Aldoxorubicin Superior to Doxorubicin in Advanced Soft-tissue Sarcoma

Share this content:
Single-agent aldoxorubicin therapy showed a significantly higher progression-free survival in patients with advanced soft-tissue sarcoma.
Single-agent aldoxorubicin therapy showed a significantly higher progression-free survival in patients with advanced soft-tissue sarcoma.

Single-agent aldoxorubicin therapy showed a significantly higher progression-free survival (PFS) and tumor response rate compared with doxorubicin in patients with advanced soft-tissue sarcoma, according to a study published online ahead of print in JAMA Oncology.1 

Standard therapy for advanced soft-tissue sarcoma has remained mostly the same for decades. Aldoxorubicin, a prodrug of doxorubicin, has shown clinical activity against soft-tissue sarcoma in phase 1 studies.

Researchers in this international, multicenter, phase 2b randomized study sought to determine the efficacy and safety of aldoxorubicin vs doxorubicin in patients with advanced soft-tissue sarcoma.

A total of 123 patients were randomly assigned 2:1 to receive aldoxorubicin 350 mg/m2 (dose equivalent to doxorubicin 260 mg/m2; n=83) or doxorubicin (75 mg/m2; n=40) administered once every 3 weeks for up to 6 cycles. Median patient age was 54.0 (21 to 77 years); 34% had leiomyosarcoma.

Results showed a significantly improved median PFS in the aldoxorubicin group (5.6 months [95% CI: 3.0 to 8.1]) vs the doxorubicin group (2.7 months [95% CI: 1.6 to 4.3]; P=0.02).

The rate of 6-month progression-free survival was also significantly higher in patients who received aldoxorubicin (46% and 23%, respectively; P=0.02). Median overall survival was 15.8 months (95% CI, 13.0 to not available) with aldoxorubicin and 14.3 months (95% CI, 8.6-20.6) with doxorubicin (P=0.21).

Overall tumor response rate (by Response Evaluation Criteria in Solid Tumors, version 1.1) by independent review was higher with aldoxorubicin than with doxorubicin (25% [20 patients, all partial response] vs 0%).

RELATED: Trabectedin Superior to Dacarbazine for Previously Treated Liposarcoma, Leiomyosarcoma

In regard to safety, grade 3 or 4 neutropenia was more frequent with aldoxorubicin than with doxorubicin (24 [29%] vs 5 [12%]), but not grade 3 or 4 febrile neutropenia (12 [14%] vs 7 [18%]).

No acute cardiotoxic effects were observed with either treatment, although left ventricular ejection fraction less than 50% occurred in 3 of 40 patients receiving doxorubicin.

The researchers concluded that further investigation of aldoxorubicin is warranted in this patient population.

Reference

  1. Chawla SP, Papai Z,  Mukhametshina G, et al. First-line aldoxorubicin vs doxorubicin in metastatic or locally advanced unresectable soft-tissue sarcoma a phase 2b randomized clinical trial. [published online ahead of print September 17, 2015]. JAMA Oncol. doi: 10.1001/jamaoncol.2015.3101

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs

Sign Up for Free e-newsletters