Phase II study of cediranib in patients with Malignant pleural mesothelioma: SWOG S0509

Linda L. Garland, Kari Chansky, Antoinette J. Wozniak, Anne S. Tsao, Shirish M. Gadgeel, Claire F. Verschraegen, Marco A. Dasilva, Mary Redman, David R. Gandara

Research output: Contribution to journalArticle

61 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1938-1945
Number of pages8
JournalJournal of Thoracic Oncology
Volume6
Issue number11
DOIs
StatePublished - Nov 2011

Keywords

  • Angiogenesis inhibitor
  • Phase 2
  • Pleural mesothelioma

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

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    Garland, L. L., Chansky, K., Wozniak, A. J., Tsao, A. S., Gadgeel, S. M., Verschraegen, C. F., Dasilva, M. A., Redman, M., & Gandara, D. R. (2011). Phase II study of cediranib in patients with Malignant pleural mesothelioma: SWOG S0509. Journal of Thoracic Oncology, 6(11), 1938-1945. https://doi.org/10.1097/JTO.0b013e318229586e