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1. Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer

Author

Harter, Philipp, Sehouli, Jalid, Vergote, Ignace, Ferron, Gwenael, Reuss, Alexander, Meier, Werner, Greggi, Stefano, Mosgard, Berit J, Selle, Frederic, Guyon, Frédéric, Pomel, Christophe, Lécuru, Fabrice, Zang, Rongyu, Avall-Lundqvist, Elisabeth, Kim, Jae-Weon, Ponce, Jordi, Raspagliesi, Francesco, Kristensen, Gunnar, Classe, Jean-Marc, Hillemanns, Peter, Jensen, Pernille, Hasenburg, Annette, Ghaem-Maghami, Sadaf, Mirza, Mansoor R, Lund, Bente, Reinthaller, Alexander, Santaballa, Ana, Olaitan, Adeola, Hilpert, Felix, du Bois, Andreas, S Buchholz, A Burges, U Canzler, D Denschlag, A El-Balat, G Emons, R Felberbaum, N de Gregorio, M Gropp-Meier, V Hanf, L Hanker, R Hils, C Kurzeder, B Lampe, A Mustea, M Schmidt, R Schutz, M Weigel, S Weiser, A Zorr, C Marth, E Petru, T Scholl, M Beltran, I Bover, A Gomez di Laino, N Lainez, S Martinez, A Poveda Velasco, M Romeo, H Crouet, E de Gournay, G Deplanque, P Follana, A Floquet, D Lanvin, J Leveque, E Pujade-Lauraine, N Raban, B Resch, A M Savoye, G Aletti, G Giorda, F Landoni, C Scaffa, J Abu, F Alexander-Sefre, D Barton, S Butler-Manuel, R Clayton, R Crawford, T Duncan, A El-Ghobashy, C Fotopoulou, M Hall, C Intrivici, A Lawrence, D Luesley, R Naik, A Nordin, J Tidy, L Fokdahl, A Hofsjö, P Kjolhede, B Eyjolfsdottir, Z Y Dai, P Zhang, B Aminossadati, M Hahmann, C Nasemann, S Yahiaoui, M Wittenberg, C Schade-Brittinger, G Elser, D Reddig, M Kuncke, S Polleis, Y Mattukat, A Riha, R Berger, J de Roover, B Kaur, J Crook, F Nepote, B Votan, M Andriamamonjy, J Bryce, S Ristinge, Philipp, H, Jalid, S, Ignace, V, Gwenael, F, Alexander, R, Werner, M, Stefano, G, Berit J, M, Frederic, S, Frédéric, G, Christophe, P, Fabrice, L, Rongyu, Z, Elisabeth, A, Jae-Weon, K, Jordi, P, Francesco, R, Gunnar, K, Jean-Marc, C, Peter, H, Pernille, J, Annette, H, Sadaf, G, Mansoor R, M, Bente, L, Ana, S, Adeola, O, Felix, H, Andreas, D, Buchholz, S, Burges, A, Canzler, U, Denschlag, D, El-Balat, A, Emons, G, Felberbaum, R, de Gregorio, N, Gropp-Meier, M, Hanf, V, Hanker, L, Hils, R, Kurzeder, C, Lampe, B, Mustea, A, Schmidt, M, Schutz, R, Weigel, M, Weiser, S, Zorr, A, Marth, C, Petru, E, Scholl, T, Beltran, M, Bover, I, Gomez di Laino, A, Lainez, N, Martinez, S, Poveda Velasco, A, Romeo, M, Crouet, H, de Gournay, E, Deplanque, G, Follana, P, Floquet, A, Lanvin, D, Leveque, J, Pujade-Lauraine, E, Raban, N, Resch, B, M Savoye, A, Aletti, G, Giorda, G, Landoni, F, Scaffa, C, Abu, J, Alexander-Sefre, F, Barton, D, Butler-Manuel, S, Clayton, R, Crawford, R, Duncan, T, El-Ghobashy, A, Fotopoulou, C, Hall, M, Intrivici, C, Lawrence, A, Luesley, D, Naik, R, Nordin, A, Tidy, J, Fokdahl, L, Hofsjö, A, Kjolhede, P, Eyjolfsdottir, B, Y Dai, Z, Zhang, P, Aminossadati, B, Hahmann, M, Nasemann, C, Yahiaoui, S, Wittenberg, M, Schade-Brittinger, C, Elser, G, Reddig, D, Kuncke, M, Polleis, S, Mattukat, Y, Riha, A, Berger, R, de Roover, J, Kaur, B, Crook, J, Nepote, F, Votan, B, Andriamamonjy, M, Bryce, J, and Ristinge, S

Subjects
EPITHELIAL OVARIAN, Oncology, medicine.medical_specialty, BEVACIZUMAB, MULTICENTER, Antineoplastic Agents, PACLITAXEL, Systemic therapy, law.invention, Antineoplastic Agent, Randomized controlled trial, law, Internal medicine, Humans, Medicine, RECURRENT, Proportional Hazards Models, Aged, Ovarian Neoplasms, SECONDARY CYTOREDUCTION, business.industry, Ovarian Neoplasm, Antineoplastic Agents/therapeutic use, Obstetrics and Gynecology, Ovarian Neoplasms/drug therapy, Cytoreduction Surgical Procedures, General Medicine, CHEMOTHERAPY, Middle Aged, OPEN-LABEL, medicine.disease, Survival Analysis, Combined Modality Therapy, Neoplasm Recurrence, Local/drug therapy, Recurrent Ovarian Cancer, Proportional Hazards Model, Quality of Life, Female, Survival Analysi, Neoplasm Recurrence, Local, business, Cytoreductive surgery, Ovarian cancer, Human
Abstract

BACKGROUND: Treatment for patients with recurrent ovarian cancer has been mainly based on systemic therapy. The role of secondary cytoreductive surgery is unclear. METHODS: We randomly assigned patients with recurrent ovarian cancer who had a first relapse after a platinum-free interval (an interval during which no platinum-based chemotherapy was used) of 6 months or more to undergo secondary cytoreductive surgery and then receive platinum-based chemotherapy or to receive platinum-based chemotherapy alone. Patients were eligible if they presented with a positive Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) score, defined as an Eastern Cooperative Oncology Group performance-status score of 0 (on a 5-point scale, with higher scores indicating greater disability), ascites of less than 500 ml, and complete resection at initial surgery. A positive AGO score is used to identify patients in whom a complete resection might be achieved. The primary end point was overall survival. We also assessed quality of life and prognostic factors for survival. RESULTS: A total of 407 patients underwent randomization: 206 were assigned to cytoreductive surgery and chemotherapy, and 201 to chemotherapy alone. A complete resection was achieved in 75.5% of the patients in the surgery group who underwent the procedure. The median overall survival was 53.7 months in the surgery group and 46.0 months in the no-surgery group (hazard ratio for death, 0.75; 95% confidence interval, 0.59 to 0.96; P = 0.02). Patients with a complete resection had the most favorable outcome, with a median overall survival of 61.9 months. A benefit from surgery was seen in all analyses in subgroups according to prognostic factors. Quality-of-life measures through 1 year of follow-up did not differ between the two groups, and we observed no perioperative mortality within 30 days after surgery. CONCLUSIONS: In women with recurrent ovarian cancer, cytoreductive surgery followed by chemotherapy resulted in longer overall survival than chemotherapy alone. (Funded by the AGO Study Group and others; DESKTOP III ClinicalTrials.gov number, NCT01166737.).

