Mitoxantrone, 5-fluorouracil, and high dose leucovorin (NFL) versus intravenous cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) in frist-line chemotherapy for patients with metastatic breast carcinoma: A randomized Phase II trial

Cancer

Volumn 79, Issue 4, 1997, Pages 740-748

  Hainsworth, John D ^a   Jolivet, Jacques ^b   Birch, Robert ^c   Hopkins, Lisa G ^a   Greco, F Anthony ^a  

^a SARAH CANNON RESEARCH INSTITUTE   (United States)

^b Institut du Cancer de Montreal   (Canada)

^c Response Technologies   (United States)

Author keywords

cyclophosphamide, methotrexate, and 5 fluorouracil (CMF) regimen; metastatic breast carcinoma; mitoxantrone, 5 fluorouracil, and leucovorin (NFL) regimen

Indexed keywords

CYCLOPHOSPHAMIDE; DOXORUBICIN; FLUOROURACIL; FOLINIC ACID; METHOTREXATE; MITOXANTRONE;

ADULT; ARTICLE; BONE MARROW SUPPRESSION; BREAST CARCINOMA; CANCER COMBINATION CHEMOTHERAPY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG MEGADOSE; FEMALE; FEVER; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; METASTASIS; MUCOSA INFLAMMATION; NAUSEA; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SURVIVAL RATE; VOMITING;

EID: 0031053204     PISSN: 0008543X     EISSN: None     Source Type: Journal    
DOI: 10.1002/(sici)1097-0142(19970215)79:4<740::aid-cncr11>3.0.co;2-%23     Document Type: Article

References (40)

