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1. Intensive chemotherapy as salvage treatment for solid tumors: focus on germ cell cancer

Author

F. Selle, J. Gligorov, S. Richard, A. Khalil, I. Alexandre, D. Avenin, S. Provent, D.G. Soares, and J.P. Lotz

Subjects
High-dose chemotherapy, Germ cell tumors, Stem cell transplantation, Solid tumors, Breast cancer, Ovarian cancer, Medicine (General), R5-920, Biology (General), QH301-705.5
Abstract

Germ cell tumors present contrasting biological and molecular features compared to many solid tumors, which may partially explain their unusual sensitivity to chemotherapy. Reduced DNA repair capacity and enhanced induction of apoptosis appear to be key factors in the sensitivity of germ cell tumors to cisplatin. Despite substantial cure rates, some patients relapse and subsequently die of their disease. Intensive doses of chemotherapy are used to counter mechanisms of drug resistance. So far, high-dose chemotherapy with hematopoietic stem cell support for solid tumors is used only in the setting of testicular germ cell tumors. In that indication, high-dose chemotherapy is given as the first or late salvage treatment for patients with either relapsed or progressive tumors after initial conventional salvage chemotherapy. High-dose chemotherapy is usually given as two or three sequential cycles using carboplatin and etoposide with or without ifosfamide. The administration of intensive therapy carries significant side effects and can only be efficiently and safely conducted in specialized referral centers to assure optimum patient care outcomes. In breast and ovarian cancer, most studies have demonstrated improvement in progression-free survival (PFS), but overall survival remained unchanged. Therefore, most of these approaches have been dropped. In germ cell tumors, clinical trials are currently investigating novel therapeutic combinations and active treatments. In particular, the integration of targeted therapies constitutes an important area of research for patients with a poor prognosis.

Published
2015
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2. Intensive chemotherapy as salvage treatment for solid tumors: focus on germ cell cancer

Author

F. Selle, J. Gligorov, S. Richard, A. Khalil, I. Alexandre, D. Avenin, S. Provent, D.G. Soares, and J.P. Lotz

Subjects
High-dose chemotherapy, Germ cell tumors, Stem cell transplantation, Solid tumors, Breast cancer, Ovarian cancer, Medicine (General), R5-920, Biology (General), QH301-705.5
Abstract

Germ cell tumors present contrasting biological and molecular features compared to many solid tumors, which may partially explain their unusual sensitivity to chemotherapy. Reduced DNA repair capacity and enhanced induction of apoptosis appear to be key factors in the sensitivity of germ cell tumors to cisplatin. Despite substantial cure rates, some patients relapse and subsequently die of their disease. Intensive doses of chemotherapy are used to counter mechanisms of drug resistance. So far, high-dose chemotherapy with hematopoietic stem cell support for solid tumors is used only in the setting of testicular germ cell tumors. In that indication, high-dose chemotherapy is given as the first or late salvage treatment for patients with either relapsed or progressive tumors after initial conventional salvage chemotherapy. High-dose chemotherapy is usually given as two or three sequential cycles using carboplatin and etoposide with or without ifosfamide. The administration of intensive therapy carries significant side effects and can only be efficiently and safely conducted in specialized referral centers to assure optimum patient care outcomes. In breast and ovarian cancer, most studies have demonstrated improvement in progression-free survival (PFS), but overall survival remained unchanged. Therefore, most of these approaches have been dropped. In germ cell tumors, clinical trials are currently investigating novel therapeutic combinations and active treatments. In particular, the integration of targeted therapies constitutes an important area of research for patients with a poor prognosis.

Published
2014
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3. Olaparib plus bevacizumab first-line maintenance in ovarian cancer : final overall survival results from the PAOLA-1/ENGOT-ov25 trial

Author

I. Ray-Coquard, A. Leary, S. Pignata, C. Cropet, A. González-Martin, C. Marth, S. Nagao, I. Vergote, N. Colombo, J. Mäenpää, F. Selle, J. Sehouli, D. Lorusso, E.M. Guerra Alia, G. Bogner, H. Yoshida, C. Lefeuvre-Plesse, P. Buderath, A.M. Mosconi, A. Lortholary, A. Burges, J. Medioni, A. El-Balat, M. Rodrigues, T.-W. Park-Simon, C. Dubot, D. Denschlag, B. You, E. Pujade-Lauraine, P. Harter, Ray-Coquard, I, Leary, A, Pignata, S, Cropet, C, González-Martin, A, Marth, C, Nagao, S, Vergote, I, Colombo, N, Mäenpää, J, Selle, F, Sehouli, J, Lorusso, D, Alia, E, Bogner, G, Yoshida, H, Lefeuvre-Plesse, C, Buderath, P, Mosconi, A, Lortholary, A, Burges, A, Medioni, J, El-Balat, A, Rodrigues, M, Park-Simon, T, Dubot, C, Denschlag, D, You, B, Pujade-Lauraine, E, and Harter, P

Subjects
Oncology, advanced ovarian cancer, overall survival, Medizin, Hematology, bevacizumab, olaparib
Abstract

Background: In the PAOLA-1/ENGOT-ov25 primary analysis, maintenance olaparib plus bevacizumab demonstrated a significant progression-free survival (PFS) benefit in newly diagnosed advanced ovarian cancer patients in clinical response after first-line platinum-based chemotherapy plus bevacizumab, irrespective of surgical status. Prespecified, exploratory analyses by molecular biomarker status showed substantial benefit in patients with a BRCA1/BRCA2 mutation (BRCAm) or homologous recombination deficiency (HRD; BRCAm and/or genomic instability). We report the prespecified final overall survival (OS) analysis, including analyses by HRD status. Patients and methods: Patients were randomized 2: 1 to olaparib (300 mg twice daily; up to 24 months) plus bevacizumab (15 mg/kg every 3 weeks; 15 months total) or placebo plus bevacizumab. Analysis of OS, a key secondary endpoint in hierarchical testing, was planned for ∼60% maturity or 3 years after the primary analysis. Results: After median follow-up of 61.7 and 61.9 months in the olaparib and placebo arms, respectively, median OS was 56.5 versus 51.6 months in the intention-to-treat population [hazard ratio (HR) 0.92, 95% confidence interval (CI) 0.76-1.12; P = 0.4118]. Subsequent poly(ADP-ribose) polymerase inhibitor therapy was received by 105 (19.6%) olaparib patients versus 123 (45.7%) placebo patients. In the HRD-positive population, OS was longer with olaparib plus bevacizumab (HR 0.62, 95% CI 0.45-0.85; 5-year OS rate, 65.5% versus 48.4%); at 5 years, updated PFS also showed a higher proportion of olaparib plus bevacizumab patients without relapse (HR 0.41, 95% CI 0.32-0.54; 5-year PFS rate, 46.1% versus 19.2%). Myelodysplastic syndrome, acute myeloid leukemia, aplastic anemia, and new primary malignancy incidence remained low and balanced between arms. Conclusions: Olaparib plus bevacizumab provided clinically meaningful OS improvement for first-line patients with HRD-positive ovarian cancer. These prespecified exploratory analyses demonstrated improvement despite a high proportion of patients in the placebo arm receiving poly(ADP-ribose) polymerase inhibitors after progression, confirming the combination as one of the standards of care in this setting with the potential to enhance cure. in press

Published
2023

5. 176O Final overall survival (OS) results from the phase III PAOLA-1/ENGOT-ov25 trial evaluating maintenance olaparib (ola) plus bevacizumab (bev) in patients (pts) with newly diagnosed advanced ovarian cancer (AOC)

Author

S. Nagao, P. Harter, A. Leary, C. Cropet, S. Pignata, K. Fujiwara, A.J. Gonzalez Martin, G. Bogner, I. Vergote, N. Colombo, J. Maenpaa, F. Selle, B. Schmalfeldt, G. Scambia, E.M. Guerra Alia, C. Lefeuvre-Plesse, A. Belau, A. Lortholary, M. Gropp-Meier, E. Pujade-Lauraine, and I. Ray-Coquard

Subjects
Oncology, Hematology
Published
2022

7. LBA29 Final overall survival (OS) results from the phase III PAOLA-1/ENGOT-ov25 trial evaluating maintenance olaparib (ola) plus bevacizumab (bev) in patients (pts) with newly diagnosed advanced ovarian cancer (AOC)

Author

I.L. Ray-Coquard, A. Leary, S. Pignata, C. Cropet, A.J. Gonzalez Martin, G. Bogner, H. Yoshida, I.B. Vergote, N. Colombo, J. Maenpaa, F. Selle, B. Schmalfeldt, G. Scambia, E.M. Guerra Alia, C. Lefeuvre-Plesse, A. Belau, A. Lortholary, M. Gropp-Meier, E. Pujade-Lauraine, and P. Harter

Subjects
Oncology, Hematology
Published
2022

9. 177 Efficacy of niraparib by timing of surgery and residual disease: a post-hoc analysis of patients in the PRIMA/ENGOT-OV26/GOG-3012 study

Author

C McCormick, Tally Levy, F Selle, I Malinowska, Shahin, I Tusquets, Antonio González-Martín, F Joly, Richard G. Moore, Divya Gupta, Christof Vulsteke, William H. Bradley, David M. O'Malley, Bradley J. Monk, JA Pérez-Fidalgo, Roisin E. O'Cearbhaill, G Artioli, Sakari Hietanen, Klaus Baumann, and Brian M. Slomovitz

Subjects
education.field_of_study, medicine.medical_specialty, Chemotherapy, business.industry, medicine.medical_treatment, Population, Hazard ratio, Debulking, medicine.disease, Placebo, Surgery, Serous fluid, Fallopian tube cancer, Post-hoc analysis, medicine, education, business
Abstract

Introduction/Background* Niraparib is a poly(ADP-ribose) polymerase (PARP) inhibitor approved as maintenance treatment for patients (pts) with newly diagnosed advanced or recurrent ovarian cancer following a response to platinum-based chemotherapy (CT) doublet. The PRIMA/ENGOT-OV26/GOG-3012 (NCT02655016) study showed that niraparib following first-line treatment improved progression-free survival (PFS) in the overall intention-to-treat (ITT) population (hazard ratio [HR] 0.62; 95% CI 0.50–0.76). Methodology This double-blind, placebo (PBO)-controlled, phase 3 trial evaluated niraparib in pts with newly diagnosed, advanced, high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer with a complete or partial response to first-line CT. Pts were considered to be at a high risk for disease progression based on their clinical characteristics. This post-hoc analysis presents the efficacy of niraparib, measured by PFS, based on time of surgery and residual disease status, and was not powered to determine differences among the subgroups. Result(s)* Data cutoff was May 2019. In total, 733 pts were randomized in the PRIMA study. Efficacy outcomes by surgical timing, either primary debulking surgery (PDS) or interval debulking surgery (IDS), and postoperative residual disease status, either no visible residual disease (NVRD) or visible residual disease (VRD), are shown in table 1. Pts who underwent PDS or IDS had similar efficacy with niraparib maintenance treatment versus PBO in the ITT population (PFS HRs were 0.67 and 0.57, respectively). Niraparib treatment reduced risk of progression by 42% in pts who received PDS and had VRD, 35% in those with IDS and NVRD, and 59% in those with IDS and VRD. Efficacy was not evaluable for pts with PDS and NVRD due to low sample size. Conclusion* In this post-hoc analysis, the impact of residual disease after PDS or IDS on the efficacy of niraparib was comparable across subgroups. Pts with IDS and VRD had the highest reduction in the risk of progression.

Published
2021

11. LBA30 Phase III ATALANTE/ov29 trial: Atezolizumab (Atz) versus placebo with platinum-based chemotherapy (Cx) plus bevacizumab (bev) in patients (pts) with platinum-sensitive relapse (PSR) of epithelial ovarian cancer (OC)

Author

J.E. Kurtz, E. Pujade-Lauraine, A. Oaknin, L. Belin, I. Tsibulak, D. Cibula, I.B. Vergote, O.S. Rosengarten, M.J. Rodrigues, N. de Gregorio, J. Martinez-Garcia, P. Pautier, M.A. Mouret Reynier, F. Selle, V. D'Hondt, F. Joly Lobbedez, E. Bultot Boissier, A. Floquet, P-E. Heudel, and F. Heitz

Subjects
Oncology, Hematology
Published
2022

12. Glassy cell carcinoma du col de l’utérus : une maladie tumorale agressive

Author

H. Kafé, Jonathan London, Olivier Lidove, J. Slama, C. Beal, F. Selle, L. Duval-Chopard, Wladimir Mauhin, L. Fredeau, C. Montagner, P. Durand, and A. Bricou

Subjects
0301 basic medicine, Gynecology, 03 medical and health sciences, medicine.medical_specialty, 030104 developmental biology, 0302 clinical medicine, Glassy Cell Carcinoma, business.industry, 030220 oncology & carcinogenesis, Gastroenterology, Internal Medicine, Medicine, business
Abstract

Resume Introduction Le cancer du col de l’uterus represente la douzieme cause de cancer de la femme en France. Le glassy cell carcinoma est une entite histologique rare de mauvais pronostic dont l’evolution est rapidement progressive. Observation Une femme de 30 ans etait adressee dans le service de medecine interne pour des polyarthralgies febriles evoluant depuis 3 semaines. Les explorations retrouvaient un syndrome inflammatoire biologique avec au TEP-scanner des lesions osteolytiques disseminees intensement hypermetaboliques associees a un foyer pelvien droit, ainsi que des foyers ganglionnaires. L’examen gynecologique retrouvait une lesion bourgeonnante de l’endocol de 3 cm dont l’histologie retrouvait un carcinome a haut index mitotique de type glassy-cell carcinoma. L’evolution etait defavorable malgre une chimiotherapie debutee en urgence, avec deces de la patiente en trois mois. Conclusion Le glassy cell carcinoma du col de l’uterus doit etre rajoute aux causes possibles de metastases osseuses chez la femme jeune.

