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Phase II trial of topically applied miltefosine solution in patients with skin-metastasized breast cancer
J M Terwogt1, I A Mandjes, H Sindermann
1Department of Medical Oncology, The Netherlands Cancer Institute/Antoni van Leeuwenhoek Huis, Amsterdam.
Abstract:
Skin deposits from breast cancer can present serious therapeutic problems, especially when resistant to conventional therapy. Topical application of a cytotoxic drug may represent an attractive new treatment modality devoid of major systemic toxicity. Miltefosine was selected because of its efficacy in breast cancer models. A mixture of alkylated glycerols of various chain lengths and water was used as the pharmaceutical vehicle to dissolve and to further facilitate tissue penetration of miltefosine. In our Institute a phase II study was performed to determine the efficacy and tolerability of topically applied miltefosine in patients with cutaneous metastases from breast cancer. Thirty-three patients in total entered the trial. A 6% miltefosine solution was applied once daily in the first week and twice daily in the following weeks. The planned minimum treatment duration was 8 weeks. We found an overall response rate of 43% for 30 evaluable patients, composed of 23% complete response and 20% partial response. The median response duration was 18 weeks, range 8-68. Toxicity consisted mainly of localized skin reactions, which could be controlled by a paraffin-based skin cream and, where appropriate, by dose modification. No systemic toxicities were observed. We conclude that topical miltefosine is an effective treatment modality in patients with skin metastases from breast cancer.
Insights
Topical miltefosine offers an effective treatment for breast cancer skin metastases, showing a 43% response rate with minimal localized side effects. This approach avoids systemic toxicity, presenting a promising new therapeutic option.
Area of Science:
- Oncology
- Dermatology
- Pharmaceutical Sciences
Background:
- Cutaneous metastases from breast cancer pose significant therapeutic challenges, particularly when conventional treatments fail.
- Topical chemotherapy offers a potential alternative to systemic therapy, aiming to reduce overall toxicity.
- Miltefosine, known for its efficacy in breast cancer models, was investigated for topical application.
Purpose of the Study:
- To evaluate the efficacy and tolerability of a novel topical miltefosine formulation for treating cutaneous breast cancer metastases.
- To determine the response rate, duration of response, and safety profile of topical miltefosine in a Phase II clinical study.
Main Methods:
- A Phase II study involving 33 patients with cutaneous breast cancer metastases.
- Application of a 6% miltefosine solution in an alkylated glycerol vehicle, with initial once-daily application, escalating to twice-daily.
- Treatment duration of at least 8 weeks, with efficacy and toxicity assessments.
Main Results:
- An overall response rate of 43% was observed in 30 evaluable patients (23% complete response, 20% partial response).
- The median duration of response was 18 weeks (range 8-68 weeks).
- Toxicity was primarily localized skin reactions, manageable with topical cream and dose adjustments; no systemic toxicity was reported.
Conclusions:
- Topical miltefosine demonstrates significant efficacy in treating skin metastases from breast cancer.
- The treatment is well-tolerated, with manageable local side effects and no observed systemic toxicity.
- Topical miltefosine represents a viable and effective new treatment modality for patients with cutaneous breast cancer disease.