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Phase 2 trial of two courses of cyclophosphamide and etoposide for relapsed high-risk osteosarcoma patients
- Source :
- Cancer. 115(13)
- Publication Year :
- 2009
-
Abstract
- BACKGROUND: A phase 2 trial was carried out to assess the antineoplastic activity of 2 courses of cyclophosphamide-etoposide in relapsed osteosarcoma patients. METHODS: Twenty-six relapsed osteosarcoma patients with a median age of 18.5 years (8.3-47.1) were enrolled. Seven patients were in first relapse (27%), 11 in second relapse (42%), 7 in third relapse (27%), and 1 in fourth relapse (4%). Eighteen patients had bone metastasis at study entry (69%). Cyclophosphamide was given at 4 g/m 2 on Day 1 followed by etoposide at 200 mg/m 2 on Days 2, 3, and 4. Second cyclophosphamide and etoposide was planned at 21 days to 28 days from the previous one. The primary endpoint of the study was the clinical benefit at 4 months measured as progression-free survival. RESULTS: Progression-free survival at 4 months was 42%. Five patients achieved responses (19%), 9 patients had stable disease (35%), and 12 had tumor progression (46%). Overall survival (OS) at 1 year was 50%. The only grade 4 extrahematological toxicities were fever (5%), acute bronchospasm (4%) and stomatitis (18%). Six patients (23%) underwent radical surgery after cyclophosphamide and etoposide � 2. CONCLUSIONS: Cyclophosphamide and etoposide � 2 may arrest osteosarcoma progression in a significant number of patients (54%). Osteosarcoma progression arrest after cyclophosphamide and etoposide � 2 translates in a better OS. Cyclophosphamide and etoposide � 2 had good tolerability and the toxicity was time-limited and resolved in all cases. Cancer 2009;115:2980–7. V C
- Subjects :
- Adult
Male
Cancer Research
medicine.medical_specialty
Cyclophosphamide
Adolescent
Bone Neoplasms
Gastroenterology
Disease-Free Survival
chemistry.chemical_compound
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
Clinical endpoint
medicine
Humans
Radical surgery
Neoplasm Metastasis
Child
Etoposide
Osteosarcoma
business.industry
Middle Aged
medicine.disease
Nitrogen mustard
Hematopoietic Stem Cell Mobilization
Surgery
Oncology
chemistry
Tolerability
cyclophosphamide
etoposide
Female
Sarcoma
Neoplasm Recurrence, Local
business
medicine.drug
Subjects
Details
- ISSN :
- 0008543X
- Volume :
- 115
- Issue :
- 13
- Database :
- OpenAIRE
- Journal :
- Cancer
- Accession number :
- edsair.doi.dedup.....4ca43f28146e87e918871a538c0215b5