Phase III Trial of Doxorubicin With or Without Cisplatin in Advanced Endometrial Carcinoma: A Gynecologic Oncology Group Study
October 1, 2004
Does the addition of cisplatin to doxorubicin improve response in women with advanced stage or recurrent endometrial cancer?
doxorubicin 60mg/m2 q3 wks
doxorubicin 60mg/m2 cisplatin 50mg/m2q3 wks
stage III, IV or recurrence endometrial cancerprior surgery and/or RT (prior hormonal or 1 biologic OK)measurable disease
doxorubicin (n=150) vs doxorubicin/cis (n=131):65% had prior RTgrade 3/4 leukopenia: 40% vs 62%grade 3/4 thrombocytopenia: 2% vs 14%grade 34/ anemia: 4% vs 22%grade 3/4 nausea/vomiting: 3% vs 13%RR: 25% vs 42% (SS)median PFS: 3.8 vs 5.7 mos (SS)median OS: 9.2 vs 9 mos (NS)
Addition of cisplatin to doxorubicin improves the response rate for women with advanced stage or recurrent endometrial cancer, yet adds toxicity. PFS, but not OS, are also improved.