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
- Submitted January 26, 2012; accepted
February 17, 2012; published online
ahead of print at www.jco.org on April
23, 2012. - Supported by Genentech.
- Presented in part at the 47th Annual
Meeting of the American Society of
Clinical Oncology, June 3-7, 2011,
Chicago, IL.
(see actual table for further details; see other tables for adverse/safety event comparisons; )
Histology subtype #'s
Serous 202
Mucinous 1
Endometrioid 16
Transitional cell 2
Clear cell 6
Mixed 5
Other 10
The limitations of OCEANS include a lack of quality-of-life data
and specimen collection for biomarker analysis. The strengths of
OCEANS, however, lie in the robustness of the primary end point,
with strict adherence to RECIST-defined progression and its supportive
IRC analysis, and to the schedule of assessments. The median
increase of 4 months in PFS is well above the frequency of radiologic
reassessments (9 weeks).24,25 TheOCEANS data demonstrate that GC
plus BV followed by BV until progression provides benefit over GC
alone in ROC. OCEANS, GOG 218, and ICON7 represent three
positive phase III trials of BVadded to chemotherapy in the treatment
of ovarian cancer.
