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GOG 107

Phase III Trial of Doxorubicin With or Without Cisplatin in Advanced Endometrial Carcinoma: A Gynecologic Oncology Group Study

Date of Publication:

October 1, 2004

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/15459211/
Hypothesis:

Does the addition of cisplatin to doxorubicin improve response in women with advanced stage or recurrent endometrial cancer?

Control Arm(s):

doxorubicin 60mg/m2 q3 wks

Experimental Arm(s):

doxorubicin 60mg/m2 cisplatin 50mg/m2q3 wks

Primary End Point:

Response rate

Inclusion Criteria:

stage III, IV or recurrence endometrial cancerprior surgery and/or RT (prior hormonal or 1 biologic OK)measurable disease

Exclusion Criteria:

prior chemotherapy

Results:

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)

Conclusions:

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.

Reviewer:
Olga T Filippova