Dose intensification of mitoxantrone in combination with levofolinic acid, fluorouracil, cyclophosphamide and granulocyte colony stimulating factor support in advanced untreated breast cancer patients. A multicentric phase II study of the Southern Italy Oncology Group

Anti-Cancer Drugs

Volumn 8, Issue 3, 1997, Pages 257-264

  Colucci, G ^a   Giotta, F ^a   Gebbia, V ^b   Riccardi, F ^c   Pezzella, G ^d   Durini, E ^e   Caruso, M ^f   Romito, S ^a   Gebbia, N ^b  

^a NATIONAL CANCER INSTITUTE GIOVANNI PAOLO II   (Italy)

^b UNIVERSITY OF PALERMO   (Italy)

^c CARDARELLI HOSPITAL   (Italy)

^d SS Annunziata Hospital   (Italy)

^e Panico Hospital   (Italy)

^f Oncology Service   (Italy)

Author keywords

5 fluorouracil; breast cancer; cyclophosphamide; granulocyte colony stimulating factor; levofolinic acid; mitoxantrone

Indexed keywords

CYCLOPHOSPHAMIDE; FLUOROURACIL; GRANULOCYTE COLONY STIMULATING FACTOR; LEVOFOLINIC ACID; MITOXANTRONE; UNCLASSIFIED DRUG;

ADULT; ANEMIA; ARTICLE; BONE MARROW SUPPRESSION; BREAST CANCER; CLINICAL TRIAL; DRUG RESPONSE; FEMALE; HAIR LOSS; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; LEUKOCYTE COUNT; MAJOR CLINICAL STUDY; METASTASIS; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; NEUTROPHIL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SUBCUTANEOUS DRUG ADMINISTRATION; SURVIVAL TIME; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; ANTIDOTES; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC AGENTS, ALKYLATING; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CYCLOPHOSPHAMIDE; FEMALE; FLUOROURACIL; GRANULOCYTE COLONY-STIMULATING FACTOR; HUMANS; ITALY; LEUCOVORIN; MIDDLE AGED; MITOXANTRONE;

EID: 0030932553     PISSN: 09594973     EISSN: None     Source Type: Journal    
DOI: 10.1097/00001813-199703000-00006     Document Type: Article

References (29)

