Vinorelbine combined with paclitaxel infused over 96 hours (VI-TA-96) for patients with metastatic breast carcinoma

Cancer

Volumn 88, Issue 12, 2000, Pages 2731-2738

  Cocconi, Giorgio ^a   Mambrini, Andrea ^a   Quarta, Maria ^a   Vasini, Giovanna ^a   Bella, Maria Angela ^a   Ferrozzi, Francesco ^a   Beretta, Myriam Debora ^a  

^a UNIVERSITY HOSPITAL OF PARMA   (Italy)

Author keywords

96 Hour infusion; Advanced breast carcinoma; Chemotherapy; Paclitaxel; Vinorelbine

Indexed keywords

NAVELBINE; PACLITAXEL;

ADULT; AGED; ARTICLE; BLOOD TOXICITY; BREAST CARCINOMA; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; DRUG CYTOTOXICITY; DRUG RESPONSE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPERSENSITIVITY REACTION; LIVER TOXICITY; METASTASIS; MICROTUBULE; NAUSEA; NEUROMUSCULAR DISEASE; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SKIN TOXICITY; STOMATITIS; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; ECONOMICS, PHARMACEUTICAL; FEMALE; FEVER; HUMANS; INFUSIONS, INTRAVENOUS; MIDDLE AGED; NEUTROPENIA; PACLITAXEL; TREATMENT OUTCOME; VINBLASTINE;

EID: 0034660354     PISSN: 0008543X     EISSN: None     Source Type: Journal    
DOI: 10.1002/1097-0142(20000615)88:12<2731::AID-CNCR11>3.0.CO;2-9     Document Type: Article

References (53)

