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/m(2) as a 1-hour infusion every 4 weeks or topotecan 1.5 mg/m(2)/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.
RCT Entities:
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/m(2) as a 1-hour infusion every 4 weeks or topotecan 1.5 mg/m(2)/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.
Authors: Keith C Bible; Prema P Peethambaram; Ann L Oberg; William Maples; David L Groteluschen; Matthew Boente; Jill K Burton; Leigh C Gomez Dahl; Jennifer D Tibodeau; Crescent R Isham; Jacie L Maguire; Viji Shridhar; Andrea K Kukla; Kalli J Voll; Mathew J Mauer; Alexander D Colevas; John Wright; L Austin Doyle; Charles Erlichman Journal: Gynecol Oncol Date: 2012-06-01 Impact factor: 5.482
Authors: Martee L Hensley; Sara Kravetz; Xiaoyu Jia; Alexia Iasonos; William Tew; Lauren Pereira; Paul Sabbatini; Christin Whalen; Carol A Aghajanian; Corinne Zarwan; Suzanne Berlin Journal: Cancer Date: 2011-09-20 Impact factor: 6.860
Authors: S John Weroha; Ann L Oberg; Katie L Allen Ziegler; Shaker R Dakhilm; Kendrith M Rowland; Lynn C Hartmann; Dennis F Moore; Gary L Keeney; Prema P Peethambaram; Paul Haluska Journal: Gynecol Oncol Date: 2011-04-22 Impact factor: 5.482
Authors: Petronella O Witteveen; Koen J C van der Mijn; Maartje Los; Roelien H Kronemeijer; Gerard Groenewegen; Emile E Voest Journal: Neoplasia Date: 2010-11 Impact factor: 5.715