@article{3089197,
    title = "Randomized, open-label, phase III study comparing patupilone (EPO906) with pegylated liposomal doxorubicin in platinum-refractory or -resistant patients with recurrent epithelial ovarian, primary fallopian tube, or primary peritoneal cancer",
    author = "Colombo, N. and Kutarska, E. and Dimopoulos, M. and Bae, D.-S. and Rzepka-Gorska, I. and Bidzinski, M. and Scambia, G. and Engelholm, S.A. and Joly, F. and Weber, D. and El-Hashimy, M. and Li, J. and Souami, F. and Wing, P. and Engelholm, S. and Bamias, A. and Schwartz, P.",
    journal = "Journal of Clinical Oncology",
    year = "2012",
    volume = "30",
    number = "31",
    pages = "3841-3847",
    issn = "0732-183X, 1527-7755",
    doi = "10.1200/JCO.2011.38.8082",
    keywords = "carboplatin;  cisplatin;  cyclophosphamide;  docetaxel;  doxorubicin;  epothilone B;  gemcitabine;  paclitaxel;  platinum derivative;  taxane derivative;  topotecan, abdominal distension;  abdominal pain;  adult;  aged;  anemia;  areflexia;  arthralgia;  article;  asthenia;  backache;  burning sensation;  cancer control;  cancer patient;  constipation;  controlled study;  decreased appetite;  dehydration;  diarrhea;  drug efficacy;  drug safety;  drug withdrawal;  dysesthesia;  dyspnea;  fatigue;  feces incontinence;  female;  fever;  hand foot syndrome;  headache;  human;  hyperesthesia;  hypesthesia;  hypokalemia;  hyporeflexia;  insomnia;  lethargy;  major clinical study;  mononeuropathy;  motor neuropathy;  mouth ulcer;  mucosa inflammation;  multiple cycle treatment;  nausea;  neuralgia;  neurotoxicity;  neutropenia;  ovary cancer;  overall survival;  pain;  paresthesia;  peripheral neuropathy;  peritoneum cancer;  phase 3 clinical trial;  polyneuropathy;  priority journal;  progression free survival;  QT interval;  randomized controlled trial;  rash;  recurrent cancer;  sensorimotor neuropathy;  sensory dysfunction;  sensory neuropathy;  side effect;  stomatitis;  treatment response;  upper abdominal pain;  uterine tube carcinoma;  vomiting;  weight reduction, Adult;  Aged;  Aged, 80 and over;  Antibiotics, Antineoplastic;  Antineoplastic Agents;  Doxorubicin;  Drug Resistance, Neoplasm;  Epothilones;  Fallopian Tube Neoplasms;  Female;  Humans;  Middle Aged;  Neoplasm Recurrence, Local;  Neoplasms, Glandular and Epithelial;  Organoplatinum Compounds;  Ovarian Neoplasms;  Peritoneal Neoplasms;  Polyethylene Glycols;  Treatment Outcome",
    abstract = "Purpose: This study compared the efficacy and safety of patupilone with those of pegylated liposomal doxorubicin (PLD) in patients with platinum-refractory or -resistant epithelial ovarian, primary fallopian tube, or primary peritoneal cancer. Patients and Methods: Patients with three or fewer prior regimens were eligible if they had received first-line taxane/ platinum-based combination chemotherapy and were platinum refractory or resistant. Patients were randomly assigned to receive patupilone (10 mg/m 2 intravenously every 3 weeks) or PLD (50 mg/m2 intravenously every 4 weeks). Results: A total of 829 patients were randomly assigned (patupilone, n = 412; PLD, n = 417). There was no statistically significant difference in overall survival (OS), the primary end point, between the patupilone and PLD arms (P = .195; hazard ratio, 0.93; 95% CI, 0.79 to 1.09), with median OS rates of 13.2 and 12.7 months, respectively. Median progression-free survival was 3.7 months for both arms. The overall response rate (all partial responses) was higher in the patupilone arm than in the PLD arm (15.5% v 7.9%; odds ratio, 2.11; 95% CI, 1.36 to 3.29), although disease control rates were similar (59.5% v 56.3%, respectively). Frequently observed adverse events (AEs) of any grade included diarrhea (85.3%) and peripheral neuropathy (39.3%) in the patupilone arm and mucositis/stomatitis (43%) and hand-foot syndrome (41.8%) in the PLD arm. Conclusion: Patupilone did not demonstrate significant improvement in OS compared with the active control, PLD. No new or unexpected serious AEs were identified. © 2012 by American Society of Clinical Oncology."
}