Τίτλος:
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
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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.
Συγγραφείς:
Colombo, N.
Kutarska, E.
Dimopoulos, M.
Bae, D.-S.
Rzepka-Gorska, I.
Bidzinski, M.
Scambia, G.
Engelholm, S.A.
Joly, F.
Weber, D.
El-Hashimy, M.
Li, J.
Souami, F.
Wing, P.
Engelholm, S.
Bamias, A.
Schwartz, P.
Περιοδικό:
Journal of Clinical Oncology
Λέξεις-κλειδιά:
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
DOI:
10.1200/JCO.2011.38.8082