Published
2019

13. Carboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial

Author

Giovanni Scambia, Daniela Sambataro, Coraline Dubot, Rossella Lauria, Francesco Raspagliesi, Patricia Pautier, Simona Frezzini, S Mammoliti, U De Giorgi, Ugo De Giorgi, C Sessa, Angiolo Gadducci, Isabelle Ray-Coquard, A Gadducci, Rémy Largillier, Francesco Perrone, Alessandra Bologna, Sandro Pignata, G Scambia, Elena Zafarana, E Breda, Florence Joly, R Largillier, Saverio Cinieri, C Pisano, Carmela Pisano, C Gallo, Frédéric Selle, Vanda Salutari, Cristiana Sessa, Aristotelis Bamias, F Joly, R Lauria, A Ardizzoia, Laure Favier, Nicoletta Colombo, D Sambataro, F Perrone, Domenica Lorusso, C Dubot, G Daniele, Emmanuel Guardiola, A Bamias, Gennaro Daniele, V Salutari, F Selle, S. Mammoliti, E Zafarana, P Pautier, M Orditura, Enrico Breda, A Bologna, E Guardiola, Michele Orditura, Ciro Gallo, L Favier, S Cinieri, N Colombo, I Ray-Coquard, S Frezzini, S Pignata, F Raspagliesi, Antonio Ardizzoia, Pignata, S., Lorusso, D., Joly, F., Gallo, C., Colombo, N., Sessa, C., Bamias, A., Salutari, V., Selle, F., Frezzini, S., De Giorgi, U., Pautier, P., Bologna, A., Orditura, M., Dubot, C., Gadducci, A., Mammoliti, S., Ray-Coquard, I., Zafarana, E., Breda, E., Favier, L., Ardizzoia, A., Cinieri, S., Largillier, R., Sambataro, D., Guardiola, E., Lauria, R., Pisano, C., Raspagliesi, F., Scambia, G., Daniele, G., Perrone, F., Pignata, S, Lorusso, D, Joly, F, Gallo, C, Colombo, N, Sessa, C, Bamias, A, Salutari, V, Selle, F, Frezzini, S, De Giorgi, U, Pautier, P, Bologna, A, Orditura, M, Dubot, C, Gadducci, A, Mammoliti, S, Ray-Coquard, I, Zafarana, E, Breda, E, Favier, L, Ardizzoia, A, Cinieri, S, Largillier, R, Sambataro, D, Guardiola, E, Lauria, R, Pisano, C, Raspagliesi, F, Scambia, G, Daniele, G, and Perrone, F

Subjects
Oncology, Adult, medicine.medical_specialty, Bevacizumab, Paclitaxel, Phases of clinical research, Disease-Free Survival, Carboplatin, Polyethylene Glycols, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Maintenance therapy, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Pelvic inflammatory disease, medicine, Humans, 030212 general & internal medicine, Progression-free survival, Aged, Ovarian Neoplasms, Antineoplastic Combined Chemotherapy Protocol, Performance status, business.industry, Ovarian Neoplasm, Middle Aged, Gemcitabine, chemistry, Doxorubicin, Drug Resistance, Neoplasm, 030220 oncology & carcinogenesis, Disease Progression, Female, Neoplasm Recurrence, Local, business, medicine.drug, Human
Abstract

Background: Bevacizumab is approved in combination with chemotherapy for the treatment of ovarian cancer, either in first-line therapy or for patients with recurrent disease not previously treated with the same drug. We aimed to test the value of continuing bevacizumab beyond progression after first-line treatment with the same drug. Methods: In our open-label, randomised, phase 3 trial done at 82 sites in four countries, we enrolled women (aged ≥18 years) who had previously received first-line platinum-based therapy including bevacizumab, and had recurrent (≥6 months since last platinum dose), International Federation of Gynaecology and Obstetrics stage IIIB–IV ovarian cancer with an Eastern Cooperative Oncology Group performance status 0–2. Patients were randomly assigned (1:1) to receive a carboplatin-based doublet intravenously (carboplatin area under the concentration curve [AUC] 5 on day 1 plus paclitaxel 175 mg/m2 on day 1, every 21 days; carboplatin AUC 4 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8, every 21 days; or carboplatin AUC 5 on day 1 plus pegylated liposomal doxorubicin 30 mg/m2 on day 1, every 28 days), or a carboplatin-based doublet plus bevacizumab (10 mg/kg intravenous every 14 days combined with pegylated liposomal doxorubicin–carboplatin, or 15 mg/kg every 21 days combined with gemcitabine–carboplatin or paclitaxel–carboplatin). Evaluable disease according to RECIST 1.1 guidelines was required before randomisation. Randomisation was done through the trial website with a minimisation procedure, stratified by centre, time of recurrence, performance status, and type of second-line chemotherapy. The primary endpoint was investigator-assessed progression-free survival, analysed on an intention-to-treat basis. Safety was assessed in all participants who received at least one dose. This trial is registered with ClinicalTrials.gov, NCT01802749 and EudraCT 2012-004362-17. Findings: Between Dec 6, 2013, and Nov 11, 2016, 406 patients were recruited (203 [50%] assigned to the bevacizumab group and 203 [50%] to the standard chemotherapy group). 130 patients (64%) in the bevacizumab group and 131 (65%) in the standard chemotherapy group had progressed after receiving a last dose of platinum more than 12 months before, and 146 patients (72%) in the bevacizumab group and 147 (72%) in the standard chemotherapy group had progressed after completion of first-line bevacizumab maintenance. 161 participants (79%) progressed in the standard chemotherapy group, as did 143 (70%) in the bevacizumab group. Median progression-free survival was 8·8 months (95% CI 8·4–9·3) in the standard chemotherapy group and 11·8 months (10·8–12·9) in the bevacizumab group (hazard ratio 0·51, 95% CI 0·41–0·65; log-rank p

Published
2021

14. [Glassy cell carcinoma of the uterine cervix: An aggressive type of cancer]

Author

C, Montagner, A, Bricou, F, Selle, H, Kafé, W, Mauhin, L, Fredeau, L, Duval-Chopard, J, Slama, P, Durand, C, Beal, J, London, and O, Lidove

Subjects
Adult, Carcinoma, Adenosquamous, Fatal Outcome, Lymphatic Metastasis, Humans, Uterine Cervical Neoplasms, Bone Neoplasms, Female, Magnetic Resonance Imaging
Abstract

Cervical cancer is the twelfth most frequent cancer in women in France. Glassy cell carcinoma is a rare histological entity, rapidly aggressive, associated with a poor prognosis.A 30-year-old woman was admitted in an internal medicine department for polyarthralgia with high grade fever, evolving for 3 weeks. There was an inflammatory syndrome. The 18-FDG-PET-scan showed inflammatory lymph nodes as well as disseminated osteolytic lesions, and a primitive pelvic tumor. A 3cm tumor of the cervix was found during the gynaecologic examination. Histological analysis elicited a high-index mitotic carcinoma, glassy cell carcinoma type. Despite chemotherapy, the outcome was poor, with early death occurring after three months of follow-up.The glassy cell carcinoma of the cervix should be considered as an aetiology of bone metastases in young female patients.

Published
2019

15. Tumores infrecuentes del ovario: estrategias terapéuticas y organización del tratamiento

Author

I. Ray-Coquard, P Méeus, Isabelle Treilleux, Jérôme Alexandre, J P Guastalla, F Selle, Eric Pujade-Lauraine, Catherine Lhommé, Patricia Pautier, M C Vacher-Lavenu, Pierre Duvillard, and P. Morice

Abstract

Los tumores infrecuentes del ovario son un grupo de tumores malignos que representan menos del 10% de las neoplasias ovaricas de la mujer adulta. Se trata, basicamente, de tumores germinales y tumores del estroma ovarico y los cordones sexuales (tumores de la granulosa y de Sertoli-Leydig), tumores de celulas pequenas o algunos tumores epiteliales infrecuentes (mucinosos, de celulas claras) y tumores ovaricos que se encuentran en el limite de la malignidad (algunas veces con implantes invasivos). La edad en el momento del diagnostico, el estadio inicial y el pronostico son muy distintos a los de los tumores epiteliales ovaricos mas frecuentes, aunque el tratamiento puede ser a veces parecido. El tratamiento de los tumores infrecuentes del ovario se apoya en primer lugar en la cirugia. El tratamiento quirurgico depende de la edad de la paciente, del tipo histologico y del grado de extension de la enfermedad. En la medida de lo posible, el objetivo es conservar la funcion ovarica y del utero. Los protocolos de quimioterapia suelen ser distintos a los de los tumores epiteliales frecuentes y se escogen en funcion del tipo histologico. Por ejemplo, para los tumores germinales y del estroma, los protocolos son los de los tumores germinales testiculares. Debido a la extrema infrecuencia de estos tumores, a las dificultades del diagnostico histologico y a la falta de factores pronosticos reconocidos y, en muchos casos, de estudios prospectivos, las decisiones terapeuticas no pueden basarse en criterios establecidos, por lo que debe recurrirse a concertaciones multidisciplinarias entre expertos. Al respecto, hay un sitio de internet de acceso libre dedicado a la intervencion sobre estos tumores. Permite conocer la opinion de expertos sobre el tratamiento quirurgico y medico de primera linea y en caso de recaida a traves de un foro de discusion. Tambien permite consultar arboles de decisiones asociados a protocolos terapeuticos para la mayoria de estas afecciones. Estos protocolos de tratamiento atanen actualmente a los tumores ovaricos malignos germinales y a los tumores malignos estromales y de los cordones sexuales. En Francia, con la creacion de los centros de referencia del Institut National du Cancer, este ambito se ha ampliado a los tumores situados en el limite de la malignidad (con implantes invasivos), los tumores epiteliales infrecuentes (carcinoma mucinoso o de celulas claras) y otros tumores ginecologicos muy infrecuentes.

Published
2012

17. The role of lymph node resection in ovarian cancer: analysis of the surveillance, epidemiology, and end results (SEER) database

Author

J. L. Brun, Serge Uzan, Emile Daraï, Christophe Pomel, C. Bergzoll, G. Dubernard, F. Selle, and Roman Rouzier

Subjects
Oncology, medicine.medical_specialty, business.industry, medicine.medical_treatment, Obstetrics and Gynecology, medicine.disease, Debulking, Surgery, medicine.anatomical_structure, Median follow-up, Internal medicine, medicine, Surveillance, Epidemiology, and End Results, Lymphadenectomy, Stage (cooking), Ovarian cancer, business, Lymph node, Survival rate
Abstract

Please cite this paper as: Rouzier R, Bergzoll C, Brun J, Dubernard G, Selle F, Uzan S, Pomel C, Darai E. The role of lymph node resection in ovarian cancer: analysis of the surveillance, epidemiology, and end results (SEER) database. BJOG 2010;117:1451–1458. Objective The therapeutic role of lymphadenectomy on the survival in patients with ovarian cancer is controversial. The aim of this study was to evaluate the survival impact of lymphadenectomy, depending on the disease stage and extent of the surgery. Design The surveillance, epidemiology, and end results (SEER) registry provided ovarian cancer data from 17 registries. Setting Surveillance, Epidemiology, and End Results database. Population The study population comprised 49 783 patients. Methods Survival was studied according to the number of lymph nodes removed, with stratifications on disease stage and extent of surgery. Main outcome measure The 5-year cause-specific survival rate. Results The median follow up for patients alive at the last follow-up visit was 39 months. The five-year cause-specific survival rates were 37, 62, and 71% for the groups in which no lymph nodes were examined, in which between one and nine nodes were examined, and in which ten or more nodes were examined, respectively (P

Published
2010

18. Pulmonary morbidity of diaphragmatic surgery for stage III/IV ovarian cancer

Author

Emile Daraï, F. Selle, Christophe Pomel, E. Chereau, Marcos Ballester, Roman Rouzier, and Annie Cortez

Subjects
medicine.medical_specialty, Blood transfusion, Lung, business.industry, Pleural effusion, medicine.medical_treatment, Obstetrics and Gynecology, Diaphragmatic breathing, medicine.disease, Surgery, medicine.anatomical_structure, Medicine, Lymphadenectomy, Stage IIIC, Prospective cohort study, business, Complication
Abstract

Objective To determine the morbidity of diaphragmatic peritonectomy. Design Prospective cohort study. Setting A Gynecology Department of a University Hospital. Population From 2005 to 2007, thirty-seven consecutive patients underwent surgery for stage IIIC or IV ovarian cancer. Methods Patients were separated into a diaphragmatic surgery group (n = 18) and a control group (n = 19). Diaphragmatic surgery may consist of coagulation, stripping or muscle resection. Main outcome measures Postoperative course and outcome were analysed. Results Patients in group 1 (diaphragmatic surgery) underwent more intestinal resection (89% versus 37%, P = 0.01) and pelvic (94% versus 63%, P = 0.02) or para-aortic lymphadenectomy (94% versus 53%, P = 0.04). Neither the mean estimated blood loss (960 ml versus 909 ml) nor the rates of intra-operative blood transfusion (11 versus 9) were significantly different between the two groups. The mean operative time was higher in group 1 (480 minutes versus 316 minutes, P

Published
2009

19. Impact of methodological choices in comparative effectiveness studies: application in natalizumab versus fingolimod comparison among patients with multiple sclerosis

Author

M. Lefort, S. Sharmin, J. B. Andersen, S. Vukusic, R. Casey, M. Debouverie, G. Edan, J. Ciron, A. Ruet, J. De Sèze, E. Maillart, H. Zephir, P. Labauge, G. Defer, C. Lebrun-Frenay, T. Moreau, E. Berger, P. Clavelou, J. Pelletier, B. Stankoff, O. Gout, E. Thouvenot, O. Heinzlef, A. Al-Khedr, B. Bourre, O. Casez, P. Cabre, A. Montcuquet, A. Wahab, J. P. Camdessanché, A. Maurousset, H. Ben Nasr, K. Hankiewicz, C. Pottier, N. Maubeuge, D. Dimitri-Boulos, C. Nifle, D. A. Laplaud, D. Horakova, E. K. Havrdova, R. Alroughani, G. Izquierdo, S. Eichau, S. Ozakbas, F. Patti, M. Onofrj, A. Lugaresi, M. Terzi, P. Grammond, F. Grand’Maison, B. Yamout, A. Prat, M. Girard, P. Duquette, C. Boz, M. Trojano, P. McCombe, M. Slee, J. Lechner-Scott, R. Turkoglu, P. Sola, D. Ferraro, F. Granella, V. Shaygannejad, J. Prevost, D. Maimone, O. Skibina, K. Buzzard, A. Van der Walt, R. Karabudak, B. Van Wijmeersch, T. Csepany, D. Spitaleri, S. Vucic, N. Koch-Henriksen, F. Sellebjerg, P. S. Soerensen, C. C. Hilt Christensen, P. V. Rasmussen, M. B. Jensen, J. L. Frederiksen, S. Bramow, H. K. Mathiesen, K. I. Schreiber, H. Butzkueven, M. Magyari, T. Kalincik, and E. Leray

Subjects
Effectiveness, Multiple sclerosis, Propensity score, Indication bias, Causal contrasts, Censoring, Medicine (General), R5-920
Abstract

Abstract Background Natalizumab and fingolimod are used as high-efficacy treatments in relapsing–remitting multiple sclerosis. Several observational studies comparing these two drugs have shown variable results, using different methods to control treatment indication bias and manage censoring. The objective of this empirical study was to elucidate the impact of methods of causal inference on the results of comparative effectiveness studies. Methods Data from three observational multiple sclerosis registries (MSBase, the Danish MS Registry and French OFSEP registry) were combined. Four clinical outcomes were studied. Propensity scores were used to match or weigh the compared groups, allowing for estimating average treatment effect for treated or average treatment effect for the entire population. Analyses were conducted both in intention-to-treat and per-protocol frameworks. The impact of the positivity assumption was also assessed. Results Overall, 5,148 relapsing–remitting multiple sclerosis patients were included. In this well-powered sample, the 95% confidence intervals of the estimates overlapped widely. Propensity scores weighting and propensity scores matching procedures led to consistent results. Some differences were observed between average treatment effect for the entire population and average treatment effect for treated estimates. Intention-to-treat analyses were more conservative than per-protocol analyses. The most pronounced irregularities in outcomes and propensity scores were introduced by violation of the positivity assumption. Conclusions This applied study elucidates the influence of methodological decisions on the results of comparative effectiveness studies of treatments for multiple sclerosis. According to our results, there are no material differences between conclusions obtained with propensity scores matching or propensity scores weighting given that a study is sufficiently powered, models are correctly specified and positivity assumption is fulfilled.

Published
2022
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20. Identification of vaginal microbiome associated with IVF pregnancy

Author

B. Lledo, A. Fuentes, F. M. Lozano, A. Cascales, R. Morales, M. Hortal, F. Sellers, A. Palacios-Marques, R. Bermejo, F. Quereda, J. C. Martínez-Escoriza, R. Bernabeu, and A. Bernabeu

Subjects
Medicine, Science
Abstract

Abstract The factors that cause a preterm birth (PTB) are not completely understood up to date. Moreover, PTB is more common in pregnancies achieved by in-vitro fertilization (IVF) than in spontaneous pregnancies. Our aim was to compare the composition of vaginal microbiome at 12 weeks of gestation between women who conceived naturally or through IVF in order to study whether IVF PTB-risk could be related to vaginal microbiome composition. We performed an observational, prospective and multicentre study among two public hospitals and a fertility private clinic in Spain. Vaginal swabs from 64 pregnant women at 12 weeks of gestation were collected to analyse the microbiome composition by sequencing the V3–V4 region of the 16S rRNA. Our results showed that the vaginal microbiome signature at 12 weeks of pregnancy was different from women who conceived naturally or through IVF. The beta diversity and the genus composition were different between both cohorts. Gardnerella, Neisseria, Prevotella, and Staphylococcus genus were enriched genus in the vaginal microbiome from the IVF group, allowing us to create a balance model to predict both cohorts. Moreover, at species level the L. iners abundance was higher and L. gasseri was lower in the IVF group. As a conclusion, our findings were consistent with a proposed framework in which IVF pregnancy are related to risk for preterm birth (PTB) suggesting vaginal microbiome could be the reason to the relation between IVF pregnancy and risk for PTB.