1. 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.
2. Jones SE, Mennel RG, Brooks B, Westrick MA, Allison MA, Paulson RS, et al. Phase II study of mitoxantrone, leucovorin, and infusional fluorouracil for treatment of metastatic breast cancer. J Clin Oncol 1991;19:1736-41.
3. Carmo-Pereira J, Costa FO, Henriques E. Mitoxantrone, folinic acid, 5-fluorouracil, and prednisone as first-line chemotherapy in advanced breast cancer [abstract]. Proc Am Soc Clin Oncol 1991;10:50.
4. Wils J. Mitoxantrone, high dose infusional fluorouracil and leucovorin: an effective and well tolerated regimen for the treatment of advanced breast cancer. Proceedings, New trends in biochemical modulation of 5-fluorouracil with leucovorin. Lyons: European Society of Medical Oncology, 1992.
5. Swain S, Honig S, Johnson K, Egan E, Walton L, Pickle L, et al. Mitoxantrone, 5-fluorouracil and high-dose leucovorin regimen as treatment for patients with metastatic breast cancer [abstract]. Proc Am Soc Clin Oncol 1991;10:54.
6. Yap HY, Blumenschein GR, Schell FC, Buzdar AU, Valdivieso M, Bodey GP. Dihydroxyanthracenedione: a promising new drug in the treatment of metastatic breast cancer. Ann Intern Med 1981;95:694-7.
7. Hendetson IC, Allegra JC, Woodcock T, Wolff S, Bryan S, Cartwright K, et al. Randomized clinical trial comparing mitoxantrone with doxorubicin in previously treated patients with metastatic breast cancer. J Clin Oncol 1989;7:560-71.
8. Swain SM, Lippman ME, Egan EF, Drake JC, Steinberg SM, Allegra CJ. Fluorouracil and high dose leucovorin in previously treated patients with metastatic breast cancer. J Clin Oncol 1989;7:890-9.
9. Doroshow JH, Leong L, Margolin K, Flanagan B, Goldberg D, Bertrand M, et al. Refractory metastatic breast cancer: salvage therapy with fluorouracil and high-dose continuous infusion leucovorin calcium. J Clin Oncol 1989;7:439-44.
10. Cummings FJ, Gelman R, Horton J. Comparison of CAF versus CMFP in metastatic breast cancer: analysis of prognostic factors. J Clin Oncol 1985;3:932-7.
11. Nemoto T, Horton J, Simon R, Dao TL, Rosner D, Cunningham T, et al. Comparison of four-combination chemotherapy programs in metastatic breast cancer. Cancer 1982;49:1988-97.
12. Aisner J, Weinberg V, Perloff M, Weiss R, Perry M, Korzun A, et al. Chemotherapy versus chemoimmunotherapy (CAF v CAFVP v CMF each ± MER) for metastatic carcinoma of the breast: a CALGB study. J Clin Oncol 1987;5:1523-31.
13. Tormey DC, Gelman R, Band PR, Sears M, Rosenthal SN, DeWys W, et al. Comparison of induction chemotherapy for metastatic breast cancer: an Eastern Cooperative Oncology Group trial. Cancer 1982;50:1235-43.
14. Hortobagyi GN, Bodey GP, Buzdar AV, Frye D, Legha SS, Malik R, et al. Evaluation of high-dose versus standard FAC chemotherapy for advanced breast cancer in protected environment units: a prospective randomized study. J Clin Oncol 1987;5:354-66.
15. Rosner D, Nemato T, Lane WW. A randomized study of intensive versus moderate chemotherapy programs in metastatic breast cancer. Cancer 1987;59:874-83.
16. Bonnadonna G, Valagussa P, Tancini G, Rossi A, Brambilla C, Zambetti M, et al. Current status of Milan adjuvant chemotherapy trials for node-positive and node-negative breast cancer. NCI Monogr 1986;1:45-56.
17. Bennett JM, Muss HB, Doroshow JH, Wolff S, Krementz ET, Cartwright K, et al. A randomized multicenter trial comparing mitoxantrone, cyclophosphamide, and fluorouracil with doxorubicin, cyclophosphamide, and fluorouracil in the therapy of metastatic breast carcinoma. J Clin Oncol 1988;6:1611-23.
18. Canellos GP, DeVita VT, Gold GL, Chabner BA, Schein PS, Young RC. Combination chemotherapy for advanced breast cancer: response and effect on survival. Ann Intern Med 1976;84:389-95.
19. Canellos GP, Pocock SJ, Taylor SG, Sears ME, Klaasen DJ, Band PR. Combination chemotherapy for metastatic breast carcinoma: prospective comparison of multiple drug therapy with L-phenylalanine mustard. Cancer 1976;38:1882-90.
20. Tannock IF, Boyd NF, DeBoer G, Erlichman C, Fine S, Larocque G, et al. A randomized trial of two dose levels of cyclophosphamide, methotrexate, and fluorouracil chemotherapy for patients with metastatic breast cancer. J Clin Oncol 1988;6:1377-84.
21. Yosef H, Slater A, Keen CW, Bunting JS, Hope-Stone H, Parmar H, et al. Prednimustine (Sterecyt) versus cyclophosphamide both in combination with methotrexate and 5-fluoro-uracil in the treatment of advanced breast cancer. Eur J Cancer 1993;29A:1100-6.
