• J. Clin. Oncol. · Oct 2014

    Randomized Controlled Trial Multicenter Study

    Incorporation of pazopanib in maintenance therapy of ovarian cancer.

    • Andreas du Bois, Anne Floquet, Jae-Weon Kim, Joern Rau, Josep M del Campo, Michael Friedlander, Sandro Pignata, Keiichi Fujiwara, Ignace Vergote, Nicoletta Colombo, Mansoor R Mirza, Bradley J Monk, Rainer Kimmig, Isabelle Ray-Coquard, Rongyu Zang, Ivan Diaz-Padilla, Klaus H Baumann, Marie-Ange Mouret-Reynier, Jae-Hoon Kim, Christian Kurzeder, Anne Lesoin, Paul Vasey, Christian Marth, Ulrich Canzler, Giovanni Scambia, Muneaki Shimada, Paula Calvert, Eric Pujade-Lauraine, Byoung-Gie Kim, Thomas J Herzog, Ionel Mitrica, Carmen Schade-Brittinger, Qiong Wang, Rocco Crescenzo, and Philipp Harter.
    • Andreas du Bois, Rainer Kimmig, Klaus H. Baumann, Christian Kurzeder, Ulrich Canzler, Philipp Harter, AGO Ovarian Cancer Study Group (AGO); Andreas du Bois, Christian Kurzeder, Philipp Harter, Kliniken Essen Mitte; Rainer Kimmig, West German Tumor Center, University of Duisburg-Essen, Essen; Joern Rau, Carmen Schade-Brittinger, Coordinating Center for Clinical Trials, Philipps-University of Marburg; Klaus H. Baumann, University of Marburg, Marburg; Ulrich Canzler, University Hospitals Carl Gustav Carus, Dresden, Germany; Anne Floquet, Isabelle Ray-Coquard, Marie-Ange Mouret-Reynier, Anne Lesoin, Eric Pujade-Lauraine, Groupe d'Investigateurs Nationaux pour l'Étude des Cancers Ovariens; Anne Floquet, Institut Bergonié, Bordeaux; Isabelle Ray-Coquard, Centre Léon Bérard, Lyon; Marie-Ange Mouret-Reynier, Centre Jean Perrin, Clermont-Ferrand; Anne Lesoin, Centre Oscar Lambret, Lille; Eric Pujade-Lauraine, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Paris, France; Jae-Weon Kim, Jae-Hoon Kim, Korean Gynecologic Oncology Group; Jae-Weon Kim, Seoul National University; Jae-Hoon Kim, Yonsei University; Byoung-Gie Kim, Samsung Medical Center, Seoul, Republic of Korea; Josep M. del Campo, Ivan Diaz-Padilla, Spanish Ovarian Cancer Research Group; Josep M. del Campo, Vall d'Hebron University Hospital, Barcelona; Ivan Diaz-Padilla, Centro Integral Oncologico Clara Campal, HM Hospitales, Madrid, Spain; Michael Friedlander, Paul Vasey, Australian and New Zealand Gynecological Oncology Group; Michael Friedlander, The Prince of Wales Clinical School University of New South Wales, Randwick, New South Wales; Paul Vasey, Wesley Medical Centre, Auchenflower, Queensland, Australia; Sandro Pignata, Giovanni Scambia, Multicenter Italian Trials in Ovarian Cancer; Sandro Pignata, Istituto Nazionale Tumori Fondazione G. Pascale, Naples; Nicoletta Colombo, Mario Negri Gynecologic Oncology Group and University of Milan-Bicocca and European Institute of Oncology, Milan
    • J. Clin. Oncol. 2014 Oct 20;32(30):3374-82.

    PurposePazopanib is an oral, multikinase inhibitor of vascular endothelial growth factor receptor (VEGFR) -1/-2/-3, platelet-derived growth factor receptor (PDGFR) -α/-β, and c-Kit. Preclinical and clinical studies support VEGFR and PDGFR as targets for advanced ovarian cancer treatment. This study evaluated the role of pazopanib maintenance therapy in patients with ovarian cancer whose disease did not progress during first-line chemotherapy.Patients And MethodsNine hundred forty patients with histologically confirmed cancer of the ovary, fallopian tube, or peritoneum, International Federation Gynecology Obstetrics (FIGO) stages II-IV, no evidence of progression after primary therapy consisting of surgery and at least five cycles of platinum-taxane chemotherapy were randomized 1:1 to receive pazopanib 800 mg once per day or placebo for up to 24 months. The primary end point was progression-free survival by RECIST 1.0 assessed by the investigators.ResultsMaintenance pazopanib prolonged progression-free survival compared with placebo (hazard ratio [HR], 0.77; 95% CI, 0.64 to 0.91; P = .0021; median, 17.9 v 12.3 months, respectively). Interim survival analysis based on events in 35.6% of the population did not show any significant difference. Grade 3 or 4 adverse events of hypertension (30.8%), neutropenia (9.9%), liver-related toxicity (9.4%), diarrhea (8.2%), fatigue (2.7%), thrombocytopenia (2.5%), and palmar-plantar erythrodysesthesia (1.9%) were significantly higher in the pazopanib arm. Treatment discontinuation related to adverse events was higher among patients treated with pazopanib (33.3%) compared with placebo (5.6%).ConclusionPazopanib maintenance therapy provided a median improvement of 5.6 months (HR, 0.77) in progression-free survival in patients with advanced ovarian cancer who have not progressed after first-line chemotherapy. Overall survival data to this point did not suggest any benefit. Additional analysis should help to identify subgroups of patients in whom improved efficacy may balance toxicity (NCT00866697).© 2014 by American Society of Clinical Oncology.

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