Published
2022
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22. Valeur prédictive des bacilles acido-alcoolo-résistants à l'examen microscopique des prélèvements pulmonaires pour les patients VIH+ ayant moins de 50 CD4/mm3

Author

J. Frottier, F. Selle, Marguerite Guiguet, Frédéric Barbut, Jean-Luc Meynard, V. Lalande, and Jean-Claude Petit

Subjects
Infectious Diseases
Abstract

Resume L'observation de bacilles acido-alcoolo-resistants (BAAR) ne permet pas de preciser l'espece en cause. Pour les patients VIH+ ayant un taux de CD4 ≤ 50/mm3, le clinicien est amene a faire un choix entre le traitement antituberculeux et le traitement d'une infection a Mycobacterium avium-intracellulare (MAI). Pour evaluer la valeur predictive de la positivite d'un examen microscopique pour M. tuberculosis (MTB), nous avons etudie retrospectivement les donnees bacteriologiques, cliniques et biologiques de patients ayant moins de 50 CD4/mm3 et des BAAR a l'examen microscopique. Les dossiers de 19 patients ont ete analyses. La valeur predictive de l'examen microscopique etait de 44 % pour MTB. La comparaison du groupe des 10 patients infectes par MTB ou MK avec le groupe des 8 patients infectes par MAI (taux moyen de CD4+/mm3 : 23 ± 14 vs 14 ± 4, p = 0,07), n'a pas permis de degager de parametres cliniques et biologiques significativement predictifs d'une tuberculose ou d'une mycobacteriose; cependant les 8 patients infectes par MAI ont tous un taux de CD4

Published
1996

23. The association of selected multiple sclerosis symptoms with disability and quality of life: a large Danish self-report survey

Author

S. Gustavsen, A. Olsson, H. B. Søndergaard, S. R. Andresen, P. S. Sørensen, F. Sellebjerg, and A. Oturai

Subjects
MS, QoL, Prevalence, Symptom burden, Neurology. Diseases of the nervous system, RC346-429
Abstract

Abstract Background People with multiple sclerosis (MS) experience a wide range of unpredictable and variable symptoms. The symptomatology of MS has previously been reported in large sample registry studies; however, some symptoms may be underreported in registries based on clinician-reported outcomes and how the symptoms are associated with quality of life (QoL) are often not addressed. The aim of this study was to comprehensively evaluate the frequency of selected MS related symptoms and their associations with disability and QoL in a large self-report study. Methods We conducted a cross-sectional questionnaire survey among all patients at the Danish Multiple Sclerosis Center, Copenhagen University Hospital, Denmark. The questionnaire included information on clinical and sociodemographic characteristics, descriptors of QoL and disability, as well as prevalence and severity of the following MS symptoms: impaired ambulation, spasticity, chronic pain, fatigue, bowel and bladder dysfunction, and sleep disturbances. Results Questionnaires were returned by 2244/3606 (62%). Participants without MS diagnosis or incomplete questionnaires were excluded, n = 235. A total of 2009 questionnaires were included for analysis (mean age 49.4 years; mean disease duration 11.7 years; and 69% were women). The most frequently reported symptoms were bowel and bladder dysfunction (74%), fatigue (66%), sleep disturbances (59%), spasticity (51%) and impaired ambulation (38%). With exception of fatigue and sleep disturbances, all other symptoms increased in severity with higher disability level. Invisible symptoms (also referred to as hidden symptoms) such as fatigue, pain and sleep disturbances had the strongest associations with the overall QoL. Conclusion We found invisible symptoms highly prevalent, even at mild disability levels. Fatigue, pain and sleep disturbances had the strongest associations with the overall QoL and were more frequently reported in our study compared with previous registry-based studies. These symptoms may be underreported in registries based on clinician reported outcomes, which emphasizes the importance of including standardized patient reported outcomes in nationwide registries to better understand the impact of the symptom burden in MS.

Published
2021
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24. External validation of a laparoscopic-based score to evaluate resectability for patients with advanced ovarian cancer undergoing interval debulking surgery

Author

E, Chereau, V, Lavoue, M, Ballester, C, Coutant, F, Selle, A, Cortez, E, Daraï, J, Leveque, and R, Rouzier

Subjects
Adult, Aged, 80 and over, Ovarian Neoplasms, Reproducibility of Results, Middle Aged, Medical Oncology, Sensitivity and Specificity, Treatment Outcome, ROC Curve, Area Under Curve, Calibration, Humans, Regression Analysis, Female, Laparoscopy, Aged
Abstract

To evaluate the relevance of laparoscopic index of Fagotti et al during staging laparoscopy (S-LPS) to predict optimal cytoreduction during interval debulking surgery (IDS) after neoadjuvant chemotherapy for ovarian cancer.Fifty-two patients with stage III-IV ovarian cancer were retrospectively analyzed. We evaluated discrimination with a receiver operating characteristic (ROC) curve analysis and calibration of Fagotti et al's model among our population and compared this performance with their data.A score4 was associated with optimal resection with sensitivity and positive predictive value (PPV) of 95% and 82% respectively. The ROC curve analysis gave an area under the curve (AUC) of 0.72 (95% confidence interval (CI) 0.65-0.80) for our population compared to 0.88 (95% CI 0.84-0.91) in Fagotti et al's population. Percentages predicted in our population were unsatisfactory (p0.01), illustrating the different rates of optimal cytoreduction between the centers (average error of 25%).The laparoscopic index of Fagotti et al is relevant in prediction of optimal cytoreduction among women undergoing IDS.

Published
2011

25. [Interest of CA 125 level in management of ovarian cancer]

Author

F, Coussy, E, Chéreau, E, Daraï, F, Dhombres, J-P, Lotz, R, Rouzier, and F, Selle

Subjects
Ovarian Neoplasms, CA-125 Antigen, Carcinoma, Biomarkers, Tumor, Humans, Female, Prognosis, Disease-Free Survival
Abstract

CA 125 is the most sensitive and the most used marker in the management of ovarian cancer at various stages of the disease. CA 125 is used at the time of diagnosis of the disease, to evaluate the possibility of complete resection during surgery, to estimate sensibility for adjuvant or neo-adjuvant chemotherapy and for diagnosis of recurrences. CA 125 has a diagnostic and therapeutic value and could be of help during therapeutic evaluation. CA 125 has been the topic of many studies for optimizing the management of epithelial ovarian cancers. Mandatory before any ovarian surgery, serum CA 125 levels is a help for the determination of the appropriate surgery. It appears to be a help in choosing therapeutic strategy, to predict optimal surgery and also global and progression-free survival. Low preoperative rates, half-life and fast normalization of CA 125 during the adjuvant chemotherapy are correlated with an optimal surgery and a better global and progression-free survival. The normal range of CA 125 is a strong predictive factor for disease recurrence even if its role in survival has not yet been determined. The dosage of CA 125 and its dynamic interpretation is an indispensable approach to the diagnosis, therapeutics and follow-up of ovarian cancer. Simple serum CA 125 concentration is a very important prognostic and predictive factor for a personalized care.

Published
2010

26. [Complications of radical surgery for advanced ovarian cancer]

Author

E, Chéreau, M, Ballester, B, Lesieur, F, Selle, C, Coutant, R, Rouzier, and E, Daraï

Subjects
Ovarian Neoplasms, Postoperative Complications, Ovariectomy, Humans, Female, Neoplasm Staging
Abstract

Treatment of advanced ovarian cancer should include surgery with optimal cytoreduction, which is the first prognosis factor. This surgery usually requires extensive resection (pelvic surgery, extensive lymphadenectomy, upper abdominal surgery and sometimes multiple intestinal resection). The complete surgery usually requires a resection of the diaphragm peritoneum in 10 to 100% of cases, intestinal resection in 20 to 100% of cases, splenectomy in 1 to 33% of cases, pancreatectomy in 0 11% of cases, resection of liver metastases in 0 to 16% of cases and cholecystectomy in 2 to 20% of cases. The main complications reported were digestive fistula (1.4 to 8.2%), lymphocyst (0.6 to 32%), septic complications (3.7 to 41.4%) and pulmonary complications (0 to 59%) in case of diaphragmatic surgery. The postoperative mortality ranges from 0.3 to 5.7%. Radical surgery increases the rate of complete cytoreduction with significant morbidity and postoperative mortality. Because these complications decrease survival, it is essential to assess the risk of occurrence of these events to inform patients.

Published
2010

27. [Rare ovarian tumours: therapeutic strategies in 2010, national website observatory for rare ovarian cancers and delineation of referent centers in France]

Author

I, Ray-Coquard, P, Pautier, E, Pujade-Lauraine, P, Méeus, P, Morice, I, Treilleux, P, Duvillard, J, Alexandre, C, Lhommé, F, Selle, and Jp, Guastalla

Subjects
Adult, Ovarian Neoplasms, Rare Diseases, Humans, Sex Cord-Gonadal Stromal Tumors, Antineoplastic Agents, Female, Sarcoma, France, Cancer Care Facilities, Neoplasms, Germ Cell and Embryonal, Adenocarcinoma, Mucinous, Adenocarcinoma, Clear Cell
Abstract

Majorities of the rare ovarian cancers were represented by germ cell tumours and sex cords ovarian tumours with borderline tumours, clear cell carcinoma and mucinous carcinoma and are extremely rare malignant diseases of the ovaries. Tumors of the stromal (Leydig cells) and/or sex cords (Sertoli cells) represent approximately 7% of ovarian cancers and develop from the conjunctive tissue (respectively, interstitial and nurse cells) of the ovaries. All together, they represented less than 5% of the adult malignant and non malignant ovarian tumours. Treatment of rare ovarian tumors is currently as follows. Surgery is the same as that for ovarian adenocarcinoma, with one major difference: conservation of reproductive function in women of reproductive age is usual case for this type of tumor. Chemotherapy for germ cell and sex cords tumors, based on data reported in the literature is the same as that prescribed for testicular germ-cell tumors. For rare epithelial carcinoma, carboplatin plus paclitaxel remains the standard attitude with a well-known less efficiency than for other epithelial subtypes. Surgery, chemotherapy and possible surgical intervention for residual lesions are highly complex. Too rare to be included in randomized studies, treatment of these tumors has benefited from the therapeutic advancements made against testicular germ-cell tumors or with publications using retrospective data. Effectively, some prognostic factors such stage, histology, number of managed patients seems to be prognostic for survival. Because of the rarity of these tumours a specialized website (www.ovaire-rare.org) was developed in France in 2002. Objectives were: to delineate prognostic factors of these very rare diseases, to favour patient inclusion in a clinical trial available online, to provide access to online medical expert forum (disease-related) for complex cases, and finally to demonstrate the impact of these tools on improving medical practice. The website provides very interesting data for a better knowledge of these rare tumors and will possibly help improve medical practice. Since 2008, referent centers were delineated to promote optimal management of these tumors, organization of clinical and molecular research at a national or international level and to elaborate guidelines. The other new scientific data concern surgical procedures for sex cords tumors, evidence for presence of FOXL2 mutation in adult granulosa cell tumors, the use of paclitaxel plus carboplatin for sex cords tumors.

Published
2009

28. Pulmonary morbidity of diaphragmatic surgery for stage III/IV ovarian cancer

Author

E, Chéreau, M, Ballester, F, Selle, A, Cortez, C, Pomel, E, Darai, and R, Rouzier

Subjects
Lung Diseases, Ovarian Neoplasms, Muscle Neoplasms, Postoperative Complications, Case-Control Studies, Diaphragm, Humans, Female, Neoplasm Invasiveness, Prospective Studies, Middle Aged, Prognosis
Abstract

To determine the morbidity of diaphragmatic peritonectomy.Prospective cohort study.A Gynecology Department of a University Hospital.From 2005 to 2007, thirty-seven consecutive patients underwent surgery for stage IIIC or IV ovarian cancer.Patients were separated into a diaphragmatic surgery group (n = 18) and a control group (n = 19). Diaphragmatic surgery may consist of coagulation, stripping or muscle resection.Postoperative course and outcome were analysed.Patients in group 1 (diaphragmatic surgery) underwent more intestinal resection (89% versus 37%, P = 0.01) and pelvic (94% versus 63%, P = 0.02) or para-aortic lymphadenectomy (94% versus 53%, P = 0.04). Neither the mean estimated blood loss (960 ml versus 909 ml) nor the rates of intra-operative blood transfusion (11 versus 9) were significantly different between the two groups. The mean operative time was higher in group 1 (480 minutes versus 316 minutes, P0.05). There were thirteen postoperative complications in group 1 and eight in group 2 (P = 0.065). In group 1, the main complication was pleural effusion (seven cases): four patients required secondary pleural drainage, two required only pleural puncture and one had both procedures. There were more complete cytoreduction in group 1 than in group 2 (89% versus 63%, P = 0.068).Diaphragm peritonectomies and resections are an effective way to cytoreduce diaphragm carcinomatosis and increase the rate of optimal debulking surgery. Such procedures frequently result in pleural effusion, but with no long-term morbidity.

Published
2009

29. Uncommon tumours of the testis

Author

I. Alexandre, E. Horn, and F. Selle

Subjects
Infertility, endocrine system, Pathology, medicine.medical_specialty, business.industry, Incidence (epidemiology), Nodule (medicine), Disease, medicine.disease, Sertoli cell, medicine.anatomical_structure, medicine, Carcinoid tumour, Testicular tumours, Young adult, medicine.symptom, business
Abstract

Testicular neoplasms are rare pathologies that occur most frequently in the young adult with an incidence of 3:100,000 men per year and account for 1-2% of all neoplasms. For the most common forms of testicular neoplasms, the maximum age of incidence occurs between 15 and 35 years with a good prognosis, 90% of patients being cured. Diagnosis of rare testicular tumours is made in similar fashion to that of more widespread tumours of the testis: self-palpation of the nodule and swelling or heaviness of the testis. Occasionally, a tumour may be discovered by pain in the testis or other symptoms related to extended disease. Less frequently, an examination for infertility may uncover a rare testicular tumour.

Published
2009

30. Rare Ovarian Cancers

Author

P Morice, É. Pujade Lauraine, Catherine Lhommé, Joseph Gligorov, F Selle, Patricia Pautier, Isabelle Ray-Coquard, J.-P. Lotz, and P Duvillard

Subjects
Oncology, medicine.medical_specialty, Endometrial stromal sarcoma, business.industry, Incidence (epidemiology), Mortality rate, Cancer, Ovary, medicine.disease, Transitional cell carcinoma, medicine.anatomical_structure, Internal medicine, medicine, Ovarian cancer, business, Cause of death
Abstract

Tumours of the ovary represent about 30% of all cancers of the female genital system. Ovarian cancer is the fifth leading cause of death from cancer in women and the leading cause of death from gynaecological cancer. The annual worldwide estimated incidence is about 200.000 new cases and the annual mortality rate is about 115.000 [5].

Published
2009

31. Bilan des traitements ciblés de la phase métastatique : quelles perspectives pour demain ?

Author

A. Khalil, F. Selle, Joseph Gligorov, and J. P. Lotz

Abstract

La question qui m’a ete posee est avant tout celle d’un bilan. L’origine italienne de ce mot, remontant au XVIe siecle et provenant de bilancio (voulant dire balance), m’amene donc a « peser » l’apport des therapies ciblees dans la prise en charge du cancer du sein metastatique.