Published
2021
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2. Phase 2 Placebo-Controlled, Double-Blind Trial of Dasatinib Added to Gemcitabine for Patients with Locally-Advanced Pancreatic Cancer

Author

Lewis C. Strauss, D. Pezet, G. Deplanque, T.R.J. Evans, Edwin P. Rock, Alexander S. Rosemurgy, G. Bodoky, Chester Lin, M. Harrison, Bohuslav Melichar, A. Elekes, Igor Bazin, Peter O'Dwyer, Malcolm J. Moore, E. Van Cutsem, Department of Gastroenterology, Tasmanian Institute of Agriculture (TIA), University of Tasmania (UTAS), Department of computer science and ingineering, Faculty of electrical ingineering, Czech Technical University in Prague, Service Chirurgie Digestive, Centre Hospitalier Universitaire de Clermont-Ferrand, Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte - Clermont Auvergne (M2iSH), Institut National de la Recherche Agronomique (INRA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA)-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne), Unité des Maladies Métaboliques et Micronutriments, INRA Clermont-Ferrand (INRA Clermont), Institut National de la Recherche Agronomique (INRA)-Institut National de la Recherche Agronomique (INRA), University of Tasmania [Hobart, Australia] (UTAS), Faculty of Electrical Engineering [Prague] (FEL CTU), Czech Technical University in Prague (CTU)-Czech Technical University in Prague (CTU), CHU Clermont-Ferrand, Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte (M2iSH), and Institut National de la Recherche Agronomique (INRA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne)

Subjects
0301 basic medicine, Oncology, Adult, Male, medicine.medical_specialty, endocrine system diseases, Dasatinib, Phases of clinical research, Kaplan-Meier Estimate, Placebo, Deoxycytidine, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Pancreatic cancer, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Medicine, Humans, Progression-free survival, ComputingMilieux_MISCELLANEOUS, Aged, Neoplasm Staging, Proportional Hazards Models, Aged, 80 and over, business.industry, Mortality rate, [SDV.BBM.BM]Life Sciences [q-bio]/Biochemistry, Molecular Biology/Molecular biology, Hematology, Middle Aged, medicine.disease, Gemcitabine, [SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology, Confidence interval, 3. Good health, Pancreatic Neoplasms, 030104 developmental biology, Treatment Outcome, 030220 oncology & carcinogenesis, Female, business, medicine.drug, Carcinoma, Pancreatic Ductal
Abstract

Background Pancreatic ductal adenocarcinoma (PDAC) has a high mortality rate with limited treatment options. Gemcitabine provides a marginal survival benefit for patients with advanced PDAC. Dasatinib is a competitive inhibitor of Src kinase, which is overexpressed in PDAC tumors. Dasatinib and gemcitabine were combined in a phase 1 clinical trial where stable disease was achieved in two of eight patients with gemcitabine-refractory PDAC. Patients and methods This placebo-controlled, randomized, double-blind, phase II study compared the combination of gemcitabine plus dasatinib to gemcitabine plus placebo in patients with locally advanced, non-metastatic PDAC. Patients received gemcitabine 1000 mg/m2 (30-min IV infusion) on days 1, 8, 15 of a 28-day cycle combined with either 100 mg oral dasatinib or placebo tablets daily. The primary objective was overall survival (OS), with safety and progression-free survival (PFS) as secondary objectives. Exploratory endpoints included overall response rate, freedom from distant metastasis, pain and fatigue progression and response rate, and CA19-9 response rate. Results There was no statistically significant difference in OS between the two treatment groups (HR = 1.16; 95% confidence interval [CI]: 0.81–1.65; P = 0.5656). Secondary and exploratory endpoint analyses also showed no statistically significant differences. The burden of toxicity was higher in the dasatinib arm. Conclusions Dasatinib failed to show increased OS or PFS in patients with locally advanced PDAC. Alternative combinations or trial designs may show a role for src inhibition in PDAC treatment.

Published
2017
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3. Toxicité pulmonaire des traitements en oncologie

Author

L. Taillade and G. Deplanque

Subjects
Gynecology, medicine.medical_specialty, Oncology, Lung disease, business.industry, Respiratory disease, medicine, Interstitial pneumonia, medicine.disease, business, Interstitial pneumonitis
Abstract

De nombreux agents incluant les substances cytotoxiques et non cytotoxiques peuvent entrainer une toxicite pulmonaire, qui concerne essentiellement le parenchyme et moins frequemment les voies aeriennes, la plevre et la circulation sanguine pulmonaire. Les symptomes induits par la toxicitede ces traitements sont peu specifiques et peuvent etre difficiles a distinguer de ceux provoques par plusieurs pathologies survenant dans ce contexte de cancer en cours de traitement. Ainsi, le diagnostic est essentiellement realiseapres exclusion de toutes les autres causes possibles de pathologie pulmonaire, et repose aussi sur la relation temporelle entre l’exposition du medicament et le debut des symptomes respiratoires. Les signes cliniques et radiologiques de ces traitements refletent en general le processus histopathologique sousjacent et incluent la pneumopathie interstitielle non specifique, les dommages alveolaires diffus, la bronchiolite obliterante avec organisation pneumonique (BOOP), l’œdeme et l’hemorragie alveolaire. De plus, plusieurs de ces traitements alterent les tests fonctionnels respiratoires des patients. La connaissance de l’ensemble de ces signes et des traitements les plus frequemment incrimines peut faciliter le diagnostic et l’initiation d’un traitement approprie. Pneumotox® (www.pneumotox.com) apporte une information regulierement mise a jour sur les pathologies respiratoires iatrogenes.

