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Phase II study of cediranib in patients with malignant pleural mesothelioma: SWOG S0509
Linda L Garland1, Kari Chansky, Antoinette J Wozniak
1Arizona Cancer Center, University of Arizona, Tucson, Arizona 85724, USA. lgarland@azcc.arizona.edu
Introduction:
Malignant pleural mesothelioma (MPM) tumors express vascular epithelial growth factor (VEGF) and VEGF receptors. We conducted a phase II study of the oral pan-VEGF receptor tyrosine kinase inhibitor, cediranib, in patients with MPM after platinum-based systemic chemotherapy.
Methods:
Patients with MPM previously treated with a platinum-containing chemotherapy regimen and a performance status 0 to 2 were eligible for enrollment. Cediranib 45 mg/d was administered until progression or unacceptable toxicity. The primary end point was response rate. Tumor measurements were made by RECIST criteria, with a subset analysis conducted using modified RECIST. A two-stage design with an early stopping rule based on response rate was used.
Results:
Fifty-four patients were enrolled. Of 47 evaluable patients, 4 patients (9%) had objective responses, 16 patients (34%) had stable disease, 20 patients (43%) had disease progression, 2 patients (4%) had symptomatic deterioration, and 1 patient (2%) had early death. The most common toxicities were fatigue (64%), diarrhea (64%), and hypertension (70%); 91% of patients required a dose reduction. Median overall survival was 9.5 months, 1-year survival was 36%, and median progression-free survival was 2.6 months.
Conclusion:
Cediranib monotherapy has modest single-agent activity in MPM after platinum-based therapy. However, some patient tumors were highly sensitive to cediranib. This study provides a rationale for further testing of cediranib plus chemotherapy in MPM and highlights the need to identify a predictive biomarker for cediranib.
Insights
Cediranib showed modest activity in malignant pleural mesothelioma (MPM) after chemotherapy. Further research is needed to identify biomarkers for cediranib effectiveness in MPM treatment.
Area of Science:
- Oncology
- Medical Research
Background:
- Malignant pleural mesothelioma (MPM) tumors express vascular epithelial growth factor (VEGF) and VEGF receptors.
- VEGF signaling pathways are implicated in MPM pathogenesis.
Purpose of the Study:
- To evaluate the efficacy and safety of cediranib, an oral pan-VEGF receptor tyrosine kinase inhibitor, as a single agent in patients with MPM.
- To determine the response rate of cediranib in patients with previously treated MPM.
Main Methods:
- A phase II, two-stage study design was employed.
- Eligible patients with MPM received cediranib 45 mg/d until disease progression or unacceptable toxicity.
- Tumor response was assessed using RECIST criteria.
Main Results:
- Of 47 evaluable patients, 9% had objective responses and 34% had stable disease.
- The most frequent toxicities included hypertension (70%), fatigue (64%), and diarrhea (64%).
- Median overall survival was 9.5 months, with a 1-year survival rate of 36%.
Conclusions:
- Cediranib monotherapy demonstrates modest activity in MPM following platinum-based chemotherapy.
- The study suggests potential for cediranib in combination therapy and emphasizes the need for predictive biomarkers.
