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GOG 87L

Fixed-dose rate gemcitabine plus docetaxel as first-line therapy for metastatic uterine leiomyosarcoma

Date of Publication:

February 19, 2008

Pubmed Link:
https://www.ncbi.nlm.nih.gov/pubmed/18534250
Hypothesis:

Are Gemcitabine and Docetaxel active as a first-line regiment for metastatic leiomyosarcoma?

Control Arm(s):
Experimental Arm(s):

Gemcitabine 900 mg/m2 IV days 1-8

Docetaxel 100 mg/m2 IV  day 8

Filgastrim 150 ug/m2 SQ day 9-15 or Pegfilgrastrim 6mg SQ day 9 or 10

q3 wks

Primary End Point:

ORR

Inclusion Criteria:

Advanced, unresectable uterine leiomyosarcoma

Exclusion Criteria:

prior chemotherapy

Results:

Gem/Doce:

ORR 35.8%

Duration of Response: 6 months

Median PFS: 4.4 mos

Median OS: 16+ mos

G3/4 Neutropenia: 17%

G3 Anemia: 24%

G3 Thrombocytopenia: 14.5%

Conclusions:

Gemcitabine with Docetaxel has high objective response rates as first-line therapy in metastatic uterine leiomyosarcoma

Reviewer:
Diana Pearre, OTF