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A phase II trial of sorafenib in relapsed and unresectable high-grade osteosarcoma after failure of standard multimodal therapy: An Italian sarcoma group study
- Publication Year :
- 2012
-
Abstract
- Purpose: After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade osteosarcoma is dismal and unchanged over the last decades. Recently, mitogen-activated protein kinases were shown to be activated in osteosarcoma specimens, suggesting, therefore, they are suitable targets for the multikinase inhibitor sorafenib. Thus, we explored sorafenib activity in patients with relapsed and unresectable osteosarcoma. Experimental design: Patients >14 years, progressing after standard treatment, were eligible to receive 400 mg of sorafenib twice daily until progression or unacceptable toxicity. The primary end point was progression-free survival (PFS) at 4 months. Secondary objectives were PFS, overall survival (OS), clinical benefit rate (CBR), defined as no progression at 6 months and safety. This nonrandomized phase II study used a Simon two-stage design. PFS and OS at 95% confidence intervals (95% CIs) were calculated by the Kaplan-Meier method. All tests were two sided. Results: Thirty-five patients were enrolled. PFS at 4 months was 46% (95% CI 28% to 63%). Median PFS and OS were 4 (95% CI 2-5) and 7 (95% CI 7-8) months, respectively. The CBR was 29% (95% CI 13% to 44%). We observed 3 (8%) partial responses (PRs), 2 (6%) minor responses (
- Subjects :
- Adult
Male
Niacinamide
Sorafenib
medicine.medical_specialty
Adolescent
Pyridines
Phases of clinical research
Antineoplastic Agents
bone neoplasms
MAPK
osteosarcoma
relapse
sorafenib
Bone neoplasm
Gastroenterology
Target therapy
Young Adult
Internal medicine
Clinical endpoint
Humans
Medicine
Treatment Failure
Progression-free survival
Relapse
neoplasms
Osteosarcoma
business.industry
Phenylurea Compounds
Standard treatment
Benzenesulfonates
Multimodal therapy
Hematology
Middle Aged
medicine.disease
Surgery
Treatment Outcome
Unresectable Osteosarcoma
Oncology
Female
Sarcoma
Neoplasm Recurrence, Local
business
medicine.drug
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....a9f33ce3c126265e21e5ba8c5acef872