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Zentralbl Gynakol 2001; 123(9): 520-528
DOI: 10.1055/s-2001-18225
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J.A.Barth Verlag in Medizinverlage Heidelberg GmbH & Co.KG

Die palliative Behandlung des metastasierten Mammakarzinoms mit Taxanen: Ein Wirkungsvergleich zwischen Docetaxel und Paclitaxel mittels Matched-Pair-Analyse

Taxane-based palliative chemotherapy for metastatic breast cancer: matched pair analysis to compare the efficacy and safety of docetaxel and paclitaxelA. Schneeweiss, F. Lenz, F. Beldermann, M. Geberth, R. Goerner, E. Solomayer, G. Bastert
  • Universitäts-Frauenklinik Heidelberg (Geschäftsführender Direktor: Prof. Dr. Dr. h. c. G. Bastert)
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Publication History

Publication Date:
06 November 2001 (online)

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Zusammenfassung

Um die Wirksamkeit und Toxizität von Docetaxel und Paclitaxel bei der Behandlung von Patientinnen mit metastasiertem Mammakarzinom zu vergleichen, analysierten wir retrospektiv den Krankheitsverlauf der seit 1992 in unserer Institution behandelten Patientinnen. 43 Patientinnen mit metastasiertem Mammakarzinom, die mit einem Docetaxel- haltigen Therapieregime behandelt wurden, konnten einer Kontrollgruppe von 43 Patientinnen mit der gleichen Anzahl an Vortherapien gegenübergestellt werden, die ein vergleichbares Paclitaxel- haltiges Schema erhalten hatten. Die Toxizität war in beiden Behandlungsgruppen gering. Die klinische Tumorkontrollrate (komplette oder partielle Remission oder Tumorstabilisierung für mindestens 6 Monate) lag bei Docetaxel signifikant höher als bei Paclitaxel (67 % vs. 44 %, p = 0,001). Auch waren weniger Patientinnen unter der Behandlung mit Docetaxel progredient (28 % vs. 53 %, p < 0,001). Nach einer medianen Beobachtungszeit von 17 Monaten (Spanne 5-61 Monate) bestand kein signifikanter Unterschied bezüglich der medianen progressionsfreier Zeit (7 vs. 5 Monate, p = 0,123) und der medianen Überlebenszeit (12 vs. 11 Monate, p = 0,211) zwischen beiden Gruppen. Die nach der Methode von Kaplan und Meier [17]geschätzten 1-Jahres- (74 % vs. 62 %) und 2-Jahres-Überlebensraten (50 % vs. 26 %) favorisierten allerdings eine Behandlung mit Docetaxel. Ein positiver Hormonrezeptorstatus war der einzige unabhängige Prognosefaktor für ein längeres Ü berleben in der multivariaten Analyse. Diesen Ergebnissen zufolge könnte Docetaxel beim metastasierten Mammakarzinom möglicherweise wirksamer sein als Paclitaxel.

Taxane-based palliative chemotherapy for metastatic breast cancer: matched pair analysis to compare the efficacy and safety of docetaxel and paclitaxel

Summary

Objective: A retrospective comparison of the efficacy and toxicity of docetaxel and paclitaxel in the treatment of metastatic breast cancer (MBC) was conducted based on our institution's experience since 1992. Methods: Two groups of 43 patients who received a similar chemotherapy regimen containing either docetaxel or paclitaxel were matched for the number of prior treatments. Results: Toxicity was mild in both groups. Tumour growth control, defined as either objective response or stable disease for at least 6 months, was obtained in a significantly higher proportion of patients treated with docetaxel compared with paclitaxel (67 % vs. 44 %, p = 0.001). Moreover, fewer patients progressed during treatment with docetaxel (28 % vs. 53 %, p < 0.001). At a median follow-up of 17 months there was no significant difference between the groups in median progression-free survival (7 vs. 5 months, p = 0.123) or median overall survival (OS) (12 vs. 11 months, p = 0.211). According to the method of Kaplan and Meier [17] estimated OS rates at 1 year (74 % vs. 62 %) and 2 years (50 % vs. 26 %), however, were in favour of docetaxel. In a multivariate analysis only a positive hormone receptor status was significantly associated with improved OS. Conclusion: These results suggest that docetaxel may be superior to paclitaxel in the treatment of MBC.

