Journal of Clinical Oncology, Vol 19, Issue 14
(July), 2001: 3312-3322
© 2001 American Society for Clinical Oncology
Recurrent Epithelial Ovarian Carcinoma: A Randomized Phase III Study of Pegylated Liposomal Doxorubicin Versus Topotecan
By Alan N. Gordon,
John T. Fleagle,
David Guthrie,
David E. Parkin,
Martin E. Gore,
Angel J. Lacave
From the Texas Oncology, Professional Association, Dallas, TX; Rocky Mountain Cancer Center, Boulder Valley Oncology, Boulder, CO; Hospital General de Asturias, Oviedo, Spain; Derbyshire Royal Infirmary; Royal Marsden Hospital, London; and and Aberdeen Royal Infirmary, Aberdeen, United Kingdom.
Address reprint requests to Alan N. Gordon, MD, Division of Gynecology, Texas Oncology P.A., 3535 Worth St, Suite S-200, Dallas, TX 75246; email: alan.gordon{at}usoncology.com
PURPOSE: To compare the efficacy and safety of pegylated liposomal doxorubicin (PLD) and topotecan in patients with epithelial ovarian carcinoma that recurred after or didn’t respond to first-line, platinum-based chemotherapy.
PATIENTS AND METHODS: Patients with measurable and assessable disease were randomized to receive either PLD 50 mg/m2 as a 1-hour infusion every 4 weeks or topotecan 1.5 mg/m2/d for 5 consecutive days every 3 weeks. Patients were stratified prospectively for platinum sensitivity and for the presence or absence of bulky disease.
RESULTS: A total of 474 patients were treated (239 PLD and 235 topotecan). They comprised the intent-to-treat population. The overall progression-free survival rates were similar between the two arms (P = .095). The overall response rates for PLD and topotecan were 19.7% and 17.0%, respectively (P = .390). Median overall survival times were 60 weeks for PLD and 56.7 weeks for topotecan. Data analyzed in platinum-sensitive patients demonstrated a statistically significant benefit from PLD for progression-free survival (P = .037), with medians of 28.9 for PLD versus 23.3 weeks for topotecan. For overall survival, PLD was significantly superior to topotecan (P = .008), with a median of 108 weeks versus 71.1 weeks. The platinum-refractory subgroup demonstrated a nonstatistically significant survival trend in favor of topotecan (P = .455). Severe hematologic toxicity was more common with topotecan and was more likely to be associated with dosage modification, or growth factor or blood product utilization.
CONCLUSION: The comparable efficacy, favorable safety profile, and convenient dosing support the role of PLD as a valuable treatment option in this patient population.
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D. S. Dizon, M. L. Hensley, E. A. Poynor, P. Sabbatini, C. Aghajanian, A. Hummer, E. Venkatraman, and D. R. Spriggs
Retrospective Analysis of Carboplatin and Paclitaxel as Initial Second-Line Therapy for Recurrent Epithelial Ovarian Carcinoma: Application Toward a Dynamic Disease State Model of Ovarian Cancer
J. Clin. Oncol.,
March 1, 2002;
20(5):
1238 - 1247.
[Abstract]
[Full Text]
[PDF]
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