22. Ingle JN, Foley JF, Mailliard JA, Krook JE, Hartmann LC, Jung SH, et al. Randomized trial of cyclophosphamide, methotrexate, and 5-fluorouracil with or without estrogenic recruitment in women with metastatic breast cancer. Cancer 1994;73:2337-46.
23. Engelsman E, Klijn JCM, Rubens RD, Wilders J, Beex LV, Nooij MA, et al. "Classical" CMF versus a 3-weekly intravenous CMF schedule in postmenopausal patients with advanced breast cancer. Eur J Cancer 1991;27:966-71.
24. Wood WC, Budman DR, Korzun AH, Cooper MR, Younger J, Hart RD, et al. Dose and dose intensity of adjuvant chemotherapy for stage II, node-positive breast carcinoma. N Engl J Med 1994;330:1253-66.
25. Valagussa P, Tancini G, Bonnadonna G. Salvage treatment of patients suffering relapse after adjuvant CMF chemotherapy. Cancer 1986;58:1411-23.
26. Kardinal CG, Perry MC, Korzun AH, Rice MA, Ginsberg S, Wood WK. Responses to chemotherapy or chemohormonal therapy in advanced breast cancer patients treated previously with adjuvant chemotherapy: a subset analysis of CALGB study 8081. Cancer 1988;61:415-29.
27. Holmes FA, Walters RS, Theriault RL, Forman AD, Newton LK, Raber MN, et al. Phase II trial of taxol, an active drug in the treatment of metastatic breast cancer. J Natl Cancer Inst 1991;83:1797-805.
28. Reichman BS, Seidman AD, Crown SPA, Heelan R, Hakes TB, Lebwohl DE, et al. Paclitaxel and recombinant human granulocyte colony-stimulating factor as initial chemotherapy for metastatic breast cancer. J Clin Oncol 1993;11:1943-51.
29. Fumoleau P, Delgado FM, Delozier T, Monnier A, Delgado G, Kerbrat P, et al. Phase II trial of weekly intravenous vinorelbine in first-line advanced breast cancer chemotherapy. J Clin Oncol 1993;11:1245-55.
30. Gasparini G, Caffo O, Barni S, Frontini L, Testolin A, Guglielmi R, Ambrosini G. Vinorelbine is an active antiproliferative agent in pretreated advanced breast cancer patients: a phase II study. J Clin Oncol 1994;12:2094-103.
31. Chevallier B, Fumoleau P, Kerbrat P, Dieras V, Roche H, Krakowski I, et al. Docetaxel is a major cytotoxic drug for the treatment of advanced breast cancer: a phase II trial of the clinical screening cooperative group of the European Organization for Research and Treatment of Cancer. J Clin Oncol 1995;13:314-22.
32. Carmichael J, Possinger K, Philip P, Beykirch M, Kerr H, Walling J, Harris AL. Difluorodeoxycytidine (gemcitabine): a phase II study in patients with advanced breast cancer [abstract]. Proc Am Soc Clin Oncol 1993;12:64.
33. Clavel M, Mathieu-Bone A, Dumortier A. Phase I study of CPT-11 administered as a daily infusion for 3 consecutive days [abstract]. Proc Am Assoc Cancer Res 1992;33:260.
34. Valero V, Holmes FA, Walters RS, Theriault RL, Esparza L, Fraschini G, et al. Phase II trial of docetaxel: a new, highly effective antineoplastic agent in the management of patients with anthracycline-resistant metastatic breast cancer. J Clin Oncol 1995;13:2886-94.
35. Ravdin PM, Burris HA, Cook G, Eisenberg P, Kane M, Bierman WA, et al. Phase II trial of docetaxel in advanced anthracycline-resistant or anthracenedione-resistant breast cancer. J Clin Oncol 1995;13:2879-85.
36. Seidman AD, Reichman BS, Crown JPA, Yao TJ, Currie V, Hakes TB, et al. Paclitaxel as second and subsequent therapy for metastatic breast cancer: activity independent of prior anthracycline response. J Clin Oncol 1995;13:1152-9.
37. Nabholtz JM, Gelmon K, Bontenbal M, Spielmann M, Catimel G, Conte P, et al. Multicenter, randomized comparative study of two doses of paclitaxel in patients with metastatic breast cancer. J Clin Oncol 1996;14:1858-90.
38. Seidman AD, Tiersten A, Hudis C, Gollub M, Barren S, Yao TJ, et al. Phase II trial of paclitaxel by 3-hour infusion as initial and salvage chemotherapy for metastatic breast cancer. J Clin Oncol 1995;13:2575-81.
39. Gianni L, Munzone E, Capri G, Fullaro F, Tarenzi E, Villani F, et al. Paclitaxel by 3-hour infusion in combination with bolus doxorubicin in women with untreated metastatic breast cancer: high antitumor efficacy and cardiac effects in a dose-finding and sequence-finding study. J Clin Oncol 1995;13:2688-99.
40. Bezwoda WR, Seymour L, Dansey RD. High-dose chemotherapy with hematopoietic rescue as primary treatment for metastatic breast cancer: a randomized trial. J Clin Oncol 1995;13:2483-94.