Phase II study of doxorubicin and bevacizumab for patients with metastatic soft-tissue sarcomas Journal Article
| Authors: | D'adamo, D. R.; Anderson, S. E.; Albritton, K.; Yamada, J.; Riedel, E.; Scheu, K.; Schwartz, G. K.; Chen, H.; Maki, R. G. |
| Article Title: | Phase II study of doxorubicin and bevacizumab for patients with metastatic soft-tissue sarcomas |
| Abstract: | 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. © 2005 by American Society of Clinical Oncology. |
| Keywords: | adult; cancer survival; clinical article; controlled study; treatment outcome; treatment response; aged; middle aged; treatment failure; clinical trial; constipation; drug tolerability; fatigue; neutropenia; bevacizumab; doxorubicin; cancer combination chemotherapy; diarrhea; drug efficacy; drug safety; monotherapy; side effect; antineoplastic agent; metastasis; controlled clinical trial; phase 2 clinical trial; anemia; bleeding; leukopenia; stomatitis; thrombocytopenia; antineoplastic combined chemotherapy protocols; weight reduction; pathology; monoclonal antibody; abdominal pain; asthenia; dyspnea; febrile neutropenia; lymphocytopenia; sarcoma; hypoxia; antibodies, monoclonal; pneumothorax; thrombosis; neoplasm metastasis; soft tissue sarcoma; nausea and vomiting; infusions, intravenous; intravenous drug administration; injections, intravenous; electrolyte disturbance; phlebitis; razoxane |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 23 |
| Issue: | 28 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2005-10-01 |
| Start Page: | 7135 |
| End Page: | 7142 |
| Language: | English |
| DOI: | 10.1200/jco.2005.16.139 |
| PUBMED: | 16192597 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 134" - "Export Date: 24 October 2012" - "CODEN: JCOND" - "Source: Scopus" |
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