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Milano, Italy

Olivieri A.,Unita Operativa di Ematologia e Trapianto di Cellule Staminali | Marchetti M.,Hematology Unit | Lemoli R.,University of Bologna | Tarella C.,University of Turin | And 2 more authors.
Bone Marrow Transplantation | Year: 2012

Many lymphoma and myeloma patients fail to undergo ASCT owing to poor mobilization. Identification of poor mobilizers (PMs) would provide a tool for early intervention with new mobilization agents. The Gruppo italianoTrapianto di Midollo Osseo working group proposed a definition of PMs applicable to clinical trials and clinical practice. The analytic hierarchy process, a method for group decision making, was used in setting prioritized criteria. Lymphoma or myeloma patients were defined as 'proven PM' when: (1) after adequate mobilization (G-CSF 10 μg/kg if used alone or ≥5 μg/kg after chemotherapy) circulating CD34 + cell peak is <20/μL up to 6 days after mobilization with G-CSF or up to 20 days after chemotherapy and G-CSF or (2) they yielded <2.0 × 10 6 CD34 + cells per kg in ≤3 apheresis. Patients were defined as predicted PMs if: (1) they failed a previous collection attempt (not otherwise specified); (2) they previously received extensive radiotherapy or full courses of therapy affecting SC mobilization; and (3) they met two of the following criteria: advanced disease (≥2 lines of chemotherapy), refractory disease, extensive BM involvement or cellularity <30% at the time of mobilization; age ≥65 years. This definition of proven and predicted PMs should be validated in clinical trials and common clinical practice. © 2012 Macmillan Publishers Limited All rights reserved. Source

Goldberg J.H.,University of Texas Southwestern Medical Center | Henson M.,Childrens Medical Center Dallas | Buchanan G.R.,Hematology Oncology
Pediatric Blood and Cancer | Year: 2014

Background: Kidney disease is an important cause of morbidity and mortality in patients with sickle cell anemia (SCA). The factors that affect progression of renal disease are unknown, especially in children and adolescents. Alterations in blood pressure, including hypertension and lack of the normal nocturnal dip in blood pressure, are important determinants of diabetic nephropathy and other renal diseases and may play a role in sickle cell nephropathy. Our primary hypothesis was that children with SCA who have microalbuminuria will demonstrate less nocturnal dipping of blood pressure compared to patients without microalbuminuria. We also investigated other potential factors associated with microalbuminuria. Procedure: This prospective study of 52 adolescents with SCA followed in the Children's Medical Center Dallas Comprehensive Sickle Cell Center characterized 24-hour ambulatory blood pressure profiles and presence of microalbuminuria. Stepwise logistic regression was performed to identify significant independent factors that are associated with microalbuminuria. Results: Thirty-five percent of patients were identified as having previously unrecognized hypertension, and 17% had pre-hypertension (blood pressure greater than the 90th percentile but less than the 95th percentile). Fifty-six percent of patients lacked the normal nocturnal dip in blood pressure. In addition, 21% had microalbuminuria, and their percent nocturnal dip was significantly less than those without microalbuminuria (P=0.01). Conclusions: Blood pressure abnormalities are common in adolescents with SCA and are a possible modifiable risk factor in the progression of sickle cell nephropathy. © 2013 Wiley Periodicals, Inc. Source

Sebastian M.,University Hospital Frankfurt | Schmittel A.,Hematology Oncology | Reck M.,Member of the German Center for Lung Research
European Respiratory Review | Year: 2014

Recent advances in understanding the mechanisms of nonsmall cell lung cancer (NSCLC) has led to the development of targeted treatments, including the reversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors gefitinib and erlotinib, and the irreversible ErbB family blocker afatinib. Several important activating EGFR mutations have now been identified, which correlate strongly with response to treatment with these agents. Multiple randomised controlled trials have confirmed the association between the presence of activating EGFR mutations and objective response to gefitinib, erlotinib and afatinib, thus demonstrating their superiority over platinum-based chemotherapy as first-line treatment for NSCLC patients with EGFR mutation-positive tumours, and resulting in approval of these agents for use in this setting. It can be tempting to compare outcome data across multiple clinical trials and agents; however, substantial differences in methodology between studies, including investigator versus independent assessment and differences in patient eligibility, makes such comparisons fraught with difficulty. This critical review provides an overview of the evolution of the methodology used in eight phase III trials investigating first-line targeted treatment of NSCLC, identifies key differences in methodology and reporting, and critically assesses how these differences should be taken into account when interpreting the findings from such trials. © ERS 2014. Source

