Abstract
Background: A named patient program (NPP) was designed to provide patients with advanced soft-tissue sarcoma (aSTS) access to pazopanib, a multitargeted tyrosine kinase inhibitor. The SPIRE study was a retrospective chart review of participating patients. Patients and methods: Eligibility criteria for the NPP and SPIRE mirrored those of the pivotal phase-III study, PALETTE, which compared pazopanib with placebo in patients ≥18 years with aSTS and whose disease had progressed during or following prior chemotherapy or were otherwise unsuitable for chemotherapy. Outcomes of interest included treatment patterns, treatment duration, relative dose intensity, progression-free survival (PFS), overall survival (OS), clinical benefit rate, adverse events (AEs) and reasons for treatment discontinuation. Results: A total of 211 patients were enrolled (median age 56 years; 60% female). Most patients received pazopanib in second- and third-line therapy (28.0% and 28.4%, respectively), followed by fourth line (19.0%) and ≥ fifth line (18.5%). The median duration of pazopanib treatment was 3.1 months (95% CI: 2.8–3.8), with a mean daily dose of 715 mg equating to 92% of recommended dose. Median OS was 11.1 months and clinical benefit rate was 46%. There was evidence of some clinical benefit across most histological subtypes. At study end, 40% of patients were alive and of these, 18% remained on pazopanib. Thirteen percent (13%) of patients discontinued pazopanib due to AEs. Conclusions: The SPIRE study demonstrated activity of pazopanib in heavily pretreated aSTS patients in a compassionate use setting. No new safety concerns were noted. Reassuringly, the relative dose intensity of pazopanib was 92%.
| Original language | English |
|---|---|
| Pages (from-to) | 1769-1775 |
| Number of pages | 7 |
| Journal | Acta Oncologica |
| Volume | 56 |
| Issue number | 12 |
| DOIs | |
| Publication status | Published - Dec 2 2017 |
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ASJC Scopus subject areas
- Hematology
- Oncology
- Radiology Nuclear Medicine and imaging
Cite this
Treatment patterns and clinical outcomes with pazopanib in patients with advanced soft tissue sarcomas in a compassionate use setting : results of the SPIRE study*. / Gelderblom, Hans; Judson, Ian R.; Benson, Charlotte; Merimsky, Ofer; Grignani, Giovanni; Katz, Daniela; Freivogel, Klaus W.; Stein, Dara; Jobanputra, Minesh; Mungul, Arron; Manson, Stephanie C.; Sanfilippo, Roberta.
In: Acta Oncologica, Vol. 56, No. 12, 02.12.2017, p. 1769-1775.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Treatment patterns and clinical outcomes with pazopanib in patients with advanced soft tissue sarcomas in a compassionate use setting
T2 - results of the SPIRE study*
AU - Gelderblom, Hans
AU - Judson, Ian R.
AU - Benson, Charlotte
AU - Merimsky, Ofer
AU - Grignani, Giovanni
AU - Katz, Daniela
AU - Freivogel, Klaus W.
AU - Stein, Dara
AU - Jobanputra, Minesh
AU - Mungul, Arron
AU - Manson, Stephanie C.
AU - Sanfilippo, Roberta
PY - 2017/12/2
Y1 - 2017/12/2
N2 - Background: A named patient program (NPP) was designed to provide patients with advanced soft-tissue sarcoma (aSTS) access to pazopanib, a multitargeted tyrosine kinase inhibitor. The SPIRE study was a retrospective chart review of participating patients. Patients and methods: Eligibility criteria for the NPP and SPIRE mirrored those of the pivotal phase-III study, PALETTE, which compared pazopanib with placebo in patients ≥18 years with aSTS and whose disease had progressed during or following prior chemotherapy or were otherwise unsuitable for chemotherapy. Outcomes of interest included treatment patterns, treatment duration, relative dose intensity, progression-free survival (PFS), overall survival (OS), clinical benefit rate, adverse events (AEs) and reasons for treatment discontinuation. Results: A total of 211 patients were enrolled (median age 56 years; 60% female). Most patients received pazopanib in second- and third-line therapy (28.0% and 28.4%, respectively), followed by fourth line (19.0%) and ≥ fifth line (18.5%). The median duration of pazopanib treatment was 3.1 months (95% CI: 2.8–3.8), with a mean daily dose of 715 mg equating to 92% of recommended dose. Median OS was 11.1 months and clinical benefit rate was 46%. There was evidence of some clinical benefit across most histological subtypes. At study end, 40% of patients were alive and of these, 18% remained on pazopanib. Thirteen percent (13%) of patients discontinued pazopanib due to AEs. Conclusions: The SPIRE study demonstrated activity of pazopanib in heavily pretreated aSTS patients in a compassionate use setting. No new safety concerns were noted. Reassuringly, the relative dose intensity of pazopanib was 92%.
AB - Background: A named patient program (NPP) was designed to provide patients with advanced soft-tissue sarcoma (aSTS) access to pazopanib, a multitargeted tyrosine kinase inhibitor. The SPIRE study was a retrospective chart review of participating patients. Patients and methods: Eligibility criteria for the NPP and SPIRE mirrored those of the pivotal phase-III study, PALETTE, which compared pazopanib with placebo in patients ≥18 years with aSTS and whose disease had progressed during or following prior chemotherapy or were otherwise unsuitable for chemotherapy. Outcomes of interest included treatment patterns, treatment duration, relative dose intensity, progression-free survival (PFS), overall survival (OS), clinical benefit rate, adverse events (AEs) and reasons for treatment discontinuation. Results: A total of 211 patients were enrolled (median age 56 years; 60% female). Most patients received pazopanib in second- and third-line therapy (28.0% and 28.4%, respectively), followed by fourth line (19.0%) and ≥ fifth line (18.5%). The median duration of pazopanib treatment was 3.1 months (95% CI: 2.8–3.8), with a mean daily dose of 715 mg equating to 92% of recommended dose. Median OS was 11.1 months and clinical benefit rate was 46%. There was evidence of some clinical benefit across most histological subtypes. At study end, 40% of patients were alive and of these, 18% remained on pazopanib. Thirteen percent (13%) of patients discontinued pazopanib due to AEs. Conclusions: The SPIRE study demonstrated activity of pazopanib in heavily pretreated aSTS patients in a compassionate use setting. No new safety concerns were noted. Reassuringly, the relative dose intensity of pazopanib was 92%.
UR - http://www.scopus.com/inward/record.url?scp=85025140647&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85025140647&partnerID=8YFLogxK
U2 - 10.1080/0284186X.2017.1332779
DO - 10.1080/0284186X.2017.1332779
M3 - Article
AN - SCOPUS:85025140647
VL - 56
SP - 1769
EP - 1775
JO - Acta Oncologica
JF - Acta Oncologica
SN - 0284-186X
IS - 12
ER -