1. Early Breast Cancer Trialistis Collaborative Group. Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy. Lancet 1992; 339 1-15.
2. Sledge GW Jr, Amman KH. Progress in chemotherapy for metastatic breast cancer. Semin Oncol 1992; 19: 317-32.
3. Gabrilove JL, Jakubowski A, Sher H, et al. Effect of granulocyte colony stimulating factor on neutropenia and associated morbidity due to chemotherapy for transitional cell carcinoma of the urothelium. N Engl J Med 1988; 318: 1414-22.
4. Trillet Lenoir V, Green J, Manegold C, et al. Recombinant granulocyte colony stimulating factor reduces the infectious complications of cytotoxic chemotherapy. Eur J Cancer 1993; 29A: 319-24.
5. Chevallier B, Chollet P, Merrouche Y, et al. Lenograstim prevents morbidity from intensive induction chemotherapy in the treatment of inflammatory breast cancer. J Clin Oncol 1995; 13: 1564-71.
6. Buyukunal E, Derman U, Serdengecti S, Bekarda B. A clinical trial of mitoxantrone (novantrone) versus doxorubicin (adriamycin) in combination chemotherapy for metastatic breast cancer. Chemioterapia 1987; 6: 377-9.
7. Vorobof DA, Iturralde M, Falkson G. Assessment of ventricular function by radionuclide angiography in patients receiving 4′-epidoxonibicin and mitoxantrone. Cancer Chemother Pharmacol 1985; 15: 253-5.
8. Henderson IC, Allegra CJ, Woodcock T, et al. Randomized clinical trial comparing mitoxantrone with doxorubicin in previously treated patients with metastatic breast cancer. J Clin Oncol 1989: 7: 560-71.
9. Robertson JFR, Williams MR, Todd JH, Blarney RW. Mitoxantrone: a useful palliative therapy in advanced breast cancer. Am J Clin Oncol 1989; 12: 393-6.
10. Neidhart JA, Gochnour D, Roach R, et al. A comparion of mitoxantrone and doxorubicin in breast cancer. J Clin Oncol 1986; 4: 672-7.
11. Rosso R, Pronzato P. Monochemotherapy with novantrone in advanced breast cancer. New Trends Ther Leuk Lymph 1988; 3: 55-67.
12. Brambilla C, Moliterni A, Codazzi D, Villani F, Crippa F, Bonadonna G. Mitoxantrone: a first line salvage chemotherapy in relapsed breast cancer. Tumori 1989; 75: 145-8.
13. Margolin KA, Doroshow JH, Akman SA, et al. Effective initial therapy of advanced breast cancer with fluorouracil and high dost continuous infusion calcium leucovorin. J Clin Oncol 1992; 10: 1278-83.
14. Hainsworth JD, Andrews MB, Johnson DH, Greco FA. Mitoxantrone, fluorouracil, and high-dose leucovorin: an effective, well-tolerated regimen for metastatic breast cancer. J Clin Oncol 1991; 9: 1731-5.
15. Jones SE, Mennel RG, Brooks B, et al. Phase II study of mitoxantrone, leucovorin, and infusional fluorouracil for treatment of metastatic breast cancer. J Clin Oncol 1991; 9: 1736-9.
16. Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer 1981; 47: 207-14.
17. Hryniuk WM. Average relative dose intensity and the impact on design of clinical trials. Semin Oncol 1987; 14: 65-74.
18. Hortobagyi GN. The importance of dose response in cyctotoxic therapy for breast cancer. In: Henderson IC, Broden EC, eds. Advances in breast cancer treatment. Therapeutic strategies in Oncology. London: Mediscript 1990; 47-69.
19. Hryniuk WM, Bush H. The importance of dose intensity in chemotherapy of metastatic breast cancer. J Clin Oncol 2: 1281.
20. Demetri GD, Horowitz J, McGuire W, Merica EA, Howard G, Henderson LC. Dose-intensification of mitoxantrone with acljunctive G-CSF (r-metHu-G-CSF) in patients with advanced breast cancer: a phase I trial. Proc Am Soc Clin Oncol 1992; 11: 137.
21. Caffner G, Cappelaere P, Guestalla JP, et al. A phase I trial of r-metHuG-CSF as an adjunct to escalating doses of mitoxantrone (MTZ) in combination chemotherapy with cycclophosphamide (C) and 5-fluorouracil (F) in metastatic breast cancer. Proc Am Soc Clin Oncol 1993; 12: 141.
22. Helson I., Helson C, Ostrow S, et al. A phase II study of mitoxantrone, cyclophosphamide, and thiothepa with peripheral huffy coat support in patients with advanced breast cancer failing standard dose therapy. Proc Am Soc Clin Oncol 1993; 12: 132.
23. Gebbia V, Valenza R, Testa A, Cannata G, Verderame F, Gebbia N. Escalating doses of mitoxantrone with granulocyte colony-stimulating factor (G-CSF) rescue plus 5-fluorouracil and high-dosc laevofolinic acid in metastatic breast cancer. Eur J Cancer 1994; 30A: 1734-36.
24. Bruni GS, Silvestro P, Caparrotti G, Ferrari E, D'Alessio A. Pergola M. 5-fluorouracilc con alte dosi di acido folinico, ciclofosfamide + epirubicina o mitoxantrone nel trattamento del carcinoma mammario avanzato. Tumori 1991; 77 (suppl): 69.
25. De Matteis A, Imperato G, Labonia V, Landi G, Nicolella D. Terapia di prima linea nel ca. mammario metastatico con mitoxantrone, ciclofosfamide, acido folinico ad alte dosi (HDFA) e 5-fluorouracile (5-FU): risultati iniziali. Tumori 1991; 77 (suppl): 74.
26. Aitini E, Cavazzini G, Cantore M, et al. A phase II study of 5-fluorouracil and high-dose folinic acid in combination with cyclophosphamide and mitoxantrone for advanced breast cancer. Eur J Cancer 1992; 28A: 1968-70.
27. Louvet C, de Gramont A, Demuynck B, et al. Folinic acid. 5-fluorouracil bolus and infusion and mitoxantrone with or without cyclophosphamide in metastatic breast cancer. Eur J Cancer 1993; 29A: 1835-8.
28. Leonardi V, Meli M, Palmeri S, et al. A phase II trial of mitoxantrone plus cyclophosphamide and 5-tluorouracil in modulation with levo-folinate for advanced breast cancer patients. J Chemother 1995; 7: 160-6.
29. Colucci G, Romito S, Gebbia V. et al. Laevofolinic acid, 5-fluorouracil, cyclophosphamide and escalating doses of epirubicin with granulocyte colony-stimulating factor support in locally advanced and/or metastatic breast carcinoma: a phase I II study of the Southern Italy Oncology Group (GOIM). Br J Cancer 1995; 72: 1245-50.