valine(V)/phenylalanine(F), FcγRIIa-131 histidine(H)/arginine(R), and FcγRIIb-232 isoleucine(I)/threonine(T) polymorphisms. Trastuzumab-mediated ADCC of patients' peripheral blood mononuclear cells (PBMCs) was measured by chromium-51 release using a HER-2/neu–expressing human breast cancer cell line as a target. Controls comprised thirty-four patients treated with taxane alone.ResultsOur population was in Hardy-Weinberg equilibrium except for the FcγRIIb polymorphism. The FcγRIIIa-158 V/V genotype was significantly correlated with objective response rate (ORR) and progression-free survival (PFS). Also, there was trend significance in ORR and PFS for the FcγRIIa-131 H/H genotype. The combination of the two favorable genotypes (VV and/or H/H) was independently associated with better ORR and PFS compared with the other combinations. The ADCC analysis showed that V/V and/or H/H PBMCs had a significantly higher trastuzumab-mediated cytotoxicity than PBMCs harboring different genotypes.ConclusionThese data support for the first time the hypothesis that FcγR-mediated ADCC plays an important role in the clinical effect of trastuzumab. Prospective studies are needed to confirm the role of FcγR polymorphisms in predicting clinical outcome of patients with breast cancer treated with trastuzumab-based therapy.
Structural Features of Dinoflagellate Toxins Underlying Biological Activity as Viewed by NMR
Authors: Murata Michio , Matsumori Nobuaki , Konoki Keiichi , Oishi Tohru 
Published: March 2008

Abstract
Marine dinoflagellates are a rich source of structurally and biologically intriguing secondary metabolites. Among those, maitotoxin may be one of the best known examples, which is the largest natural product known to date and possesses the most potent toxicity known amongst non-proteinaceous compounds. Structural studies of maitotoxin are reviewed with a particular focus on the configuration and mode of action of this unique toxin. In addition, there are many marine natural products which bind to biomembranes to exert their biological activities. To gain a better understanding of their mode of action, conformation, and bimolecular interaction occurring in biomembranes are particularly important. Recent results from NMR studies of membrane systems in the authors’ group are reviewed briefly.
Creation of Cyclic π-Electron-Conjugated Systems through the Functionalization of Fullerenes and Synthesis of Their Multinuclear Metal Complexes
Authors: Matsuo Yutaka 
Published: March 2008

Abstract
This account article describes the synthesis of a cyclic benzenoid system, [10]cyclophenacene, using a one-step deca-fold addition reaction to [60]fullerene, and a double-decker buckyferrocene complex, [(FeCp)2(C60Me10)]. Luminescent and electronic communication properties for each material may give us new opportunities to study photo- and electrochemical functional materials. Theoretical studies on electronic structure of finite-length single-walled carbon nanotubes are also described with respect to the structure of cyclophenacenes.
Direct Conversion of Aromatic Ketones to Arenecarboxylic Esters via Carbon–Carbon Bond-Cleavage Reactions
Authors: Yin Guodong , Gao Meng , Wang Zihua , Wu Yandong , Wu Anxin 
Published: March 2008

Abstract
Aromatic methyl ketones, β-keto esters, and trifluoromethyl-1,3-diketones can be directly converted to arenecarboxylic esters via carbon–carbon bond cleavage of pyridinium iodide intermediates in the presence of copper(II) oxide, iodine, pyridine, and potassium carbonate in alcoholic media. The advantages of the present method in terms of good yields, mild reaction conditions, and inexpensive reagents should make this protocol a valuable alternative to the existing methods.
Enhanced Photocatalytic Water Splitting of Hydrous LiCa2Ta3O10 Prepared by Hydrothermal Treatment
Authors: Mitsuyama Tomohiro , Tsutsumi Akiko , Hata Takakazu , Ikeue Keita , Machida Masato 
Published: March 2008

Abstract
Hydration behavior of A′Ca2Ta3O10 (A′ = Cs, Rb, K, Na, and Li) was studied focusing on the photocatalytic activity for overall water splitting under UV-irradiation. Interlayer hydration was only observed for A′ = Na and Li, which possess a large enthalpy of hydration (ΔHh°). A Na phase readily yielded a stable hydrous phase even at ambient temperature, whereas a Li phase required hydrothermal treatment at ≥160 °C. This is consistent with the fact that the Na phase kept its space group (I4⁄mmm) unchanged during hydration, whereas the Li phase changed from I4⁄mmm to P4⁄mmm. Hydration of the Li phase doubled the rate of photocatalytic gas evolution (≥700 μmol-H2 h−1) in the presence of 0.5 wt % Ni load, which was the highest in the series of A′Ca2Ta3O10. It was demonstrated that the hydrated interlayer is an efficient structural modification to enhance the photocatalytic activity of the ion-exchangeable layered perovskite-type oxides.
Preparation of Mesoporous Silica with Well-Defined Hexagonal Array of Pores by Using Octyltrimethylammonium Chloride
Authors: Sawada Takuya , Yano Toshihiro , Isshiki Nobuyuki , Isshiki Toshiyuki , Iwamoto Masakazu 
Published: March 2008

Abstract
Hexagonally ordered mesoporous silica MCM-41 was successfully prepared by using titled (OTMA) chloride at OTMA/SiO2=2.8–3.5. The BJH pore diameters were 1.4–1.5 nm which was on the prolongation of the correlation line between the chain length of surfactant and the pore diameter.
One-dimensional Halogen-bridged NiIII Compounds: Chemistry and Physics in Strongly Correlated Electron Systems
Authors: Takaishi Shinya , Yamashita Masahiro 
Published: March 2008

Abstract
In this review, we describe the structure, physical properties, and electronic structure of halogen-bridged one-dimensional (1D) NiIII compound [Ni(chxn)2Br]Br2, which is one of the mostly studied 1D strongly correlated electron compounds. We also introduce recent progress of our study of NiIII compounds.