Escalated M-VAC chemotherapy and recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF) in patients with advanced urothelial tract tumors

C. N. Sternberg, P. H M De Mulder, A. T. Van Oosterom, S. D. Fossa, D. Giannarelli, J. R. Soedirman

Research output: Contribution to journalArticle

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Abstract

Background: The M-VAC regimen (methotrexate, vinblastine, adriamycin, and cisplatin) has significant antitumor activity in patients with advanced urothelial tract cancer. Growth factors may provide the possibility of treating patients with higher doses of chemotherapy, for longer periods, with less morbidity, and improved results. A trial of an escalated dosage of M-VAC with recombinant GM-CSF (rhGMCSF) was initiated. Patients and methods: 23 patients were treated with an escalated dose of M-VAC every 2 weeks plus rhGM-CSF 250 micrograms/m2 s.c. days 4-10. Dose level I (n = 13) was 1.65 times the dose of standard M-VAC. Adriamycin and cisplatin were given at 2.5 times the dose of standard M-VAC. Dose level II (n = 10) was a relative dose intensity of 1.95. Adriamycin and cisplatin were both given at 2.9 times the dose. Conclusions: The response rate was 70% (95% CI 60%- 80%). Seven patients (30%) had CR, and 9 (39%) had a PR. Five (22%) patients had stable disease and 2 (9%) had progression. Of the CR patients, 3 had the CR confirmed pathologically (CRp). Response occurred in 11 patients treated at dose level I and 5 at dose level II. Toxicity was primarily hematologic. Dose level II was too toxic due to thrombocytopenia. Non-hematologic toxicity was minimal. The value of this schedule (dose level I) compared to standard M-VAC will be further evaluated in a randomized trial to be initiated by the Genitourinary Group of the EORTC.

Original languageEnglish
Pages (from-to)403-407
Number of pages5
JournalAnnals of Oncology
Volume4
Issue number5
Publication statusPublished - May 1993

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Macrophage
Chemotherapy
Macrophages
Granulocyte-Macrophage Colony-Stimulating Factor
Tumors
Tumor
Dose
Drug Therapy
Toxicity
Neoplasms
Doxorubicin
Cisplatin
Vinblastine
Human
Recombinant
Factors
Poisons
Methotrexate
Thrombocytopenia
Intercellular Signaling Peptides and Proteins

Keywords

  • Chemotherapy
  • Colony stimulating factors
  • M-VAC
  • RhGM-CSF
  • Urothelial tract tumors

ASJC Scopus subject areas

  • Statistics, Probability and Uncertainty
  • Applied Mathematics
  • Public Health, Environmental and Occupational Health
  • Neuropsychology and Physiological Psychology
  • Hematology
  • Oncology
  • Cancer Research

Cite this

Escalated M-VAC chemotherapy and recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF) in patients with advanced urothelial tract tumors. / Sternberg, C. N.; De Mulder, P. H M; Van Oosterom, A. T.; Fossa, S. D.; Giannarelli, D.; Soedirman, J. R.

In: Annals of Oncology, Vol. 4, No. 5, 05.1993, p. 403-407.

Research output: Contribution to journalArticle

Sternberg, C. N. ; De Mulder, P. H M ; Van Oosterom, A. T. ; Fossa, S. D. ; Giannarelli, D. ; Soedirman, J. R. / Escalated M-VAC chemotherapy and recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF) in patients with advanced urothelial tract tumors. In: Annals of Oncology. 1993 ; Vol. 4, No. 5. pp. 403-407.
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abstract = "Background: The M-VAC regimen (methotrexate, vinblastine, adriamycin, and cisplatin) has significant antitumor activity in patients with advanced urothelial tract cancer. Growth factors may provide the possibility of treating patients with higher doses of chemotherapy, for longer periods, with less morbidity, and improved results. A trial of an escalated dosage of M-VAC with recombinant GM-CSF (rhGMCSF) was initiated. Patients and methods: 23 patients were treated with an escalated dose of M-VAC every 2 weeks plus rhGM-CSF 250 micrograms/m2 s.c. days 4-10. Dose level I (n = 13) was 1.65 times the dose of standard M-VAC. Adriamycin and cisplatin were given at 2.5 times the dose of standard M-VAC. Dose level II (n = 10) was a relative dose intensity of 1.95. Adriamycin and cisplatin were both given at 2.9 times the dose. Conclusions: The response rate was 70{\%} (95{\%} CI 60{\%}- 80{\%}). Seven patients (30{\%}) had CR, and 9 (39{\%}) had a PR. Five (22{\%}) patients had stable disease and 2 (9{\%}) had progression. Of the CR patients, 3 had the CR confirmed pathologically (CRp). Response occurred in 11 patients treated at dose level I and 5 at dose level II. Toxicity was primarily hematologic. Dose level II was too toxic due to thrombocytopenia. Non-hematologic toxicity was minimal. The value of this schedule (dose level I) compared to standard M-VAC will be further evaluated in a randomized trial to be initiated by the Genitourinary Group of the EORTC.",
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AU - Sternberg, C. N.

AU - De Mulder, P. H M

AU - Van Oosterom, A. T.

AU - Fossa, S. D.

AU - Giannarelli, D.

AU - Soedirman, J. R.

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