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Fizazi K.,University Paris - Sud | Delva R.,Center Paul Papin | Caty A.,Center Galilee | Chevreau C.,Center Claudius Regaud | And 9 more authors.
European Urology | Year: 2014

Background Whether patients with good prognosis and intermediate/poor prognosis advanced seminoma should be treated differently has not been defined. Objective To assess a risk-adapted chemotherapy regimen in patients with advanced seminoma. Design, setting, and participants A total of 132 patients were included in this prospective study. Patients with a good prognosis according to the International Germ Cell Cancer Collaboration Group (IGGCCG) were treated with four cycles of cisplatin-etoposide (EP). Patients with an intermediate prognosis according to the IGCCCG (or a poor prognosis according to the Medical Research Council classification) were treated with four cycles of VIP (EP and ifosfamide) and granulocyte colony-stimulating factor (G-CSF). Outcome measurements and statistical analysis Survival curves were estimated using the Kaplan-Meier method. Results and limitations The median follow-up was 4.5 yr (range: 0.4-11.6 yr). Among 108 patients (82%) with a good prognosis who received EP, grade 3-4 toxicity included neutropenia (47%) and neutropenic fever (12%). Among the 24 patients (18%) with an intermediate/poor prognosis who received VIP plus G-CSF, toxicity included grade 3-4 neutropenia (36%), neutropenic fever (23%), thrombocytopenia (23%), anemia (23%), and a toxicity-related death (n = 1; 4%). The 3-yr progression-free survival (PFS) rate was 93% (range: 85-97%) in the good prognosis group and 83% (range: 63-93%) in the intermediate/poor prognosis group (p = 0.03 for PFS). The 3-yr overall survival (OS) rate was 99% (range: 92-100%) and 87% (range: 67-95%), respectively (p < 0.005 for OS). Only four patients died of seminoma or its treatment. Conclusions A risk-adapted chemotherapy policy for advanced seminoma yielded an excellent outcome with a 3-yr OS rate of 96%.

Senat M.-V.,Center for Research in Epidemiology and Population Health | Porcher R.,French Institute of Health and Medical Research | Winer N.,Hopital Mere enfant | Vayssiere C.,Hopital Paul de Viguier | And 7 more authors.
American Journal of Obstetrics and Gynecology | Year: 2013

Objective: The objective of the study was to evaluate the use of 17 alpha-hydroxyprogesterone caproate (17P) to reduce preterm delivery in women with a twin pregnancy and short cervix. Study Design: This open-label, multicenter, randomized controlled trial included women with a twin pregnancy between 24+0 and 31+6 weeks of gestation who were asymptomatic and had a cervical length of 25 mm or less measured by routine transvaginal ultrasound. Women were randomized to receive (or not) 500 mg of intramuscular 17P, repeated twice weekly until 36 weeks or preterm delivery. The primary outcome was time from randomization to delivery. Analysis was performed according to the intent-to-treat principle. Results: The 17P and control groups did not differ significantly for median [interquartile range] time to delivery: 45 (26-62) and 51 (36-66) days, respectively. However, treatment with 17P was associated with a significant increase in the rate of preterm delivery before 32 weeks. Conclusion: Twice-weekly injections of 17P did not prolong pregnancy significantly in asymptomatic women with a twin pregnancy and short cervix. © 2013 Mosby, Inc.

Lucas G.,University of Rennes 1 | Mallet J.F.,Caen University Hospital Center | Neagoe P.,HOpital Morvan | Cottalorda J.,Montpellier University Hospital Center | And 5 more authors.
Spine | Year: 2013

STUDY DESIGN.: Multicenter retrospective study of 54 children. OBJECTIVE.: To describe the complication rate of the French vertical expandable prosthetic titanium rib (VEPTR) series involving patients treated between August 2005 and January 2012. SUMMARY OF BACKGROUND DATA.: Congenital chest wall and spine deformities in children are complex entities. Most of the affected patients have severe scoliosis often associated with a thoracic deformity. Orthopedic treatment is generally ineffective, and surgical treatment is very challenging. These patients are good candidates for VEPTR expansion thoracoplasty. The aim of this study was to evaluate the potential complications of VEPTR surgery. METHODS.: Of the 58 case files, 54 were available for analysis. The series involved 33 girls and 21 boys with a mean age of 7 years (range, 20 mo-14 yr and 2 mo) at primary VEPTR surgery. During the follow-up period, several complications occurred. RESULTS.: Mean follow-up was 22.5 months (range, 6-64 mo). In total, 184 procedures were performed, including 56 VEPTR implantations, 98 expansions, and 30 nonscheduled procedures for different types of complications: mechanical complications (i.e., fracture, device migration), device-related and infectious complications, neurological disorders, spine statics disturbances. Altogether, there were 74 complications in 54 patients: a complication rate of 137% per patient and 40% per surgery. Comparison of the complications in this series with those reported in the literature led the authors to suggest solutions that should help decrease their incidence. CONCLUSION.: The complication rate is consistent with that reported in the literature. Correct determination of the levels to be instrumented, preoperative improvement of nutritional status, and better evaluation of the preoperative and postoperative respiratory function are important factors in minimizing the potential complications of a technique that is used in weak patients with complex deformities. © 2013, Lippincott Williams & Wilkins.

