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

Citation
Se. Jones et al., 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, J CL ONCOL, 17(10), 1999, pp. 3025-3032
Citations number
18
Categorie Soggetti
Oncology,"Onconogenesis & Cancer Research
Journal title
JOURNAL OF CLINICAL ONCOLOGY
ISSN journal
0732183X → ACNP
Volume
17
Issue
10
Year of publication
1999
Pages
3025 - 3032
Database
ISI
SICI code
0732-183X(199910)17:10<3025:RDPTTE>2.0.ZU;2-5
Abstract
Purpose: To measure the effect of PIXY321 (granulocyte-macrophage colony-st imulating factor/interleukin-3 S. cerevisiae fusion protein) on the inciden ce, duration, and complications of neutropenia and thrombacytopenia after m oderate-dose fluorouracil 600 mg/m(2), doxarubicin 60 mg/m(2), and cyclopho sphamide 750 mg/m(2) (FAC) chemotherapy in patients with stage II and III b reast 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 mu g/m(2) subcutaneously twice a day) on days 3 to 15, All patients were to receive prophylactic oral cip rofloxacin when the absolute neutrophil count was less than 1,000/mu L. 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 neu tropenia in cycles 1 through 4. In cycles 3 and 4, grade 3 thrombocytopenia was significantly more common with PIXY321 (P < .05), Two patients, both i n the PIXY321 group, required platelet transfusions. Fever and hospitalizat ion for intravenous antibiotics were significantly more common in the PIXY3 21 group during cycle 1 only. More patients in the PIXY321 group achieved h ematologic recovery by day 22 in cycles 1 through 3, and time to recovery w ets significantly shorter with PIXY321 in all cycles. FAC dose intensity wa s roughly 2% higher in the PIXY321 group (P = NS). Nonhematologic events of any intensity occurring with significantly greater overall frequency in th e PIXY321 group included injection-site reactions, fever, chills, abdominal pain, and arthralgia. No patient died on study or within 30 days of her la st dose of study drug. Conclusion: PIXY321 decreased the incidence and duration of FAG-induced gra de 3 and 4 neutropenia in cycles 1 and 2 and significantly shortened the ti me to hematologic recovery in all cycles. However, if produced more systemi c toxicity as well as thrombocytopenia in cycles 3 and 4. (C) 1999 by Ameri can Society of Clinical Oncology.