Published
2007

34. [The use of GnRH analogues in early and advanced breast carcinomas]

Author

C, Ségura, D, Avenin, J, Gligorov, F, Selle, A, Estéso, K, Beerblock, G, Emile, N, Do Huyen, and J-P, Lotz

Subjects
Gonadotropin-Releasing Hormone, Postmenopause, Tamoxifen, Premenopause, Aromatase Inhibitors, Chemotherapy, Adjuvant, Ovariectomy, Quality of Life, Humans, Breast Neoplasms, Female, Neoplasm Metastasis, Neoplasm Recurrence, Local
Abstract

Breast cancer is often an estrogen-dependent disease. The primary goals of the treatment of breast carcinomas are multiple, depending on the situation in which the patients are treated. In adjuvant setting, the aims are to delete the time of relapse, to increase the overall survival, and to offer to the patients the best quality of life they may expect. Tamoxifen is the standard hormonal agent for premenopausal women with receptor-positive breast cancer. Recent data show an increasing role for aromatase inhibitors in postmenopausal women. In metastatic setting, the primary goals are improved quality of life and prolonged survival; effective therapies with minimal toxicity, such as endocrine therapy, are highly desirable and should be considered a primary option over chemotherapy for selected estrogen-receptor positive patients. Ovarian ablation has been worldwide used. Methods of irreversible ovarian ablation include surgical oophorectomy and ovarian irradiation. Potentially reversible castration can be medically accomplished using luteinizing hormone releasing hormone analogues (LHRH agonists). In the metastatic setting, ovarian ablation (induced by the use of LHRH agonists or by surgical ovarian ablation) and tamoxifen monotherapies produce comparable outcomes, and may be more effective when used together (combined estrogen blockade). In advanced breast cancer, the combination prolongs the progression-free survival and increases response rates and duration of response rate relative to the use of LHRH agonist alone. In the adjuvant setting, data suggest that ovarian ablation followed by tamoxifen produces similar results to those obtained with adjuvant chemotherapy in hormone-receptor positive breast cancer women. The value of combining these modalities remains unclear, but the addition of the LHRH analogue goserelin to standard treatment results in a significant benefit in terms of relapse-free and overall survival, especially for estrogen-receptor positive patients. Finally, considering the efficacy of the new aromatase inhibitors, the interest of combining these drugs with the LHRH analogues has yet to be defined, both for pre- and post-menopausal patients.

Published
2005

35. In-line monitoring of electrolytes and urea during continuous renal replacement therapy

Author

M. Berger, M. Sehlmeyer, F. Sellering, H. Röhrich, T. Perl, H. Mansour, D. Baasner, and S. Zimmermann

Subjects
Technology
Abstract

The individualization of dialysis treatment using a customized dialysate composition usually requires a continuous measurement of electrolytes and urea in blood. The current practices are spot measurements of blood samples either with blood gas analyzers or in the laboratory, involving considerable personnel effort. Furthermore, the measured values are time delayed and not available in a continuous fashion. In this paper we investigate an in-line concept for continuous monitoring of important blood parameters such as sodium, potassium, calcium and urea concentrations in blood serum using ion-selective electrodes. This concept is evaluated in a preclinical study with human packed red blood cells as a test medium over a period of 7 h. It has been shown that the electrolytes can be well monitored. In addition, we present first measurements with ion-sensitive field-effect transistors in a miniaturized sensor assembly. Therefore, new low-cost electronics for such ion-sensitive field-effect transistors have been developed.

Published
2020
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37. [Acid-alcohol-resistant bacilli detected by microscopic analysis of exhaled air from HIV-infected patients: tuberculosis or mycobacteriosis?]

Author

J L, Meynard, V, Lalande, F, Selle, M, Guiguet, M C, Meyohas, O, Picard, C, Duvivier, J C, Petit, and J, Frottier

Subjects
Adult, Male, Acquired Immunodeficiency Syndrome, AIDS-Related Opportunistic Infections, Antitubercular Agents, CD8-Positive T-Lymphocytes, Middle Aged, CD4 Lymphocyte Count, HIV Seropositivity, Humans, Female, Lymphocyte Count, Tuberculosis, Pulmonary, Mycobacterium avium-intracellulare Infection, Retrospective Studies
Abstract

The incidence of atypical mycobacterial infections has increased with the AIDS epidemic. To present, microscopic examinations of airway specimens positive for acid-fast bacteria were highly suggestive of tuberculosis. However, since the AIDS epidemic, certain authors have reported an increase in Mycobacterium avium intracellulare found in respiratory specimens. The aim of this work was to determine what factors might distinguish between these two infections revealed discovery of an acid-fact bacilli.Hospital files of all HIV seropositive patients seen between November 1992 and March 1995 and with at least one airway specimen positive for acid-fast bacilli were studied retrospectively.Mycobacterium tuberculosis was isolated in 19 patients, Mycobacterium avium intracellulare in 8 and culosis and M. avium intracellulare. There was no difference for age, sex, geographical origin, transmission mode, antigen positivity, radiologic findings or clinical signs between patients with the different types of mycobacterium. The CD4 count was however significantly lower in patients with an atypical mycobacteriosis (14.5/mm3) than in patients with tuberculosis (91.7 +/- 83.7) (p = 0.004).These findings show that in HIV-infected patients with a CD4 count under 100/mm3, the presence of acid-fact bacilli can indicate either M. tuberculosis or M. avium intracellulare. Combined anti-tuberculosis and antimycobacteriosis therapy thus would appear to be justified until the germ can be identified.

Published
1996

38. PCN20 PEGFILGRASTIM IS PREFERRED TO FILGRASTIM IN CANCER PATIENTS ON MYELOSUPPRESSIVE CHEMOTHERAPY TREATMENT REGIMENS

Author

F Selle, P Viens, and M Namer

Subjects
Oncology, Myelosuppressive Chemotherapy, medicine.medical_specialty, endocrine system diseases, Treatment regimen, business.industry, Health Policy, Public Health, Environmental and Occupational Health, Cancer, Filgrastim, medicine.disease, Internal medicine, medicine, business, health care economics and organizations, Pegfilgrastim, medicine.drug
Published
2003

39. Association Between Tumor Egfr and Kras Mutation Status and Clinical Outcomes in Nsclc Patients Randomized to Sorafenib Plus Best Supportive Care (BSC) or Bsc Alone: Subanalysis of the Phase III Mission Trial

Author

Chris Twelves, J. Thompson, C. Fernández, H. Bonnefoi, Robert Jones, R. de Wit, Yves Humblet, C. Boni, T. Seto, P. Rougier, I.T. Rubio, S. McMahon, V. Patel, David Gentien, A. Santoro, José Baselga, M. Barrié, E. Ciruelos, R.A. Madan, U. Jungnelius, E. Esteban, H. Abbas, C. Robert, J. Martin, F. Selle, Dong Wook Kim, H. Singh-Jasuja, Arthur L. Klatsky, Harald A. Weber, A. Bonetti, Florence Lerebours, A. Hamed, Georgina V. Long, Véronique Diéras, A. Savarese, E.M. Guerra, Richard Bell, Nick Thatcher, M.S.L. Teng, Toni K. Choueiri, M. Untch, Nicole M. Kuderer, H-J. Lenz, D. Serin, A. Fandi, Frédéric Commo, Y-L. Wu, A.S. Daud, Kazuhiko Nakagawa, Debora Barton, D. Brewer, G. Folprecht, Frank Cihon, Michael Thomas, M. Fleischer, T. Nakajima, Mary Anne Armstrong, Jonathan Cebon, M. Rios, L. Gissmann, P. Preux, A. Loundou, Lluis M. Mir, F. Lordick, Lynn M. Schuchter, B. Vasseur, Ulrika Harmenberg, B. Massuti Sureda, M. Matta, X. Durando, C. Costa, J-P. Guastalla, Brigitte Sigal-Zafrani, S. Falk, Nicolas Servant, M. Campone, Richard M. Goldberg, Petronella O. Witteveen, A. Grothey, T. Olive, Andrea Wagner, L. Crinò, R. Rosell, T. De Pas, P. Attali, Mitchell Dowsett, M. Lacroix, Y. Xu, F. Hilpert, Benjamin Solomon, Enriqueta Felip, A. Pasic, D. Genet, A. Falcone, A. Niethammer, K. Tauer, D. Berton-Rigaud, L. Bedenne, Enrico Mini, J-P. Jacquin, J.-L. Van Laethem, Egbert F. Smit, R.J. Jones, David Cella, K. Pittman, W. Hwu, D. Bollag, Yan Li, Roma Parikh, P.J. Wiechno, C. Jouannaud, Masahiro Takeuchi, P. Slaouti, Eric Pujade-Lauraine, A. Sobrero, C. Campello, H. Y. Lim, Ellie Guardino, L.S. Schwartzberg, Margarita Majem, F. Dalenc, Bruno R. Bastos, P. Senico, J.S. de Bono, Olivier Rosmorduc, Bernard Asselain, J. Atkins, C. Centeno, F. Subtil, H.J.M. Groen, F. Bonnetain, Benjamin Besse, Sarah Pearson, N. Vogelzang, J.T. Hartmann, Susan J Dutton, B. Zaric, G.A. Bjarnason, S. Olsen, L. Jia, Jun Guo, L. Venat-Bouvet, R. D. Gelber, Silvia Novello, Etienne Brain, Carlo Barone, S. Lavau-Denes, S. Zhu, C.N. Sternberg, Roman Perez-Soler, V. Tassell, D. Frappaz, C. Cremolini, J. Clancy, D. Wan, G. Masi, M. Jensen, Richard F. Kefford, Michael Baum, D. Lu, A. Gonzalez Martin, Alain Algazi, C. Valsuani, A. Maubon, C. Heery, L. Cupit, R.J. Motzer, P. Kerbrat, N. Gadea, A. P. Dei Tos, C.S. Cooper, Ricardo J. Gonzalez, A. Vuorela, A. Gonçalves, H. Tan, Thomas E. Hutson, G. Goss, M. Frenay, M. Munill, R. Kudchakar, J. Schlom, L. Mineur, Max Bulsara, J. Wei, Y. Wang, T.J. Ong, Wasaburou Koizumi, Michael Staehler, F. Ghiringhelli, F. Barlesi, C. Mermel, M. Provansal, David R. Spigel, Bernard Escudier, C. Granetto, Trever G. Bivona, Gerold Meinhardt, Jaime R. Merchan, A. Chatterjee, L. Salvatore, Suzette Delaloge, D. Laurent, J. Clark, Fabrice Andre, I. Ray-Coquard, P. Salman, Peng Sun, S. Hodge, M. Schneider, Petr Kavan, B. Biesma, Paul Ross, A. Gimenez-Capitan, T. Schmelter, J. Ritchie, Jean-Yves Pierga, W. Mansoor, R. Hubner, C. Girault, S. Di Cosimo, D.W. Fyfe, G. Allegrini, Yang Sun, S. Burgers, J. Reeves, P. Mulholland, B. Chauffert, S.M. Steinberg, David R. Ferry, H.C. Chung, N. Budnik, Sang Cheul Oh, R. Gervais, M.A. Molina, Iben Spanggaard, X. Pivot, Anna C. Pavlick, Jeffrey Crawford, M. Schirripa, K. Fife, M. Davoudianfar, Alexander Reuss, C. Sonaglio, Elena Castro, Nicholas Choong, A. Kramar, I. Chan, J. Ferrero, M. Snoj, L. Peachey, Jaap Verweij, I. El-Hariry, H.A. Azim, E. Tabouret, P. Arlen, Ian Judson, M. Praet, J.C-H. Yang, D.G. Power, R. Schott, N. Karachaliou, R. Midgely, Lei Zhang, L. Paz-Ares, W.T.A. van der Graaf, J. Labourey, Andrew X. Zhu, H. Wang, A.D. Vincent, Chris Parker, Masashi Fujii, Hirotsugu Uemura, M-J. Ahn, J. Mehta, Lauren McCann, Samar Alsafadi, A.M. Poveda, Y. Lou, S. Peoples, K. Sivarajan, S. Chiara, P. Fumoleau, O. Aren, G. McArthur, J. Zhu, Julie Gehl, P. Laurent-Puig, Martine Piccart, J. Evans, Laurence Collette, K. B. Kim, Jeffrey S Tobias, J. A. Sosman, Carol Peña, Frederik Wenz, A. Goldhirsch, F. Teofilovici, J. Thaler, Jose Leal, P. Giannikopoulos, Mark A. Socinski, Patrick Julier, L. Boni, L. Cany, C. Boucard, Ludovic Lacroix, A. Dahle-Smith, Y-K. Kang, Yi-Long Wu, Ian E. Krop, C. Heredia, O. Ishibashi, M. Santarpia, Aoife M. Ryan, B. Leyland-Jones, Paul Nathan, A-M.C. Dingemans, F.H. Blackhall, Anna Polli, C. Lepage, L. Antonuzzo, S. Cushen, D-Y. Oh, C. Dalban, A. Mori, M. Espié, V. Semiglazov, MA LeBerre, J. Adelaide, Natalia Udaltsova, Nuhad K. Ibrahim, Richard Sullivan, D.A. Fennell, J. Skrzypski, G. Romieu, H. Eidtmann, J. Bosch-Barrera, Taofeek K. Owonikoko, M. DeSilvio, C. Jackisch, Robert J. Motzer, G. Sersa, F. Boudouresque, Russell D. Petty, S. Jefferies, T. Moran Bueno, M.O. Palumbo, M. Ouafik, J. Balmana, D. Valcárcel, S. Cupini, G. Bodoky, S. Szyldergemajn, A. Fabi, M. Cardoso, R. Allerton, U. Kenny, O. Chinot, Daniel J. Sargent, U. De Giorgi, Mark D. Pegram, J. M. Del Campo, J. Surralles, H. Oltean, A. Garcia-Alonso, Kensaku Yoshida, E. Juhasz, Howard I. Scher, H. Goette, David Baer, L. Fornaro, D. Cameron, Nicholas D. James, Thomas F. Gajewski, P. Lacroix, M. Harrison, G.D. Friedman, A. Enke, C. Bouquet, I. Bradbury, S. Halford, M. Jimenez, A. Chang, J-Y Pierga, P. Pultar, T. Bachelot, Daniel C. Danila, L. Eckert, J. Douillard, L. Burns, F. De Marinis, David Miles, Q. Wang, A. Vergnenegre, D. Khayat, F.J. Carrilho, H. Codrington, K. Wang, D. Moro-Sibilot, N. Bosch, J.L. Quesada, M.D. Dibonaventura, E. de Azambuja, S. Abadie-Lacourtoisie, Christophe Massard, L. Fang, I. Pauporte, L. Feuvret, C. Manegold, Ramon Luengo-Fernandez, M. Banzi, J.S. Guillamo, B. Żurawski, Suresh S. Ramalingam, J.L. Gulley, M. Liu, M. Ychou, O. Al-Salihi, T. Hutson, S. Santillana, Alice T. Shaw, I.E. Smith, S. Culine, H. Tailla, Kiran Patel, Patrick Schöffski, Adil Daud, Luca Gianni, R. Camidge, A. Lortholary, M. Lu, L. Taillandier, A. James, M. Procter, Carmen Criscitiello, Mika Mustonen, R. Rampling, Jayant S. Vaidya, D. Agbor-Tarh, T. Gamble, Subramanian Hariharan, Andrea Cavalcanti, R. Malik, Ignace Vergote, Sandrine Marreaud, Heather A. Wakelee, Shonda M Little, Hans Gelderblom, M. Arnedos Ballester, J. Tabernero, J. Honnorat, S. Li, O. Bouché, Isabelle Gilloteau, A. Goren, J.G. Aerts, J. Blay, W. Eiermann, D. Joseph, Jie Jin, J.F. Emile, Gerhardt Attard, Markus Moehler, Yang Hyun Kim, S. Verma, Nicole Tubiana-Mathieu, J. Taieb, G. Giaccone, Shahneen Sandhu, Kenneth J. O'Byrne, E. Van Cutsem, T. Yoshino, Saskia Litière, Keith T. Flaherty, J. R. Infante, Chetan Lathia, V. Vukovic, E. Giommoni, Alison Reid, S. Siena, Keith C. Deen, Tony Mok, J. Wang, J.S. Weber, Corey J. Langer, E. Fea, P. de Souza, C. Levy, K. Kumari, A. Casado, M. Welslau, Karl D. Lewis, O. Dalesio, R. Swaby, M. Fabbro, Brian I. Rini, Janusz Jankowski, Daniel P. Petrylak, Robert E. Hawkins, M. Mohebtash, A. Adenis, A. Ribas, Igor Puzanov, I. Tennevet, H. Kim, Karim Fizazi, O. Hamid, D. Olmos Hidalgo, J.A. Bridgewater, S. Catala, H. Melezinkova, G. Kurteva, Aristotle Bamias, F. Loupakis, Vera Hirsh, Pasi A. Jänne, Kimberly L. Blackwell, M.R. Garcia-Campelo, C. Kahatt, J. Bellmunt, and J. Alexandre

