Adding Olaratumab to Doxorubicin Improves Survival in Soft-tissue Sarcoma

Share this content:
Addition of olaratumab to doxorubicin significantly improves PFS and OS in patients with advanced soft-tissue sarcoma.
Addition of olaratumab to doxorubicin significantly improves PFS and OS in patients with advanced soft-tissue sarcoma.

The addition of olaratumab to doxorubicin significantly improves median progression-free and overall survival in contrast with doxorubicin alone in patients with advanced soft-tissue sarcoma, a study published in The Lancet has shown.1

Investigators evaluated the safety and efficacy of olaratumab, a human antiplatelet-derived growth factor receptor α monoclonal antibody that has antitumor activity in human sarcoma xenografts, combined with doxorubicin.

Researchers enrolled 15 patients with unresectable or metastatic soft-tissue sarcoma without prior anthracycline therapy in the phase 1b portion; 129 patients were enrolled in phase 2. Phase 2 patients were randomly assigned 1:1 to receive olaratumab 15 mg/kg IV on days 1 and 8 plus doxorubicin 75 mg/m2 on day 1 of each 21-day cycle, for a maximum of 8 cycles, or doxorubicin alone.

Results showed that median progression-free survival in the phase 2 part was 6.6 months (95% CI, 4.1-8.3) with olaratumab plus doxorubicin compared with 4.1 months (95% CI, 2.8-5.4) with doxorubicin (hazard ratio, 0.67; 95% CI, 0.44-1.02; P = .0615). Median overall survival was 26.5 months (95% CI, 20.9-31.7) and 14.7 months (95% CI, 9.2-17.1), respectively (hazard ratio, 0.46; 95% CI, 0.30-0.71; P = .0003).

The objective response rate for the combination was 18.2% (95% CI, 9.8—29.6) versus 11.9% (95% CI, 5.3-22.2) for doxorubicin alone.

RELATED: FDA Grants Priority Review to Olaratumab for Advanced Soft Tissue Sarcoma

Adverse events associated with olaratumab plus doxorubicin, versus those associated with doxorubicin alone, were neutropenia, mucositis, nausea, vomiting, and diarrhea. The rates of grade 3 or worse febrile neutropenia were similar in both treatment arms.

The findings suggest that olaratumab might provide a shift in the treatment of advanced soft-tissue sarcoma.

Reference

1. Tap WD, Jones RL, Van Tine BA, Chmielowski B, Elias AD, Adkins D, et al. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial [published online ahead of print June 9, 2016]. Lancet. doi: 10.1016/S0140-6736(16)30587-6.

Related Resources

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

Sign Up for Free e-newsletters

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