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GOG 111

Cyclophosphamide and Cisplatin Compared With Paclitaxel and Cisplatin in Patients With Stage III and Stage IV Ovarian Cancer

Date of Publication:

January 4, 1996

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/7494563
Hypothesis:

Does the addition of paclitaxel to first-line therapy improve survival in incompletely resected stage III and IV ovarian cancer?

Control Arm(s):

Cyclophosphamide 750 mg/m2 IV

Cisplatin 75 mg/m2 IV

q3 weeks x6 cycles

2nd look laparotomy if complete CR or no measurable disease and no interval progression

Experimental Arm(s):

Paclitaxel 135 mg/lm2 IV over 24 hr infusion

Cisplatin 75 mg/m2 IV

q3 weeks x6 cycles

2nd look laparotomy if complete CR or no measurable disease and no interval progression

Primary End Point:

OS and PFS

Inclusion Criteria:

Stage III or IV epithelial ovarian cancer

>1 cm residual

Exclusion Criteria:
Results:

Paclitaxel vs. Cyclophospahmide:

median f/u: 37 mos

median OS: 38 vs. 24 months (SS)

median PFS 18 vs. 13 months (SS)

Complete response: 51% vs. 31% (SS)

2nd look laparotomy showing persistent disease: 59% vs. 76%

Paclitaxel arm had more neutropenia, febrile neutropenia, peripheral neurotoxicity, and alopecia

Conclusions:

Cisplatin/paclitaxel resulted in improved OS, PFS,  and complete response, but more toxicity, in women with suboptimally resected advanced ovarian cancer.

Reviewer:
Stephanie Chow, OTF