Published
2007
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4. A Phase I/II Study of Dose-Escalated Ifosfamide plus Carboplatin Combination for Advanced Ovarian Carcinoma

Author

J.P. Bergerat, Brigitte Duclos, Patrick Dufour, G. Deplanque, Raoul Herbrecht, Bruno Lioure, Jean-Emmanuel Kurtz, Anne Laplace, Jean-Marc Limacher, and Cathy Giron

Subjects
Oncology, Cancer Research, Chemotherapy, medicine.medical_specialty, Advanced ovarian cancer, Ifosfamide, business.industry, medicine.medical_treatment, Hematology, Carboplatin, chemistry.chemical_compound, Phase i ii, chemistry, Internal medicine, Ovarian carcinoma, Medicine, Fatal disease, business, medicine.drug
Abstract

Summary Background: Advanced ovarian cancer is often a fatal disease, despite good initial response to chemotherapy. Dose-intense schedules have been reported, but faile

Published
1999
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5. Bevacizumab plus chemotherapy continued beyond first progression in patients with metastatic colorectal cancer previously treated with bevacizumab plus chemotherapy : ML18147 study KRAS subgroup findings

Author

S. Kubicka, R. Greil, T. André, J. Bennouna, J. Sastre, E. Van Cutsem, R. von Moos, P. Österlund, I. Reyes-Rivera, T. Müller, M. Makrutzki, D. Arnold, J. Andel, P. Balcke, B. Benedicic, W. Eisterer, M. Fridrik, B. Jagdt, F. Keil, A. Kretschmer, P. Krippl, H. Oexle, M. Pecherstorfer, H. Samonigg, M. Schmid, J. Thaler, C. Tinchon, H. Weiss, J. Arts, M. De Man, G. Demolin, J. Janssens, M. Polus, B. Benczikova, B. Melichar, J. Prausova, P. Vitek, F.Z. Andersen, B.B. Jensen, N. Keldsen, K. Østerlind, K. Vistisen, A. Elme, A. Magi, K. Ojamaa, R. Ristamäki, T. Salminen, M. Ben Abdelghani, O. Bouche, C. Borg, K. Bouhier-Leporrier, G. Breysacher, L. Chone, M.-C. Clavero Fabri, G. Deplanque, F. Desseigne, L.-M. Dourthe, J. Ezenfis, R. Faroux, E. François, C. Garnier, M.-H. Gaspard, M. Hebbar, J.F. Illory, M.-C. Kaminsky, T. Lecomte, J.-L. Legoux, B. Levache, C. Lobry, J.-P. Lotz, M. Mabro, S. Manet-Lacombe, S. Manfredi, T. Matysiak Budnik, L. Miglianico, L. Mineur, I. Moullet, H. Naman, P. Nouyrigat, S. Oziel-Taieb, H. Perrier, D. Pezet, J. Philip, V. Pottier, M. Porneuf, M. Ramdani, D. Re, Y. Rinaldi, D. Spaeth, J. Taieb, E. Terrebonne, P. Texereau, A. Thirot Bidault, C. Tournigand, N. Tubiana-Mathieu, J.-M. Vantelon, F. Viret, M. Ychou, M. Bangerter, M.E. Bertram, B. Bohnsteen, L. Brinkmann, K. Caca, C. Constantin, H.-J. Cordes, G. Dietrich, J. Eggert, E. Engel, J. Fahlke, H. Fensterer, A. Florschütz, G. Folprecht, H. Forstbauer, W. Freier, M. Freund, N. Frickhofen, E. Gäbele, M. Geißler, F. Gieseler, T. Göhler, U. Graeven, M. Groschek, M. Grundeis, U. Hacker, V. Hagen, H.F. Hebart, S. Hegewisch-Becker, M. Heike, T. Herrmann, B. Hildebrandt, H.-G. Höffkes, G. Hübner, J. Hübner, E. Kettner, M. Kneba, J.W. Kohnke, G. Kojouharoff, C. König, A. Kretzschmar, H. Kröning, K. Kürner, F. Lammert, C. Lerchenmüller, A. Lück, J. Meiler, H.-G. Mergenthaler, L. Müller, C. Müller-Naendrup, A. Nusch, J. Papke, R. Porschen, J. Rädle, C. Reddemann, K. Ridwelski, J. Riera-Knorrenschild, J. Rudi, A. Schmalenberger, C.-C. Schimanski, F. Schlegel, C. Schlichting, P. Schmidt, W. Schmiegel, S. Schmitz, H. Schulze-Bergkamen, I. Schwaner, A. Schwarzer, M. Schwerdtfeger, J. Selbach, M. Sieber, J. Siebler, P. Staib, M. Stauch, C.-C. Steffens, P. Stübs, J. Tischendorf, T. Trarbach, D. Tummes, A.-R. Valdix, A. Vogel, G.P.L. Von Wichert, M. Walther, W. Welslau, G. Wilhelm, H. Wobster, T. Wolf, N. Zeigenhagen, B. Zomorodbaksch, E. Batman, H.J. Bloemendal, D.F.S. Kehrer, T. Guren, G. Indrebø, C. Kersten, H. Soerbye, M. Fragoso, R. Fragoso, J.C. Mellidez, A. Sa, A. Aljobran, T. Darwish, V. Alonso-Orduna, J. Aparicio, E. Aranda, C. Bosch, A. Galan-Brotons, I. Busquier Hernandez, J.C. Camara, J.M. Campos Cervera, C. Carlos Garcia Giron, P.M. Del Prado, O. Donnay, P. Escudero, E. Falco, J. Gallego Plazas, P. Garcia Alfonso, E. Gonzalez Flores, C. Gravalos, R. Guardeno, A. Juárez, A. Lopez Ladron, F. Losa Gaspa, J. MªVicent Vergé, E. Marcuello Gaspar, B. Massuti Sureda, J. Molina, I.C. Montero, A.L. Muñoa, M.B. Naranjo, M.J. Oruezabal Moreno, V. Pachón Olmos, C. Pericay, J.J. Reina Zoilo, F. Rivera, A. Ruiz Casado, M.J. Safont, A. Salud Salvia, M. Tobena, J.C. Toral, V. Valenti, M. Valladares Ayerbes, J.M. Vieitez, R. Vera, A. Berglund, E. Fernebro, V. Hess-Umbricht, M. Pless, R. Popescu, R. Winterhalder, and Trarbach, Tanja (Beitragende*r)

Subjects
Adult, Male, Vascular Endothelial Growth Factor A, Oncology, medicine.medical_specialty, Survival, Bevacizumab, Colorectal cancer, medicine.medical_treatment, Medizin, Antibodies, Monoclonal, Humanized, medicine.disease_cause, Disease-Free Survival, Proto-Oncogene Proteins p21(ras), Capecitabine, Young Adult, Proto-Oncogene Proteins, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, medicine, Humans, Prospective Studies, Neoplasm Metastasis, neoplasms, Aged, Aged, 80 and over, Chemotherapy, business.industry, Hematology, Middle Aged, medicine.disease, Chemotherapy regimen, digestive system diseases, Oxaliplatin, Surgery, Treatment Outcome, Fluorouracil, ras Proteins, Female, KRAS, Colorectal Neoplasms, business, medicine.drug
Abstract

