Phase III comparative study of vinorelbine combined with doxorubicin versus doxorubicin alone in disseminated metastatic/recurrent breast cancer: National Cancer Institute of Canada Clinical Trials Group Study MA8

Journal of Clinical Oncology

Volumn 18, Issue 12, 2000, Pages 2385-2394

  Norris, B ^a   Pritchard, K I ^a   James, K ^a   Myles, J ^a   Bennett, K ^a   Marlin, S ^a   Skillings, J ^a   Findlay, B ^a   Vandenberg, T ^a   Goss, P ^a   Latreille, J ^a   Rudinskas, L ^a   Lofters, W ^a   Trudeau, M ^a   Osoba, D ^a   Rodgers, A ^a  

^a TORONTO WESTERN HOSPITAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

DOXORUBICIN; NAVELBINE;

ADULT; AGED; ANTINEOPLASTIC ACTIVITY; ARTICLE; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CLINICAL TRIAL; GRANULOCYTOPENIA; HUMAN; MAJOR CLINICAL STUDY; NEUROTOXICITY; NEUTROPENIA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL;

EID: 0034049808     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2000.18.12.2385     Document Type: Article

References (33)

1. Ahmann DL, Bisel HF, Eagan RT, et al: Controlled evaluation of adriamycin (NSC-123127) in patients with disseminated breast cancer. Cancer Chemotherapy Rep 58:877-882, 1974
2. Richards MA, Hopwood P, Ramirez AJ, et al: Doxorubicin in advanced breast cancer: Influence of schedule on response, survival and quality of life. Eur J Cancer 28A:1023-1028, 1992
3. Carmo-Pereira J, Costa FO, Henriques E, et al: A comparison of two doses of Adriamycin in the primary chemotherapy of disseminated breast cancer. Br J Cancer 56:471-473, 1987
4. Cowan JD, Neidhart J, McClure S, et al: Randomized trial of doxorubicin, bisantrene and mitoxantrone in advanced breast cancer: A Southwest Oncology Group study. J Natl Cancer Inst 83:1077-1084, 1991
5. Henderson IC, Allegra JC, Woodcock T, et al: Randomized clinical trial comparing mitoxantrone with doxorubicin in previously treated patients with metastatic breast cancer. J Clin Oncol 7:560-571, 1987
6. Ingle JN, Pfeifle DM, Green SJ, et al: Randomized clinical trial of doxorubicin alone or combined with mitolactol in women with advanced breast cancer and prior chemotherapy exposure. Am J Clin Oncol 8:275-282, 1985
7. Henderson IC: Chemotherapy for metastatic disease, in Harris JR, Hellman S, Henderson IC, et al (eds): Breast Diseases (ed 2). Philadelphia, PA, JB Lippincott, 1991, pp 604-665
8. Rubens RD: Single-agent chemotherapy, in Powles TJ, Smith IE (eds): Medical Management of Breast Cancer. London, United Kingdom, Martin Dunitz, 1991, pp 133-137
9. Ahmann DL, Schaid DJ, Bisel HF, et al: The effect of survival on initial chemotherapy in advanced breast cancer: Polychemotherapy versus single drug. J Clin Oncol 5:1928-1932, 1987
10. A'Hern RP, Smith IE, Ebbs SR: Chemotherapy and survival in advanced breast cancer: The inclusion of doxorubicin in Cooper type regimens. Br J Cancer 67:801-805, 1993
11. Bennett JM, Muss HB, Doroshow JH, et al: A randomized multicenter trial comparing mitoxantrone, cyclophosphamide and fluorouracil with doxorubicin, cyclophosphamide and fluorouracil in the therapy of metastatic breast cancer. J Clin Oncol 6:1611-1620, 1988
12. Muss HB, Case LD, Richards F, et al: Interrupted versus continuous chemotherapy in patients with metastatic breast cancer. N Engl J Med 325:1342-1348, 1991
