Phase I-II study of vinorelbine in combination with 5-fluorouracil and folinic acid as first-line chemotherapy in metastatic breast cancer: A regimen with a low subjective toxic burden

Annals of Oncology

Volumn 8, Issue 9, 1997, Pages 865-870

  Nole F ^a   De Braud, F ^a   Aapro, M ^a   Minchella, I ^a   De Pas, M ^a   Zampino, M G ^a   Monti, S ^a   Andreoni, G ^a   Goldhirsch, A ^a  

^a EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

Author keywords

Breast cancer; Chemotherapy; Fluorouracil; Folates; Vinorelbine

Indexed keywords

BIPERIDEN; FLUOROURACIL; FOLINIC ACID; NAVELBINE;

ABDOMINAL PAIN; ADULT; AGED; ALOPECIA; ANOREXIA; ARTICLE; ASTHENIA; BREAST CARCINOMA; CANCER COMBINATION CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; DOSE RESPONSE; EXTRAPYRAMIDAL SYMPTOM; FEMALE; FEVER; GRANULOCYTOPENIA; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; METASTASIS; NAUSEA; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; STOMATITIS; VOMITING;

EID: 0030805286     PISSN: 09237534     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1008209429204     Document Type: Article

References (33)

1. Flamm Honig S. Treatment of metastatic disease. In Harris JR, Lippman ME, Morrow M, Hellman S (eds): Diseases of the Breast. Philadelphia: Lippincott-Raven 1996; 669-734.
2. Rovinsky EK, Onetto N, Canetta RM. Taxol: The first of taxanes, an important new class of antitumor agents. Semin Oncol 1992; 19: 646-62.
3. Maral N, Bourut C, Chenu E et al. Experimental antitumor activity of 5′-nor-anhydro-vinblastine (Navelbine). Cancer Lett 1984; 22: 49-54.
4. Cros S, Wright M, Morimoto M et al. Experimental antitumor activity of Navelbine. Semin Oncol 1989; 16 (Suppl 4): 15-20.
5. Ashizawa T, Miyoshi K, Asada M et al. Antitumor activity of navelbine (vinorelbine ditartrate), a new vinca alkaloid analog. Jpn J Cancer Chem 1993; 59-66.
6. Ashizawa T, Asada M, Ko Bayashi E et al. Combination effect of navelbine (vinorelbine ditartrate) with cisplatin against murine p338 leukaemia and human lung carcinoma xenografts in mice. Anticancer Drugs 1993; 4: 577-83.
7. Binet S, Fellous A, Lataste H et al. In situ analysis of the action of navelbine on various types of microtubules using immunofluorescence. Semin Oncol 1989; 16 (Suppl 4): 5-8.
8. Fumoleau P, Delozier T, Extra JM et al. Vinorelbine (navelbine) in the treatment of breast cancer: The European experience. Semin Oncol 1995; 22: 22-9.
9. Cannobbio L, Boccardo F, Pastorino G et al. Phase II study of Navelbine in advanced breast cancer. Semin Oncol 1989; 16 (Suppl 4): 33-6.
10. Fumoleau P, Delgado F, Delozier T et al. Phase II trial of weekly intravenous vinorelbine in first line advanced breast cancer chemotherapy. J Clin Oncol 1993; 11: 1245-52.
11. Garcia-Conde J, Lluch A, Martin M et al. Phase II trial of weekly i.v. vinorelbine in first-line advanced breast cancer chemotherapy. Ann Oncol 1994; 5: 854-7.
12. Bruno S, Puerto L, Mickiewicz E et al. Phase II trial of weekly i.v. vinorelbine as a single agent in first-line advanced breast cancer. Am J Clin Oncol 1995; 18: 392-6.
13. Romero A, Rabinovich MG, Vallejo CT et al. Vinorelbine as first-line chemotherapy for metastatic breast carcinoma. J Clin Oncol 1994; 12: 336-41.
14. Marty M, Leandri S, Extra J et al. A phase II study of vinorelbine (NVB) in patients with advanced breast cancer (BC). Proc Am Assoc Cancer Res 1989; 30: 256, A 1017.
15. Tresca P, Fumoleau P, Roche H et al. Vinorelbine an active new drug in breast carcinoma: Results of an ARTAC phase II trial. Proc 13th Ann San Antonio Breast Cancer Symposium 1990; 16: A66.
16. Degardin M, Bonneterre J, Hecquet B et al. Vinorelbine (Navelbine) as a salvage treatment for advanced breast cancer. Ann Oncol 1994; 5: 423-6.
17. Gasparini G, Caffo O, Barni S et al. Vinorelbine is an active antiproliferative agent in pretreated advanced breast cancer patients. J Clin Oncol 1994; 12: 2094-101.
18. Jones S, Winer E, Vogel C et al. Randomised comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer. J Clin Oncol 1995; 13: 2567-74.
19. 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 1994; 12: 1764-70.
20. Spielmann M, Brain E, Sari C et al. Salvage chemotherapy with combination of mitoxantrone and vinorelbine in resistant to anthracyclines advanced breast cancer. Proc IVth International Congress Anticancer Chemotherapy 1993; 61: Abstr 48.
21. Ferrero JM, Wendling JH, Hoch M et al. Mitoxantrone, vinorelbine as first-line chemotherapy in metastatic breast cancer: A pilot study. Proc Am J Clin Oncol 1993; 12:108.
22. Dieras V, Extra JM, Bellissant E et al. Efficacy and tolerance of vinorelbine and fluorouracil combination as first-line chemotherapy of advanced breast cancer: Results of a phase II study using a sequential group method. J Clin Oncol 1996; 12: 3097-104.
23. Swain SM, Lippman ME, Egan EF et al. Fluorouracil and high-dose leucovorin in previously treated patients with metastatic breast cancer. J Clin Oncol 1989; 7 (7): 890-9.
24. Doroshow JH, Leong L, Margolin K et al. Refractory metastatic breast cancer: Salvage therapy with fluorouracil and high-dose continuous infusion leucovorin calcium. J Clin Oncol 1989; 7: 439-44.
25. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-81.
26. Simon R. Confidence interval for reporting results of clinical trials. Ann Intern Med 1986; 105(3): 429-35.
27. Gehan EA. The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. J Chron Dis 1961; 20: 346-53.
28. Henderson IC, Cannellos GP. Cancer of the breast: The past decade. N Engl J Med 1980; 302: 78-80.
29. Ahman DL, Bisel HF, Eagan RT et al. Controlled evaluation of adriamycin (NSC-123127) in patients with disseminated breast cancer. Cancer Chemother Rep 1974; 58: 877-82.
30. Cannellos GP, Pocock SJ, Taylor SG et al. Combination chemotherapy of metastatic breast carcinoma: Prospective comparison of multiple drug therapy with L-penilalanine mustard. Cancer 1976; 38: 1882-6.
31. Ingle JN, Mailliard JA, Schaid DJ et al. Randomized trial of doxorubicin alone or combined with vincristine and mitomycin C in women with metastatic breast cancer. Am J Clin Oncol 1986; 4: 474-80.
32. Bore P, Rahmani, Van Cantfort J et al. Pharmacokinetics of a new anticancer drug, Navelbine, in patients. Comparative study of radioimmunologic and radiactive determination methods. Cancer Chemother Pharmacol 1989; 23: 247-51.
33. Marty M, Extra JM, Espie M et al. Advances in vinca-alkaloids: Navelbine. Nouv Rev Fr Hematol 1989; 31: 77-84.