Recurrent Epithelial Ovarian Carcinoma: A Randomized Phase III Study of Pegylated Liposomal Doxorubicin Versus Topotecan
Top Cited Papers
- 15 July 2001
- journal article
- clinical trial
- Published by American Society of Clinical Oncology (ASCO) in Journal of Clinical Oncology
- Vol. 19 (14), 3312-3322
- https://doi.org/10.1200/jco.2001.19.14.3312
Abstract
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.Keywords
This publication has 30 references indexed in Scilit:
- Cancer statistics, 2000CA: A Cancer Journal for Clinicians, 2000
- Topotecan in Platinum- and Paclitaxel-Resistant Ovarian CancerGynecologic Oncology, 1997
- Activity of Gemcitabine in Patients with Advanced Ovarian Cancer: Responses Seen Following Platinum and PaclitaxelGynecologic Oncology, 1996
- Cyclophosphamide and Cisplatin Compared with Paclitaxel and Cisplatin in Patients with Stage III and Stage IV Ovarian CancerThe New England Journal of Medicine, 1996
- Comparing Treatments Using Quality-Adjusted Survival: The Q-TWiST MethodThe American Statistician, 1995
- Phase II Study of Gemcitabine (2',2'-Difluorodeoxycytidine) in Previously Treated Ovarian Cancer PatientsJNCI Journal of the National Cancer Institute, 1994
- The European Organization for Research and Treatment of Cancer QLQ-C30: A Quality-of-Life Instrument for Use in International Clinical Trials in OncologyJNCI Journal of the National Cancer Institute, 1993
- Hexamethylmelamine as second-line therapy in platin-resistant ovarian cancerGynecologic Oncology, 1992
- Effect of liposomes on P-glycoprotein function in multidrug resistant cellsBiochemical and Biophysical Research Communications, 1992
- Comparative pharmacokinetic study of adriamycin and 4'epi-adriamycin after their simultaneous intravenous administrationEuropean Journal of Clinical Pharmacology, 1986