13. Sledge GW Jr, Neuberg D, Ingle J, et al: Phase III trial of doxorubicin (A) vs paclitaxel (T) vs doxorubicin + paclitaxel (A + T) as first-line therapy for metastatic breast cancer (MBC): An intergroup trial. Proc Am Soc Clin Oncol 16:1a, 1997 (abstr 2)
14. Gamucci T, Piccart M, Bruning P, et al: Single agent Taxol (T) versus doxorubicin (D) as first-line chemotherapy (CT) in advanced breast cancer (ABC): Final results of an EORTC randomized study with crossover. Proc Am Soc Clin Oncol 17:111a, 1998 (abstr 428)
15. Chan S, Friedrichs K, Noel D, et al: Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol 17:2341-2354, 1999
16. Fumoleau P, Delgado FM, Delozier T, et al: Phase II trial of weekly intravenous vinorelbine in first-line advanced breast cancer. J Clin Oncol 11:1245-1252, 1993
17. Weber BL, Vogel C, Jones S, et al: Intravenous vinorelbine as first-line and second-line therapy in advanced breast cancer. J Clin Oncol 13:2722-2730, 1995
18. Gasparini G, Caffo O, Barni S, et al: Vinorelbine is an active anti-proliferative agent in pre-treated advanced breast cancer patients: a phase II study. J Clin Oncol 12:2094-2101, 1994
19. Jones S, Winer E, Vogel C, et al: Randomized comparison of vinorelbine and melphalan in anthracyline-refractory advanced breast cancer. J Clin Oncol 13:2567-2574, 1995
20. Spielmann M, Dorval T, Turpin F, et al: Phase II trial of vinorelbine/doxorubicin as first-line therapy of advanced breast cancer. J Clin Oncol 12:1764-1770, 1994
21. Aaronson NK, Ahmedzai S, Bergman B, et al: The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85:365-376, 1993
22. Brundage M, Pater J, Zee B: Assessing the reliability of two toxicity scales: Reason for concern. Proc Am Soc Clin Oncol 12:184, 1993 (abstr 530)
23. Hayward JL, Carbone PP, Heuson JC, et al: Assessment of response to therapy in advanced breast cancer. Cancer 39:1289-1294, 1977
24. Kaplan E, Meier P: Nonparametric estimations from incomplete observations. J Am Stat Assoc 53:457-481, 1958
25. Cox DR: Regression models and life-tables (with discussion). J R Stat Soc B 34:187-220, 1972
26. Payers P, Aaronson N, Bjordal K, et al: EORTC QLQ-C-30 Scoring Manual. Brussels, Belgium, Quality of Life Unit, European Organization for the Research and Treatment of Cancer Data Centre, 1995
27. Meyer RM, Browman GP, Samosh ML, et al: Randomized phase II comparison of standard CHOP with weekly CHOP in elderly patients with non-Hodgkin's lymphoma. J Clin Oncol 13:2386-2393, 1995
28. Joensuu H, Holli K, Heikkinen M, et al: Combination chemotherapy versus single-agent therapy as first- and second-line treatment in metastatic breast cancer: A prospective randomized trial. J Clin Oncol 16:3720-3730, 1998
29. Coates A, Gebski V, Signorini D, et al: Prognostic value of QOL score during chemotherapy for advanced breast cancer. J Clin Oncol 10:1833-1838, 1992
30. Testa MA, Simonson DC: Assessment of quality of life outcomes. N Engl J Med 334:835-839, 1996
31. Health Services Research Outcomes Working Group, American Society of Clinical Oncology: Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. J Clin Oncol 14:671-679, 1996
32. Hochster H: Combined doxorubicin/vinorelbine (Navelbine) therapy in the treatment of advanced breast cancer. Semin Oncol 22:55-60, 1995 (suppl 5)
33. Blajman C, Balbiani L, Block J, et al: A prospective, randomized phase III trial comparing combination chemotherapy with cyclophosphamide, doxorubicin and 5-fluorouracil with vinorelbine plus doxorubicin in the treatment of advanced breast cancer. Cancer 85:1091-1097, 1999