Weekly paclitaxel, 5-fluorouracil and folinic acid with granulocyte colony-stimulating factor support in metastatic breast cancer patients: A phase II study

Anti-Cancer Drugs

Volumn 17, Issue 3, 2006, Pages 345-351

  Nisticò, Cecilia ^a   Bria, Emilio ^a   Agostara, Biagio ^b   Barni, Sandro ^c   Colella, Elvira ^a   Frontini, Luciano ^d   D'Ottavio, Anna Maria ^e   Cuppone, Federica ^a   Valenza, Roberto ^b   Sperduti, Isabella ^a   Izzo, Fiorentino ^a   Terzoli, Edmondo ^a  

^a REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

^b Ospedale Oncologico M Ascoli   (Italy)

^c AO Treviglio Caravaggio ^*  (Italy)

^d SAN GERARDO HOSPITAL   (Italy)

^e S EUGENIO HOSPITAL   (Italy)

Author keywords

5 fluorouracil; Granulocyte colony stimulating factor; Metastatic breast cancer; Weekly paclitaxel

Indexed keywords

ANTHRACYCLINE DERIVATIVE; DEXAMETHASONE; DOCETAXEL; FLUOROURACIL; FOLINIC ACID; NAVELBINE; PACLITAXEL; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; SEROTONIN ANTAGONIST;

ADULT; AGED; ALOPECIA; ANEMIA; ARTICLE; ASTHENIA; BREAST CANCER; BREAST METASTASIS; CANCER GROWTH; CANCER RESISTANCE; CANCER SURVIVAL; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONJUNCTIVITIS; DIARRHEA; DISEASE COURSE; DISEASE SEVERITY; DOSE TIME EFFECT RELATION; DRUG ACTIVITY; DRUG TOLERABILITY; EYE DISEASE; FEMALE; HEART DISEASE; HUMAN; MAJOR CLINICAL STUDY; MUCOSA INFLAMMATION; NAIL DISEASE; NAUSEA; NEUROLOGIC DISEASE; NEUROTOXICITY; NEUTROPENIA; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SKIN DISEASE; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; ANTHRACYCLINES; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE, NEOPLASM; FEMALE; FLUOROURACIL; GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR; HUMANS; LEUCOVORIN; MIDDLE AGED; NEOPLASM METASTASIS; PACLITAXEL;

EID: 33646082492     PISSN: 09594973     EISSN: None     Source Type: Journal    
DOI: 10.1097/00001813-200603000-00014     Document Type: Article

References (36)