Zinner R.G.,University of Texas M. D. Anderson Cancer Center | Obasaju C.K.,Eli Lilly and Company | Spigel D.R.,Medical Oncology | Weaver R.W.,Hematology Oncology | And 14 more authors.
Journal of Thoracic Oncology | Year: 2015

Introduction: PRONOUNCE compared the efficacy and safety of pemetrexed+carboplatin followed by pemetrexed (Pem+Cb) with paclitaxel+carboplatin+bevacizumab followed by bevacizumab (Pac+Cb+Bev) in patients with advanced nonsquamous non-small-cell lung cancer (NSCLC). Methods: Patients ≥18 years of age with stage IV nonsquamous NSCLC (American Joint Committee on Cancer v7.0), and Eastern Cooperative Oncology Group performance status 0/1 were randomized (1:1) to four cycles of induction Pem+Cb (pemetrexed, 500 mg/m2, carboplatin, area under the curve = 6) followed by Pem maintenance or Pac+Cb+Bev (paclitaxel, 200 mg/m2, carboplatin, area under the curve = 6, and bevacizumab, 15 mg/kg) followed by Bev maintenance in the absence of progressive disease or discontinuation. The primary objective was progression-free survival (PFS) without grade 4 toxicity (G4PFS). Secondary end points were PFS, overall survival (OS), overall response rate (ORR), disease control rate (DCR), and safety. Resource utilization was also assessed. Results: Baseline characteristics of the patients randomized to Pem+Cb (N = 182) and Pac+Cb+Bev (N = 179) were well balanced between the arms. Median (months) G4PFS was 3.91 for Pem+Cb and 2.86 for Pac+Cb+Bev (hazard ratio = 0.85, 90% confidence interval, 0.7-1.04; p = 0.176); PFS, OS, ORR, or DCR did not differ significantly between the arms. Significantly more drug-related grade 3/4 anemia (18.7% versus 5.4%) and thrombocytopenia (24.0% versus 9.6%) were reported for Pem+Cb. Significantly more grade 3/4 neutropenia (48.8% versus 24.6%), grade 1/2 alopecia (28.3% versus 8.2%), and grade 1/2 sensory neuropathy were reported for Pac+Cb+Bev. Number of hospitalizations and overall length of stay did not differ significantly between the arms. Conclusions: Pem+Cb did not produce significantly better G4PFS compared with Pac+Cb+Bev. Pem+Cb was not superior in PFS, OS, ORR, or DCR compared with Pac+Cb+Bev. Both regimens were well tolerated, although, toxicity profiles differed. Copyright © 2014 by the International Association for the Study of Lung Cancer. Source

Dowell J.E.,Hematology Oncology | Dowell J.E.,Southwestern Medical Center
American Journal of the Medical Sciences | Year: 2010

Although the incidence of small cell lung cancer (SCLC) has declined during the past 30 years, it remains a significant cause of cancer mortality in the United States and across the world. With appropriate treatment, about 20% of patients who present with limited stage SCLC can be cured of their disease. Unfortunately, the outcome for the remainder of patients is extremely poor. The only significant advance in extensive stage SCLC in the past 2 decades is the recent discovery that prophylactic cranial irradiation improves survival in those patients whose disease has responded to initial chemotherapy. Numerous attempts to enhance the antitumor effects of traditional chemotherapy for SCLC have not been successful. As the understanding of the biology of SCLC increased, a number of rational molecular targets for therapy have been identified. Although initial attempts at "targeted therapy" in SCLC have been unsuccessful, several newly identified targets hold promise and give hope that significant improvements in therapy for this challenging disease are not far away. © 2010 Southern Society for Clinical Investigation. Source

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