Efficacy and safety of docetaxel (Taxotere(TM)) in heavily pretreated advanced breast cancer patients: The French compassionate use programme experience

European Journal of Cancer

Volumn 35, Issue 10, 1999, Pages 1431-1439

  Bonneterre, J ^a   Spielman, M ^b   Guastalla, J P ^c   Marty, M ^d   Viens, P ^e   Chollet, P ^f   Roche H ^g   Fumoleau, P ^h   Mauriac, L ⁱ   Bourgeois, H ^j   Namer, M ^k   Bergerat, J P ^l   Misset, J L ^m   Trandafir, L ^m   Mahjoubi, M ⁿ  

^a CENTRE OSCAR LAMBRET   (France)

^b INSTITUT GUSTAVE ROUSSY   (France)

^c CENTRE LÉON BÉRARD   (France)

^d SAINT LOUIS HOSPITAL   (France)

^e INSTITUT PAOLI CALMETTES   (France)

^f CENTRE JEAN PERRIN   (France)

^g INSTITUT CLAUDIUS REGAUD   (France)

^h CENTRE RENÉ GAUDUCHEAU   (France)

ⁱ INSTITUT BERGONIÉ   (France)

^j INSTITUT CURIE   (France)

^k CENTRE ANTOINE LACASSAGNE   (France)

^l HÔPITAL CIVIL   (France)

^m HÔPITAL PAUL BROUSSE   (France)

ⁿ SANOFI   (France)

more..

Author keywords

Advanced breast cancer; Anthracycline; Compassionate use; Docetaxel; Liver impairment; Liver metastasis

Indexed keywords

ANTHRACYCLINE; DOCETAXEL;

ADOLESCENT; ADULT; ARTICLE; BREAST CANCER; DRUG EFFICACY; DRUG SAFETY; FEBRILE NEUTROPENIA; FEMALE; HUMAN; LIVER DYSFUNCTION; LIVER METASTASIS; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL;

ADULT; AGED; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; DRUG RESISTANCE, NEOPLASM; FEMALE; HUMANS; LIVER NEOPLASMS; MIDDLE AGED; PACLITAXEL; PALLIATIVE CARE; RETROSPECTIVE STUDIES; SURVIVAL ANALYSIS; TAXOIDS; TREATMENT OUTCOME;

EID: 0032829692     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0959-8049(99)00174-4     Document Type: Article

References (30)

