PMID- 26755507 OWN - NLM STAT- MEDLINE DCOM- 20160629 LR - 20220311 IS - 1527-7755 (Electronic) IS - 0732-183X (Linking) VI - 34 IP - 7 DP - 2016 Mar 1 TI - Volasertib Versus Chemotherapy in Platinum-Resistant or -Refractory Ovarian Cancer: A Randomized Phase II Groupe des Investigateurs Nationaux pour l'Etude des Cancers de l'Ovaire Study. PG - 706-13 LID - 10.1200/JCO.2015.62.1474 [doi] AB - PURPOSE: Volasertib is a potent and selective cell-cycle kinase inhibitor that induces mitotic arrest and apoptosis by targeting Polo-like kinase. This phase II trial evaluated volasertib or single-agent chemotherapy in patients with platinum-resistant or -refractory ovarian cancer who experienced failure after treatment with two or three therapy lines. PATIENTS AND METHODS: Patients were randomly assigned to receive either volasertib 300 mg by intravenous infusion every 3 weeks or an investigator's choice of single-agent, nonplatinum, cytotoxic chemotherapy. The primary end point was 24-week disease control rate. Secondary end points included best overall response, progression-free survival (PFS), safety, quality of life, and exploratory biomarker analyses. RESULTS: Of the 109 patients receiving treatment, 54 received volasertib and 55 received chemotherapy; demographics were well balanced. The 24-week disease control rates for volasertib and chemotherapy were 30.6% (95% CI, 18.0% to 43.2%) and 43.1% (95% CI, 29.6% to 56.7%), respectively, with partial responses in seven (13.0%) and eight (14.5%) patients, respectively. Median PFS was 13.1 weeks and 20.6 weeks for volasertib and chemotherapy (hazard ratio, 1.01; 95% CI, 0.66 to 1.53). Six patients (11%) receiving volasertib achieved PFS fore more than 1 year, whereas no patient receiving chemotherapy achieved PFS greater than 1 year. No relationship between the expression of the biomarkers tested and their response was determined. Patients treated with volasertib experienced more grade 3 and 4 drug-related hematologic adverse events (AEs) and fewer nonhematologic AEs than did patients receiving chemotherapy. Discontinuation resulting from AEs occurred in seven (13.0%) and 15 (27.3%) patients in the volasertib and chemotherapy arms, respectively. Both arms showed similar effects on quality of life. CONCLUSION: Single-agent volasertib showed antitumor activity in patients with ovarian cancer. AEs in patients receiving volasertib were mainly hematologic and manageable. CI - (c) 2016 by American Society of Clinical Oncology. FAU - Pujade-Lauraine, Eric AU - Pujade-Lauraine E AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. epujade@arcagy.org. FAU - Selle, Frederic AU - Selle F AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Weber, Beatrice AU - Weber B AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Ray-Coquard, Isabelle-Laure AU - Ray-Coquard IL AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Vergote, Ignace AU - Vergote I AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Sufliarsky, Jozef AU - Sufliarsky J AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Del Campo, Josep Maria AU - Del Campo JM AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Lortholary, Alain AU - Lortholary A AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Lesoin, Anne AU - Lesoin A AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Follana, Philippe AU - Follana P AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Freyer, Gilles AU - Freyer G AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Pardo, Beatriz AU - Pardo B AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Vidal, Laura AU - Vidal L AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Tholander, Bengt AU - Tholander B AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Gladieff, Laurence AU - Gladieff L AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Sassi, Mouna AU - Sassi M AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Garin-Chesa, Pilar AU - Garin-Chesa P AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Nazabadioko, Serge AU - Nazabadioko S AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Marzin, Kristell AU - Marzin K AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Pilz, Korinna AU - Pilz K AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. FAU - Joly, Florence AU - Joly F AD - Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frederic Selle, Hopitaux Universitaires de l'Est Parisien-site Tenon and Alliance Pour la Recherche En Cancerologie, Paris; Beatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Leon Berard and Universite Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice; Gilles Freyer, Lyon University, Hospices Civils de Lyon, Pierre-Benite Cedex; Laurence Gladieff, Institut Claudius Regaud-IUCTO, Toulouse; Mouna Sassi and Serge Nazabadioko, Boehringer Ingelheim, Reims; Florence Joly, Centre Francois Baclesse, Caen, France; Ignace Vergote, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Jozef Sufliarsky, National Cancer Institute, Bratislava, Slovakia; Josep Maria Del Campo, Hospital University, Vall d'Hebron; Beatriz Pardo, Institut Catala d'Oncologia-Instituto de Investigacion Biomedica de Bellvitge; Laura Vidal, Hospital Clinic de Barcelona, Barcelona, Spain; Bengt Tholander, Uppsala University Hospital, Uppsala, Sweden; Pilar Garin-Chesa, Boehringer Ingelheim, Vienna, Austria; Kristell Marzin, Boehringer Ingelheim, Biberach; and Korinna Pilz, Boehringer Ingelheim, Ingelheim, Germany. LA - eng SI - ClinicalTrials.gov/NCT01121406 PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20160111 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Antineoplastic Agents) RN - 0 (BI 6727) RN - 0 (Biomarkers, Tumor) RN - 0 (Pteridines) RN - BG3F62OND5 (Carboplatin) RN - Q20Q21Q62J (Cisplatin) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents/*therapeutic use MH - Biomarkers, Tumor/analysis MH - Carboplatin/therapeutic use MH - Cisplatin/therapeutic use MH - Disease Progression MH - Drug Resistance, Neoplasm MH - Female MH - Humans MH - Infusions, Intravenous MH - Middle Aged MH - Ovarian Neoplasms/*drug therapy MH - Pteridines/administration & dosage/*therapeutic use MH - Quality of Life MH - Treatment Outcome EDAT- 2016/01/13 06:00 MHDA- 2016/06/30 06:00 CRDT- 2016/01/13 06:00 PHST- 2016/01/13 06:00 [entrez] PHST- 2016/01/13 06:00 [pubmed] PHST- 2016/06/30 06:00 [medline] AID - JCO.2015.62.1474 [pii] AID - 10.1200/JCO.2015.62.1474 [doi] PST - ppublish SO - J Clin Oncol. 2016 Mar 1;34(7):706-13. doi: 10.1200/JCO.2015.62.1474. Epub 2016 Jan 11.