Schlüsselwörter

Docetaxel - Paclitaxel - metastasiertes Mammakarzinom - Ansprechen - Überleben

Key words

Docetaxel - paclitaxel - metastatic breast cancer - response - survival

Literatur

  • 1 Biganzoli L, Cufer T, Bruning P, Coleman R, Calvert H, Gamucci T, Twelves C, Donato di Paola E, Duchateau L, Yague C, Epelbaum R, Piccart M. Doxorubicin (A)/taxol (T) versus doxorubicin/cyclophosphamide (C) as first line chemotherapy in metastatic breast cancer (MBC): a phase III study.  Proc Am Soc Clin Oncol. 2000;  19 (Abstract 282) 73 a
    PubMedSearch in Google Scholar
  • 2 Bishop J F, Dewar J, Toner C G, Smith J, Tattersall M H, Olver I N, Ackland S, Kennedy I, Goldstein D, Gurney H, Walpole E, Levi J, Stephenson J, Canetta R. Initial paclitaxel improves outcome compared with CMFP combination chemotherapy as front-line therapy in untreated metastatic breast cancer.  J Clin Oncol. 1999;  17 2355-2364
    PubMedSearch in Google Scholar
  • 3 Bourgeois H, Gruia G, Dieras V, Kalla S, Giaccetti S, Cvitkovic E, Aussel J P, Azli N, Riva A, Pouillart P, Misset J L. Docetaxel in combination with doxorubicin as first-line chemotherapy of metastatic breast cancer: a phase I dose-finding study.  Proc Am Soc Clin Oncol. 1996;  15 (Abstract) 148
    PubMedSearch in Google Scholar
  • 4 Brown R E, Hutton J. Cost-utility model comparing docetaxel and paclitaxel in advanced breast cancer breast cancer patients.  Anticancer Drugs. 1998;  9 899-907
    CrossrefPubMedSearch in Google Scholar
  • 5 Chan S, Friedrichs K, Noel D, Pinter T, Van Belle S, Vorobiof D, Duarte R, Gil M, Bodrogi I, Murray E, Yelle L, von Minckwitz G, Korec S, Simmonds P, Buzzi F, Gonzalez Mancha R, Richardson G, Walpole E, Ronzoni M, Murawsky M, Alakl M, Riva A. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer.  J Clin Oncol. 1999;  17 2341-2354
    PubMedSearch in Google Scholar
  • 6 Cox D R. Regression models and life tables.  J R Stat Soc (B). 1972;  34 187-220
    PubMedSearch in Google Scholar
  • 7 Eisenhauer E A, ten Bokkel Huinink W W, Swenerton K D, Gianni L, Myles J, van der Burg M E, Kerr I, Vermorken J B, Buser K, Colombo N. et al . European-canadian randomized trial of paclitaxel in relapsed ovarian cancer: high-dose versus low-dose and long versus short infusion.  J Clin Oncol. 1994;  12 2654-2666
    PubMedSearch in Google Scholar
  • 8 Eisenhauer E A, Vermorken J B. The taxoids - comparative clinical pharmacology and therapeutic potenzial.  Drugs. 1998;  55 5-30
    PubMedSearch in Google Scholar
  • 9 Extra J M, Rousseau F, Bruno R, Clavel M, Le Bail N, Marty M. Phase I and pharmacokinetic study of Taxotere (RP569876; NSC 628503) given as a short intravenous infusion.  Cancer Res. 1993;  53 1037-1042
    PubMedSearch in Google Scholar
  • 10 Gehl J, Boesgaard M, Paaske T, Vittrup Jensen B, Dombernowsky P. Combined doxorubicin and paclitaxel in advanced breast cancer: effective and cardiotoxic.  Ann Oncol. 1996;  7 687-693
    PubMedSearch in Google Scholar
  • 11 Gianni L, Munzone E, Capri G, Fulfaro F, Tarenzi E, Villani F, Spreafico C, Laffranchi A, Caraceni A, Martini C. et al . Paclitaxel by 3-hour infusion in combination with bolus doxorubicin in women with untreated metastatic breast cancer; high antitumor efficacy and cardiac effects in a dose-finding and sequence-finding study.  J Clin Oncol. 1995;  13 2688-2699
    PubMedSearch in Google Scholar
  • 12 Gibbs H, Ewer M, Holmes F. et al . Cardiac monitoring during administration of taxol-doxorubicin chemotherapy in patients with metastatic breast cancer: A preliminary report.  Proc Am Soc Clin Oncol. 1992;  11 (Abstract) 86
    PubMedSearch in Google Scholar
  • 13 Hainsworth J D, Burris H A, Erland J B, Thomas M, Greco F A. A phase I trial of docetaxel administered by wekly infusion in patients with advanced refractory cancer.  J Clin Oncol. 1998;  16 2164-2168
    PubMedSearch in Google Scholar