1. Mouridsen H.T. Systemic therapy of advanced breast cancer. Drugs. 44(Suppl. 4):1992;17-28.
2. Rouësse J., Soulié P., Delalande B.et al. Survival outcome from a cohort of 953 metastatic breast cancer patients reffered and treated in a single institution during the last 40 years. Proc. Am. Soc. Clin. Oncol. 15:1996;105. (abstract 85).
3. Nabholtz J.M., Thuerlimann B., Bezwoda W.R.et al. Taxotere versus mitomycin C and vinblastine in patients with metastatic breast cancer who have failed an anthracycline-containing regimen. preliminary results of a randomized phase III study Proc. Am. Soc. Clin. Oncol. 16:1997;148a. (abstract 519).
4. Degardin M., Bonneterre J., Hecquet B.et al. Vinorelbine (navelbine) as a salvage treatment for advanced breast cancer. Ann. Oncol. 5:1994;423-426.
5. Jones S., Winer E., Vogel C.et al. Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer. J. Clin. Oncol. 13:1995;2567-2574.
6. Chevallier B., Fumoleau P., Kerbrat P.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. 13:1995;314-322.
7. 2 as first-line chemotherapy for patients with advanced breast cancer. report of the clinical screening group of the EORTC Br. J. Cancer. 74:1996;650-656.
8. Fumoleau P., Chevallier B., Kerbrat P.et al. A multicentre phase II study of the efficacy and safety of docetaxel as first-line treatment of advanced breast cancer. report of the clinical screening group of the EORTC Ann. Oncol. 7:1996;165-171.
9. Hudis C.A., Seidman A.D., Crown J.P.A.et al. Phase II and pharmacologic study of docetaxel as initial chemotherapy for metastatic breast cancer. J. Clin. Oncol. 14:1996;58-65.
10. Trudeau M.E., Eisenhauer E.A., Higgins B.P.et al. Docetaxel in patients with metastatic breast cancer. a phase II study of the National Cancer Institute of Canada - clinical trials group J. Clin. Oncol. 14:1996;422-428.
11. Adachi I., Watanabe T., Takashima S.et al. A late phase II study of RP 566976 (docetaxel) in patients with advanced or recurrent breast cancer. Br. J. Cancer. 73:1996;210-216.
12. Guastalla J.P., Bonneterre J., Fumoleau P.et al. A phase II trial of docetaxel in patients with anthracycline resistant metastatic breast cancer. Eur. J. Cancer. 31(Suppl. 5):1995;S75. (abstract 348).
13. Ravdin P.M., Burris H.A., Cook G., Eisenberg P., Kane M., Bierman W.A. Phase II trial of Docetaxel in advanced anthracycline-resistant or anthracenedione-resistant breast cancer. J. Clin. Oncol. 13:1995;2879-2885.
14. Ten Bokkel Huinink W.W., Prove A.M., Piccart M.et al. A phase II trial with docetaxel (Taxotere) in second line treatment with chemotherapy for advanced breast cancer. Ann. Oncol. 5:1994;527-532.
15. Valero V., Holmes F.A., Walters R.S.et al. Phase II of docetaxel. a new highly effective antineoplastic agent in the management of patients with anthracycline-resistant metastatic breast cancer J. Clin. Oncol. 13:1995;2886-2894.
16. Riva A., Fumoleau P., Roche H.et al. Efficacy and safety of different corticosteroid premedications in breast cancer patients treated with Taxotere. Proc. Am. Soc. Clin. Oncol. 16:1997;188a. (abstract 660).
17. Bruno R., Sanderink G.J. Pharmacokinetics and metabolism of Taxotere (docetaxel). Cancer Surv. 17:1993;305-313.
18. Bruno R., Hille D., Riva A.et al. Population pharmacokinetics/pharmacodynamics of docetaxel in phase II studies in patients with cancer. J. Clin. Oncol. 16:1998;187-196.
19. Klink-Alakl M., Riva A., Bruno R., Azli N., Lebecq A. Taxotere safety profile in patients with liver metastases with or without impaired liver function. Proc. Am. Soc. Clin. Oncol. 16:1997;220a. (abstract 770).
20. Miller A.B., Hoogstraten B., Staquet M., Winkler A. Reporting results of cancer treatment. Cancer. 47:1981;207-214.
21. Kaplan E., Meier P. Non parametric estimation from incomplete observation. J. Am. Stat. Assoc. 53:1958;457-471.
22. Trandafir L., Chahine A., Spielman M.et al. Efficacy of Taxotere in advanced breast cancer patients not eligible for further anthracyclines. Proc. Am. Soc. Clin. Oncol. 15:1996;105. (abstract 86).
23. Bonneterre J, Misset JL, Guastalla JP et al. Feasibility and safety of Taxotere in heavily pre-treated metastatic breast cancer: preliminary report of a multicentre compassionate use program. Proc Am Soc Clin Oncol 1996, 15 (abstract 130).
24. Alexandre J., Misset J.L., Viens P.et al. Antitumoral efficacy of Taxotere in women with anthracycline mitoxantrone resistant or contraindicated advanced breast cancer from the French extended access program. Proc. Am. Soc. Clin. Oncol. 16:1997;157a. (abstract 547).
25. Bonneterre M.E., Mahjoubi M., Faivre S.et al. A safety/toxicity analysis of the French Taxotere extended access program in advanced breast cancer patients with resistance or contraindication to anthracyclines. Proc. Am. Soc. Clin. Oncol. 16:1997;162a. (abstract 563).
26. Dillman R.O. Why event-free survival is better than tumor response or other measures of survival as an endpoint in cancer trials. Cancer Biotherapy Radiopharmaceuticals. 11:1996;99-104.
27. Goldhirsch A., Gelber A., Castiglione M. Relapse of breast cancer after adjuvant treatment in premenopausal and perimenopausal women. patterns and prognoses J. Clin. Oncol. 6:1988;89-97.
28. Leonard R.C.F., O'Brien M., Barrett-Lee P., Maling S.J., Eggleton S.P.H. 2 year outcome analysis of 377 pretreated advanced breast cancer patients treated with docetaxel in a community setting. Proc. Am. Soc. Clin. Oncol. 17:1998;112a. (abstract 434).
29. Abrams J.S., Vena D.A., Baltz J.et al. Paclitaxel activity in heavily pretreated breast cancer. a national cancer institute treatment referral center trial J. Clin. Oncol. 13:1995;2056-2065.
30. Alexandre J, Bonneterre J, Bleuzen P, et al. Factors predicting for efficacy and safety of docetaxel in a compassionate-use cohort of 825 heavily pretreated advanced breast cancer patients. J Clin Oncol 1999, in press.