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Pazopanib shows promising activity in liposarcoma
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Pazopanib demonstrated promising rates of PFS among patients with liposarcoma, according to results of a prospective phase 2 study.
“The current study provides evidence of potential activity of pazopanib in the liposarcoma subset of patients with soft tissue sarcoma that was specifically excluded from the phase 3 PALETTE trial of other soft tissue sarcoma types,” Brian L. Samuels, MD, medical oncologist at Summit Cancer Centers, and colleagues wrote.
Pazopanib (Votrient, Novartis) — an oral multitargeted tyrosine kinase inhibitor — is approved in as second-line treatment for patients with advanced soft tissue sarcomas.
In the PALETTE clinical trial, pazopanib increased median PFS (4.6 months vs. 1.6 months) compared with placebo among patients with soft tissue sarcoma subtypes. However, patients with liposarcoma had been excluded from the trial per results from the phase 2 EORTC study 62043, in which only three of 17 patients with liposarcoma met criteria for a positive response.
Samuels and colleagues sought to reiterate findings of EORTC with a liposarcoma cohort composed of 41 patients (median age, 64 years) from nine sarcoma centers in the United States. Patients received 800 mg oral pazopanib once daily for 28-day cycles until disease progression, outstanding toxicity or withdrawal of consent.
Most patients (82.9%) had received at least one prior therapy and approximately one-third (36.6%) of patients had received more than two therapies.
The researchers used local radiology assessments to evaluate tumor response every three cycles. PFS at 12 weeks served as the primary endpoint.
PFS at 12 weeks was 68.3% (95% CI, 51.9-81.9), a significantly greater rate than the study hypothesis value of 40% (P = .0002). Median PFS was 4.4 months (95% CI, 3.2-6.5) and median OS was 12.6 months (95% CI, 8.5-16.2).
At 24 weeks, 39% of patients (95% CI, 24.2-55.5) remained progression free, and 44% experienced tumor control consisting of partial response or stable disease.
The most common adverse events — typically less than grade 3 — included nausea (39%), hypertension (36.6%), diarrhea (34.1%) and fatigue (29.3%). Five deaths occurred, of which three may have resulted from possible complications with therapy.
PFS among patients with liposarcoma appeared similar to PFS observed in the PALETTE trial (4.4 months vs. 4.6 months), the researchers noted.
“We believe that, in contrast to the conclusions of EORTC study 62043, pazopanib can be considered as a potential option for therapy in patients with soft tissue sarcomas, including those with intermediate-grade and high-grade liposarcomas,” the researchers wrote. – by Melinda Stevens
Disclosures: Samuels reports consulting fees from Eisai, Janssen Pharmaceuticals and Threshold outside of the published work. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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