ML18147 evaluated continued bevacizumab with second-line chemotherapy for patients with metastatic colorectal cancer (mCRC) progressing after the standard first-line bevacizumab-containing therapy.Evaluating outcomes according to tumor Kirsten rat sarcoma virus oncogene (KRAS) status was an exploratory analysis. KRAS data were collected from local laboratories (using their established methods) and/or from a central laboratory (mutation-specific Scorpion amplification-refractory mutation system). No adjustment was made for multiplicity; analyses were not powered to detect statistically significant differences.Of 820 patients, 616 (75%) had unambiguous KRAS data; 316 (51%) had KRAS wild-type tumors and 300 (49%) had mutant KRAS tumors. The median progression-free survival (PFS) was 6.4 months for bevacizumab plus chemotherapy and 4.5 months for chemotherapy [P0.0001; HR = 0.61; 95% confidence interval (CI): 0.49-0.77] for wild-type KRAS and 5.5 and 4.1 months, respectively (P = 0.0027; HR = 0.70; 95% CI: 0.56-0.89) for mutant KRAS. The median overall survival (OS) was 15.4 and 11.1 months, respectively (P = 0.0052; HR = 0.69; 95% CI: 0.53-0.90) for wild-type KRAS and 10.4 versus 10.0 months, respectively (P = 0.4969; HR = 0.92; 95% CI: 0.71-1.18) for mutant KRAS. In both analyses, no treatment interaction by KRAS status was observed (PFS, P = 0.4436; OS, P = 0.1266).Bevacizumab beyond first progression represents an option for patients with mCRC treated with bevacizumab plus standard first-line chemotherapy, independent of KRAS status.

Published
2013

7. A phase II study of a paclitaxel and oxaliplatin combination in platinum-sensitive recurrent advanced ovarian cancer patients

Author

Thierry Petit, Paul-Henri Cottu, A. Yovine, Patrice Viens, J.-P. Lotz, Esteban Cvitkovic, S. V. Belle, G. Deplanque, Remy Delva, P. Bougnoux, and J.-M. Extra

Subjects
Adult, medicine.medical_specialty, Organoplatinum Compounds, Paclitaxel, Gastroenterology, chemistry.chemical_compound, Median follow-up, Recurrence, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Progression-free survival, Aged, Cisplatin, Aged, 80 and over, Ovarian Neoplasms, business.industry, Hematology, Middle Aged, Chemotherapy regimen, Carboplatin, Surgery, Oxaliplatin, Treatment Outcome, Oncology, chemistry, Response Evaluation Criteria in Solid Tumors, Concomitant, Female, business, medicine.drug
Abstract

Purpose A multicentric, phase II study to evaluate the efficacy and safety of the combination paclitaxel and oxaliplatin in patients with platinum-sensitive recurrent ovarian cancer. Patients and methods Patients received 175 mg/m2 paclitaxel (over 3 h) followed by 130 mg/m2 oxaliplatin (over 2 h) every 21 days for up to nine cycles without hydration or primary granulocyte colony-stimulating factor prophylaxis. Patients had to have an Eastern Cooperative Oncology Group performance status of 0–2 and to have received no more than one prior cisplatin- and/or carboplatin-containing chemotherapy regimen with a platinum-progression-free interval ≥6 months. Results Of the 105 patients enrolled and treated, 98 were eligible. An overall response rate of 81% (79 of 98 patients) (95% confidence interval 71% to 88%) was observed according to RECIST criteria (third party reviewed), and 88% (86 of 98) when this was complemented with CA-125 response. With a median follow up of 43.6 months (range 30.2–64.2) the median progression-free survival was 10.2 months (range 0.3–21.4) and the overall survival 32.4 months. Seven hundred and eight cycles were administered (median seven per patient; range one to nine). A total of 67% of patients experienced National Cancer Institute Common Toxicity Criteria grade 3–4 neutropenia, including 8% with concomitant febrile episode, without treatment-related deaths. Ninety-three per cent of patients experienced neuropathy of grade 1 or more, including 25% with cumulative reversible peripheral neuropathy of grade 3–4. Oxaliplatin doses were reduced in 30 patients due to neurotoxicity. Conclusions The oxaliplatin/paclitaxel combination can be administered in an outpatient setting every 3 weeks without specific measures. The high level of activity and its duration observed warrants further evaluation of this combination in pretreated platinum-sensitive advanced ovarian cancer patients.

Published
2006

8. Dose-finding study of weekly 24-h continuous infusion of 5-fluorouracil associated with alternating oxaliplatin or irinotecan in advanced colorectal cancer patients

Author

P. Herait, L. Merad, G. Deplanque, A. Laadem, J. M. Bereder, L. Cals, O. Rixe, D. Bernardini, R. Favre, P. Juin, and Eric Francois

Subjects
Diarrhea, medicine.medical_specialty, Neutropenia, Time Factors, Organoplatinum Compounds, medicine.medical_treatment, Irinotecan, Gastroenterology, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Infusion Pumps, Aged, Chemotherapy, Dose-Response Relationship, Drug, business.industry, Nausea, Hematology, Middle Aged, medicine.disease, Chemotherapy regimen, Surgery, Oxaliplatin, Regimen, Treatment Outcome, Oncology, Camptothecin, Fluorouracil, business, Colorectal Neoplasms, Febrile neutropenia, Progressive disease, medicine.drug
Abstract

Purpose: To determine maximum tolerated dose, safety and efficacy of weekly 24 h infusional 5-fluorouracil (5-FU) combined alternately with oxaliplatin and irinotecan. Patients and methods: Advanced colorectal carcinoma patients in first- or second-line chemotherapy received increasing doses of 5-FU (weekly 24 h continuous intravenous infusion without leucovorin) on days 1, 8, 15 and 22, irinotecan days 1 and 15; and oxaliplatin days 8 and 22, every 35 days. Results: Thirty-four patients received 175 cycles. The median age was 64 years (range 47 – 78). Eighteen per cent of patients had the primary tumor in the rectum, with a median of one disease site (range one to three), and liver involvement in 88% and lung in 38%. Six (18%) patients had chemotherapy for prior advanced disease. The most frequent grade 3 – 4 toxicity was neutropenia (41% of patients), but the regimen was well tolerated clinically, with febrile neutropenia in two patients and grade 4 neutropenia lasting >7 days in one; grade 3 – 4 diarrhea, nausea and vomiting in 6% of patients; grade 3 – 4 peripheral neuropathy in 9% of patients. Seventeen patients had a partial response (50%; 95% confidence interval 33% – 67%), 13 had stable disease and one had progressive disease. Five patients underwent metastatic surgical resection after tumor shrinkage. Median response duration was 14 months (range 4.7– 29.2+) and median time to progression was 11.3 months (range 1.1+ – 30.7+). Conclusions: This combination three-drug regimen is feasible and well tolerated without toxicity overlap. Preliminary antitumor activity compares well with standard double combinations, with an unusually long median time to progression. The recommended dose is 5-FU 3000 mg/m 2 , weekly for 4 weeks, irinotecan 100 mg/m 2 days 1 and 15, oxaliplatin 80 mg/m 2 days 8 and 22. Further assess