Subjects
Oncology, Sorafenib, medicine.medical_specialty, Proportional hazards model, business.industry, Hematology, medicine.disease_cause, Placebo, medicine.disease, Breast cancer, Egfr mutation, Internal medicine, Medicine, Biomarker (medicine), KRAS, Stage (cooking), business, medicine.drug
Abstract

Background Tumor EGFR and KRas mutations are both predictive and prognostic biomarkers in patients with advanced NSCLC. We analyzed the correlation between these biomarkers and treatment outcomes in a phase III trial of 3rd/4th line sorafenib in patients with NSCLC. Methods The global, randomized, placebo-controlled MISSION trial enrolled 703 patients with advanced relapsed/refractory NSCLC of predominantly non-squamous histology. The primary study endpoint was overall survival (OS). EGFR and KRas mutations were analyzed in archival tumor samples and in circulating tumor DNA isolated from plasma. Results Tumor and/or plasma mutation data were available from 347 patients (49%). EGFR and KRas mutations were detected in 89 (26%) and 68 (20%) patients, respectively, and were well balanced between treatment arms. Analysis of the interaction between EGFR mutation status and treatment effect on survival suggested that patients with EGFR mutations (mEGFR) benefitted from sorafenib, while those with wild-type EGFR (wtEGFR) did not (p = 0.023). Median OS was two-fold longer in mEGFR patients receiving sorafenib versus placebo (423 vs 197 days, HR 0.48, p = 0.002). There was no significant difference in OS between patients with wtEGFR receiving sorafenib or placebo (253 vs 256 days, HR 0.92, p = 0.559). An interaction was also seen between EGFR mutation status and the sorafenib effect on PFS (p = 0.015). Patients with mEGFR treated with sorafenib had better outcomes compared to placebo based on Cox regression analysis (HR 0.27, p Conclusion Post-hoc analyses of efficacy outcomes in MISSION suggest that advanced NSCLC patients with EGFR mutations may derive a survival benefit from receiving 3rd/4th line sorafenib. These results must be interpreted with caution due to the small, non-representative nature of the genetic biomarker subpopulation analyzed in this trial. Further prospective investigation may be warranted. Disclosure T.S.K. Mok: Honoraria: AstraZeneca, Roche, Eli Lilly, Merck Serono, Eisai, BMS, BeiGene, AVEO, Pfizer, Taiho, Boehringer Ingelheim, and GSK Biologicals Speaker: Astrazeneca, Roche, Eli Lilly, Boehringer Ingelheim, and Merck Serono Research funding: Astrazeneca. L. Paz-Ares: Dr. Paz-Ares has received honoraria from Bayer HealthCare Pharmaceuticals, Lilly, Roche and Pfizer. Y. Wu: Dr. Wu has received lecture fees from Roche, AstraZeneca, Eli Lilly, and Pfizer. V. Hirsh: Member of the steering committee for the MISSION trial. C. Lathia: Dr. Lathia is an employee of Bayer HealthCare. T.J. Ong: Dr. Ong is an employee of, and owns shares in, Bayer HealthCare. C. Pena: Dr. Pena is an employee of Bayer HealthCare. All other authors have declared no conflicts of interest.

Published
2012

40. RANDOMIZED PHASE II STUDY OF FIRST-LINE EVEROLIMUS (EVE) + BEVACIZUMAB (BEV) VERSUS INTERFERON ALFA-2A (IFN) + BEV IN PATIENTS (PTS) WITH METASTATIC RENAL CELL CARCINOMA (MRCC): RECORD-2

Author

Rickard Sandin, Javier Diaz, David Smith, investigators, H. Pandha, A. Damato, M. Del Prete, M. Reckova, E. Korbenfeld, A. Seth, Cristina Suarez, P. Celiz, S. Liskova, R.K. Sahoo, A. Felici, A. Suder, Francesco Cognetti, P. Gronesova, G. Martignoni, M. Jebali, E. Fernández-Parra, C. Bokemeyer, Yingwei Peng, M.C. Sebastia, H. Mullot, Daniele Raggi, D. Urosa Velasco, Begoña Mellado, J. Chester, Corina Andresen, Sally Ellis, N. Nicolai, A. Omar, A. Ambavane, Georg A. Bjarnason, Frank Priou, A. Vieillefond, T. Wahlgren, U. Harmenberg, H. Nemeth, M. Rivoire, Guru Sonpavde, C. Binder, V. Prati, M. Witkowski, R. Delva, J.F. Rodríguez-Moreno, L. Stern, V. Calderero, O. Bauduceau, Andrea Viqueira, K. Kaiser, Maurizio Colecchia, M.P. López Martí, M.E. Lampron, J.T. Hartmann, D. Tunali, Reza Elaidi, V. Galvis, Z. Sycova-Mila, Veg Team, R. von Moos, Jose Carlos Benitez, Simon Chowdhury, H. Mergenthaler, F. Arpaci, S. Cascinu, G. Erdem, A. Comte, J.M. Sepulveda Sanchez, K. Slimane, Mustafa Benekli, Paul Nathan, S. Van Belle, B. Metzner, Hussein M. Khaled, Q. Wang, Denice D. Tsao-Wei, J. Jin, H. Cortes-Funes, N. Clottens, P. Wilson, G. Procopio, A.L. Gentile, L. Burattini, Robert E. Hawkins, R. Montironi, G.R. Pond, Viorel Jinga, B. Ceccaldi, Tanya B. Dorff, S. Lata, Sergio Bracarda, P. Palacka, N. Karadurmus, S. Tumolo, Mario Sznol, A. Guillot, H. Spliid, C. Kahl, Cora N. Sternberg, K. Nagyivanyi, N. Sarwar, G. Krekeler, G. Fischer, S. Le Moulec, Brian I. Rini, R. Casciano, Derek Raghavan, F. Mehmud, N.V. Jensen, Suleyman Buyukberber, J.P. Fusco, Kim Edmonds, C. Messina, H.G. Sayer, Sanjiv S. Agarwala, R.J. Jones, J. Ribeiro, T. Geldart, A. González del Alba, E. López Juarez, G. Mead, Ben Challacombe, I. Brindel, T. M-H, F. Lumachi, S.M. M. Basso, E.Q. Bergan, R. Morales-Barrera, J.L. Perez Gracia, P. Cislo, I. Victoria, B. Sarsık, M. Cakar, S. Lee, Marc Campayo, R. Roy, A. Necchi, M. Ozturk, Hai T. Tran, R. Mondéjar Solís, M. Schmidt, N. Dalal, J. Coombs, Danka Cholujova, Ashok Kumar Gupta, C. Poehlein, S. Ozkan, B. Maughan, W.E. Berdel, C. Masini, F. Pili, A. Vuillemin, R. Martínez-Monge, J.J. Zudaire, F. Orlandi, C. Cianci, J. Bay, J. Thompson, C. Theodore, L. McCann, Anne Gold, N. Muzaffar, A. Houlgatte, L. Bergmann, X. Ren, G.B. Chiara, M. Ktiouet, Muhammad A. Khattak, J. Eymard, N. Nagaraj, J. Yu, Alfredo Falcone, Oezlem Anak, C. Korn, Karim Fizazi, P. Biron, V. Usakova, E. Gökmen, A. Flechon, R.R. Prasad, R. Bianco, M.E. Zudaire, S.J. Park, U. De Giorgi, Brad Rosbrook, F. Selle, A. Zurita-Saavedra, E. Verzoni, Günter Niegisch, J.L. Álvarez-Ossorio, Börje Ljungberg, N. Lainez, T.M. Kim, Irina Proskorovsky, C. Rodriguez-Antona, L. Maute, Komel Khabra, F. Algaba, A.C. Palozzo, L. Bodnar, O. Etxaniz, L. Galli, J.-P. Lotz, S.S. Sridhar, Yongchel Ahn, G. El Hussiny, E. Paze, M. Bianconi, E. Esteban, I. Fernandes, Omid Hamid, V. Kruse, P.F. Geertsen, Laurence Albiges, Joseph C. Cappelleri, M. Gaulet, Mayer Fishman, W. Kong, Aslam Sohaib, L. Formisano, B. Biswas, Heui June Ahn, C. Nicolau, G. Ye, P. Beuzeboc, C. Arqueros, A. Bair, H. Abdel Azim, F. Riet, T. Turker, J. Fouque, John D. Powderly, G. Velasco, J. Areal, G. Papiani, B. Wittig, D.R. Siemens, U. Anido, G. Anguera, J. Medioni, K. Pennert, G.G. Hermann, Igor Puzanov, D. Herchenhorn, James Larkin, B. Bui, P. Srinivasan, I. Waxman, J. Garcia-Donas, M. Ermani, J. Malet, R. Buzzoni, C. Emmanouilides, L. Kumar, Xin-Yun Huang, J. Beaumont, M. Bragagni, F. Fabbri, M. Santoni, A. Castillo, A. Pantuck, S. Imbevaro, G. Chahine, K. Zhang, D. Ondrus, Parminder Singh, Francesco Massari, S. Spanik, Svetozar Gogov, J. Kowalski, N. Pardo, J.M. Miclea, Dae Ho Lee, P. Gerletti, P. Rocca Cossu, H.J. Choi, Stéphane Oudard, J. Guo, A. Berkenblit, Pablo Maroto, A.R. Jazeih, L. Hodge, D. Ye, Daniel Castellano, David Cella, I.G. Sullivan, Vsevolod Matveev, I. Temby, Gwenaelle Gravis, J. Khalil, R. Fougeray, M. Wheater, G. Di Lorenzo, P. Landsman-Blumberg, A.J. Birtle, S. Zanetta, M. Harza, Y. Su, A. Badran, A. Alcaraz, K. Wood, S. Weikert, D. Chen, M. Bonomi, B. Paño, E. Garanzini, L. Ciuffreda, Lisa Derosa, D.J. George, L. Cerbone, J-H Ahn, A.J. McPartlin, E. Barsoum, J. Droz, Antonin Levy, T. Brechenmacher, J. Kim, A. Ozet, S Songül Yalçin, P.A. Zucali, F. Brusa, L. Steelman, J.J. Sánchez, O.E. Carranza, I. Bodrogi, Alain Ravaud, E. Boleti, L. Santomé, I. Chaib, J.V. Heymach, B. Sanchez, E. Matczak, Ying Chen, E. Castanon Alvarez, C. Farfan, J-P. Machiels, J. P. Maroto, J.H. Hong, S. Babakulov, G. Elhussiny, D. Santeufemia, L. Chen, A. Shamseddine, Jacek Pinski, S. Stergiopoulos, J.L. Cuadra Urteaga, A. Boeckenhoff, Viktor Grünwald, P. Sandström, C. Ketchens, S. Rudman, L. Costa, I. Cañamares, Shaowen Qin, M.C. Lopez Lopez, Darrel P. Cohen, A. Cappetta, R. De Vivo, M.J. Méndez-Vidal, Georgia Kollia, U. Kube, K.M. Boucher, Tim O'Brien, Z. Küronya, A.M. Molina, Y.-N. Wong, C. Ferrario, A.M. Gianni, M.D. Michaelson, R. Salvioni, Walter M. Stadler, M. Taron, S. Sarker, B. Kopf, L. Wang, B. Lutiger, Jon M. Wigginton, C. Sacco, J. Shanks, Sarvendra Kumar, C. Buges, L. Wood, M. Domenech, Riccardo Giampieri, M.P. Trojniak, R. Sabbatini, N. Leonhartsberger, R. Lewis, L. Anton-Aparicio, A.J. Zurita Saavedra, Yohann Loriot, D. Giannarelli, M. Cichowicz, M. Aglietta, E. Horn, N. Bonnin, J. Wang, M. Nicodemo, A. Bamias, X. Xiao, M. Calderon, P. Giannatempo, K. Dykstra, Lisa Pickering, Patricia A. English, G. Rosti, J. Ma, G. Guderian, Jean Jacques Patard, Andrew G. Bushmakin, N. Siddqui, P. Sabin Domínguez, C. Chevreau, J. Carles, D. Muskett, I.F. Tannock, A. Scarpa, G. Deplanque, Emilio Bria, L. Védrine, C. Chen, H. Villavicencio, S. Pan, Bohuslav Melichar, J. Palou, W. Kozłowski, Michal Mego, E. Jones, H. Ozturk, J.A. Arranz Arija, A. Benedict, C. Helissey, R. González Beca, G. Kooiman, Yuan Liu, C. May, K. Bíró, E. Hall, S. Vazquez-Estevez, M. Morente, R. Rosa, Raika Durusoy, A. Caty, R. Keyser, A. Shablak, J.A. Williams, D. Burcoveanu, M. Tschaika, S. Navruzov, E. Weith, F. de Braud, R. Kockelbergh, Begoña Perez-Valderrama, A.V. Soerensen, J.A. Peña, Christophe Massard, A. Chandra, M. Staehler, L.E. Abella, W. Arafat, G. Fargues, A. Darwish, E. De Coene, H. Sun, C. Martin Lorente, Robin Wiltshire, Cyrus Chargari, A. Louveau, E. Aitini, L. van Bortel, A. Onofri, A.A. Patel, I. Chirivella Gonzalez, F. Villacampa, J. Rajec, D. Biasoni, C. Szczylik, J. Schmitz, U. Mueller, P.F. Conte, M. Carducci, G. Tapia Rico, Anne Schuckman, Xun Lin, I. Alemany, A. Farnesi, E. Arevalo, Meral Kurt, M.O. Giganti, C. Song, I.G. Schmidt-Wolf, J. Pan, M. De Fromont, M. Schmidinger, K. Das, M. Yaman, C. Teghom, C. Boni, I. Ozer-Stillman, F. Maines, B. Moya Ortega, T.B. Powles, S. Pusceddu, I. Barista, I. Duran, S. Cierniak, M.E. Gore, R. Rosell, Jamal Tarazi, E. Kurt, D. Svetlovska, G. Li, F. Gyergyay, W. Yin, C. Porta, I. Park, M. Smoter, G. Rottenberg, S. Crabb, M. Rizzo, G. Gravis-Mescam, A. Spencer-Shaw, David M. Berman, R. Janciauskiene, F. Pons Valladares, I. Testa, E. Bajetta, Olga Valota, M. Lazaro, B. Esteves, Mario Scartozzi, M. Catanzaro, M. Arzoz, David F. McDermott, E. Sevin, Charles G. Drake, L. Ye, Ugur Coskun, A. Lorch, D. Pelov, D. Xanthaki, L. Nappi, G. Lo Re, Giampaolo Tortora, L. Ruiz, Kolette D. Fly, P. Mendez, M. Johnson, M. Jakobsson, Y. Lin, Sinil Kim, J.Y. Yuan, I. Chiappino, I.A. Muazzam, Xudong Zhang, K.J. Park, Stéphane Culine, C. Papandreou, S. Hauser, B. Paolini, O. Fernandez, D. Kalanovic, L. León, C. De La Piedra, R. Iacovelli, S. Provent, P.D. Simmonds, Michele Milella, D. Jäger, K. Massopust, G. Miolo, J. Neves, D. Amadori, F.L. Lim, M. Ramos Vazquez, A. De Both, S. Ozaydin, O. Reig Torras, E. Villa, G. Mickisch, T. Nguyen, R. Stec, M. Schroff, Cristina Suarez Rodriguez, S. Rottey, Boris Alekseev, O. Rick, D. Condori, W.J. Mackillop, J. Gligorov, Christopher M. Booth, A. Fontana, A.S. Ataergin, L. Capdevila, J.-F. Martini, M. Jimenez, J. Loewy, Piotr Tomczak, J. Hu, K.L. Baker-Neblett, M. Pastorek, P. Rescigno, V. Miskovska, F. Atzori, Thomas Gauler, K. Fode, Ü.E. Bagriacik, D. Nosov, Y. Kim, P.C. Lara, Frede Donskov, Michael B. Atkins, L. Géczi, V. Lorusso, Kiruthikah Thillai, F. Zhou, A.M. Aparicio, B. González, Susan Groshen, M. Aieta, R. Cathomas, E. Calvo, A. Lopez, S. Hernando, D.S. Heo, F. Goldwasser, F. Boccardo, Carlos H. Barrios, V. Damiano, Toni K. Choueiri, L.N. Pandite, F.J. Afonso, Jonathan Shamash, Fiona C Thistlethwaite, G.R. Hudes, Mellar P. Davis, D. Macedo, A. Font, Joaquim Bellmunt, S. Lundstam, Ignacio Gil-Bazo, T. Eisen, J. Qiu, Siamak Daneshmand, David I. Quinn, Ashok Panneerselvam, S. De Placido, L. Jacobasch, M. Climent, Luca Faloppi, Petri Bono, B.K. Mohanti, F. Valduga, Y. Huang, M. Zemanova, M. Fehr, E. Biasco, A. Kaprin, T. Montella, Cristian Loretelli, O. Ekinci, S. S¸en, C. Bailly, Sylvie Negrier, L. Ozkan, Beata Korytowsky, T. de Revel, A. Somers, B. Escudier, Umut Demirci, K. Stauch, Helen Boyle, A. Jirillo, C. Kim, R.A. Figlin, N. Shi, Joseph K. T. Lee, A. Jouinot, G. Abdel Metaal, R. Marconcini, C. Dubot, A. Pinto, L. Crino, T.E. Hutson, Thomas Powles, J. Mardiak, D. Cesic, Sook Ryun Park, D. Kim, S. Cetintas, Subramanian Hariharan, Alessandro Bittoni, M. Cotreau, J. Donovan, J. Obertova, Robert J. Motzer, and T. Steiner