  • 14 Hayward J L, Carbone P P, Heuson J-C, Kumaoka S, Segaloff A, Rubens R D. Assessment of response to therapy in advanced breast cancer.  Cancer. 1977;  39 1289-1294
    PubMedSearch in Google Scholar
  • 15 Howell A, Mackintosh J, Jones M, Redford J, Wagstaff J, Sellwood R A. The definition of the ‚no change’ category in patients treated with endocrine therapy and chemotherapy for advanced carcinoma of the breast.  Eur J Cancer Clin Oncol. 1988;  24 1567-1572
    CrossrefPubMedSearch in Google Scholar
  • 16 Hutton J, Brown R, Borowitz M, Abrams K, Rothman M, Shakespeare A. A new decision model for cost-utility comparisons of chemotherapy in recurrent metastatic breast cancer.  Pharmacoeconomics. 1996;  9 (Suppl 2) 8-22
    PubMedSearch in Google Scholar
  • 17 Kaplan E L, Meier P. Non-parametric estimation from incomplete observation.  J Am Stat Assoc. 1958;  47 457-481
    PubMedSearch in Google Scholar
  • 18 Kris M G, O'Connel J P, Gralla R, Wertheim M S, Parente R M, Schiff P B, Young C W. Phase I trial of taxol given as a 3-hour infusion every 21 days.  Cancer Treat Rep. 1986;  70 605-607
    PubMedSearch in Google Scholar
  • 19 Lamp H M, Wiseman L R. Docetaxel. A pharmacoeconomic review of its use in the treatment of metastatic breast cancer.  Pharmacoeconomics. 1998;  14 447-459
    PubMedSearch in Google Scholar
  • 20 Launois R, Reboul- Marty J, Henry B, Bonneterre J. A cost-utility analysis of second-line chemotherapy in metastatic breast cancer: docetaxel versus paclitaxel versus vinorelbine.  Pharmacoeconomics. 1996;  10 504-521
    PubMedSearch in Google Scholar
  • 21 Lö ffler T M, Freund W, Dröge C, Hausamen T U. Activity of weekly taxotere in patients with metastatic breast cancer.  Proc Am Soc Clin Oncol. 1998;  17 (Abstract) 113
    PubMedSearch in Google Scholar
  • 22 Lü ck H J, Donne S, Glaubitz M. et al . Phase I study of weekly docetaxel in heavily pretreated breast cancer patients.  Eur J Cancer. 1997;  33 (Abstract) 703
    CrossrefPubMedSearch in Google Scholar
  • 23 Lück H J, Thomssen C, Untch M, Kuhn W, Eidtmann H, du Bois A, Olbricht S, Moebus V, Steinfeld D, Bauknecht T, Schroeder W, Jackisch C. Multicentric phase III study in first line treatment of advanced metastatic breast cancer (ABC). A study of the AGO Breast Cancer Group. Epirubicin/paclitaxel (ET) vs epirubicin/cyclophosphamide (EC).  Proc Am Soc Clin Oncol. 2000;  19 (Abstract 280) 73 a
    PubMedSearch in Google Scholar
  • 24 Miller K D, McCaskill-Stevens W, Sisk J, Loesch D M, Monaco F, Seshadri R, Sledge G W. Combination versus sequential doxorubicin and docetaxel as primary chemotherapy for breast cancer: A randomized pilot trial of the Hoosier Oncology Group.  J Clin Oncol. 1999;  17 3033-3037
    PubMedSearch in Google Scholar
  • 25 Nabholtz J M, Falkson G, Campos D, Szanto J, Martin M, Chan S, Pienkowski T, Bezwoda W R, Zaluski J, Pinter T, Krzakowski M, Vorobiof D, Leonard R, Kennedy I, Azli N, Murawsky M, Riva A, Pouillart P. A phase III trial comparing doxorubicin (A) and docetaxel (T) (AT) to doxorubicin and cyclophosphamide (AC) as first line chemotherapy for MBC.  Proc Am Soc Clin Oncol. 1999;  18 (Abstract 485) 127 a
    PubMedSearch in Google Scholar
  • 26 Nabholtz J M, Senn H J, Bezwoda W R, Melnychuk D, Deschenes L, Douma J, Vandenberg T A, Rapoport B, Rosso R, Trillet-Lenoir V, Drbal J, Molino A, Nortier J W, Richel D J, Nagykalnai T, Siedlecki P, Wilking N, Genot J Y, Hupperets P S, Pannuti F, Skarlos D, Tomiak E M, Murawsky M, Alakl M, Aapro M. et al . Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy.  J Clin Oncol. 1999;  17 1413-1424
    PubMedSearch in Google Scholar
  • 27 Paridaens R, Biganzoli L, Brüning P, Klijn J G, Gamucci T, Houston S, Coleman R, Schachter J, van Vreckem A, Sylvester R, Awada A, Wildiers J, Piccart M. Paclitaxel versus doxorubicin as first-line single-agent chemotherapy for metastatic breast cancer: a European Organization for Research and Treatment of Cancer randomized study with cross-over.  J Clin Oncol. 2000;  18 724-733
