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Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Hematopoietic Growth Factor PIXY321 After Moderate-Dose Fluorouracil, Doxorubicin, and Cyclophosphamide in Stage II and III Breast Cancer

From the Texas Oncology, PA, Physician Reliance Network, and Sammons Cancer Center of Baylor University Medical Center, Dallas, TX; Hematology Clinic, Portland, OR; North Shore University Hospital, Manhasset, NY; Michigan State University, East Lansing, MI; and Immunex Corp, Seattle, WA.

Address reprint requests to Stephen E. Jones, MD, Sammons Cancer Center, Baylor University Medical Center, 3535 Worth St, Collins Building, Floor 5, Dallas, TX 75246.

PURPOSE: To measure the effect of PIXY321 (granulocyte-macrophage colony-stimulating factor/interleukin-3 S. cerevisiae fusion protein) on the incidence, duration, and complications of neutropenia and thrombocytopenia after moderate-dose fluorouracil 600 mg/m², doxorubicin 60 mg/m², and cyclophosphamide 750 mg/m² (FAC) chemotherapy in patients with stage II and III breast cancer.

PATIENTS AND METHODS: In this multicenter, randomized, double-blind placebo-controlled trial, 71 women were to receive four 21-day cycles of treatment with moderate-dose FAC chemotherapy by short intravenous infusion on day 1, followed by either placebo or PIXY321 (375 µg/m² subcutaneously twice a day) on days 3 to 15. All patients were to receive prophylactic oral ciprofloxacin when the absolute neutrophil count was less than 1,000/µL.

RESULTS: PIXY321 significantly reduced the incidence and duration of grade 3 and grade 4 neutropenia in cycles 1 and 2 and the duration of grade 3 neutropenia in cycles 1 through 4. In cycles 3 and 4, grade 3 thrombocytopenia was significantly more common with PIXY321 (P < .05). Two patients, both in the PIXY321 group, required platelet transfusions. Fever and hospitalization for intravenous antibiotics were significantly more common in the PIXY321 group during cycle 1 only. More patients in the PIXY321 group achieved hematologic recovery by day 22 in cycles 1 through 3, and time to recovery was significantly shorter with PIXY321 in all cycles. FAC dose intensity was roughly 2% higher in the PIXY321 group (P = NS). Nonhematologic events of any intensity occurring with significantly greater overall frequency in the PIXY321 group included injection-site reactions, fever, chills, abdominal pain, and arthralgia. No patient died on study or within 30 days of her last dose of study drug.

CONCLUSION: PIXY321 decreased the incidence and duration of FAC-induced grade 3 and 4 neutropenia in cycles 1 and 2 and significantly shortened the time to hematologic recovery in all cycles. However, it produced more systemic toxicity as well as thrombocytopenia in cycles 3 and 4.

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