Subjects
medicine.medical_specialty, medicine.medical_treatment, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Prostate, Internal medicine, medicine, Stomatitis, Objective response, 030304 developmental biology, 0303 health sciences, Proteinuria, Genitourinary system, business.industry, Treatment options, Hematology, medicine.disease, Nephrectomy, 3. Good health, medicine.anatomical_structure, Oncology, Tolerability, 030220 oncology & carcinogenesis, medicine.symptom, business
Abstract

Background Study results demonstrated that IFN augments BEV activity and improves median PFS in pts with mRCC. Thus, combination BEV + IFN is a standard first-line treatment option for mRCC. Combining BEV with the mTOR inhibitor EVE may be an efficacious and well-tolerated treatment option. The open-label, phase II RECORD-2 trial compared first-line EVE + BEV and IFN + BEV in mRCC. Patients and methods: Therapy-naive pts with clear cell mRCC and prior nephrectomy were randomized 1:1 to BEV 10 mg/kg IV every 2 weeks with either EVE 10 mg oral daily or IFN (9 MIU SC 3 times/week, if tolerated). Tumour assessments were every 12 weeks. Primary objective was treatment effect on progression-free survival (PFS) per central review based on an estimate of the chance of a subsequent phase III trial success (50% threshold for phase II success). Results In EVE + BEV (n = 182) and IFN + BEV (n = 183) arms, median age was 60/60 years, 76/72% of pts were men, MSKCC risk was favourable/intermediate/poor in 36/57/7% and 36/57/7% of pts, and 43/46% of pts had >2 organs involved, respectively. For EVE + BEV and IFN + BEV, median treatment duration was 8.5/8.3 months, respectively; 23/26% of pts discontinued due to AEs. In EVE + BEV and IFN + BEV arms, median PFS by central review was 9.3/10.0 months (HRIFN/EVE, 0.91; 95% CI, 0.69-1.19; P =0.485), respectively; probability of subsequent phase III success was 5.1%. Results of central and local PFS analysis were consistent. Objective response rate was 27/28% in EVE + BEV and IFN + BEV arms, respectively. Median overall survival (OS) was not reached in the EVE + BEV arm and was 25.9 months (95% CI: 21.1, 30.2) in the IFN + BEV arm. Most frequent AEs (%) were stomatitis (63), proteinuria (49), diarrhoea (39), hypertension (38), and epistaxis (35) in EVE + BEV arm and decreased appetite (45), fatigue (41), proteinuria (37), and pyrexia (35) in IFN + BEV arm. Conclusions In RECORD-2, PFS and tolerability were similar for first-line EVE + BEV and IFN + BEV. Final OS analysis will occur after 2-year follow-up. Disclosure A. Ravaud: Alain Ravaud is a member of global, European, and/or French boards on urological tumors for Pfizer, Novartis, GlaxoSmithKline, Bayer-Schering, and Dendreon, and has received institutional grant support from Pfizer, Novartis, and Roche. O. Anak: Ozlem Anak is an employee of Novartis Pharma AG. D. Pelov: Diana Pelov is an employee of Novartis Pharmaceuticals Corporation. A. Louveau: Anne-Laure Louveau is an employee of Novartis Pharma S.A.S. T. M-H: Tay M-H is a speaker for an advisory board for Novartis Pharmaceuticals Corporation. B. Melichar: Bohuslav Melichar has received honoraria from Novartis and Roche and served on an advisory board for Roche. All other authors have declared no conflicts of interest.

Published
2012

41. Cancer de l’ovaire

Author

I. Thomassin-Naggara, Emile Daraï, and F. Selle

Subjects
Radiological and Ultrasound Technology, Radiology, Nuclear Medicine and imaging
Abstract

Objectifs Rappeler le protocole TDM standard pour le bilan d’extension d’un cancer de l’ovaire. Connaitre les principales localisations abdomino-pelviennes a rechercher. Exposer les attentes du chirurgien oncologue et du radiotherapeute a la lecture d’un compte rendu de TDM pour bilan d’extension de cancer de l’ovaire. Messages a retenir La dissemination se fait principalement par voie peritoneale. Les trois principales localisations peritoneales sont le cul-de-sac de Douglas, le grand epiploon et la region sous-phrenique droite. Les ganglions inguinaux, les ganglions iliaques externes et les ganglions lombo-aortiques sont les troix principaux sites d’extension ganglionnaire. La presence d’un epanchement pleural droit doit faire suspecter une extension a distance. Resume Le but de la tomodensitometrie pre-operatoire est de faire un bilan d’extension complet afin de limiter les chirurgies purement diagnostiques. Le compte rendu doit donc detailler les differents facteurs pronostiques contenus dans la classification FIGO decrit lors de chirurgie exploratrice realisee pour cancer de l’ovaire. Ainsi, seront detaillees l’extension aux organes de voisinage (uterus, trompes, charniere recto sigmoidienne), l’extension peritoneale (et notamment le cul-de-sac de Douglas, le grand epiploon et la region sous-phrenique droite) ainsi que l’extension lymphatique pelvienne et lombo-aortique. Enfin, les premieres coupes, centrees sur les bases pulmonaires, permettront de depister un epanchement pleural droit associe.