1. Chang AY, Garrow GC. Pilot study of vinorelbine (Navelbine) and paclitaxel (Taxol) in patients with refractory breast cancer and lung cancer. Sem Oncol 1995;22(Suppl 5):66-70.
2. Hin M, Ko Bayashi K, Hayashihara K, Shinoda K, Nukarya N, Shibuya A, et al. In vitro combination effect of docetaxel (RP56976) with Vinca alkaloids in cancer cell line. Jpn J Cancer Res 1995;7:618.
3. Miller CG, Knick VC, Eberwein D, Murray D. Navelbine and paclitaxel combinations provide improved activity with reduced toxicity by an immune status dependent mechanism. Proc Am Assoc Cancer Res 1996;37:A2989.
4. Bissery MC, Azli N, Fumoleau P. Docetaxel in combination with vinorelbine: preclinical-clinical correlation. Proc Am Soc Clin Oncol 1996;15:487.
5. Budman DR, Calabro A, Stiel L, Kreis W. In vitro studies of paclitaxel in combination with either etoposide or vinorelbine: sequence dependent effects causing synergism or antagonism. Proc Am Assoc Cancer Res 1996;37:A2493.
6. Knick VC, Eberwein DJ, Miller CG. Preclinical activity of navelbine and taxol drug combinations. Proc Am Assoc Cancer Res 1994;35:A1945.
7. Eisenhauer EA, ten Bokkel Huinink WW, Swenerton KD, Gianni L, Myles J, van der Burg MEL, et al. European-Canadian randomized trial of taxol in relapsed ovarian cancer: high vs. low-dose and long vs. short infusion. J Clin Oncol 1994;12:2654-66.
8. Gianni L, Kearns CM, Giani A, Capri G, Viganó L, Locatelli A, et al. Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationship in humans. J Clin Oncol 1995;13:180-90.
9. Huizing MT, Keung ACF, Rosing H, van der Kuij V, ten Bokkel Huinink WW, Mandjes IM, et al. Pharmacokinetics of paclitaxel and metabolites in a randomized comparative study in platinum-pretreated ovarian cancer patients. J Clin Oncol 1993;11:2127-35.
10. Winer E, Berry D, Duggan D, Henderson IC, Cirrincione C, Cooper R, et al. Failure of higher dose paclitaxel to improve outcome in patients with metastatic breast cancer. Results from CALGB 9342. Proc Am Soc Clin Oncol 1998;17:101a.
11. Mamounas E, Brown A, Smith R, Lembersky B, Fisher B, Wickerham DL, et al. Effect of taxol duration of infusion in advanced breast cancer: results from NSABP B-26 trial comparing 3-to 24-hr infusion of high dose taxol. Proc Am Soc Clin Oncol 1998;17:101a.
12. Liebmann J, Cook JA, Lipschultz C, Teague D, Fisher J, Mitchell JB, et al. The influence of Cremophor EL on the cell cycle effects of paclitaxel (Taxol) in human tumor cell lines. Cancer Chemother Pharmacol 1994;33:331-9.
13. Rowinsky EK, Donehower RC, Jones RJ, Tucker RW. Microtubule changes and cytotoxicity in leukemic cell lines treated with taxol. Cancer Res 1988;48:4093-100.
14. Liebmann JE, Cook JA, Lipschultz C, Teague D, Fisher J, Mitchel JB. Cytotoxic studies of paclitaxel (Taxol) in human tumor cell lines. Br J Cancer 1993;68:1104-9.
15. Spriggs DR, Tondini C. Taxol administered as a 120-hour infusion. Invest New Drugs 1992;10:275-8.
16. Fisherman JS, Cowan KH, Noone M, Denicoff A, Berg S, Poplack D, et al. Phase I/II study of 72-hour infusional paclitaxel and doxorubicin with granulocyte colony-stimulating factor in patients with metastatic breast cancer. J Clin Oncol 1996;14:774-82.
17. Wilson WH, Berg SL, Bryant G, Wittes RE, Bates S, Fojo A, et al. Paclitaxel in doxorubicin-refractory or mitoxantrone-refractory breast cancer: a phase I-II trial of 96-hour infusion. J Clin Oncol 1994;12:1621-9.
18. Seidman AD, Hochhauser D, Gollub M, Edelman B, Yao T-J, Hudis CA, et al. Ninety-six-hour paclitaxel infusion after progression during short taxane exposure: a phase II pharmacokinetic and pharmacodynamic study in metastatic breast cancer. J Clin Oncol 1996;14:1877-84.
19. Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer 1981;47:207-14.
20. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
21. Sledge GW. Adjuvant chemotherapy: shifting rules, shifting roles. In: Michael C Perry editor. American Society of Clinical Oncology 1999 Educational Book. Baltimore: Lippincott William & Wilkins, 1999:208-10.
22. Mansour EG, Gray R, Shatila AH, Osborne CK, Tormey DC, Gilchrist KW, et al. Efficacy of adjuvant chemotherapy in high-risk node-negative breast cancer: an intergroup study. N Engl J Med 1989;320:485-90.
23. Mansour EG, Gray R, Shatila AH, Tormey DC, Cooper MR, Osborne CK, et al. Survival advantage of adjuvant chemotherapy in high-risk node-negative breast cancer: ten-year analysis. An intergroup study. J Clin Oncol 1998;16:3486-92.
24. Fisher B, Dignam J, De Cillis A, Wickerham DL, Wolmark N, Emir B, et al. The worth of chemotherapy and tamoxifen (TAM) over TAM alone in node-negative patients with estrogen-receptor positive invasive breast cancer: first results from NSABP B-20. Proc Am Soc Clin Oncol 1997;16:1a.
25. Castiglione-Gertsch M, Johnsen C, Goldhirsch A, Gelber RD, Rudenstam CM, Collins J, et al. The International (Ludwig) Breast Cancer Study Group trials I-IV: 15 years follow-up. Ann Oncol 1994;5:717-24.
26. Levine MN, Bramwell VH, Pritchard KI, Norris BD, Shepherd LE, Abu-Zahra H, et al. Randomized trial of intensive cyclophosphamide, epirubicin and fluorouracil chemotherapy compared with cyclophosphamide, methotrexate, and fluorouracil in premenopausal women with node-positive breast cancer. J Clin Oncol 1998;16:2651-8.
