Phase II study of doxorubicin and bevacizumab for patients with metastatic soft-tissue sarcomas

D'Adamo, D. R., Anderson, S. E., Albritton, K., Yamada, J., Riedel, E., Scheu, K., Schwartz, G. K., Chen, H., Maki, R. G. (October 2005) Phase II study of doxorubicin and bevacizumab for patients with metastatic soft-tissue sarcomas. J Clin Oncol, 23 (28). pp. 7135-42. ISSN 0732-183X (Print)0732-183X (Linking)

DOI: 10.1200/JCO.2005.16.139


PURPOSE: To evaluate the antitumor activity and tolerability of bevacizumab and doxorubicin in patients with metastatic soft-tissue sarcoma (STS). PATIENTS AND METHODS: Patients may have had up to one nonanthracycline line of therapy. Seventeen patients with metastatic STS were treated with doxorubicin at 75 mg/m2 intravenous (IV) push followed by bevacizumab 15 mg/kg IV every 3 weeks. Dexrazoxane was started for total doxorubicin dose exceeding 300 mg/m2. RESULTS: A total of 85 cycles of doxorubicin/bevacizumab were administered, median four cycles (range, one to 11), with three patients receiving one to four cycles of bevacizumab maintenance after reaching 600 mg/m2 doxorubicin. All 17 patients were assessable for response. Two partial responses (12%, 95% CI = 1% to 36%) were observed, lasting seven and 12 cycles of therapy. Eleven patients (65%) had stable disease for four cycles or more. Six patients developed cardiac toxicity grade 2 or greater, with four patients grade 2 (cumulative doxorubicin 75, 150, 300, 300 mg/m2, respectively), one grade 3 (total doxorubicin 591 mg/m2), and one grade 4 (total doxorubicin 420 mg/m2). One patient with extensive lung disease died of recurrent bilateral pneumothoraces, possibly treatment-related. CONCLUSION: The 12% response rate for these patients was no greater than that observed for single-agent doxorubicin. However, the 65% of patients with stable disease lasting four cycles or longer suggests further study is warranted in STSs. The observed cardiac toxicity, despite close monitoring and standard use of dexrazoxane, obliges a change in the dose and/or schedule in future studies of this combination.

Item Type: Paper
Uncontrolled Keywords: Adult Aged Antibodies, Monoclonal/administration & dosage Antibodies, Monoclonal, Humanized Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use Bevacizumab Doxorubicin/administration & dosage Female Humans Infusions, Intravenous Injections, Intravenous Male Middle Aged Neoplasm Metastasis Sarcoma/*drug therapy/*pathology Treatment Outcome
Subjects: diseases & disorders > cancer > drugs and therapies
diseases & disorders > cancer > metastasis
diseases & disorders > cancer > cancer types > sarcoma
CSHL Authors:
Communities: CSHL labs > Maki lab
Depositing User: Matt Covey
Date: 1 October 2005
Date Deposited: 26 Oct 2016 20:20
Last Modified: 26 Oct 2016 20:20
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