Published
2009

44. Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry

Author

Jitendra PS. Sawhney, Veerappa A. Kothiwale, Vikas Bisne, Rajashekhar Durgaprasad, Praveen Jadhav, Manoj Chopda, Velam Vanajakshamma, Ramdhan Meena, Govindan Vijayaraghavan, Kamaldeep Chawla, Jagan Allu, Karen S. Pieper, A. John Camm, Ajay K. Kakkar, Jean-Pierre Bassand, David A. Fitzmaurice, Samuel Z. Goldhaber, Shinya Goto, Sylvia Haas, Werner Hacke, Lorenzo G. Mantovani, Frank Misselwitz, Alexander G.G. Turpie, Martin van Eickels, Freek W.A. Verheugt, Gloria Kayani, Keith A.A. Fox, Bernard J. Gersh, Hector Lucas Luciardi, Harry Gibbs, Marianne Brodmann, Frank Cools, Antonio Carlos Pereira Barretto, Stuart J. Connolly, Alex Spyropoulos, John Eikelboom, Ramon Corbalan, Dayi Hu, Petr Jansky, Jørn Dalsgaard Nielsen, Hany Ragy, Pekka Raatikainen, Jean-Yves Le Heuzey, Harald Darius, Matyas Keltai, Sanjay Kakkar, Jitendra Pal Singh Sawhney, Giancarlo Agnelli, Giuseppe Ambrosio, Yukihiro Koretsune, Carlos Jerjes Sánchez Díaz, Hugo Ten Cate, Dan Atar, Janina Stepinska, Elizaveta Panchenko, Toon Wei Lim, Barry Jacobson, Seil Oh, Xavier Viñolas, Marten Rosenqvist, Jan Steffel, Pantep Angchaisuksiri, Ali Oto, Alex Parkhomenko, Wael Al Mahmeed, David Fitzmaurice, D.Y. Hu, K.N. Chen, Y.S. Zhao, H.Q. Zhang, J.Z. Chen, S.P. Cao, D.W. Wang, Y.J. Yang, W.H. Li, Y.H. Yin, G.Z. Tao, P. Yang, Y.M. Chen, S.H. He, Ying Wang, Yong Wang, G.S. Fu, X. Li, T.G. Wu, X.S. Cheng, X.W. Yan, R.P. Zhao, M.S. Chen, L.G. Xiong, P. Chen, Y. Jiao, Y. Guo, L. Xue, F.Z. Wang, H. Li, Z.M. Yang, C.L. Bai, J. Chen, J.Y. Chen, X. Chen, S. Feng, Q.H. Fu, X.J. Gao, W.N. Guo, R.H. He, X.A. He, X.S. Hu, X.F. Huang, B. Li, J. Li, L. Li, Y.H. Li, T.T. Liu, W.L. Liu, Y.Y. Liu, Z.C. Lu, X.L. Luo, T.Y. Ma, J.Q. Peng, X. Sheng, X.J. Shi, Y.H. Sun, G. Tian, K. Wang, L. Wang, R.N. Wu, Q. Xie, R.Y. Xu, J.S. Yang, L.L. Yang, Q. Yang, Y. Ye, H.Y. Yu, J.H. Yu, T. Yu, H. Zhai, Q. Zhan, G.S. Zhang, Q. Zhang, R. Zhang, Y. Zhang, W.Y. Zheng, B. Zhou, Z.H. Zhou, X.Y. Zhu, S. Kakkar, J.P.S. Sawhney, P. Jadhav, R. Durgaprasad, A.G. Ravi Shankar, R.K. Rajput, K. Bhargava, R. Sarma, A. Srinivas, D. Roy, U.M. Nagamalesh, M. Chopda, R. Kishore, G. Kulkarni, P. Chandwani, R.A. Pothiwala, M. Padinhare Purayil, S. Shah, K. Chawla, V.A. Kothiwale, B. Raghuraman, G. Vijayaraghavan, V.M. Vijan, G. Bantwal, V. Bisne, A. Khan, J.B. Gupta, S. Kumar, D. Jain, S. Abraham, D. Adak, A. Barai, H. Begum, P. Bhattacharjee, M. Dargude, D. Davies, B. Deshpande, P. Dhakrao, V. Dhyani, S. Duhan, M. Earath, A. Ganatra, S. Giradkar, V. Jain, R. Karthikeyan, L. Kasala, S. Kaur, S. Krishnappa, A. Lawande, B. Lokesh, N. Madarkar, R. Meena, P. More, D. Naik, K. Prashanth, M. Rao, N.M. Rao, N. Sadhu, D. Shah, M. Sharma, P. Shiva, S. Singhal, S. Suresh, V. Vanajakshamma, S.G. Panse, Y. Koretsune, S. Kanamori, K. Yamamoto, K. Kumagai, Y. Katsuda, K. Sadamatsu, F. Toyota, Y. Mizuno, I. Misumi, H. Noguchi, S. Ando, T. Suetsugu, M. Minamoto, Hiroshi Oda, K. Shiraishi, S. Adachi, K. Chiba, H. Norita, M. Tsuruta, T. Koyanagi, H. Ando, T. Higashi, K. Okada, S. Azakami, S. Komaki, K. Kumeda, T. Murayama, J. Matsumura, Y. Oba, R. Sonoda, K. Goto, K. Minoda, Y. Haraguchi, H. Suefuji, H. Miyagi, H. Kato, Tadashi Nakamura, Tsugihiro Nakamura, H. Nandate, R. Zaitsu, Yoshihisa Fujiura, A. Yoshimura, H. Numata, J. Ogawa, H. Tatematsu, Y. Kamogawa, K. Murakami, Y. Wakasa, M. Yamasawa, H. Maekawa, S. Abe, H. Kihara, S. Tsunoda, Katsumi Saito, Kazuyuki Saito, T. Fudo, K. Obunai, H. Tachibana, I. Oba, T. Kuwahata, S. Higa, M. Gushiken, T. Eto, H. Yoshida, D. Ikeda, Yoshitake Fujiura, M. Ishizawa, M. Nakatsuka, K. Murata, C. Ogurusu, M. Shimoyama, M. Akutsu, I. Takamura, F. Hoshino, N. Yokota, T. Iwao, K. Tsuchida, M. Takeuchi, Y. Hatori, Y. Kitami, Yoichi Nakamura, R. Oyama, M. Ageta, Hiroyuki Oda, Y. Go, K. Mishima, T. Unoki, S. Morii, Yuhei Shiga, H. Sumi, T. Nagatomo, K. Sanno, K. Fujisawa, Y. Atsuchi, T. Nagoshi, T. Seto, T. Tabuchi, M. Kameko, K. Nii, K. Oshiro, H. Takezawa, S. Nagano, N. Miyamoto, M. Iwaki, Yuichiro Nakamura, M. Fujii, M. Okawa, Masahiko Abe, Masatake Abe, Mitsunori Abe, T. Saito, T. Mito, K. Nagao, J. Minami, T. Mita, I. Sakuma, T. Taguchi, S. Marusaki, H. Doi, M. Tanaka, T. Fujito, M. Matsuta, T. Kusumoto, S. Kakinoki, K. Ashida, N. Yoshizawa, J. Agata, O. Arasaki, M. Manita, M. Ikemura, S. Fukuoka, H. Murakami, S. Matsukawa, Y. Hata, T. Taniguchi, T. Ko, H. Kubo, M. Imamaki, M. Akiyama, M. Inagaki, H. Odakura, T. Ueda, Y. Katsube, A. Nakata, H. Watanabe, M. Techigawara, M. Igarashi, K. Taga, T. Kimura, S. Tomimoto, M. Shibuya, M. Nakano, K. Ito, T. Seo, S. Hiramitsu, H. Hosokawa, M. Hoshiai, M. Hibino, K. Miyagawa, Hajime Horie, N. Sugishita, Yukio Shiga, A. Soma, K. Neya, Tetsuro Yoshida, Tomoki Yoshida, M. Mizuguchi, M. Ishiguro, T. Minagawa, M. Wada, H. Mukawa, F. Okuda, S. Nagasaka, Y. Abe, Sen Adachi, Susumu Adachi, T. Adachi, K. Akahane, T. Amano, K. Aoki, T. Aoyama, H. Arai, S. Arima, T. Arino, H. Asano, T. Asano, J. Azuma, T. Baba, T. Betsuyaku, H. Chibana, H. Date, J. Doiuchi, Y. Emura, M. Endo, Y. Fujii, R. Fujiki, A. Fujisawa, Y. Fujisawa, T. Fukuda, T. Fukui, N. Furukawa, T. Furukawa, W. Furumoto, T. Goto, M. Hamaoka, N. Hanazono, K. Hasegawa, T. Hatsuno, Y. Hayashi, K. Higuchi, K. Hirasawa, H. Hirayama, M. Hirose, S. Hirota, M. Honda, Hideki Horie, T. Ido, O. Iiji, H. Ikeda, K. Ikeda, K. Ikeoka, M. Imaizumi, H. Inaba, T. Inoue, F. Iseki, A. Ishihara, N. Ishioka, N. Ito, T. Iwase, H. Kakuda, J. Kamata, H. Kanai, H. Kanda, M. Kaneko, H. Kano, T. Kasai, T. Kato, Y. Kato, Y. Kawada, K. Kawai, K. Kawakami, S. Kawakami, T. Kawamoto, S. Kawano, J. Kim, T. Kira, H. Kitazawa, H. Kitazumi, T. Kito, T. Kobayashi, T. Koeda, J. Kojima, H. Komatsu, I. Komatsu, Y. Koshibu, T. Kotani, T. Kozuka, Y. Kumai, T. Kumazaki, I. Maeda, K. Maeda, Y. Maruyama, S. Matsui, K. Matsushita, Y. Matsuura, K. Mineoi, H. Mitsuhashi, N. Miura, S. Miyaguchi, S. Miyajima, H. Miyamoto, A. Miyashita, S. Miyata, I. Mizuguchi, A. Mizuno, T. Mori, O. Moriai, K. Morishita, O. Murai, Sho Nagai, Shunichi Nagai, E. Nagata, H. Nagata, A. Nakagomi, S. Nakahara, M. Nakamura, R. Nakamura, N. Nakanishi, T. Nakayama, R. Nakazato, T. Nanke, J. Nariyama, Y. Niijima, H. Niinuma, Y. Nishida, Y. Nishihata, K. Nishino, H. Nishioka, K. Nishizawa, I. Niwa, K. Nomura, S. Nomura, M. Nozoe, T. Ogawa, N. Ohara, M. Okada, K. Okamoto, H. Okita, M. Okuyama, H. Ono, T. Ono, Y. Onuki Pearce, S. Oriso, A. Ota, E. Otaki, Y. Saito, H. Sakai, N. Sakamoto, Y. Sakamoto, Y. Samejima, Y. Sasagawa, H. Sasaguri, A. Sasaki, T. Sasaki, Kazuki Sato, Kiyoharu Sato, M. Sawano, S. Seki, Y. Sekine, Y. Seta, K. Sezaki, N. Shibata, Y. Shiina, H. Shimono, Y. Shimoyama, T. Shindo, H. Shinohara, R. Shinohe, T. Shinozuka, T. Shirai, T. Shiraiwa, Y. Shozawa, T. Suga, C. Sugimoto, Kazuo Suzuki, Keita Suzuki, Shu Suzuki, Shunji Suzuki, Susumu Suzuki, Y. Suzuki, M. Tada, A. Taguchi, T. Takagi, Y. Takagi, K. Takahashi, S. Takahashi, H. Takai, C. Takanaka, S. Take, H. Takeda, K. Takei, K. Takenaka, T. Tana, G. Tanabe, K. Taya, H. Teragawa, S. Tohyo, S. Toru, Y. Tsuchiya, T. Tsuji, K. Tsuzaki, H. Uchiyama, O. Ueda, Y. Ueyama, N. Wakaki, T. Wakiyama, T. Washizuka, M. Watanabe, T. Yamada, T. Yamagishi, H. Yamaguchi, Kenichi Yamamoto, Kentaro Yamamoto, Kunihiko Yamamoto, T. Yamamoto, M. Yamaura, M. Yamazoe, K. Yasui, Y. Yokoyama, K. Yoshida, T.W. Lim, C.K. Ching, C.G. Foo, J.H. Chow, D.D. Chen, F.R. Jaufeerally, Y.M. Lee, G. Lim, W.T. Lim, S. Thng, S.Y. Yap, C. Yeo, S. Oh, H.N. Pak, J.-B. Kim, J.H. Kim, S.-W. Jang, D.H. Kim, D.R. Ryu, S.W. Park, D.-K. Kim, D.J. Choi, Y.S. Oh, M.-C. Cho, S.-H. Kim, H.-K. Jeon, D.-G. Shin, J.S. Park, H.K. Park, S.-J. Han, J.H. Sung, J.-G. Cho, G.-B. Nam, Y.K. On, H.E. Lim, J.J. Kwak, T.-J. Cha, T.J. Hong, S.H. Park, J.H. Yoon, N.-H. Kim, K.-S. Kim, B.C. Jung, G.-S. Hwang, C.-J. Kim, D.B. Kim, J.J. Ahn, H.J. An, H. Bae, A.L. Baek, W.J. Chi, E.A. Choi, E.H. Choi, H.K. Choi, H.S. Choi, S. Han, E.S. Heo, K.O. Her, S.W. Hwang, E.M. Jang, H.-S. Jang, S. Jang, H.-G. Jeon, S.R. Jeon, Y.R. Jeon, H.K. Jeong, I.-A. Jung, Hyeon Jeong Kim, Hyun Ju Kim, Ji Seon Kim, Jung Sook Kim, J.A. Kim, K.T. Kim, M.S. Kim, Sang Hee Kim, Sang Hyun Kim, Y.-I. Kim, C.S. Lee, E.H. Lee, G.H. Lee, H.Y. Lee, H.-Y. Lee, K.H. Lee, K.R. Lee, M.S. Lee, M.-Y. Lee, R.W. Lee, S.E. Lee, S.H. Lee, S. Lee, W.Y. Lee, I.K. Noh, A.R. Park, B.R. Park, H.N. Park, J.H. Park, M. Park, Y. Park, S.-Y. Seo, J. Shim, J.H. Sim, Y.M. Sohn, W.S. Son, Y.S. Son, H.J. Song, H.K. Wi, J.J. Woo, S. Ye, K.H. Yim, K.M. Yoo, E.J. Yoon, S.Y. Yun, P. Angchaisuksiri, S. Chawanadelert, P. Mongkolwongroj, K. Kanokphatcharakun, S. Cheewatanakornkul, T. Laksomya, S. Pattanaprichakul, T. Chantrarat, S. Rungaramsin, S. Silaruks, W. Wongcharoen, K. Siriwattana, K. Likittanasombat, P. Katekangplu, W. Boonyapisit, D. Cholsaringkarl, B. Chatlaong, P. Chattranukulchai, Y. Santanakorn, P. Hutayanon, P. Khunrong, T. Bunyapipat, S. Jai-Aue, P. Kaewsuwanna, P. Bamungpong, S. Gunaparn, S. Hongsuppinyo, R. Inphontan, R. Khattaroek, K. Khunkong, U. Kitmapawanont, C. Kongsin, B. Naratreekoon, S. Ninwaranon, J. Phangyota, A. Phrommintikul, P. Phunpinyosak, K. Pongmorakot, S. Poomiphol, N. Pornnimitthum, S. Pumprueg, S. Ratchasikaew, K. Sanit, K. Sawanyawisuth, B. Silaruks, R. Sirichai, A. Sriwichian, W. Suebjaksing, P. Sukklad, T. Suttana, A. Tangsirira, O. Thangpet, W. Tiyanon, Y. Vorasettakarnkij, T. Wisaratapong, W. Wongtheptien, A. Wutthimanop, S. Yawila, A. Oto, A. Altun, I. Ozdogru, K. Ozdemir, O. Yilmaz, A. Aydinlar, M.B. Yilmaz, E. Yeter, Z. Ongen, M. Cayli, H. Pekdemir, M. Ozdemir, M. Sucu, T. Sayin, M. Demir, H. 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Domenech Borras, A. Elorriaga Madariaga, A. Espallargas, M. Fernandez, E. Fernandez Escobar, E. Fernandez Mas, A. Ferrer, J. Fosch, M. Garcia Bermudez, V. Garcia Millan, M. Gavira Saenz, C. Gines Garcia, C. Gomez, Y. Gomez Perez, A. Gonzales Segovia, P. Gonzalez, L. Grigorian, A. Guerrero Molina, M. del C. Gutierrez del Val, B. Herrero Maeso, E. Hevia Rodriguez, A. Iglesias Garcia, M.J. Jimenez Fernandez, B. Jimeno Besa, P. Juan Salvadores, M.B. Lage Bouzamayor, I. Lasuncion, L.E. Lezcano Gort, M. Llobet Molina, M. Lopez, A. Manzanal Rey, J. Mara Guerra, S. Marcus, A. Martin Vila, M. Martinez Mena, P. Mazon, F. Mendez Zurita, G. Millán, M. Molina, P. Montero Alia, D. Montes, M. Moure Gonzalez, R.B. Munoz Munoz, A. Negrete Palma, H.N. Orellana Figueroa, V.M. Ortega, C. Ortiz Cortes, D. Otero Tomera, N. Palomo Merchan, I. Pareja Ibar, E. Pena Garcia, M. Pereda Armayor, M. Perez Carasa, I. Prieto, V. Quintern, R. Renom, L.M. Rincon Diaz, V. Rios, L. Riquelme Sola, R. Rivera, X. Robiro Robiro, M. Roca, C. Roca Saumell, C. Rodrigo, E. Rodriguez, M. Rodriguez Garcia, S. Saez Jimenez, P. Sanchez Calderon, L. Sanchez Mendez, S. Sanchez Parra, C. Santolaya, M.R. Senan Sanz, A. Seoane Blanco, E. Serralvo, N. Sierra, C. Simon Valero, J. Sorribes Lopez, M. Teixido Fontanillas, M. Terns Riera, G. Tobajas, C. Torres, J. Torres Marques, M. Ubeda Pastor, M. Rosenqvist, A. Wirdby, J. Linden, K. Henriksson, M. Elmersson, A. Egilsson, U. Börjesson, G. Svärd, B. Liu, A. Lindh, L.-B. Olsson, M. Gustavsson, Lars Andersson, Lisbeth Andersson, L. Benson, C. Bothin, A. Hajimirsadeghi, K. Kadir, M. Ericsson, A. Ohlsson, H. Lindvall, P. Svensson, K. Thorne, H. Handel, P. Platonov, B. Eriksson, I. Timberg, K. Romberg, M. Crisby, J.-E. Karlsson, S.A. Jensen, A. Andersson, L. Malmqvist, B. Martinsson, F. Bernsten, J. Engdahl, J. Thulin, A. Hot-Bjelac, P. Stalby, H. Aaröe, E. Ahbeck, H. Ahlmark, F. Al-Khalili, G. Bonkowski, S. Dzeletovic, A.-B. Ekstrand, G.-B. Eriksson, K. Floren, C. Grässjö, S. Hahn, P. Jaensson, B. Jansson, J.-H. Jansson, R.-M. Kangert, A. Koch, D. Kusiak, A. Lettenström, A. Lindberg, C.-J. Lindholm, A. Mannermyr, K. Mansson, M. Millborg, C. Nilsson, A.-M. Ohlin, A. Olofsson, A. Osberg, A. Pedersen, K. Risbecker, K. Rosenberg, J. Samuelsson, M. Shayesteh, K. Skoglund, M. Stjernberg, C. Thorsen, J. Steffel, J.H. Beer, J. Debrunner, D. Amstutz, J. Bruegger, G. Elise, A. Grau, A. Guinand, I. Henriette, E. Saga, S. Winnik, A. Parkhomenko, I. Rudyk, V. Tseluyko, O. Karpenko, S. Zhurba, I. Kraiz, I. Kupnovytska, N. Serediuk, Y. Mostovoy, O. Ushakov, O. Koval, I. Kovalskyi, Y. Svyshchenko, O. Sychov, M. Stanislavchuk, O. Kraydashenko, A. Yagensky, S. Tykhonova, I. Fushtey, R. Belegai, G. Berko, L. Burdeuna, O. Chabanna, I. Daniuk, A. Ivanov, E. Kamenska, P. Kaplan, O. Khyzhnyak, S. Kizim, O. Matova, O. Medentseva, V. Mochonyi, M. Mospan, V. Nemtsova, T. Ovdiienko, O. Palamarchuk, M. Pavelko, R. Petrovskyy, D. Plevak, O. Proshak, S. Pyvovar, L. Rasputina, O. Romanenko, O. Romanova, A. Sapatyi, O. Shumakov, R. Stets, L. Todoriuk, V. Varenov, D. Fitzmaurice, N. Chauhan, D. Goodwin, P. Saunders, R. Evans, J. Leese, P.S. Jhittay, A. Ross, M.S. Kainth, G. Pickavance, J. McDonnell, A. Williams, T. Gooding, H. Wagner, S. Suryani, A. Singal, S. Sircar, R. Bilas, P. Hutchinson, A. Wakeman, M. Stokes, N. Paul, M. Aziz, C. Ramesh, P. Wilson, S. Franklin, S. Fairhead, J. Thompson, V. St Joseph, G. Taylor, D. Tragen, D. Seamark, C. Paul, M. Richardson, A. Jefferies, H. Sharp, H. Jones, C. Giles, M. Page, O. Oginni, J. Aldegather, S. Wetherwell, W. Lumb, P. Evans, F. Scouller, N. Macey, Y. Stipp, R. West, S. Thurston, P. Wadeson, J. Matthews, P. Pandya, A. Gallagher, T. Railton, B. Sinha, D. Russell, J.A. Davies, P. Ainsworth, C.P. Jones, P. Weeks, J. Eden, D. Kernick, W. Murdoch, L. Lumley, R.P. Patel, S.W. Wong, M. Saigol, K. Ladha, K. Douglas, D.F. Cumberlidge, C. Bradshaw, G. Van Zon, K.P. Jones, M.J. Thomas, E. Watson, B. Sarai, N. Ahmad, W. Willcock, J. Cairns, S. Sathananthan, N. de Kare-Silver, A. Gilliland, E. Strieder, A. Howitt, B. Vishwanathan, N. Bird, D. Gray, M. Clark, J. Bisatt, J. Litchfield, E. Fisher, T. Fooks, A.R. Kelsall, E. Alborough, J. Wakeling, M. Parfitt, K. Milne, S. Rogers, R. Priyadharshan, J.L. Oliver, E. Davies, S. Abushal, M. Jacobs, C. Hutton, N.I. Walls, R. Thompson, C. Chigbo, S.M.A. Zaidi, M. Howard, K.C. Butter, S. Barrow, H. Little, I.U. Haq, L. Gibbons, S. Glencross, A.J. McLeod, K. Poland, C. Mulholland, A. Warke, P. Conn, G. Burns, R.N. Smith, S. Lowe, R. Kamath, H.S. Dau, J. Webster, I. Hodgins, S. Vercoe, P.C. Roome, H. Pinnock, J.R.A. Patel, A. Ali, N. Hart, R. Davies, E. Stuart, C.A. Neden, M. Danielsen, R. Heath, P. Sharma, S. Galloway, C. Hawkins, R. Oliver, M. Aylward, S. Mannion, M. Braddick, D. Edwards, A.C. Rothwell, A. Sabir, F. Choudhary, S. Khalaque, A. Wilson, S. Peters, W. Coulson, N. Roberts, A. Heer, S. Coates, B. Ward, D. Jackson, S. Walton, D. Shepherd, M. Sterry, T. Wong, M. Boon, R. Bunney, R. Haria-Shah, R.T. Baron, S. Davies, T. Schatzberger, N. Hargreaves, T. Stephenson, H. Choi, R. Batson, L. Lucraft, T. Myhill, S. Estifano, D. Geatch, J. Wilkinson, R. Veale, K. Forshaw, T. Davies, K. Zaman, P. Vinson, C. Liley, M. Bandrapalli, P. McGinty, R. Wastling, P. McEleny, A. Beattie, P. Cooke, M. Wong, J. Gunasegaram, M. Pugsley, S. Ahmad, C. A'Court, J. Ayers, J. Bennett, S. Cartwright, S. Dobson, C. Dooldeniya, A. Flynn, R. Fox, J. Goram, A. Halpin, A. Hay, P. Jacobs, L. Jeffers, L. Lomax, I. Munro, R. Muvva, M. Nadaph, K. Powell, S. Randfield, D. Redpath, R. Reed, M. Rickenbach, G. Rogers, P.B. Saunders, C. Seamark, J. Shewring, P. Simmons, H. Simper, H. Stoddart, A. Sword, N. Thomas, A. Thomson, H. Gibbs, A. Blenkhorn, B. Singh, W. Van Gaal, W. Abhayaratna, R. Lehman, P. Roberts-Thomson, J. Kilian, D. Coulshed, A. Catanchin, D. Colquhoun, H. Kiat, D. Eccleston, J. French, L. Zimmett, B. Ayres, T. Phan, P. Blombery, D. Crimmins, D. O'Donnell, A. Choi, P. Astridge, M. Arstall, N. Jepson, M. Binnekamp, A. Lee, J. Rogers, G. Starmer, P. Carroll, J. Faunt, A. Aggarwala, L. Barry, C. Batta, R. Beveridge, A. Black, M. Bonner, J. Boys, E. Buckley, M. Campo, L. Carlton, A. Connelly, B. Conway, D. Cresp, H. Dimitri, S. Dixon, M. Dolman, M. Duroux, M. Eskandari, R. Eslick, A. Ferreira-Jardim, T. Fetahovic, D. Fitzpatrick, R. Geraghty, J. Gibbs, T. Grabek, M.H. Modi, K. Hayes, M.P. Hegde, L. Hesketh, B. Hoffmann, B. Jacobson, K. Johnson, C. Juergens, I. Kassam, V. Lawlor, M. Lehman, S. Lehman, D. Leung, S. Mackay, M. MacKenzie, C. McCarthy, C. McIntosh, L. McKeon, H. Morrison, C. Mussap, J.-D. Myers, V. Nagalingam, G. Oldfield, V. O'May, J. Palmer, L. Parsons, K. Patching, T. Patching, V. Paul, M. Plotz, S. Preston, H. Rashad, M. Ratcliffe, S. Raynes, J. Rose, L. Sanders, M. Seremetkoska, H. Setio, S. Shone, P. Shrestha, C. Singh, C. Singleton, N. Stoyanov, S. Sutcliffe, K. Swaraj, J. Tarrant, S. Thompson, I.M. Tsay, M. Vorster, A. Waldman, L. Wallis, E. Wilford, K. Wong, S.J. Connolly, A. Spyropoulos, J. Eikelboom, R. Luton, M. Gupta, A.S. Pandey, S. Cheung, R. Leader, P. Beaudry, F. Ayala-Paredes, J. Berlingieri, J. Heath, G. Poirier, M. Du Preez, R. Nadeau, G. Dresser, R. Dhillon, T. Hruczkowski, B. Schweitzer, B. Coutu, P. Angaran, P. MacDonald, S. Vizel, S. Fikry, R. Parkash, A. Lavoie, J. Cha, B. Ramjattan, J. Bonet, K. Ahmad, L. Aro, T. Aves, K. Beaudry, C. Bergeron, J. Bigcanoe, N. Bignell, L. Breakwell, E. Burke, L. Carroll, B. Clarke, T. Cleveland, S. Daheb, P. Dehghani, I. Denis, Z. Djaidani, P. Dorian, S. Douglass, J. Dunnigan, A. Ewert, D. Farquhar, A. Fearon, L. Ferleyko, D. Fournier, B. Fox, M.-C. Grenier, W. Gulliver, K. Haveman, C. Hines, K. Hines, A.M. Jackson, C. Jean, G. Jethoo, R. Kahlon, S. Kelly, R. Kim, V. Korley, J. Kornder, L. Kwan, J. Largy, C. Lewis, S. Lewis, I. Mangat, R. Moor, J. Navratil, I. Neas, J. Otis, R. Otis, M. Pandey, F. Petrie, A. Pinter, M. Raines, P. Roberts, M. Robinson, G. Sas, S. Schulman, L. Snell, S. Spearson, J. Stevenson, T. Trahey, S. Wong, D. Wright, H. Ragy, A. Abd El-Aziz, S.K. Abou Seif, M.G. El Din, S. El Etriby, A. Elbahry, A. El-Etreby, M. Elkhadem, A. Katta, T. Khairy, A. Mowafy, M. Nawar, A. Ohanissian, A. Reda, M. Reda, H. Salem, N. Sami, S. Samir, M. Setiha, M. Sobhy, A. Soliman, N. Taha, M. Tawfik, E. Zaatout, D. Kettles, J. Bayat, H. Siebert, A. Horak, Y. Kelfkens, R. Garda, T. Pillay, M. Guerra, L. van Zyl, H. Theron, A. Murray, R. Louw, D. Greyling, P. Mntla, V. Ueckermann, R. Loghdey, S. Ismail, F. Ahmed, J. Engelbrecht, A. Ramdass, S. Maharajh, W. Oosthuysen, G. Angel, C. Bester, M. Booysen, C. Boshoff, C. Cannon, S. Cassimjee, C. Chami, G. Conway, A. Davids, L. de Meyer, G. Du Plessis, T. Ellis, L. Henley, M. Karsten, E. Loyd, J. Marks, L. Mavhusa, M. Mostert, A. Page, L. Rikhotso, M. Salie, J. Sasto, F. Shaik, A. Skein, L. Smith, G. Tarr, T. Tau, F. van Zyl, W. Al Mahmeed, G. Yousef, A. Agrawal, M. Nathani, M. Ibrahim, E.M. Esheiba, R. Singh, A. Naguib, M. Abu-Mahfouz, M. Al Omairi, A. Al Naeemi, R. Maruthanayagam, N. Bazargani, A. Wassef, R. Gupta, M. Khan, B. Subbaraman, A. Abdul, A. Al Mulla, S. El Bardisy, P. Haridas, S. Jadhav, K. Magdaluyo, M. Makdad, I. Maqsood, R. Mohamed, N. Sharma, R. Sharma, M. Thanzeel, S.Z. Goldhaber, R. Canosa, P. Rama, E. Blumberg, J. Garcia, P. Mullen, V. Wilson, A. Quick, K. Ferrick, W.M. Kutayli, M. Cox, M. Franco, S. Falkowski, R. Mendelson, M. Williams, S. Miller, S. Beach, A. Alfieri, T. Gutowski, I. Haque, R. Reddy, W. Ahmed, P. Delafontaine, D. Diercks, D. Theodoro, K. Remmel, M. Alberts, R. Ison, H. Noveck, P. Duffy, S. Pitta, D. Nishijima, C. Treasure, N. Asafu-Adjaye, K. Ball, M. Bartlett, M. Bentley, S. Bowers, A. Brown, A. Browne, J. Cameron-Watts, M. Canova, D. Cassidy, K. Cervellione, S. Congal, J. DePauw, A. Dickerson, M. Eley, L. Evans, S. Felpel, K. Ferdinand, D. Fielder, P. Gentry, A. Haideri, F. Hakimi, T. Harbour, E. Hartranft, B. Hawkins, M. Headlee, L. Henson, C. Herrick, T. Hicks, S. Jasinski, A. Jones, L. Jones, P. Jones, S. Karl, M. Keeling, J. Kerr, P. Knowles, J. Langdon, M. Lay, J.A. Lee, T. Lincoln, E. Malone, A. Merliss, D. Merritt, J. Minardo, B. Mooso, C. Orosco, V. Palumbo, M. Parker, T. Parrott, S. Paserchia, G. Pearl, J. Peterson, N. Pickelsimer, T. Purcell, J. Raynor, S. Raziano, C. Richard, T. Richardson, C. Robertson, A. Sage, T. Sanghera, P. Shaw, J. Shoemaker, K. Smith, B. Stephanie, A. Thatcher, H. Theobald, N. Thompson, L. Treasure, T. Tripti, C. Verdi, and V. Worthy

