Clinical Care Options - OCEANS: PFS Improvement of 4 Months With the Addition of Bevacizumab to Carboplatin/Gemcitabine in Patients With Platinum-Sensitive Recurrent Ovarian Cancer ASCO 2011

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Clinical Care Options - Oncology CME - OCEANS: PFS Improvement of 4 Months With the Addition of Bevacizumab to Carboplatin/Gemcitabine in Patients With Platinum-Sensitive Recurrent Ovarian Cancer

CCO Independent Conference Coverage of the 2011 American Society of Clinical Oncology Annual Meeting*

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OCEANS: PFS Improvement of 4 Months With the Addition of Bevacizumab to Carboplatin/Gemcitabine in Patients With Platinum-Sensitive Recurrent Ovarian Cancer

Posting Date: June 15, 2011

• OCEANS: randomized, double-blind, placebo-controlled phase III trial^[1]

Summary of Key Conclusions

• Addition of bevacizumab to carboplatin/gemcitabine yielded significant benefits vs carboplatin/gemcitabine alone in patients with platinum-sensitive recurrent ovarian cancer
  • Median PFS improved by 4 months
  • Objective response improved by 21%
  • Median duration of response improved by 3 months
  • Trend toward improved OS
    • Data not yet mature
• Safety profile of bevacizumab plus carboplatin/gemcitabine consistent with previous reports
  • No new safety signals observed
  • No gastrointestinal (GI) perforations reported

Background

• Carboplatin/gemcitabine US Food and Drug Administration approved in 2006 for treatment of platinum-sensitive recurrent ovarian cancer based on improvement in PFS vs carboplatin alone in phase III clinical trial^[2]
• Bevacizumab: humanized anti-VEGF monoclonal antibody
  • Demonstrated single-agent activity in recurrent ovarian cancer^[3,4]
• Current study assessed carboplatin/gemcitabine chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer...............cont'd

Add-on bevacizumab slows progression of recurrent ovarian cancer - - ModernMedicine

Add-on bevacizumab slows progression of recurrent ovarian cancer - - ModernMedicine


(from Reuters) "....Dr. Aghajanian and colleagues note that overall survival data from the trial are not yet available; information on clinicaltrials.gov indicates a predicted study completion date of October 2013.
For now, say the researchers, "The data from OCEANS demonstrate that the addition of BV (bevacizumab) to GC (gemcitabine and carboplatin) can improve outcomes, and ongoing studies will assess whether this ability to add benefit is universal to other platinum-based combinations."
OCEANS is supported by Genentech, which markets bevacizumab as Avastin.

open access: JCO - 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

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.

Table 1. Baseline Patient Demographics and Disease Characteristics: 
(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.