Fax: (216) 445-3434
A Phase II trial of pegylated liposomal doxorubicin, vincristine, and reduced-dose dexamethasone combination therapy in newly diagnosed multiple myeloma patients
Article first published online: 31 OCT 2002
Copyright © 2002 American Cancer Society
Volume 95, Issue 10, pages 2160–2168, 15 November 2002
How to Cite
Hussein, M. A., Wood, L., Hsi, E., Srkalovic, G., Karam, M., Elson, P. and Bukowski, R. M. (2002), A Phase II trial of pegylated liposomal doxorubicin, vincristine, and reduced-dose dexamethasone combination therapy in newly diagnosed multiple myeloma patients. Cancer, 95: 2160–2168. doi: 10.1002/cncr.10946
- Issue published online: 31 OCT 2002
- Article first published online: 31 OCT 2002
- Manuscript Accepted: 17 JUN 2002
- Manuscript Revised: 6 JUN 2002
- Manuscript Received: 11 APR 2002
- Pastore Foundation
- Reisacher family
- Ortho Biotech Products, L.P.
- drug resistance;
- drug toxicity;
- multiple myeloma;
- pegylated liposomal doxorubicin;
Patients with multiple myeloma (MM) have increased bone marrow angiogenesis, a low plasma cell labeling index, and multidrug resistance (the primary cause of chemotherapy failure). MM patients receiving the vincristine, doxorubicin, and dexamethasone (VAD) regimen develop resistance and cardiac and steroid toxicity. Pegylated liposomal doxorubicin (Doxil®/CAELYX™) could potentially extend the duration of malignant plasma cell exposure to therapeutic levels of doxorubicin. This Phase II study evaluates combination pegylated liposomal doxorubicin, vincristine, and reduced-dose dexamethasone in MM patients.
Thirty-three newly diagnosed patients with MM received intravenous pegylated liposomal doxorubicin (40 mg/m2), vincristine (2.0 mg, Day 1), and oral or intravenous dexamethasone (40 mg per day for 4 days) every 4 weeks for six or more cycles and/or for two cycles after the best response.
The overall response rate was 88%: 4 (12%) patients achieved a complete response, 18 (55%) a major response, and 7 (21%) a minor response. Three patients (9%) had stable and one (3%) had progressive disease. The median time to progression was 23.1 months, with 2-year and 3-year progression-free survival rates of 42% and 23%, respectively. The patient survival rate at 3 years was 67%. No patients discontinued treatment due to adverse events. Myelosuppression was manageable. The most common toxicities were Grade 3 palmar–plantar erythrodysesthesia, mucositis, and neutropenia. Only one patient experienced cardiotoxicity.
Substituting pegylated liposomal doxorubicin for doxorubicin in the VAD regimen and reducing the dose of dexamethasone in patients with MM improve the safety profile and convenience of the treatment regimen without compromising efficacy. Cancer 2002;95:2160–8. © 2002 American Cancer Society.