Purpose
This Phase 1/2 study evaluated safety and efficacy of a topical anhydrous ointment, SOR007, which contains submicron particles of the chemotherapy Taxol primarily in breast cancer patients with cutaneous metastases.
Methods
One of three concentrations of SOR007 (0.15%, 1.0%, or 2.0%) was applied twice daily over an area of 50 cm2 for up to 28 days, with the option for expansion to an additional 28 days at the highest dose under a Phase 2a study once safety was established.
Efficacy was analyzed by lesion measurements and photographs to determine Response Rate (reduction in size by at least 30%), Complete Response (100% reduction, disappearance), and Progression Free Survival (time until the metastases came back) by day 28 or 56.
Results in Cutaneous Metastases of Breast Cancer
23 patients were enrolled, 21 with cutaneous metastases of breast cancer. 4 patients received SOR007 0.15% for a median of 28 days, 3 at a dose of 1.0% for a median of 28 days, and 16 at 2.0% for a median of 55 days.
All doses were well tolerated, and 19 patients were evaluable for efficacy.
At day 28 across all dose levels, 16% of patients achieved a Response Rate and another 63% had Stable Disease.
The proportion of patients being without progression at 28 days across all treatments was 79%.
Conclusion
Application of SOR007 0.15%, 1.0%, and 2.0% to cutaneous metastases of breast cancer was safe and well tolerated with some reduction in lesion pain, and minimal systemic absorption of Taxol.
Lesion stabilization was observed in most subjects over the study period.
Key Messages for Breast Cancer Patients
This phase I/II trial evaluated the safety and effectiveness of topical submicron particle Taxol in an anhydrous ointment base, SOR007, in patients with breast cancer with cutaneous metastases.
The findings showed that topical SOR007 was well-tolerated, with pain reduction in 64% of the patients.
Topical SOR007 led to cutaneous metastases lesion stabilization or improvement in the majority of the patients over a 1- to 2-month period.
Systemic Taxol absorption was negligible.
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