Published
2004

9. Comparison of prognostic factors in patients in phase I trials of cytotoxic drugs vs new noncytotoxic agents

Author

Denis C. Talbot, D T Mackintosh, J P Braybrooke, K Samouri, G Deplanque, K Kaur, Adrian L. Harris, Trivadi S. Ganesan, M Taylor, and Cheng Han

Subjects
Adult, Male, Cancer Research, medicine.medical_specialty, Prognostic variable, medicine.medical_treatment, Antineoplastic Agents, Gastroenterology, Disease-Free Survival, Clinical, cytotoxic, Risk Factors, Internal medicine, Neoplasms, Biomarkers, Tumor, Medicine, Humans, noncytotoxic, Survival rate, Aged, Retrospective Studies, Aged, 80 and over, Chemotherapy, Performance status, Clinical Trials, Phase I as Topic, business.industry, Cancer, Retrospective cohort study, Middle Aged, medicine.disease, Prognosis, Surgery, phase one, Clinical trial, Survival Rate, multivariate analysis, Oncology, Toxicity, Female, business
Abstract

The aims of this study were to identify prognostic variables for toxicity and survival in patients with cancer participating in phase I clinical trials and compare characteristics of those treated with cytotoxic chemotherapy (CT) and non-cytotoxic drugs (non-CT). Data were collected from 420 (114 CT, 306 non-CT) patients enrolled in 16 phase I trials (five CT and 11 non-CT trials) in one cancer centre. Analyses of all patients were used to compare treatment groups, identify predictive variables for toxicity and to estimate prognostic factors in overall survival (OS). These were used to develop a prognostic index (PI). Multivariate analysis found those patients with better performance status, fewer sites of metastases, baseline Hb12 g dl(-1) and WBC or LDH in the normal range had significantly better OS. Male gender, platelet count450 x 10(9) l(-1), high WBC or treatment with a non-CT phase I agent significantly reduced the chance of grade 3/4 toxicity. Overall survival was not significantly different between the CT and non-CT groups (260 vs 192 days, P=0.47) except for those with liver metastases (228 vs 137 days, P=0.02). Overall tumour response was 4.9% (95% CI: 2.7-7.0%). The PI identified three distinct patient groups with median survival of 321, 257 and 117 days. In conclusion, entry into a phase I trial of a non-CT drug is a safe option for heavily pretreated patients with cancer. The PI generated from these data can estimate the survival probability for patients entering phase I studies.

Published
2003

11. Paclitaxel-anthracycline combination chemotherapy in relapsing advanced ovarian cancer after platinum-based chemotherapy: a pilot study

Author

Jean-Emmanuel Kurtz, G. Deplanque, Patrick Dufour, Jean-Marc Limacher, Florian Eichler, J.P. Bergerat, Brigitte Duclos, F. Oberling, Raoul Herbrecht, Frédéric Maloisel, and Cathy Giron

Subjects
Oncology, Adult, medicine.medical_specialty, Combination therapy, Anthracycline, Adolescent, Paclitaxel, medicine.medical_treatment, Pilot Projects, Platinum Compounds, Disease-Free Survival, Drug Administration Schedule, chemistry.chemical_compound, Recurrence, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Carcinoma, Humans, Doxorubicin, Aged, Ovarian Neoplasms, Salvage Therapy, Chemotherapy, Antibiotics, Antineoplastic, business.industry, Obstetrics and Gynecology, Combination chemotherapy, Middle Aged, medicine.disease, Surgery, Treatment Outcome, chemistry, Female, business, medicine.drug, Epirubicin
Abstract

Despite high response rates with platinum-based front-line chemotherapy, the prognosis for advanced ovarian carcinoma (AOC) is poor. Salvage chemotherapy for recurrent AOC was of little benefit before paclitaxel as single-agent therapy showed appreciable efficacy. Anthracyclines are effective, but are not often part of first-line therapy. In this pilot study, we investigated the feasibility of an anthracycline plus paclitaxel combination therapy for recurrent AOC. Twenty-four patients received 150 mg/m 2 paclitaxel on day 1, with either 50 mg/m 2 doxorubicin on day 1 or 75 mg/m 2 epirubicin on day 1 every 3 weeks. A 27% overall response rate was obtained. Myelosuppression was the major toxicity, but was manageable. No myocardiac toxicity was observed. We conclude that paclitaxel–anthracyclines is a promising salvage combination therapy in AOC that should be investigated further.

Published
1998

12. OHP-019 Day-1 Call in an Oncology Day Unit: What Improvements?

Author

L Tran, M Cherifi, G Deplanque, Y Bezie, and M Jardin

Subjects
Oncology, Waiting time, medicine.medical_specialty, Medical consultation, business.industry, Workload, Pharmacy, Unit (housing), Patient satisfaction, Production unit, Internal medicine, medicine, General Pharmacology, Toxicology and Pharmaceutics, Medical prescription, business
Abstract

Background The preparation in advance of anticancer drugs can decrease the waiting time of patients in oncology day units. Purpose To establish a system of phoning patients before their session (D-1 call) to cheque their availability. A year after its deployment, we evaluated the impact of this plan. Materials and Methods The oncologist and a nurse call patients one day before their appointment. The prescriptions are validated when the patient’s condition permits it in the light of the patient’s biological assessment, done in an outside medical analysis laboratory, and an interview using a standardised questionnaire. After pharmaceutical validation, anticancer drugs are prepared in the afternoon for the next day. Indicators of routine monitoring were defined. Results A median of 13 patients with 23 planned day-hospital appointments were called the day before their appointment. An oncologist validated the treatment of 45% of the patients on D-1 and 95% of the cancer treatments were delivered on D1 before 9:00 am. The total time the patients spent in the unit was reduced from 273 minutes to 242 minutes after our plan was adopted. The average time between the end of the medical consultation and the start of the treatment went down from 79 minutes before the D-1 call to 52 minutes. In addition, 2/3 of patients received the treatment only 30 minutes after seeing their doctor. Finally, fewer than 2% of anticipated preparations were not administered. Conclusions The D-1 call requires significant effort, but it enables us to improve the organisation of care in the oncology day unit and the preparation of the anticancer drugs by the pharmacy’s production unit. The workload is more even throughout the day and is not stressful for the staff. All of this contributes to making the system safer. We are hoping to extend the D-1 call to the oncology week unit and evaluate patient satisfaction. No conflict of interest.

