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GOG 177

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

Date of Publication:

June 1, 2004

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/15169803/
Hypothesis:

Does the addition of paclitaxel to doxorubicin/cisplatin improve survival in women with chemotherapy-naive advanced stage or recurrent endometrial cancer?

Control Arm(s):

doxorubicin 60mg/m2 day 1cisplatin 50mg/m2 day 1q21 days x7 cycles

Experimental Arm(s):

doxorubicin 45mg/m2 day 1cisplatin 50mg/m2 day 1paclitaxel 160mg/m2 over 3 hrs day 2filgrastim day 3-12q21 days x7 cycles

Primary End Point:

OS

Inclusion Criteria:

stage III or IV or recurrent endometrial cancerany cell type

Exclusion Criteria:

prior chemotherapy

Results:

doxo/cis (n=129) vs doxo/cis/paclitaxel (n=134):more patients in the experimental arm D/C treatment due to toxicitytreatment related deaths: n=0 vs n=5grade 3 neutropenia: 50% vs 35%grade 3 neuropathy: 1% vs 12%response rate: 34% vs 57% (SS)median PFS: 5.3 vs 8.3 mos (SS)median OS: 12.3 vs 15.3 mos (SS)

Conclusions:

The addition of paclitaxel to doxorubicon/cisplatin improves the OS in women with chemotherapy-naive advanced or recurrent endometrial cancer

Reviewer:
Olga T Filippova