27. Early Breast Cancer Trialists' Collaborative Group. Polychemotherapy for early breast cancer: an overview of the randomised trials. Lancet 1998;352:930-42.
28. Fossati R, Confalonieri C, Torri V, Ghislandi E, Penna A, Pistotti V, et al. Cytotoxic and hormonal treatment for metastatic breast cancer: a systematic review of published randomized trials involving 31,510 women. J Clin Oncol 1998; 16:3439-60.
29. Foumoleau P, Delgado FM, Delozier T, Monnier A, Delgado MAG, Kerbrat P, et al. Phase II trial of weekly intravenous vinorelbine in first line advanced breast cancer chemotherapy. J Clin Oncol 1993;11:1245-52.
30. Gasparini G, Caffo O, Barni S, Frontini L, Testolin A, Guglielmi RB, et al. Vinorelbine is an active anti-proliferative agent in pre-treated advanced breast cancer patients: a phase II study. J Clin Oncol 1994;12:2094-101.
31. Weber BL, Vogel C, Jones S, Harvey H, Hutchins L, Bigley J, et al. Intravenous vinorelbine as first-line and second-line therapy in advanced breast cancer. J Clin Oncol 1997;13: 2722-30.
32. Chevalier B, Fumoleau P, Kerbrat P, Dieras V, Roche H, Krakkowski 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.
33. ten Bokkel Huinink WW, Prove AM, Piccart M, Steward W, Turoz T, Wanders J, et al. A Phase II trial with docetaxel (taxotere) in second line treatment with chemotherapy for advanced breast cancer. A study of the EORTC Early Clinical Trial Group. Ann Oncol 1994;5:527-32.
34. 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.
35. Reichman BS, Seidman AD, Crown JPA, 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.
36. Holmes FA, Valero V, Theriault RL, Walters RS, Booser DB, Frye D, et al. Phase II trial of taxol in metastatic breast cancer refractory to multiple prior treatments. Proc Am Soc Clin Oncol 1993;12:94.
37. Mamounas E, Brown A, Fisher B, Wickerham DL, Sidhom M, Vogel C. 3-hour high-dose Taxol infusion in advanced breast cancer. Proc Am Soc Clin Oncol 1995;14:127.
38. Romero Acuña L, Langhi M, Pérez J, Romero Acuña J, Machiavell M, Lacava J, et al. Vinorelbine and paclitaxel as first-line chemotherapy in metastatic breast cancer. J Clin Oncol 1999;17:74-81.
39. Chang A, Garrow G, Hines J. Pilot study of vinorelbine (V, Navelbine) and paclitaxel (P, Taxol) in patients with refractory breast cancer. Proc Am Assoc Cancer Res 1995;37:91.
40. Hortobagyi GN, Holmes FA, Ibrahim N, Champlin R, Buzdar AU. The University of Texas M.D. Anderson Cancer Center experience with paclitaxel in breast cancer. Semin Oncol 1997;24(Suppl. 3):S3-33.
41. Michelotti A, Gennari A, Salvadori B, Tognoni A, Tibaldi C, Baldini E, et al. Paclitaxel and vinorelbine in anthracycline pretreated breast cancer: phase II study. Ann Oncol 1996;7: 857-60.
42. Jaremtchuk A, Matwiejuk M, Polera O, Lozano M, Gil Deza E, Muro H, et al. Feasibility study of the combination Navelbine and paclitaxel in advanced breast cancer. Proc Am Soc Clin Oncol 1997;16:175a.
43. Ibrahim N, Hortobagyi GN, Valero V, Dhingra K, Willey J, Hohneker J, et al. Phase I study of vinorelbine and paclitaxel by simultaneous 3-hr infusion for untreated metastatic breast cancer. Proc Am Assoc Cancer Res 1995;36:A1443.
44. Gardin G, Pronzato P, Tognoni A, Vigani A, Vaira F, Gasco M, et al. A phase II trial of vinorelbine and paclitaxel in patients with metastatic breast cancer who have failed prior anthracycline containing chemotherapy. Proc Am Soc Clin Oncol 1998;17:142a.
45. Martin M, Garcia Carbonero J, Lluch A, Casado A, de Paz L, Perez Segura P, et al. Paclitaxel plus vinorelbine: an active regimen in metastatic breast cancer patients with prior anthracycline exposure. Proc Am Soc Clin Oncol 1998;17:158a.
46. Culine S, Roch I, Pinguet F. Combination paclitaxel and vinorelbine therapy: in vitro cytotoxic interactions and dose-escalation study in patients with anthracycline-resistant metastatic breast cancer. Proc Am Soc Clin Oncol 1998; 17:135a.
47. Ellis GK, Gralow JR, Pierce HI, Williams MA, Livingston RB. Infusional paclitaxel and weekly vinorelbine with concurrent filgrastim for metastatic breast cancer: high complete response rate in a phase I-II study of doxorubicin-treated patients. J Clin Oncol 1999;17:1407-12.
48. Vici P, Amodio A, Di Lauro L, Paoletti G, Foggi P, Squilloni E, et al. Simultaneous infusion of vinorelbine and paclitaxel as first-line chemotherapy in advanced breast cancer patients. Proc Am Soc Clin Oncol 1997;16:196a.
49. Budman DR, Weiselberg L, O'Mara V, Buchbinder A, Lichtman SM, Donahue L, et al. A phase I study of sequential vinorelbine followed by paclitaxel. Ann Oncol 1999;10:861-3.
50. Seidman AD. The emerging role of paclitaxel in breast cancer therapy. Clin Cancer Res 1995;1:247-55.
51. Gianni L. Theoretical and practical aspects of paclitaxel scheduling. AnnOncol 1995;6:861-3.
52. Parimoo D, Jeffers S, Muggia FM. Severe neurotoxicity from vinorelbine-paclitaxel combinations. J Natl Cancer Inst 1996;88:1079-80.
53. Seidman AD, Hudis CA, Albanel J, Tong W, Tepler I, Currie V, et al. Dose-dense therapy with weekly 1-hour paclitaxel infusions in the treatment of metastatic breast cancer. J Clin Oncol 1998;16:3353-61.