Angiogenesis has been shown to be important in tumor growth and metastasis. Thalidomide, an oral sedative, has recently been found to inhibit angiogenesis. We therefore set out to ask whether thalidomide can be used as therapy for breast cancer. In a mouse model of breast cancer, we found that thalidomide alone did not suppress tumor growth. However, mice treated with thalidomide in combination with cytoxan and adriamycin had significantly smaller tumors than those given the two chemotherapeutic agents alone (3,432 +/- 303 mm(3) versus 4,643 +/- 203 mm(3), p = 0.0005). We proceeded to administer thalidomide together with chemotherapy to seven breast cancer patients in the context of a Phase I trial. Side effects attributed to thalidomide were minimal, and included constipation and a rash. We concluded that an approach at cancer therapeutics combining an antiangiogenic agent such as thalidomide with conventional chemotherapy may be feasible and deserves further studies.

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