    PubMedSearch in Google Scholar
  • 28 Peto R, Peto J. Asymptotically efficient rank invariant test procedures.  J R Stat Soc (A). 1972;  135 185 ff.
    PubMedSearch in Google Scholar
  • 29 Piccart M J, Klijn J, Paridaens R, Nooij M, Mauriac L, Coleman R, Bontenbal M, Awada A, Selleslags J, van Vreckem A, van Glabbeke M. Corticosteroids significantly delay the onset of docetaxel-induced fluid retention: final results of a randomized study of the European Organization for Research and Treatment of Cancer Investigational Drug Branch for Breast Cancer.  J Clin Oncol. 1997;  15 3149-3155
    PubMedSearch in Google Scholar
  • 30 Postma T J, Vermorken J B, Liefting A JM, Pinedo H M, Heimans J J. Paclitaxel induced neuropathy.  Ann Oncol. 1995;  6 489-494
    PubMedSearch in Google Scholar
  • 31 Ravdin P M, Burris H A, Cook G, Eisenberg P, Kane M, Bierman W A, Mortimer J, Genevois E, Bellet R E. Phase II trial of docetaxel in advanced anthracycline-resistant or anthracenedione-resistant breast cancer.  J Clin Oncol. 1995;  13 2879-2885
    PubMedSearch in Google Scholar
  • 32 Riou J F, Naudin A, Lavelle F. Effects of Taxotere on murine and human tumor cell lines.  Biochem Biophys Res Comm. 1992;  187 164-170
    CrossrefPubMedSearch in Google Scholar
  • 33 Rizzieri D A, Vredenburgh J J, Jones R, Ross M, Shpall E J, Hussein A, Broadwater G, Berry D, Petros W P, Gilbert C, Affronti M L, Coniglio D, Rubin P, Elkordy M, Long G D, Chao N J, Peters W P. Prognostic and predictive factors for patients with metastatic breast cancer undergoing aggressive induction therapy followed by high-dose chemotherapy with autologous stem-cell support.  J Clin Oncol. 1999;  17 3064-3074
    PubMedSearch in Google Scholar
  • 34 Robertson J F, Willsher P C, Cheung K L, Blamey R W. Clinical relevance of static disease (no change) category for 6 months on endocrine therapy in patients with breast cancer.  Eur J Cancer. 1997;  33 1774-1779
    CrossrefPubMedSearch in Google Scholar
  • 35 Sjöström J, Blomqvist C, Mouridsen H, Pluzanska A, Ottosson-Lonn S, Bengtsson N O, Ostenstad B, Mjaaland I, Palm- Sjovall M, Wist E, Valvere V, Anderson H, Bergh J. Docetaxel compared with sequential methotrexate and 5-fluorouracil in patients with advanced breast cancer after anthracycline failure: a randomized phase III study with crossover on progression by the Scandinavian Breast Group.  Eur J Cancer. 1999;  35 1194-1201
    CrossrefPubMedSearch in Google Scholar
  • 36 Valero V, Holmes F A, Walters R S, Theriault R L, Esparza L, Fraschini G, Fonseca G A, Bellet R E, Buzdar A U, Hortobagyi G N. Phase II trial of docetaxel (Taxotere®): a highly effective antineoplastic agent in the management of patients with anthracycline-resistant metastatic breast cancer.  J Clin Oncol. 1995;  13 2886-2894
    PubMedSearch in Google Scholar
  • 37 Valero V, Jones S E, von Hoff D D, Booser D J, Mennel R G, Ravdin P M, Holmes F A, Rahman Z, Schottstaedt M W, Erban J K, Esparza-Guerra L, Earhart R H, Hortobagyi G N, Burris H A. A phase II study of docetaxel in patients with paclitaxel- resistant metastatic breast cancer.  J Clin Oncol. 1998;  16 3362-3368
    PubMedSearch in Google Scholar
  • 38 Valero V. Treatment of patients resistant to paclitaxel therapy.  Anti-cancer Drugs. 1996;  7 (Suppl 2) 17-19
    PubMedSearch in Google Scholar
  • 39 Vogel M, Hilsenbeck S G, Depenbrock H, Danhauser-Riedl S, Block T, Nekarda H, Fellbaum C, Aapro M S, Bissery M C, Rastetter J. et al . Preclinical activity of taxotere (RP 56976, NSC 628503) against freshly explanted clonogenic human tumour cells: Comparison with taxol and conventional antineoplastic agents.  Eur J Cancer. 1993;  29 A 2009-2014
    CrossrefPubMedSearch in Google Scholar

Dr. Andreas Schneeweiss

Universitäts-Frauenklinik

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Email: andreas_schneeweiss@med.uni-heidelberg.de