Initial toxicity assessment of ICON6 trial
Author Information
Author(s): Raja F A, Griffin C L, Qian W, Hirte H, Parmar M K, Swart A M, Ledermann J A
Primary Institution: Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute, University College London
Hypothesis
Is the addition of cediranib to chemotherapy safe and beneficial for patients with platinum-sensitive relapsed ovarian cancer?
Conclusion
The addition of cediranib to platinum-based chemotherapy is sufficiently well tolerated to expand the ICON6 trial and progress to stage II.
Supporting Evidence
- Sixty patients were included in the stage I analysis.
- Thirty patients experienced grade 3 or 4 toxicity during chemotherapy.
- Eighty-six percent of patients completed six cycles of chemotherapy.
Takeaway
This study looked at how well a new drug called cediranib works with chemotherapy for women with a specific type of ovarian cancer, and found it was safe enough to keep testing.
Methodology
The ICON6 trial is a 3-arm, double-blind, placebo-controlled randomised trial assessing the safety of cediranib in combination with chemotherapy.
Potential Biases
The trial included a control arm that did not contain cediranib, which may affect the assessment of toxicity.
Limitations
The small sample size may underestimate the toxicity of cediranib in combination with chemotherapy.
Participant Demographics
The median age of participants was 62 years, with 83% having platinum plus paclitaxel as first-line therapy.
Digital Object Identifier (DOI)
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