Abstract
Introduction: We investigated the activity and safety of sorafenib, a multitargeted tyrosine-kinase inhibitor, in patients with advanced soft tissue sarcomas (STS). Patients and methods: An open-label nonrandomised multicentre phase II study was conducted in advanced STS patients pre-treated with anthracycline-based chemotherapy. Patients received sorafenib 400 mg twice daily for 28 days. The primary end point was the progression-free survival (PFS) rate at 6 months. Toxicity was assessed. Clinical outcomes were evaluated in all histologies and in leiomyosarcoma (L) and angiovascular sarcomas (A). Results: Between November 2006 and January 2010, 101 patients (36 L, 19 A, and 46 others) were enrolled; 76 patients per-protocol (PP) and 100 per intention-to-treat (ITT) were assessable for the primary end point. In the PP analysis, 11 (14.5) achieved partial response and 25 (32.9) stable disease; 6-month PFS rates were all histologies, 34.5; L, 38.4; and A, 56.3. In the ITT analysis, 6-month PFS results were 27.1, 35, and 35.5 in all histologies, L, and A, respectively. When stratified by histology, we observed a better PFS favouring leiomyosarcoma versus other histologies (P 0.033). Treatment was well tolerated. Conclusions: Sorafenib appears to be a promising option in leiomyosarcoma patients. This finding warrants further evaluation in histology-driven trials.
| Original language | English |
|---|---|
| Article number | mds607 |
| Pages (from-to) | 1093-1098 |
| Number of pages | 6 |
| Journal | Annals of Oncology |
| Volume | 24 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - Apr 2013 |
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Keywords
- Angiosarcoma
- Leiomyosarcoma
- Soft tissue sarcoma
- Sorafenib
- Vascular sarcoma
ASJC Scopus subject areas
- Oncology
- Hematology
Cite this
Phase ii prospective study with sorafenib in advanced soft tissue sarcomas after anthracycline-based therapy. / Santoro, A.; Comandone, A.; Basso, U.; Soto Parra, H.; De Sanctis, R.; Stroppa, E.; Marcon, I.; Giordano, L.; Lutman, F. R.; Boglione, A.; Bertuzzi, A.
In: Annals of Oncology, Vol. 24, No. 4, mds607, 04.2013, p. 1093-1098.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Phase ii prospective study with sorafenib in advanced soft tissue sarcomas after anthracycline-based therapy
AU - Santoro, A.
AU - Comandone, A.
AU - Basso, U.
AU - Soto Parra, H.
AU - De Sanctis, R.
AU - Stroppa, E.
AU - Marcon, I.
AU - Giordano, L.
AU - Lutman, F. R.
AU - Boglione, A.
AU - Bertuzzi, A.
PY - 2013/4
Y1 - 2013/4
N2 - Introduction: We investigated the activity and safety of sorafenib, a multitargeted tyrosine-kinase inhibitor, in patients with advanced soft tissue sarcomas (STS). Patients and methods: An open-label nonrandomised multicentre phase II study was conducted in advanced STS patients pre-treated with anthracycline-based chemotherapy. Patients received sorafenib 400 mg twice daily for 28 days. The primary end point was the progression-free survival (PFS) rate at 6 months. Toxicity was assessed. Clinical outcomes were evaluated in all histologies and in leiomyosarcoma (L) and angiovascular sarcomas (A). Results: Between November 2006 and January 2010, 101 patients (36 L, 19 A, and 46 others) were enrolled; 76 patients per-protocol (PP) and 100 per intention-to-treat (ITT) were assessable for the primary end point. In the PP analysis, 11 (14.5) achieved partial response and 25 (32.9) stable disease; 6-month PFS rates were all histologies, 34.5; L, 38.4; and A, 56.3. In the ITT analysis, 6-month PFS results were 27.1, 35, and 35.5 in all histologies, L, and A, respectively. When stratified by histology, we observed a better PFS favouring leiomyosarcoma versus other histologies (P 0.033). Treatment was well tolerated. Conclusions: Sorafenib appears to be a promising option in leiomyosarcoma patients. This finding warrants further evaluation in histology-driven trials.
AB - Introduction: We investigated the activity and safety of sorafenib, a multitargeted tyrosine-kinase inhibitor, in patients with advanced soft tissue sarcomas (STS). Patients and methods: An open-label nonrandomised multicentre phase II study was conducted in advanced STS patients pre-treated with anthracycline-based chemotherapy. Patients received sorafenib 400 mg twice daily for 28 days. The primary end point was the progression-free survival (PFS) rate at 6 months. Toxicity was assessed. Clinical outcomes were evaluated in all histologies and in leiomyosarcoma (L) and angiovascular sarcomas (A). Results: Between November 2006 and January 2010, 101 patients (36 L, 19 A, and 46 others) were enrolled; 76 patients per-protocol (PP) and 100 per intention-to-treat (ITT) were assessable for the primary end point. In the PP analysis, 11 (14.5) achieved partial response and 25 (32.9) stable disease; 6-month PFS rates were all histologies, 34.5; L, 38.4; and A, 56.3. In the ITT analysis, 6-month PFS results were 27.1, 35, and 35.5 in all histologies, L, and A, respectively. When stratified by histology, we observed a better PFS favouring leiomyosarcoma versus other histologies (P 0.033). Treatment was well tolerated. Conclusions: Sorafenib appears to be a promising option in leiomyosarcoma patients. This finding warrants further evaluation in histology-driven trials.
KW - Angiosarcoma
KW - Leiomyosarcoma
KW - Soft tissue sarcoma
KW - Sorafenib
KW - Vascular sarcoma
UR - http://www.scopus.com/inward/record.url?scp=84875632694&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84875632694&partnerID=8YFLogxK
U2 - 10.1093/annonc/mds607
DO - 10.1093/annonc/mds607
M3 - Article
C2 - 23230134
AN - SCOPUS:84875632694
VL - 24
SP - 1093
EP - 1098
JO - Annals of Oncology
JF - Annals of Oncology
SN - 0923-7534
IS - 4
M1 - mds607
ER -