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Pazopanib improved PFS in soft-tissue sarcoma
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The VEGF inhibitor pazopanib increased PFS in patients with metastatic soft-tissue sarcoma and may represent a new treatment option for this rare disease, according to the results of the PALETTE study.
In the phase 3 study, researchers from 72 institutions and 13 countries enrolled patients with metastatic soft-tissue sarcoma. All patients had to be angiogenesis inhibitor-naive and progressing after first-line chemotherapy.
Three-hundred sixty-nine patients were randomly assigned to treatment with pazopanib (n=246) or placebo (123). The primary endpoint was PFS.
At follow-up, patients assigned to pazopanib had a median PFS of 4.6 months vs. 1.6 months for those assigned to placebo (P<.0001). Patients assigned to pazopanib had an OS of 12.5 months vs. 10.7 months for those assigned to placebo, a difference that was not significant.
In an editorial that accompanied the study, Vivien H. C. Bramwell, MD, of Alberta Health Services Cancer Care questioned how positive these results were for patients with soft-tissue sarcoma. Specifically, she noted that pazopanib is a targeted agent and, as such, will only slow tumor progression rather than cause tumor regression.
In addition, “the desired effect of palliative chemotherapy is that tumor shrinkage or delay in progression will improve patients’ activity or wellbeing, but this effect was not definitely shown,” she wrote.
In fact, quality-of-life data were only available for the first 12 weeks of treatment, and those patients assigned to pazopanib had significant increases in certain adverse effects, including fatigue (49% in the placebo group vs. 65% in the pazopanib group), nausea (28% vs. 54%), weight loss (20% vs. 48%), diarrhea (16% vs. 58%) and hypertension (7% vs. 41%).
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Vandergraaf WTA. Lancet. 2012;doi:10.1016/S0140-6736(12)60651-5.
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