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Escalated dosages of methotrexate, vinblastine, doxorubicin, and cisplatin plus recombinant human granulocyte colony-stimulating factor in advanced urothelial carcinoma: an Eastern Cooperative Oncology Group trial.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 1994 Mar; Vol. 12 (3), pp. 483-8. - Publication Year :
- 1994
-
Abstract
- Purpose: This multicenter cooperative group phase I/II trial evaluated the toxicity and efficacy of escalated dosages of methotrexate, vinblastine, doxorubicin, and cisplatin (M-VAC) with recombinant human granulocyte colony-stimulating factor (rhG-CSF) in patients with advanced urothelial carcinoma.<br />Patients and Methods: From November 1990 through October 1991, 35 patients with advanced urothelial cancer previously untreated with chemotherapy were treated with escalated dosages of M-VAC (M-VACII). In patients with prior pelvic radiotherapy, standard M-VAC (M-VACI) was administered plus rhG-CSF. For other patients, M-VACII dosages were methotrexate 40 mg/m2 (days 1, 15, and 22), vinblastine 4 mg/m2 (days 2, 15, and 22), doxorubicin 40 mg/m2 (day 2), and cisplatin 100 mg/m2 (day 2). In addition, rhG-CSF was administered at a dosage of 300 micrograms subcutaneously on days 4 to 11. Cycles were repeated every 4 weeks. For patients who tolerated the first course of therapy, subsequent escalation by 25% of all drugs was performed.<br />Results: Six complete responses and 15 partial responses were observed (60%; 95% confidence interval, 42% to 76%). The median duration of response was 4.6 months, and the median survival time was 9.4 months (range, 0.5 to 23.5+). Twenty-eight of 35 patients experienced grade 3 or 4 leukopenia, including 14 patients who developed fever associated with neutropenia. Eight (23%) early deaths were observed.<br />Conclusion: This regimen (M-VACII) with escalated dosages of M-VAC was associated with significant toxicity and had no apparent benefit over M-VACI therapy with regard to complete response rate or survival. Further evaluation of the dose-intensity of the components of this regimen in this disease is likely to be of limited benefit to patients.
- Subjects :
- Aged
Antineoplastic Combined Chemotherapy Protocols adverse effects
Bone Marrow Diseases chemically induced
Cisplatin administration & dosage
Doxorubicin administration & dosage
Drug Administration Schedule
Female
Humans
Male
Methotrexate administration & dosage
Middle Aged
Prospective Studies
Recombinant Proteins therapeutic use
Survival Analysis
Treatment Outcome
Urinary Bladder Neoplasms drug therapy
Vinblastine administration & dosage
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Bone Marrow Diseases prevention & control
Carcinoma, Transitional Cell drug therapy
Granulocyte Colony-Stimulating Factor therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 0732-183X
- Volume :
- 12
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 7509853
- Full Text :
- https://doi.org/10.1200/JCO.1994.12.3.483