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

Editorial :: VIEWPOINT: Randomised controlled trials using invasive ‘placebo’ controls are unethical and should be excluded from Cochrane Reviews - The Cochrane Library

"Placebo controls are frequently used to ‘blind’ participants, trial personnel and outcome assessors to intervention and control in clinical trials. Effective blinding of treatment reduces the risk of performance bias (differences between groups in the care provided apart from the intervention being evaluated) and detection bias (differences between groups in how outcomes are ascertained, diagnosed or verified). A placebo has traditionally been defined as an “inert or innocuous substance”,[1] such as a ‘sugar pill’. However, some randomised controlled trials (RCTs) have been shown to erroneously use the term ‘placebo’ to describe an invasive intervention that exposes participants, allocated to a control group, to risks of serious harm.[2,3] In this context therefore, the term ‘placebo’ describes an invasive intervention which is neither inert nor innocuous.
In a recent study of local anaesthesia RCTs, over half the RCTs used an invasive ‘placebo’ control.[2] The ‘placebo’ interventions mostly involved deep-needle insertion through body tissues with potential damage to nerves, vessels and other structures such as liver and bowel. These interventions exposed control group participants to risks of serious morbidity.[2,3].......

Placebo interventions for all clinical conditions. Cochrane Database Systematic Rev. 2010 Jan 20

Note: includes comments from numerous healthcare professional disciplines