Published
2013
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13. 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
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14. Survival Analysis of a Randomized Phase III Trial Comparing Androgen Deprivation Therapy (ADT) Plus Docetaxel Versus ADT Alone in Hormone-Sensitive Metastatic Prostate Cancer (GETUG-AFU 15/0403)

Author

S. Xiong, J. D. Wesley, F. Rolland, S. Chan, Bradley C. Carthon, L. G. Garcia, M. Fenner, Linda Sharp, Frank Priou, R. Morales-Barrera, W. Gerritsen, Bernhard J. Eigl, M. Tod, A.J.M. van den Eertwegh, Lawrence Fong, D. Baertschi, Arnoud J. Templeton, J.N. Graff, J. Morote, C. G. O'Bryan-Tear, Mert Basaran, S. Dixit, L. Mourey, J.P. Fusco, James B. Trager, C. Arbayo, Z. Peng, E. Solsona, D. D. Tsao-Wei, David P. Dearnaley, M. Hirmand, G. Procopio, M. Hancock, E. Verzoni, Eric Winquist, L. Shen, A. Sella, R. Tang, E. Ileana, J. A. Rinck, J.-G. Judde, B. Mellado, J. Simko, Martin E. Gleave, A. G. Caamano, Maha Hussain, Shaw Ling Wang, V. Ortega, L. Nicacio, Omar Esteban Carranza, D. G. Power, Frances P. Stewart, L. Bourre, Lawrence Karsh, B. Bennett, R. van Gool, S. Moran, M. Schulze, G. C. Cedermark, B. Esterni, Sophie D. Fosså, R. N. Dass, Guru Sonpavde, Anthony M. Joshua, B. A. Blumenstein, Christophe Massard, Andre Deeke Sasse, C. Suarez, D. Hawes, M. Marin-Aguilera, J. Lackey, M. Sharma, V. Pasov, J. T. Dalton, G. Velasco, G. Liu, J. Li, M. I. Murdock, D. Rathkopf, P. Vrignaud, R. Strebel, F. de Braud, Karim Fizazi, P. Raina, Linda Zinoli, V. De Angelis, A. J. Lloyd, B. Laguerre, S. Hitier, F. Vazquez, L. Zubiri, G. Maier, H. Lannert, M. A. Johnston, Stéphane Oudard, S.J. Hotte, X. Zhou, Nancy A. Dawson, Michael E. Cox, S. Donegani, M. Sisani, Jeffrey R. Gingrich, J. M. Ferrero, C. Papandreou, J. B. Whitmore, R. Sands, Q. Wang, Matthew R. Smith, C. Theodore, P. Perrin, P. M. Hoff, C. S.-L. Thibault, J.S. de Bono, J. Droz, Steinbjørn Hansen, M. A. Morgan, John M. Corman, P. Tryon, M. Climent, S. Berry, C. W. M. Reuter, A. Ozcimen, G. De Castro, T. Sella, G. Geiges, I. Kocak, U. Anido, Y. Hao, N. Bedini, Tanya B. Dorff, María E. Zudaire, David Smith, S. Li, Mansoor N. Saleh, M. Junqueira, I. Krakowski, Nadeem A. Sheikh, G. Sanchez-Olle, Raymond S. McDermott, G. Deplanque, Marianna de Camargo Cancela, L. Bellardita, W. Ye, R. Valdagni, J. Pinski, Nina Tunariu, C. Cavaliere, T. Devries, Silke Gillessen, Vasileios J. Assikis, Christopher J. Logothetis, K. Staudacher, A. Bahl, G. Chodak, R. Wei, Pasquale Rescigno, T. Shahid, M. Taplin, L. Ahrlund-Richter, Chadi Nabhan, N. Batista, Simon J. Hall, A. Heidenreich, Deborah Mukherji, Kim N. Chi, S. Zanetta, Ethan Basch, C. Kim, M. Haggman, Kurt Miller, S. Crowe, L. G. Fonseca, M. Nister, V. Grunwald, David I. Quinn, P. Cabrera, J. Wong, Peter F.A. Mulders, Noah M. Hahn, E. Levesque, W. Liu, Chris Parker, I. Gil-Aldea, I. Testa, Shahneen Sandhu, F. Ricci, N. Sacks, J. E. Brown, Eric J. Small, A. Ganser, C. Pezaro, S. Boccardo, E. Small, C. V. Morales, R. P. Taylor, Przemyslaw Twardowski, W. R. Clark, L. M. A. Aparicio, David Olmos, D. E. Castellano, Phillip Parente, R. Delva, A. Sanchez, Michael L. Meyers, A. Ruffion, P. Gascon, J. R. Gingerich, U. Harmenberg, D. Pouessel, Joshi J. Alumkal, L. Reyno, M. Spencer, S. Neibart, C. Korn, M. Habibian, Hazem I. Assi, J. Sarantopoulos, J. Charpentier, J. Squire, Christian Rothermundt, J. Versluis, G. Liskovsky, Saskia J. A. M. Santegoets, Maria Jose Lechuga, A. Hamzaj, E. Arevalo, Andrew J. Armstrong, Steven M. Larson, V. Naini, F. Kueppers, H. Ozen, R. Barroso-Sousa, C.J. Amling, Andrea L. Harzstark, L. Puglia, S. Bracarda, S. Le Moulec, S. Hubay, S. V. Liu, A. Horchani, L. Lui, F. Joly Lobbedez, S. Del Buono, S. Basu, N. Tiftik, D. Nicolle, P. de Souza, G. Freyer, T. Magnani, E. Benaim, E. Y. Yu, V. Yvonnet, N. Rozumna-Martynyuk, S. Salvi, P. Samper, M. S. N. M. Sharial, R. Salvioni, J. G. Gandhi, O. Terekhov, Elizabeth Eisenhauer, G. Gravis, I. Bodrogi, J. Lin, I. N. Boyko, B. Zhang, Patricia Martin, S. Kovel, Eleni Efstathiou, A. Cross, S. Villa, Cora N. Sternberg, Vivian Weinberg, M. Soulie, J. Zou, M. Wilbaux, David B. Agus, Yohann Loriot, C. Goessl, A. Stam, I. De Torres, D. W. Davis, M. Hjelm-Eriksson, P. Federico, J. E. Garcia-Vargas, M. Gedamke, Philip W. Kantoff, A. Petremolo, F. Marrocolo, B. Perez-Valderrama, G. Mordenti, X. Maldonado, P. Hamberg, Roberto Pili, M. Doherty, K. Hege, Pier Vitale Nuzzo, Winald R. Gerritsen, D. P. Petrylak, L. Ji, O. A. Sartor, Leonard G. Gomella, Sumanta K. Pal, J. Bruce, Scott North, Mario A. Eisenberger, Robert E. Coleman, Diletta Bianchini, E. Henin, Michael A. Carducci, A. G. Omlin, S. De Placido, A. Liede, J. Good, A. Hartford, Richard Cathomas, Anna C. Ferrari, S. S. Sridhar, Alessandra Rubagotti, A. C. R. Chaves, P. Sieber, L. O. Reis, D. Lin, A. Arican, Y. Zhang, O. Nordle, J. Tito, G. Bhattacharyya, V. Melnikova, N. Aucoin, P. W. Price, Susan Ellard, P. Beuzeboc, K. Noonan, A. A. Ranade, M. W. Frohlich, B. Anand, K. Buyukafsar, William R. Berry, Mitchell S. Steiner, D. Raghavan, Daniel J. George, C. D. L. Piedra, Gregory R. Pond, F. Acosta, A. O. Sartor, A. Yildirim, G. Di Lorenzo, Thomas W. Griffin, P. M. Parikh, Harry Comber, Matthew D. Galsky, A. J. Armstrong, J. M. Fitzpatrick, M. Legrier, J. R. Piulats, Neal D. Shore, Walter M. Stadler, J. Powers, R. J. Amato, S. O'Reilly, G. B. Kanaka, M. Girard, N. Nicolai, D. Maillet, C. Piatek, Robert H. Getzenberg, Dana E. Rathkopf, J. Eymard, E. C. Alvarez, S. Wong, H. Kurt, Elisabeth I. Heath, R. C. Winterhalder, T. Zoubir, A. Tagliapietra, I. N. Hernandez, Oliver Sartor, H. Malhotra, Amir Goldkorn, E. J. Leonard, J. M. Wolff, Ronald F. Tutrone, Charles S. Cleeland, Q. Perez, A. Ulyanov, Christopher Sweeney, Mustafa Ozguroglu, Jolanda Paolini, I. Lowy, Ignacio Gil-Bazo, C. Dzik, Fred Saad, William Oh, L. Skoog, S. Stagni, Emmanuel S. Antonarakis, Maria J. Ribal, C. L. Nourani, E. Chow-Maneval, J-P. Machiels, K. Anderes, Shannon Matheny, T. de La Motte Rouge, A. Ata, Celestia S. Higano, Malcolm David Mason, Heather Haynes, L. Sengelov, M. Poupon, S. Nilsson, K. Jelaca-Maxwell, R. A. Stephenson, Thian Kheoh, Howard I. Scher, S. Groshen, P. Schellhammer, Y. Pawitan, C. Li, C. D'Aniello, A. Olsson, Michael Pollak, T. Harding, I. Latorzeff, Ralph J. Hauke, Arturo Molina, Paul N. Mainwaring, J. J. Lozano, F. McDonnell, B. You, R. B. Sims, P. Carroll, Z. I. Malik, Joan Carles, Ainhoa Castillo, D. T. Castro, M.D. Michaelson, T.D. de Gruijl, Joaquim Bellmunt, N. Houede, Manisha Singh, A. Guillot, A. M. Cassidy, Charles J. Ryan, E. Esteban, M. Truini, Laurence Albiges, C. Buonerba, O. Gunther, G. Forsberg, Bryan Selby, Paul G. Corn, B. A. Wood, J. K. Singh, Michael J. Morris, J. Biswas, M. Gross Goupil, Francesco Boccardo, W. de Schultz, P. Czaykowski, Nicholas J. Vogelzang, M. Y. Teo, P. Afzal, and Gerhardt Attard

