Aldoxorubicin Improves Outcomes in Relapsed/Refractory Sarcoma
Aldoxorubicin significantly prolongs PFS and provides better objective response rates than investigators’ choice of treatment or standard of care in the treatment of soft tissue sarcoma.
|The following article features coverage from the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. Click here to read more of Cancer Therapy Advisor's conference coverage.|
Editor's Note: This article was changed to address an error stating that aldoxorubicin provides a significant overall survival benefit over standard of care.
Aldoxorubicin significantly prolongs progression-free survival (PFS) and provides better objective response rates than investigators' choice of treatment or standard of care (SOC) in the treatment of soft tissue sarcomas, according to data reported at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.1
Aldoxorubicin is a superior treatment and, even at a dose equivalent of 10,000 mg/m2 of doxorubicin, the typical cardiac toxicities are not significant, presenter Sant Chawla, MD, of the Sarcoma Oncology Center in Santa Monica, California, indicated.
Aldoxorubicin — a novel drug that binds covalently to circulating albumin — accumulates in tumors and in its acidic environment releases doxorubicin.
Data were presented data from the global, multicenter, phase 3 study (ClinicalTrials.gov Identifier: NCT02049905), which enrolled 433 patients with refractory soft tissue sarcoma.
Patients were randomly assigned to receive 350 mg/m2 (260 mg/m2 of doxorubicin equivalent; n = 218) or investigators' choice of drugs used in standard practice, which included dacarbazine, doxorubicin, pazopanib, ifosfamide, or gemcitabine/docetaxel (n = 215) — all administered per package insert or based on institution protocol.
Patients presented with leiomyosarcoma (43%), liposarcoma (13%), synovial sarcoma (9%), and other sarcomas (34%). Approximately two-thirds of the patients had received prior doxorubicin.
For the primary endpoint, median PFS was 4.11 months for patients receiving aldoxorubicin (n = 218) and 2.96 months for SOC (n = 215). Although this difference was not significant, median PFS was significantly longer for patients with leiomyosarcoma or liposarcoma who received aldoxorubicin: 5.32 months vs 2.96 months, respectively; P = .007.
Objective response rate was 8.3% for aldoxorubicin and 4.2% for SOC.
For leiomyosarcoma and liposarcoma, ORR was 10% vs 4% for SOC (P = 0.079) Overall survival was, however, similar: 12.88 vs 12.16 months for SOC.
Dr Chawla indicated that there was no hair loss with aldoxorubicin. Fewer patients on aldoxorubicin discontinued due to treatment-emergent adverse events: 4.2% vs 6.3% for SOC.
Unlike doxorubicin, cardiac toxicity was lower in patients on aldoxorubicin. Left ventricular ejection fraction less than 50% was reported in 3.8% of patients on aldoxorubicin and in 8.5% of patients on doxorubicin.
The data reported indicate that aldoxorubicin is active and well-tolerated in the treatment of soft tissue sarcomas, and is significantly better than SOC in leiomyosarcoma and liposarcoma.
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“Aldoxorubicin will be the anthracycline of the future,” Dr Chawla concluded.
Read more of Cancer Therapy Advisor's coverage of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting by visiting the conference page.
- Chawla SP, Ganjoo KN, Schuetze S, et al. Phase III study of aldoxorubicin vs investigators' choice as treatment for relapsed/refractory soft tissue sarcomas. J Clin Oncol. 2017;35(suppl; abstr 11000).