PALETTE: trial | Bending the Curve: Trial by Trial

PALETTE

Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial

Population

369 randomised patients with metastatic soft-tissue sarcoma (abstract: non-adipocytic) progressing despite previous standard chemotherapy

Design

Double-blind, placebo-controlled phase 3 trial at 72 institutions in 13 countries; angiogenesis inhibitor-naive patients randomised 2:1 to pazopanib 800 mg once daily or placebo, with no subsequent crossover. 372 patients were registered.

Primary endpoint

PFS

Arms

Placebo (control, n = 123): Placebo once daily
Pazopanib (experimental, n = 246): Pazopanib 800 mg once daily

People

van der Graaf WT, EORTC Soft Tissue and Bone Sarcoma Group; PALETTE study group

PFSHR 0.31 (95% CI 0.24–0.40)Δ median PFS+3 monthsOSHR 0.86 (95% CI 0.67–1.11)Δ median OS+1.8 months

Show the numbers

Results reported for PALETTE
Endpoint	Analysis	Pazopanib	Placebo	Effect
PFS	primaryvan 2012	median 4.6 months (3.7–4.8)	median 1.6 months (0.9–1.8)	HR 0.31 (95% CI 0.24–0.40)P<0.0001
OS	primaryvan 2012	median 12.5 months (10.6–14.8)	median 10.7 months (8.7–12.8)	HR 0.86 (95% CI 0.67–1.11)P=0.25

Results reported for PALETTE
Endpoint	Analysis	Pazopanib	Placebo	Effect
PFS	primaryvan 2012	median 4.6 months (3.7–4.8)	median 1.6 months (0.9–1.8)	HR 0.31 (95% CI 0.24–0.40)P<0.0001
OS	primaryvan 2012	median 12.5 months (10.6–14.8)	median 10.7 months (8.7–12.8)	HR 0.86 (95% CI 0.67–1.11)P=0.25

Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.

Data table

Endpoint	HR	95% CI
PFS	0.31	0.24–0.4
OS	0.86	0.67–1.11

Illustrative — modelled from reported values, not trial data. PFS, primary.

Show curves

Pazopanib (experimental)
Placebo (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)

Months	Pazopanib	Placebo
0	100.0%	100.0%
3	63.6%	27.3%
6	40.5%	7.4%
9	25.8%	2.0%
12	16.4%	0.6%

Illustrative — modelled from reported values, not trial data. OS, primary.

Show curves

Pazopanib (experimental)
Placebo (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)

Months	Pazopanib	Placebo
0	100.0%	100.0%
8	64.2%	59.6%
16	41.2%	35.5%
23	27.9%	22.5%
31	17.9%	13.4%

Appears in

2012 PALETTE: pazopanib after chemotherapy in non-adipocytic sarcoma

Sources

van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, et al. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012;379(9829):1879-86.
PubMed DOI