Subjects
medicine.medical_specialty, Genitourinary system, business.industry, Standard treatment, Hazard ratio, Urology, Hematology, medicine.disease, Androgen deprivation therapy, Prostate cancer, medicine.anatomical_structure, Oncology, Docetaxel, Prostate, medicine, Clinical endpoint, business, medicine.drug
Abstract

Background Androgen deprivation therapy (ADT) is the standard treatment of hormone-sensitive metastatic prostate cancer (HSMPC). We performed a phase III multicentre trial to compare ADT alone with ADT plus docetaxel (D) in HNMPC. Methods Patients (pts) with HSMPC were randomly assigned to either arm A (ADT + D: 75mg/m q3w, up to 9 cycles) or arm B (ADT). The primary endpoint was overall survival (OS). The planned number of pts was 378 to detect an improvement in OS with a hazard ratio (HR) of 0.62, a power of 80% and an alpha risk of 0.05 (two-sided test). Secondary endpoints were biological progression-free survival (PFS) and clinical PFS. Data on toxicity and quality of life have been previously presented. Results From October 2004 to December 2008, 385pts were included. Baseline characteristics were well balanced between the two arms. Median age was 63 years (43-84), median PSA was 26.4 ng/ml (0.1-11900), Gleason score was ≥ 8 in 57%. Prognostic classification was as follows: good prognosis (49%), intermediate (29%) and poor (22%). The majority of pts had metastases at the time of diagnosis (72%), 28% developed metastases after local treatment failure. Median number of D cycles was 8 (range 0-9). The median follow-up was 50 months (mo) [95%CI: 49-54]. At 6 mo, a higher PSA response (≥ 50%) in arm A (94% vs 85%, p = 0.0096) and a higher PSA progression (≥ 25%) in arm B (10% vs 1%, p = 0.0015) were observed. Biological PFS was significantly longer in arm A: 22.9 vs 12.9 mo, HR; 0.72 [95%CI: 0.57-0.91] (p = 0.005). Clinical PFS was increase in arm A: 23.46 vs 15.44 mo, HR: 0.75 [95CI: 0.59-0.94] (0.015). OS was not significantly different (median: 58.9 mo in arm A and 54.2 mo in arm B, HR: 1.01 [95%CI: 0.75-1.36]. The median OS for each prognostic group was 69.1 [95%CI: 60.9-NR], 46.5 [95%CI: 37.7-NR] and 36.6 [95%CI9: 28.5-58.9] mo respectively in the good, intermediate, and poor prognosis groups (p = 0.001), with no difference between the two arms. At the cut-off time, 65% of pts from the ADT arm had received docetaxel since they developed castrate-resistant prostate cancer. Conclusion Combining docetaxel and ADT improves PFS over ADT alone in pts with HSMPC. However, no difference in OS was observed between the two arms. Disclosure G. Gravis: I have expert testimony to disclose: Sanofi Aventis, uncompensated. K. Fizazi: Participation to advisory boards and speaker for Sanofi-Aventis. F. Joly Lobbedez: advisory board/board of directors position: Sanofi, Roche, Pfizer, Novartis, Ferring; compensated consultant relationship: Roche, Novartis; honoraria: Sanofi, Roche, Pfizer, Novartis, Ferring, Ipsen,Takeda; travel remuneration: ASCO by Novartis, ESMO by Janssen. S. Oudard: I have an advisory relationship and honoraria to disclose: Pfizer Oncology, Bayer-Schering Pharma, Hoffman La Roche, Glaxo SmithKline, Novartis Pharma, Sanofi Aventis. D. Pouessel: Consultant role and honoraria: Sanofi, P. Beuzeboc: Presentations: Avantis, All other authors have declared no conflicts of interest.

