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OCEANS

OCEANS: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Chemotherapy With or Without Bevacizumab in Patients With Platinum-Sensitive Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Date of Publication:

June 10, 2012

Pubmed Link:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3646321/
Hypothesis:

Does the addition of bevacizumab to gemcitabine/carboplatin improve survival in women with recurrent platinum-sensitive ovarian cancer?

Control Arm(s):

Gemcitabine 1,000 mg/m2 Day 1, 8

Carboplatin AUC 4 Day 1

Placebo D1

q21 days x6 cycles (up to 10 allowed)

Continue placebo q21 days until progression or unacceptable toxicity

Experimental Arm(s):

Gemcitabine 1,000 mg/m2 Day 1, 8

Carboplatin AUC 4 Day 1

Bevacizumab 15 mg/kg IV Day 1

Q21 days x6 cycles (up to 10 allowed)

Continue Bevacizumab q21 days until progression or unacceptable toxicity

Primary End Point:

PFS

Inclusion Criteria:

First recurrence of platinum-sensitive ovarian cancer after completion of front-line platinum-based chemo

Measurable disease

Exclusion Criteria:

Prior bevacizumab/VEGF treatment

History of GI perforation or abdominal fistula or current GI obstruction

Major surgery within 28 days

Results:

Bev vs No Bev:

median f/u: 24 mos

Median PFS: 12.4  vs 8.4 mos (SS)

Objective Response Rate: 78.5% vs. 57.4% (SS)

Duration of Response: 10.4 vs 7.4 mos (SS)

median OS: 33.3  vs 35.2 mos (NS)

Hypertension G3+: 17.4% vs 0.4%

Proteinuria G3+: 8.5% vs 0.9%

Conclusions:

Gemcitabine/carboplatin plus bevacizumab followed by bevacizumab maintenance extends PFS compared to gemcitabine/carboplatin alone in platinum-sensitive recurrent ovarian cancer.

Reviewer:
Mona Guo, OTF