Skip Navigation LinksHome > December 2013 - Volume 8 - Issue 12 > An Open-Label, Multicenter, Randomized, Phase II Study of Pa...
Journal of Thoracic Oncology:
doi: 10.1097/JTO.0000000000000005
Original Articles

An Open-Label, Multicenter, Randomized, Phase II Study of Pazopanib in Combination with Pemetrexed in First-Line Treatment of Patients with Advanced-Stage Non–Small-Cell Lung Cancer

Scagliotti, Giorgio V. MD, PhD*; Felip, Enriqueta MD; Besse, Benjamin MD, PhD; von Pawel, Joachim MD§; Mellemgaard, Anders MD, PhD; Reck, Martin MD, PhD; Bosquee, Lionel MD#; Chouaid, Christos MD, PhD**; Lianes-Barragán, Pilar MD, PhD††; Paul, Elaine M. PhD‡‡; Ruiz-Soto, Rodrigo MD‡‡; Sigal, Entisar MPH‡‡; Ottesen, Lone H. MD, PhD‡‡; LeChevalier, Thierry MD

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Abstract

Introduction:

This randomized open-label phase II study evaluated the efficacy, safety, and tolerability of pazopanib in combination with pemetrexed compared with the standard cisplatin/pemetrexed doublet in patients with previously untreated, advanced, nonsquamous non–small-cell lung cancer.

Methods:

Patients were randomized (2:1 ratio) to receive pemetrexed 500 mg/m2 intravenously once every 3 weeks plus either oral pazopanib 800 mg daily or cisplatin 75 mg/m2 intravenously once every 3 weeks up to six cycles. All patients received folic acid, vitamin B12, and steroid prophylaxis. The primary endpoint was progression-free survival (PFS).

Results:

The study was terminated after 106 of 150 patients were randomized due to a higher incidence of adverse events leading to withdrawal from the study and severe and fatal adverse events in the pazopanib/pemetrexed arm than in the cisplatin/pemetrexed arm. At the time enrolment was discontinued, there were three fatal adverse events in the pazopanib/pemetrexed arm, including ileus, tumor embolism, and bronchopneumonia/sepsis. Treatment with pazopanib/pemetrexed was discontinued resulting in more PFS data censored for patients in the pazopanib/pemetrexed arm than those in the cisplatin/pemetrexed arm. There was no statistically significant difference between the pazopanib/pemetrexed and cisplatin/pemetrexed arms for PFS (median PFS, 25.0 versus 22.9 weeks, respectively; hazard ratio = 0.75; 95% confidence interval, 0.43%–1.28%; p = 0.26) or objective response rate (23% versus 34%, respectively; 95% confidence interval, –30.6% to 7.2%; p = 0.21).

Conclusion:

The combination of pazopanib/pemetrexed in first-line treatment of non–small-cell lung cancer showed some antitumor activity but had unacceptable levels of toxicity.

Copyright © 2013 by the International Association for the Study of Lung Cancer

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