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Murine Model for Non-invasive Imaging to Detect and Monitor Ovarian Cancer Recurrence
Published on: November 2, 2014
A Phase II, open-label study evaluating pazopanib in patients with recurrent ovarian cancer
Michael Friedlander1, Kenneth C Hancock, Danny Rischin
1Prince of Wales Hospital, Randwick, Sydney, Australia. m.friedlander@unsw.edu.au
Objective:
The progression-free and median survival of patients with advanced ovarian cancer has not appreciably improved over the last decade. Novel targeted therapies, particularly antiangiogenic agents, may potentially improve clinical outcomes in patients with ovarian cancer. This phase II, open-label study evaluated oral pazopanib monotherapy in patients with low-volume recurrent ovarian cancer.
Methods:
Patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with complete CA-125 response to initial platinum-based chemotherapy and subsequent elevation of CA-125 to ≥ 42 U/mL (> 2 × ULN) were treated with pazopanib 800 mg once daily until PD or unacceptable toxicity. This Green-Dahlberg study required 2 CA-125 responses in stage I (20 patients) to proceed to stage II (15 patients). The primary endpoint was CA-125 response (≥ 50% decrease from baseline, confirmed ≥ 21 days after initial evaluation).
Results:
Eleven of 36 patients (31%) had a CA-125 response to pazopanib, with median time to response of 29 days and median response duration of 113 days. Overall response rate was 18% in patients with measurable disease at baseline. The most common adverse events leading to discontinuation of study drug were grade 3 ALT (8%) and AST (8%) elevation. Only 1 grade 4 toxicity (peripheral edema) was reported.
Conclusions:
Pazopanib monotherapy was relatively well tolerated, with toxicity similar to other small-molecule, oral angiogenesis inhibitors, and demonstrated promising single-agent activity in patients with recurrent ovarian cancer. Further studies evaluating the potential role of pazopanib in patients with ovarian cancer are ongoing.
Insights
Pazopanib showed promising activity in recurrent ovarian cancer patients, with 31% achieving a CA-125 response. The oral angiogenesis inhibitor was well-tolerated, warranting further investigation.
Area of Science:
- Oncology
- Pharmacology
Background:
- Advanced ovarian cancer outcomes remain poor despite decades of research.
- Targeted therapies, including antiangiogenic agents, offer potential for improved patient outcomes.
- Pazopanib is an oral angiogenesis inhibitor being investigated for ovarian cancer treatment.
Purpose of the Study:
- To evaluate the efficacy and safety of pazopanib monotherapy in patients with recurrent ovarian cancer.
- To determine the CA-125 response rate in patients receiving pazopanib.
- To assess the tolerability of pazopanib in this patient population.
Main Methods:
- A phase II, open-label, Green-Dahlberg study was conducted.
- Patients received pazopanib 800 mg once daily until disease progression or unacceptable toxicity.
- The primary endpoint was CA-125 response, defined as a ≥50% decrease from baseline, confirmed ≥21 days later.
Main Results:
- Eleven of 36 patients (31%) achieved a CA-125 response.
- Median time to response was 29 days, and median response duration was 113 days.
- Common adverse events leading to discontinuation included elevated ALT and AST; toxicity was generally manageable.
Conclusions:
- Pazopanib monotherapy demonstrated promising single-agent activity in recurrent ovarian cancer.
- The drug was relatively well tolerated, with a toxicity profile consistent with other angiogenesis inhibitors.
- Further studies are ongoing to explore pazopanib's role in ovarian cancer treatment.
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