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A phase 2 randomised discontinuation trial of cabozantinib in patients with ovarian carcinoma
Ignace B Vergote1, David C Smith2, Raanan Berger3
1Division of Gynaecological Oncology, University Hospital Leuven, European Union, Leuven, Belgium.
Background:
Cabozantinib (XL184), an orally bioavailable inhibitor of vascular endothelial growth factor receptor 2 and MET, was assessed in a cohort of ovarian carcinoma patients as part of a phase 2 randomised discontinuation trial (RDT) with cohorts from nine different tumour types.
Patients And Methods:
Patients received 100-mg cabozantinib daily. Those with stable disease (SD) per Response Evaluation Criteria in Solid Tumors at week 12 were randomised to cabozantinib or placebo. Primary end-points were objective response rate (ORR) at week 12 and progression-free survival (PFS) after random assignment.
Results:
Seventy patients with ovarian carcinoma, 50% of whom were platinum refractory/resistant, were enrolled in this RDT. Median PFS from day 1 was 5.5 months for all patients. The ORR at week 12 was 21%; one patient achieved a complete response (CR), and 14 patients (20%) achieved a confirmed partial response (PR). The overall disease control rate (CR + PR + SD) at week 12 was 50%. Throughout the study, 70% of the patients with ≥1 postbaseline scan had tumour regression, and randomisation was discontinued early. For patients with SD randomised to cabozantinib, PFS was 5.9 months after randomisation. The most common grade 3/4 adverse events were diarrhoea (14%), palmar-plantar erythrodysesthesia syndrome (6%), asthenia (6%), hypertension (6%) and neutropenia (6%). Dose reductions were required in 37% of the patients during the first 12 weeks.
Conclusion:
Cabozantinib demonstrates clinical activity, with acceptable toxicities, in patients with ovarian carcinoma based on ORR and regression of tumour target lesions.
Registration:
This trial is registered at ClinicalTrial.gov (NCT00940225).
Insights
Cabozantinib showed clinical activity in ovarian cancer patients, with a 21% objective response rate and tumor regression in 70%. This targeted therapy demonstrated acceptable toxicity in the phase 2 trial.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Cabozantinib (XL184) is an oral inhibitor targeting VEGFR2 and MET.
- The study assessed cabozantinib in ovarian carcinoma patients within a phase 2 randomized discontinuation trial (RDT).
Purpose of the Study:
- To evaluate the clinical activity and safety of cabozantinib in ovarian carcinoma.
- To determine the objective response rate (ORR) and progression-free survival (PFS) after randomization.
Main Methods:
- A phase 2 RDT involving 70 ovarian carcinoma patients, with 50% platinum refractory/resistant.
- Patients received 100 mg of cabozantinib daily; those with stable disease at week 12 were randomized to cabozantinib or placebo.
Main Results:
- Median PFS from day 1 was 5.5 months. ORR at week 12 was 21% (1 CR, 14 PR).
- Overall disease control rate was 50%. 70% of patients with post-baseline scans showed tumor regression.
- Common grade 3/4 adverse events included diarrhea (14%) and palmar-plantar erythrodysesthesia (6%).
Conclusions:
- Cabozantinib exhibits clinical activity in ovarian carcinoma patients.
- The drug demonstrates acceptable toxicity, with observed tumor regression and response rates.
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