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Fader Trastuzumab

Randomized Phase II Trial of Carboplatin-Paclitaxel Versus Carboplatin-Paclitaxel-Trastuzumab in Uterine Serous Carcinomas That Overexpress Human Epidermal Growth Factor Receptor 2/neu

Date of Publication:

March 17, 2018

Pubmed Link:
https://www.ncbi.nlm.nih.gov/pubmed/29584549
Hypothesis:

Does the addition of of trastuzumab to carboplatin/paclitaxel improve PFS in uterine serous cancers?

Control Arm(s):

Carboplatin AUC 5

Paclitaxel 175 mg/m2

q3wks x6 cycles

Experimental Arm(s):

Carboplatin AUC 5

Paclitaxel 175 mg/m2

Trastuzumab 8 mg/kg (first dose) then 6 mg/kg

q3wks x6 cycles  

Primary End Point:

PFS

Inclusion Criteria:

Stage III / IV or recurrent  uterine serous cancer

tumor HER2/neu positivity

Exclusion Criteria:

Treatment free-interval <6 months from last carboplatin-paclitaxel therapy

>3 prior regimens

Prior doxorubicin ≥320 mg/m2

abnormal LV ejection fraction

Results:

Carbo/Taxol + Herceptin vs Carbo/Taxol alone:

median PFS: 12.6 vs. 8 months (SS)

median PFS, stage III/IV: 17.9 vs. 9.3 mos (SS)

median PFS, recurrent disease: 9.2 vs. 6 months (SS)

Toxicity not different between arms

Conclusions:

Adding Trastuzumab to carboplatin-paclitaxel improves PFS and was well-tolerated in women with uterine serous cancer.

Reviewer:
Diana Pearre, OTF