1. Jemal A, Thomas A, Murray T, Thun M. Cancer Statistics. CA Cancer J Clin 2002; 52:23-47.
2. Beahrs OH, Henson DE, Hutter RVP, Myers MH (editors). Manual for staging of cancer. Philadelphia: JB Lippincott; 1998.
3. Perez EA. Paclitaxel in breast cancer. Oncologist 1998; 3:373-389.
4. Gianni L, Munzone E, Capri G, Villani F, Spreafico C, Tarenzi E, et al. Paclitaxel in metastatic breast cancer: a trial of two doses by 3-hour infusion in patients with disease recurrence after prior therapy with anthracyclines. J Natl Cancer Inst 1995; 87:1169-1175.
5. Seidman AD, Tiersten A, Hudis C, Gollub M, Barrett 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; 13:2575-2581.
6. Seidman AD, Reichman BS, Crown JP, 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; 13:1152-1159.
7. Seidman AD, Hudis CA, Albanel J, Tong W, Tepler I, Currie V, et al. Dose-dense therapy with 1-hour paclitaxel infusion in the treatment of metastatic breast cancer. J Clin Oncol 1998; 16:3353-3361.
8. Perez E, Vogel CL, Irwin DH, Kirshner JJ, Patel R. Multicenter phase II trial of weekly paclitaxel in women with metastatic breast cancer. J Clin Oncol 2001; 19:4216-4223.
9. Seidman AD, Berry D, Cirrincione C, Harris L, Dressler L, Muss H, et al. CALGB 9840: phase III study of weekly paclitaxel via 1-hour infusion versus standard 3-hour infusion every third week in the treatment of metastatic breast cancer (MBC), with trastuzumab (T) for HER2 positive MBC and randomized for T in HER2 normal MBC [abstract]. Proc Am Soc Clin Oncol 2004; 22(14S).
10. Green MC, Buzdar AU, Smith T, Ibrahim NK, Valero V, Rosales MF, et al. Weekly paclitaxel improves pathologic complete remission in operable breast cancer when compared with once-every-3-weeks paclitaxel. J Clin Oncol 2005; 23:5983-5992.
11. 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; 1:3439-3460.
12. 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; 7:439-444.
13. Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer 1981; 47:207-214.
14. Simon S. Optimal two-stage design for phase II clinical trials. Controlled Clin Trials 1989; 10:1-10.
15. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Ass 1958; 53:475-481.
16. Norton L. Conceptual and practical implications of breast tissue geometry: toward a more effective, less toxic therapy. Oncologist 2005; 10:370-381.
17. Seidman A. 'Will weekly work?' seems to be so.... J Clin Oncol 2005; 23:5873-5874.
18. Taghian AG, Abi-Raad R, Assaad SI, Casty A, Ancukiewicz M, Yeh E, et al. Paclitaxel decreases the interstitial fluid pressure and improves oxygenation in breast cancers in patients treated with neoadjuvant chemotherapy: clinical implications. J Clin Oncol 2005; 23:1951-1961.
19. Pasquier E, Honore S, Pourroy B, Jordan MA, Lehmann M, Briand C, et al. Anti-angiogenic concentrations of paclitaxel induce an increase in microtubule dynamics in endothelial cells but not in cancer cells. Cancer Res 2005; 65:2433-2440.
20. Marchetti P, Urien S, Antonini Cappellini G, Ronzino G, Ficorella C. Weekly administration of paclitaxel: theoretical and clinical basis. Crit Rev Oncol Hematol 2002; 44:S3-S13.
21. Nisticò C, Cognetti F, Frontini L, Barni S, Ferretti G, Bria E, et al. Weekly docetaxel in pretreated metastatic breast cancer patients: a phase I-II study. Oncology 2005; 68:356-363.
22. Piccart-Gebhart MJ. Mathematics and oncology: a match for life? J Clin Oncol 2003; 21:1425-1428.
23. Konishi K, Tani Y, Minami S, Tamura M, Kameda H, Ogita M, et al. Pharmacokinetic comparison between weekly paclitaxel treatment and by 3 weeks treatment in patients with metastatic breast cancer. Proc Am Soc Clin Oncol 2001; 21: 2001.
24. Papaldo P, Lopez P, Marolla P, Cortesi E, Antimi M, Terzoli E, et al. Impact of five prophylactic filgrastim schedules on hematologic toxicity in early breast cancer patients treated with epirubicin and cyclophosphamide. J Clin Oncol 2005; 23:6908-6918.
25. Nistico C, Garufi C, Barni S, Frontini L, Galla DA, Giannarelli D, et al. Phase II study of epirubicin and vinorelbine with granulocyte colony-stimulating factor: a high-activity, dose-dense weekly regimen for advanced breast cancer. Ann Oncol 1999; 10:937-942.
26. Seidman AD. Single-agent paclitaxel in the treatment of breast cancer: phase I and II development. Semin Oncol 1999; 26(Suppl 8):14-20.
27. Loprinzi CL. 5-Fluorouracil with leucovorin in breast cancer. Cancer 1991; 63:1045-1047.
28. Kano Y, Akutsu M, Tsunoda S, Ando J, Matsui J, Suzuki K, et al. Schedule-dependent interaction between paclitaxel and 5-fluorouracil in human cell lines in vitro. Br J Cancer 1996; 74:704-710.
29. Grem JL, Nguyen D, Monahan BP, Kao V, Geoffroy FJ. Sequence-dependent antagonism between fluorouracil and paclitaxel in human breast cancer cells. Biochem Pharmacol 1999; 58:477-486.
30. Cortesi E, Grifalchi F, Ramponi S, Padovani A, Mancuso A, Paoluzzi L, et al. Weekly paclitaxel and 5-fluorouracil in pretreated patients with metastatic breast cancer: a phase I study. Anticancer Res 2003; 23(2C):1961-1966.
31. Klaassen U, Wilke H, Harstrick A, Philippou Pari C, Strumberg D, Neumann K, et al. Paclitaxel in combination with weekly 24-hour infusional 5-fluorouracil plus leucovorin in the second-line treatment of metastatic breast cancer: results of a phase II study. Ann Oncol 1998; 9:45-50.
32. Nicholson B, Paul D, Shyr Y, Garrett M, Hande KR, Johnson DH. Paclitaxel/5-fluorouracil/leucovorin in metastatic breast cancer: a Vanderbilt Cancer Center phase II trial. Semin Oncol 1997; 24(Suppl 11):20-23.
33. Madajewicz S, LiPera W, Pendyala L, Hentschel P, Avvento L, Chowhan N, et al. Phase I study of 96 hours continuous intravenous infusion of Taxol followed by 24 hours CI of 5-Fluorouracil and folinic acid [abstract]. Proc Am Soc Clin Oncol 1995; 14:487.
34. Loesch DM, Asmar L, Canfield VA, Parker GA, Hynes HE, Ellis PG, et al. A phase II trial of weekly paclitaxel, 5-fluorouracil, and leucovorin as first-line treatment for metastatic breast cancer. Breast Cancer Res Treat 2003; 77:115-123.
35. Albain KS, Nag S, Calderillo-Ruiz G, Jordaan JP, Llombart A, Pluzanska A, et al. Global phase III study of gemcitabine plus paclitaxel (GT) vs. paclitaxel (T) as frontline therapy for metastatic breast cancer (MBC): first report of overall survival [abstract]. Proc Am Clin Oncol 2004; 23.
36. O'Shaughnessy J, Miles D, Vukelja S, Moiseyenko V, Ayoub JP, Cervantes G, et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 2002; 20:2812-2823.