Phase 2 trial of two courses of cyclophosphamide and etoposide for relapsed high-risk osteosarcoma patients.

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 x2. CONCLUSIONS:Cyclophosphamide and etoposide x2 may arrest osteosarcoma progression in a significant number of patients (54%). Osteosarcoma progression arrest after cyclophosphamide and etoposide x2 translates in a better OS. Cyclophosphamide and etoposide x2 had good tolerability and the toxicity was time-limited and resolved in all cases.

journal_name

Cancer

journal_title

Cancer

authors

Berger M,Grignani G,Ferrari S,Biasin E,Brach del Prever A,Aliberti S,Saglio F,Aglietta M,Fagioli F

doi

10.1002/cncr.24368

subject

Has Abstract

pub_date

2009-07-01 00:00:00

pages

2980-7

issue

13

eissn

0008-543X

issn

1097-0142

journal_volume

115

pub_type

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