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GOG 161

Phase III trial of ifosfamide with or without paclitaxel in advanced uterine carcinosarcoma

Date of Publication:

February 10, 2007

Pubmed Link:
https://www.ncbi.nlm.nih.gov/pubmed/17290061
Hypothesis:

Does addition of Paclitaxel to ifosfamide improve survival in uterine carcinosarcoma?

Control Arm(s):

Ifosfamide 2 g/m2 IV days 1-3

IV or oral Mesna

Experimental Arm(s):

Ifosfamide 1.6 g/m2 IV days 1-3

Paclitaxel 135 mg/m2 by over 3 hrs day 1

IV or oral Mesna

Prophylactic G-CSF started on Day 4

Primary End Point:

OS

Inclusion Criteria:

uterine carcinosarcoma

Stage III or IV, persistent, or recurrent disease not amenable to curative intent by other means

Exclusion Criteria:

Prior chemotherapy

Results:

Ifos/Taxol (n=91) vs Ifos (n=88):

median f/u: 20 mos

Median PFS: 5.8 vs 3.6 mos (SS)

Median OS: 13.5 vs 8.4 mos (SS)

Any Neuropathy: 27% vs 7%

G3/4 Thrombocytopenia: 3% vs 3%

G3/4 neutropenia: 37% vs 47%

Conclusions:

Addition of Paclitaxel to ifosfamide improves OS in women with uterine carcinosarcoma, but with notable toxicities.

Reviewer:
Kevin McCool, OTF