Abstract

5095 Background: To determine the toxicity and efficacy of combination therapy with pegylated liposomal doxorubicin (PLD) and carboplatin in patients with malignant gynecologic tumors. Methods: Patients with recurrent or advanced uterine sarcomas, endometrial, cervical or vaginal cancer or with recurrent platinum-sensitive ovarian cancer were treated with PLD 40mg/m2 and carboplatin AUC 6, q28 over 6 cycles (up to 10 cycles allowed). Primary and secondary endpoints were tolerability and efficacy. Efficacy was measured according to RECIST and/or CA-125 GCIG criteria. Results: 67 pts with recurrent ovarian cancer, 11 pts with uterine sarcomas, 31 pts with endometrial cancer and 31 pts with cervical or vaginal cancer have been recruited (total 140 pts, 87 pts evaluable for response). Grade 3/4 hematologic toxicities occured in 8% for anemia, 14% for thrombocytopenia, 23% for leukopenia, and 25% for neutropenia of whom 2% developed febrile neutropenia. Non-hematologic Grade 3/4 toxicities have been observed in more than 5% of all patients for the following items: asthenia (14%), pain (10%), dyspnea (9%), palmo-plantar-erythema (7%), nausea and vomiting (7%), diarrhea (5%). The median dose intensity was 94% for PLD and 97% for carboplatin. 76% of all non-progressing patients received at least 5 cycles. The overall response rate was 56% in ovarian cancer, 43% in uterine sarcomas, 44% in endometrial cancer, and 14% in cervical and vaginal cancer. Conclusions: PLD/carboplatin was well tolerated, even in pretreated patients. The combination showed remarkable efficacy in patients with uterine sarcomas, endometrial cancer, and ovarian cancer which merits further evaluation. CA 125 response criteria in ovarian cancer are under evaluation and will be presented on ASCO. However, the regimen had limited efficacy in cervical and vaginal cancer. A prospective randomized trial in recurrent ovarian cancer patients comparing carboplatin/PLD with paclitaxel/carboplatin has already been started within the international study group network (AGO-OVAR 2.9; CALYPSO-trial). [Table: see text]

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call

Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.