GYOEDU

GOG 114

Phase III Trial of Standard-Dose Intravenous Cisplatin Plus Paclitaxel Versus Moderately High-Dose Carboplatin Followed by Intravenous Paclitaxel and Intraperitoneal Cisplatin in Small-Volume Stage III Ovarian Carcinoma

Date of Publication:

February 15, 2001

Pubmed Link:

https://pubmed.ncbi.nlm.nih.gov/11181662/

Hypothesis:

Is there an advantage of IP cisplatin over IV cisplatin after optimally debulked ovarian cancer?

Control Arm(s):

Cisplatin 75 mg/m2 IV

paclitaxel 135 mg/m2 IV

q3 wkc x6 cycles

Experimental Arm(s):

Carboplatin (AUC 9) IV q4 wks x 2 cycles

Cisplatin 100 mg/m2 IP + paclitaxel 135 mg/m2 IV over 24hrs q3 weeks x 6 cycles

Primary End Point:

Inclusion Criteria:

Epithelial ovarian cancer

Stage III

Optimal debulking

Exclusion Criteria:

Borderline

Prior chemo/radiation

Results:

IP vs IV:

median PFS: 27.9 vs 22.2 months (SS)

median OS: 63.2 vs 52.2 months (p=0.05)

G4 neutropenia: 28% vs 13%

G4 thrombocytopenia: 24% vs 1%

G4 GI: 20% vs 8%

Conclusions:

There is a PFS advantage associated with the use of IP cisplatin compared with IV cisplatin for stage III epithelial ovarian cancer, after optimal debulking.

Reviewer:

Mona Guo, OTF