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GOG 163

Phase III Randomized Trial of Doxorubicin + Cisplatin Versus Doxorubicin + 24-h Paclitaxel + Filgrastim in Endometrial Carcinoma: A Gynecologic Oncology Group Study

Date of Publication:

August 1, 2004

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/15277255/
Hypothesis:

Does doxorubicin/paclitaxel improve response over doxorubicin/cisplatin in women with advanced stage or recurrent endometrial cancer?

Control Arm(s):

doxorubicin 60mg/m2cisplatin 50mg/m2q3wks x7 cycles

Experimental Arm(s):

doxorubicin 50mg/m2paclitaxel 150mg/m2 over 24hrsfilgrastim days 3-12q3wks x7 cycles

Primary End Point:

Objective response rate

Inclusion Criteria:

stage III, IV or recurrent endometrial cancermeasurable diseaseprior RT and/or hormonal treatment OK

Exclusion Criteria:

prior chemotherapy

Results:

doxo/cis (n=157) vs doxo/paclitaxel (n=160):completed 7 cycles: 45% vs 49%grade 4 ganulocytopenia: 54% vs 50%median f/u: 61 mosoverall response: 40% vs 43% (NS)median PFS: 7.2 vs 6 mos (NS)median OS: 12.6 vs 13.6 mos (NS)

Conclusions:

Doxorubicin/paclitaxel is not super to doxorubicin/cisplatin in women with advanced stage or recurrent endometrial cancer.

Reviewer:
Olga T Filippova