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Breast Cancer treatment details. Chemotherapy. Radiation. Duke University Medical Center, Durham, N.C., United States

Survival: 35.6 months
Toxicity Grade: 5
Treatments: Chemotherapy
Drugs: Adriamycin
Country: United States
City/State/Province: Durham, N.C.
Hospital: Duke University Medical Center
Journal: Link
Date: 6/2006

Patients: This Phase III trial involved a total 85 patients of which 69 were randomized to one of two groups. Group A had 35 women and Group B had 34 women. In both groups the average age was 43.4 years. For all patients, the only metastatic site was bone.

Treatment: For all patients the treatment began with chemotherapy (doxorubicin, 5-fluorouracil and methotrexate). Patients in Group A (observation arm) were then treated with radiation. They were also offered the high dose chemotherapy with autologous peripheral blood transplant (the same treatment of Group B) at the time their cancers progressed.

Patients in Group B did not have an interim observation period and received high dose chemotherapy treatment soon after the initial chemotherapy was completed. High dose chemotherapy consisted of the STAMP-1 protocol (cyclophosphamide, cisplatin, and carmustine) followed by autologous peripheral blood transplant and radiation.

Toxicity: A total of six patients died of toxicity and all died in the acute post transplant phase (three in Group A and three in Group B).

Results: The median overall survival for Group A was 1.81 years (21.7 months) and 2.97 years (35.6 months) for Group B. This difference, according to the authors, was not statistically significant.

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