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Timed sequential treatment with cyclophosphamide, doxorubicin, and an allogeneic granulocyte-macrophage colony-stimulating factor-secreting breast tumor vaccine: A chemotherapy dose-ranging factorial study of safety and immune activation
Journal of Clinical Oncology, 10/08/09

Emens LA et al. – First, immunotherapy with an allogeneic, HER2-positive, GM-CSF–secreting breast tumor vaccine alone or with CY and DOX is safe and induces HER2-specific immunity in patients with metastatic breast cancer. Second, the immunomodulatory activity of low-dose CY has a narrow therapeutic window, with an optimal dose not exceeding 200 mg/m2. Third, factorial designs provide an opportunity to identify the most active combination of interacting drugs in patients. Further investigation of the impact of chemotherapy on vaccine-induced immunity is warranted.

Methods

Conducted a 3 x 3 factorial (response surface) dose-ranging study of CY, DOX, and an HER2-positive, allogeneic, GM-CSF–secreting tumor vaccine in 28 patients with metastatic breast cancer
Patients received 3 monthly immunizations, with a boost 6 to 8 mos from study entry
Primary objectives included safety and determination of chemotherapy doses that maximize HER2-specific immunity

Results

28 patients received at least 1immunization, and 16 patients received 4 immunizations
HER2-specific delayed-type hypersensitivity developed in most patients who received vaccine alone or with 200 mg/m2 CY
HER2-specific antibody responses were enhanced by 200 mg/m2 CY and 35 mg/m2 DOX, but higher CY doses suppressed immunity
Analyses revealed CY at 200 mg/m2 and DOX at 35 mg/m2 is combination that produced highest antibody responses

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