Winer N.,Hopital Mere enfant | Senat M.-V.,Assistance Publique Hopitaux de Paris | Bohec C.,HOpital Morvan | Deruelle P.,Hopital Jeanne de Flandre | And 6 more authors.
American Journal of Obstetrics and Gynecology | Year: 2015

Objective The objective of the study was to evaluate the efficacy of 17 alpha-hydroxyprogesterone caproate (17OHP-C) in prolonging gestation in patients with a short cervix and other risk factors for preterm delivery, such as previous preterm birth, cervical surgery, uterine anomalies, or prenatal diethylstilbestrol (DES) exposure. Study Design This open-label, multicenter, randomized controlled trial included asymptomatic singleton pregnancies from 20+0 through 31+6 weeks of gestation with a cervical length less than 25 mm and a history of preterm delivery or cervical surgery or uterine malformation or prenatal DES exposure. Randomization assigned them to receive (or not) 500 mg of intramuscular 17OHP-C weekly until 36 weeks. The primary outcome was time from randomization to delivery. Results After enrolling 105 patients, an interim analysis demonstrated the lack of efficacy of 17OHP-C in prolonging pregnancy. The study was discontinued because of futility. The groups were similar for maternal age, body mass index, parity, gestational age at inclusion, history of uterine anomalies, DES syndrome, previous preterm delivery or midtrimester abortion, and cervical length at randomization. The enrollment-to-delivery interval did not differ between patients allocated to 17OHP-C (n = 51) and those allocated to the control group (n = 54) (median [interquartile range] time to delivery: 77 [54-103] and 74 [52-99] days, respectively). The rate of preterm delivery less than 37 (45% vs 44%, P >.99), less than 34 (24% vs 30%, P =.51), or less than 32 (14% vs 20%, P =.44) weeks was similar in patients allocated to 17OHP-C and those in the control group. Conclusion 17OHP-C did not prolong pregnancy in women with singleton gestations, a sonographic short cervix, and other risk factors of preterm delivery (prior history, uterine malformations, cervical surgery, or prenatal DES exposure). © 2015 Elsevier Inc.

Kamioner D.,AFSOS and Hopital Prive de lOuest Parisien | Fruehauf S.,Center for Tumor Diagnostics and Therapy | Maloisel F.,Clinique Saint Anne | Cals L.,CHRU de Besancon | And 2 more authors.
BMC Cancer | Year: 2013

Background: Nivestim™ (filgrastim) is a follow-on biologic agent licensed in the EU for the treatment of neutropenia and febrile neutropenia induced by myelosuppressive chemotherapy. Nivestim™ has been studied in phase 2 and 3 clinical trials where its efficacy and safety was found to be similar to its reference product, Neupogen®. Follow-on biologics continue to be scrutinised for safety. We present a design for two observational phase IV studies that are evaluating the safety profile of Nivestim™ for the prevention and treatment of febrile neutropenia (FN) in patients treated with cytotoxic chemotherapy in general clinical practice.Methods/Design: The NEXT (Tolérance de Nivestim chez les patiEnts traités par une chimiothérapie anticancéreuse cytotoXique en praTique courante) and VENICE (VErträglichkeit von NIvestim unter zytotoxischer Chemotherapie in der Behandlung malinger Erkrankungen) trials are multicentre, prospective, longitudinal, observational studies evaluating the safety profile of Nivestim™ in 'real-world' clinical practice. Inclusion criteria include patients undergoing cytotoxic chemotherapy for malignancy and receiving Nivestim as primary or secondary prophylaxis (NEXT and VENICE), or as treatment for ongoing FN (NEXT only). In accordance with European Union pharmacovigilance guidelines, the primary objective is to evaluate the safety of Nivestim™ by gathering data on adverse events in all system organ classes. Secondary objectives include obtaining information on patient characteristics, efficacy of Nivestim™ therapy (including chemotherapy dose intensity), patterns of use of Nivestim™, and physician knowledge regarding filgrastim prescription and the reasons for choosing Nivestim™. Data will be gathered at three visits: 1. At the initial inclusion visit, 2. At a 1-month follow-up visit, and 3. At the end of chemotherapy. Recruitment for VENICE commenced in July 2011 and in November 2011 for NEXT. VENICE completed recruitment in July 2013 with 407 patients, and NEXT in September 2013 with 2123 patients. Last patient, last visit for each study will be December 2013 and March 2014 respectively.Discussion: The NEXT and VENICE studies will provide long-term safety, efficacy and practice pattern data in patients receiving Nivestim™ to support myelosuppressive chemotherapy in real world clinical practice. These data will improve our understanding of the performance of Nivestim™ in patients encountered in the general patient population. Trial registration: NEXT NCT01574235, VENICE NCT01627990. © 2013 Kamioner et al.; licensee BioMed Central Ltd.

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