Subjects
Surgery, RD1-811, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: The Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. Methods and results: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012–2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P

Published
2018
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45. Electrical Breakdown of Epr-Insulated Cables at DC and Impules Voltages

Author

D. Schulte and F. Selle

Subjects
Materials science, High amplitude, Test procedures, business.industry, General Engineering, Electrical engineering, Electrical breakdown, Impulse (physics), law.invention, law, Step test, Electrical and Electronic Engineering, Composite material, Electron paramagnetic resonance, business, Voltage, DC bias
Abstract

The electric strengths of three EPR-compounds are investigated using dc, impulse and impulse with dc bias voltages. To see whether dc and impulse strengths are affected by vulcanization residues, breakdown tests are carried out at different times after vulcanization. Different levels of dc perstress cause a considerable influence on the impulse breakdown strength, whereas the duration of dc prestress seems to be without effect. The applied mode of test procedure affects the breakdown results considerably: the breakdown strength measured in a step test procedure is lower than that obtained by the application of a single impulse with high amplitude. This behavior is valid for both polarities of dc prestress. Finally, the effect of repeated impulse discharges on the long-term performance of dc stressed cables is studied. The coherence between cable length, transient voltages, and cable failures is investigated and discussed.

Published
1987

46. The growing demand for midtrimester amniocentesis: a systems approach to forecasting the need for facilities

Author

D W Holmes, M L Ingbar, and H F Selle

Subjects
Offspring, Population, Chromosome Disorders, Custodial Care, Health services, Nursing, Pregnancy, Health care, Humans, New Hampshire, Medicine, education, Social policy, Chromosome Aberrations, Health Services Needs and Demand, education.field_of_study, medicine.diagnostic_test, business.industry, Public Health, Environmental and Occupational Health, Custodial care, Abortion, Induced, Models, Theoretical, medicine.disease, Health Planning, Amniocentesis, Costs and Cost Analysis, Female, Health Facilities, business, Forecasting, Maternal Age, Vermont, Research Article, Demography
Abstract

A predicted shift in composition of the child-bearing population of the United States to higher maternal ages by year 2000 indicates that the number of chromosomally abnormal offspring of women age 35 and over will increase by 64% while the total number of women increases only 21%. We formulated a conceptual model of a health care system that predicts demand for amniocentesis from prospective patients in any particular region, the number of defective offspring detected, and the future cost of custodial care using any given level of detection effort. It was found that as capacity of clinic facilities and use by women age 35 and over in the area increased, the expenditure for amniocentesis combined with the cost of custodial care for undetected offspring decreased, assuming termination of affected pregnancies. Use of this model will enable health care managers to anticipate need for facilities, and also guide the formulation of social policy in the provision of new health services by enabling them to take into account the predictable effects of these services upon other public services.

Published
1979

47. Progression and CSF Inflammation after Eradication of Oligoclonal Bands in an MS Patient Treated with Allogeneic Hematopoietic Cell Transplantation for Follicular Lymphoma

Author

P. Braendstrup, A.R. Langkilde, K. Schreiber, M. Ravnborg, F. Sellebjerg, and L. Vindeløv

Subjects
Multiple sclerosis, Allogeneic hematopoietic cell transplantation, Disease-modifying therapies, CXCL13, Matrix metalloproteinase-9, Oligoclonal bands, Neurology. Diseases of the nervous system, RC346-429
Abstract

Background: Allogeneic hematopoietic cell transplantation (allo-HCT) has been proposed as treatment for multiple sclerosis (MS) and other autoimmune diseases. Aims: To describe the effects of allo-HCT on the course of MS in a 49-year-old woman with longstanding progressive MS who was treated with allo-HCT for follicular lymphoma. Methods: Non-myeloablative conditioning allo-HCT, examination for IgG oligoclonal bands and measurement of CXCL13 and matrix metalloproteinase-9 (MMP-9) concentration in the cerebrospinal fluid (CSF). Results: Despite the disappearance of oligoclonal bands in CSF, disease progression and CSF inflammation was observed. Conclusions: We hypothesize that CXCL13 and MMP-9 detected in CSF may reflect ongoing, pathogenic immune activation even after the eradication of intrathecal IgG synthesis. This suggests that progressive MS may depend more on innate than on adaptive immune activation.

Published
2012
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49. Atezolizumab Combined With Platinum and Maintenance Niraparib for Recurrent Ovarian Cancer With a Platinum-Free Interval >6 Months: ENGOT-OV41/GEICO 69-O/ANITA Phase III Trial.

Author

González-Martín A, Rubio MJ, Heitz F, Depont Christensen R, Colombo N, Van Gorp T, Romeo M, Ray-Coquard I, Gaba L, Leary A, De Sande LM, Lebreton C, Redondo A, Fabbro M, Barretina Ginesta MP, Follana P, Pérez-Fidalgo JA, Rodrigues M, Santaballa A, Sabatier R, Bermejo-Pérez MJ, Lotz JP, Pardo B, Marquina G, Sánchez-Lorenzo L, Quindós M, Estévez-García P, Guerra Alía E, Manso L, Casado V, Kommoss S, Tognon G, Henry S, Bruchim I, Oaknin A, and Selle F

Abstract

Purpose: To evaluate atezolizumab combined with platinum-based chemotherapy (CT) followed by maintenance niraparib for late-relapsing recurrent ovarian cancer., Methods: The multicenter placebo-controlled double-blind randomized phase III ENGOT-OV41/GEICO 69-O/ANITA trial (ClinicalTrials.gov identifier: NCT03598270) enrolled patients with measurable high-grade serous, endometrioid, or undifferentiated recurrent ovarian cancer who had received one or two previous CT lines (most recent including platinum) and had a treatment-free interval since last platinum (TFIp) of >6 months. Patients were stratified by investigator-selected carboplatin doublet, TFIp, BRCA status, and PD-L1 status in de novo biopsy and randomly assigned 1:1 to receive either atezolizumab or placebo throughout standard therapy comprising six cycles of a carboplatin doublet followed (in patients with response/stable disease) by maintenance niraparib until progression. The primary end point was investigator-assessed progression-free survival (PFS) per RECIST v1.1., Results: Between November 2018 and January 2022, 417 patients were randomly assigned (15% BRCA- mutated, 36% PD-L1-positive, 66% TFIp >12 months, 11% previous poly [ADP-ribose] polymerase inhibitor after frontline CT, and 53% previous bevacizumab). Median follow-up was 28.6 months (95% CI, 26.6 to 30.5 months). Atezolizumab did not significantly improve PFS (hazard ratio, 0.89 [95% CI, 0.71 to 1.10]; P = .28). Median PFS was 11.2 months (95% CI, 10.1 to 12.1 months) with atezolizumab versus 10.1 months (95% CI, 9.2 to 11.2 months) with standard therapy. Subgroup analyses generally showed consistent results, including analyses by PD-L1 status. The objective response rate (ORR) was 45% (95% CI, 39 to 52) with atezolizumab and 43% (95% CI, 36 to 49) with standard therapy. The safety profile was as expected from previous experience of these drugs., Conclusion: Combining atezolizumab with CT and maintenance niraparib for late-relapsing recurrent ovarian cancer did not significantly improve PFS or the ORR.

Published
2024
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50. Clinical and radiological pattern of olaparib-induced interstitial lung disease.

Author

Brudon A, Fournier D, Selle F, Seront E, Conforti R, Veyrac G, Gouraud A, Lebrun-Vignes B, Khalil A, Zalcman G, and Gounant V

Subjects
Humans, Female, Retrospective Studies, Aged, Middle Aged, Adult, Breast Neoplasms drug therapy, Tomography, X-Ray Computed, Ovarian Neoplasms drug therapy, France, Belgium, Lung Diseases, Interstitial chemically induced, Lung Diseases, Interstitial diagnostic imaging, Phthalazines adverse effects, Phthalazines therapeutic use, Piperazines adverse effects, Piperazines therapeutic use, Pharmacovigilance, Poly(ADP-ribose) Polymerase Inhibitors adverse effects, Poly(ADP-ribose) Polymerase Inhibitors therapeutic use
Abstract

Background: PARP inhibitors (PARPi) are used in the treatment of ovarian, breast, pancreatic, and prostate cancers. Pneumonitis has been identified as a potential side effect, with a higher meta-analysis-assessed risk for olaparib versus other PARPi. Olaparib-induced interstitial lung disease (O-ILD) was first described within the Japanese population, with few information available for Caucasian patients., Methods: We performed a retrospective study by pooling data from the French and Belgian pharmacovigilance databases from 2018 to 2022. Patients with O-ILD were included following a central review by: 1) pharmacologists using the French drug causality assessment method; 2) senior pneumologists or radiologists, using the Fleischner Society's recommendations., Results: Five patients were identified and analysed. All were females, with ovarian or breast cancer. Median age at O-ILD diagnosis was 71 (38-72) years old, with no smoking history. Median delay between treatment initiation and symptom occurrence was 12 (6-33) weeks. Pneumonitis severity assessed using the Common Terminology Criteria for Adverse Events V5 was Grade 3 (n = 4) or 2 (n = 1). CT-scan review (n = 3) described hypersensitivity pneumonitis reaction as a common pattern. Bronchioalveolar lavage (n = 4) revealed lymphocytic alveolitis. Treatments relied on olaparib discontinuation (n = 5) and glucocorticoid intake (n = 4), with no fatal issue. Safe re-challenge with PARPi occurred in two patients. Forty additional O-ILD cases were identified in the WHO VigiBase database, including one fatal case., Conclusions: PARPi-ILD is a rare but potentially life-threatening disease, presenting as a hypersensitivity pneumonitis pattern within 3 months of PARPi initiation. Treatment primarily relies on medication discontinuation. Re-challenging with another PARPi could be considered., Clinical Trial Number: CEPRO #2023-010., (© 2024. The Author(s).)

Published
2024
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