Published
2012
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15. 430 Dose finding of inecalcitol, a new VDR agonist, in combination with docetaxel–prednisone regimen for castrate-resistant prostate cancer (HRPC) patients (pts)

Author

J. Medioni, T. Maurina, J.M. Rodier, S. Renaux, J-M Ferrero, G. Deplanque, G. Allyon, Eric Raymond, Stéphane Oudard, and J.F. Dufour-Lamartinie

Subjects
Oncology, Agonist, Cancer Research, medicine.medical_specialty, business.industry, medicine.drug_class, Castrate-resistant prostate cancer, Calcitriol receptor, Inecalcitol, Dose finding, Internal medicine, Medicine, Docetaxel-Prednisone Regimen, business
Published
2010
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16. POD-11.01: Dose Finding and Safety Analysis of Inecalcitol in Combination with Docetaxel-Prednisone Regimen in Hormone-Refractory Prostate Cancer (HRPC) Patients (PTS)

Author

G. Deplanque, J. Medioni, J. Allyon, S. Oudard, S. Kalla, J. Ferrero, J.M. Rodier, T. Maurina, E. Raymond, and J.F. Dufour-Lamartinie

Subjects
Oncology, medicine.medical_specialty, business.industry, Urology, medicine.disease, Hormone refractory prostate cancer, Inecalcitol, Prostate cancer, Dose finding, Internal medicine, Docetaxel-Prednisone Regimen, Medicine, Session (computer science), business
Published
2009
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17. 7030 Dose finding and safety analysis of inecalcitol in combination with docetaxel-prednisone regimen in hormone-refractory prostate cancer (HRPC) patients (pts)

Author

J-M Ferrero, Stéphane Oudard, S. Kalla, J. Medioni, T. Maurina, G. Deplanque, J.F. Dufour-Lamartinie, J. Allyon, J.M. Rodier, and Eric Raymond

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Dose finding, business.industry, Internal medicine, medicine, Docetaxel-Prednisone Regimen, business, Hormone refractory prostate cancer, Inecalcitol
Published
2009
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18. Long term follow-up of primary lung cancer permits a high resection rate of second cancers with a curative intent

Author

S. Salmeron, J. M. Vannetzel, J. L. Bizec, J. L. Rebischung, V. Mariani, G. Deplanque, and Y. Gomri

Subjects
Cancer Research, medicine.medical_specialty, medicine.diagnostic_test, Long term follow up, business.industry, General surgery, Second cancer, Physical examination, Retrospective cohort study, Disease, medicine.disease, Surgery, Oncology, Bronchoscopy, Tumor progression, medicine, Lung cancer, business
Abstract

7282 Background: Guidelines for lung cancer follow-up are not clearly established and the interest of such a policy is unclear. Methods: A retrospective study of the clinical charts, X-rays and lab tests results of 218 consecutive patients with a diagnosis of primary lung cancer diagnosed between 1999 and 2003 at our institution were reviewed. At the time of treatment completion all patients underwent complete staging and then entered routine follow-up every 3 months for 1 year, every 6 months the second year and then yearly until 5 years. At each clinic visit patients had full clinical examination, complete blood tests, and CT scans of the chest, upper abdomen and CNS. Bronchoscopy was left at the discretion of the physician in charge of the patient. Each visit was assigned by a multidisciplinary panel a score of no evidence of disease (NED), sustained partial response (OR) or tumor control (SD), tumor progression, or second primary cancer. Non-tumoral events were described accordingly. Results: Median a...

Published
2005
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19. Phase II trial of oxaliplatin (OXA) combined with paclitaxel (P) inplatinum + taxanes sensitive advanced ovarian cancer (AOC) patients: Final results

Author

Patrice Viens, J. S. Van Belle, Jean-Marc Extra, Remy Delva, Paul-Henri Cottu, G. Deplanque, A. Yovine, Philippe Bougnoux, Thierry Petit, and Jean-Pierre Lotz

Subjects
Gynecology, Cancer Research, medicine.medical_specialty, Chemotherapy, Advanced ovarian cancer, business.industry, medicine.medical_treatment, Evaluable Disease, Dose intensity, Gastroenterology, Oxaliplatin, Regimen, chemistry.chemical_compound, Oncology, Paclitaxel, chemistry, Internal medicine, medicine, High activity, business, medicine.drug
Abstract

5023 Background: OXA is active in mismatch repair (MMR) deficient cells, a condition prevalent in pretreated AOC. OXA/P shows high activity in investigator initiated studies (Faivre et al, Ann Oncol 10:1125, 1999). We evaluated efficacy and safety of OXA/P in AOC pts with clinically evaluable disease pretreated with 1 platinum based regimen ± taxanes and a progression-platinum-free interval (PPFI) ≥6 months (mo). Methods: From Dec 99 to Apr 02, 105 pts, 14 centres received P 175 mg/m2, 3h iv followed by OXA 130 mg/m2, 2h iv, every 3 weeks, for up to 9 cycles (cy) without G-CSF. Median (m) age: 58 years (range 37–83), 96% PS 0/1. PPFI: 69 pts >12 mo, 34 pts 6–12 mo; 80 pts (76%) taxane-pretreated. Results: 708 cy administered; m 7 cy/pt (1–9). Relative dose intensity: OXA 0.95, P 0.97. Efficacy: 98 pts eligible, 7 non-eligible (3 bowel occlusion, 3 >1 prior platinum-based chemotherapy, 2 PPFI not determinable). 98 pts evaluable for response (see table) ORR: 81% (95%CI 71–88), all but 3 responses third part...

Published
2004
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20. Phase II trial of oxaliplatin (OXA) combined with paclitaxel (P) as first-line chemotherapy for patients (pts) with advanced ovarian cancer (AOC): Preliminary results

Author

G. Deplanque, Olivier Rixe, A. Goupil, B. Benettaib, E. Levy, Esteban Cvitkovic, and M. Fabbro

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Advanced ovarian cancer, business.industry, Oxaliplatin, First line treatment, chemistry.chemical_compound, Paclitaxel, chemistry, Internal medicine, medicine, First line chemotherapy, business, medicine.drug
Abstract

5075 Background: Despite the introduction of paclitaxel/platinum combinations in first line treatment of AOC, a small proportion of patients fail to respond. This has been linked to genetic or epig...

Published
2004
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