Docetaxel-containing adjuvant chemotherapy in patients with early stage breast cancer. Consistency of effect independent of nodal and biomarker status: a meta-analysis of 14 randomized clinical trials
详细信息    查看全文
  • 作者:Jean-Philippe Jacquin (1)
    Stephen Jones (2)
    Nicolas Magné (1)
    Céline Chapelle (3)
    Paul Ellis (4)
    Wolfgang Janni (5)
    Dimitrios Mavroudis (6)
    Miguel Martín (7)
    Silvy Laporte (389) Silvy.laporte@chu-st-etienne.fr
  • 关键词:Breast cancer – Taxanes – Docetaxel – Node ; negative – Meta ; analysis – Disease ; free survival
  • 刊名:Breast Cancer Research and Treatment
  • 出版年:2012
  • 出版时间:August 2012
  • 年:2012
  • 卷:134
  • 期:3
  • 页码:903-913
  • 全文大小:383.1 KB
  • 参考文献:1. Early Breast Cancer Trialists Collaborative Group (EBCTCG) (2005) Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomized trials. Lancet 365:1687–1717
    2. Chevallier B, Fumoleau P, Kerbrat P, Dieras V, Roche H, Krakowski I, Azli N, Bayssas M, Lentz MA, Van Glabbeke M (1995) Docetaxel is a major 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 13:314–322
    3. Chan S, Friedrichs K, Noel D, Pintér T, Van Belle S, Vorobiof D, Duarte R, Gil Gil M, Bodrogi I, Murray E, Yelle L, von Minckwitz G, Korec S, Simmonds P, Buzzi F, González Mancha R, Richardson G, Walpole E, Ronzoni M, Murawsky M, Alakl M, Riva A, Crown J, 303 Study Group (1999) Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol 17:2341–2354
    4. Ghersi D, Wilcken N, Simes RJ (2005) A systematic review of taxane-containing regimens for metastatic breast cancer. Br J Cancer 93:293–301
    5. Piccart-Gebhart MJ, Burzykowski T, Buyse M, Sledge G, Carmichael J, Lück HJ, Mackey JR, Nabholtz JM, Paridaens R, Biganzoli L, Jassem J, Bontenbal M, Bonneterre J, Chan S, Basaran GA, Therasse P (2008) Taxanes alone or in combination with anthracyclines as first-line therapy of patients with metastatic breast cancer. J Clin Oncol 26:1980–1986
    6. Ferguson T, Wilcken N, Vagg R, Ghersi D, Nowak AK (2007) Taxanes for adjuvant treatment of early breast cancer. Cochrane Database Syst Rev (4):CD004421
    7. De Laurentiis M, Cancello G, D’Agostino D, Giuliano M, Giordano A, Montagna E, Lauria R, Forestieri V, Esposito A, Silvestro L, Pennacchio R, Criscitiello C, Montanino A, Limite G, Bianco AR, De Placido S (2008) Taxane-based combinations as adjuvant chemotherapy of early breast cancer: a meta-analysis of randomized trials. J Clin Oncol 26:44–53
    8. Martín M, Lluch A, Seguí MA, Ruiz A, Ramos M, Adrover E, Rodríguez-Lescure A, Grosse R, Calvo L, Fernandez-Chacón C, Roset M, Antón A, Isla D, del Prado PM, Iglesias L, Zaluski J, Arcusa A, López-Vega JM, Mu?oz M, Mel JR (2006) Toxicity and health-related quality of life in breast cancer patients receiving adjuvant docetaxel, doxorubicin, cyclophosphamide (TAC) or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC): impact of adding primary prophylactic granulocyte-colony stimulating factor to the TAC regimen. Ann Oncol 17:1205–1212
    9. Martín M, Seguí MA, Antón A, Ruiz A, Ramos M, Adrover E, Aranda I, Rodríguez-Lescure A, Grosse R, Calvo L, Barnadas A, Isla D, Martinez del Prado P, Ruiz Borrego M, Zaluski J, Arcusa A, Mu?oz M, López Vega JM, Mel JR, Munarriz B, Llorca C, Jara C, Alba E, Florián J, Li J, López García-Asenjo JA, Sáez A, Rios MJ, Almenar S, Peiró G, Lluch A, AMGEIC 9805 Investigators (2010) Adjuvant docetaxel for high-risk, node-negative breast cancer. N Engl J Med 363:2200–2210
    10. Goldstein LJ, O’Neill A, Sparano JA, Perez EA, Shulman LN, Martino S, Davidson NE (2008) Concurrent doxorubicin plus docetaxel is not more effective than concurrent doxorubicin plus cyclophosphamide in operable breast cancer with 0 to 3 positive axillary nodes: North American Breast Cancer Intergroup Trial E 2197. J Clin Oncol 26:4092–4099
    11. Sylvester R, Collette L, Duchateau L (2000) The role of meta-analyses in assessing cancer treatments. Eur J Cancer 36:1351–1358
    12. Egger M, Smith GD, Phillips AN (1997) Meta-analysis: principles and procedures. BMJ 315:1533–1537
    13. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, McQuay HJ (1996) Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Control Clin Trials 17:1–12
    14. Michiels S, Piedbois P, Burdett S, Syz N, Stewart L, Pignon JP (2005) Meta-analysis when only the median survival times are known: a comparison with individual patient data results. Int J Technol Assess Health Care 21:119–125
    15. Parmar M, Torri V, Stewart L (1998) Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints. Stat Med 17:2815–2834
    16. Deeks J, Altman D, Bradburn M (2001) Statistical methods for examining heterogeneity and combining results from several studies in metaanalysis. In: Egger M (ed) Systematic reviews in health care. Metaanalysis in context. BMJ Books, London
    17. Sterne JA, Gavaghan D, Egger M (2000) Publication and related bias in meta-analysis: power of statistical tests and prevalence in the literature. J Clin Epidemiol 53:1119–1129
    18. EasyMA.net. http://www.spc.univ-lyon1.fr/easyma.net. Accessed 5 March 2007
    19. Jones SE, Savin MA, Holmes FA, O’Shaughnessy JA, Blum JL, Vukelja S, McIntyre KJ, Pippen JE, Bordelon JH, Kirby R, Sandbach J, Hyman WJ, Khandelwal P, Negron AG, Richards DA, Anthony SP, Mennel RG, Boehm KA, Meyer WG, Asmar L. (2006) Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol 24:5381–5387. Erratum in: J Clin Oncol 2007;25:1819
    20. Jones S, Holmes FA, O’Shaughnessy J, Blum JL, Vukelja SJ, McIntyre KJ, Pippen JE, Bordelon JH, Kirby RL, Sandbach J, Hyman WJ, Richards DA, Mennel RG, Boehm KA, Meyer WG, Asmar L, Mackey D, Riedel S, Muss H, Savin MA (2009) Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide: 7-year follow-up of US Oncology Research Trial 9735. J Clin Oncol 27:1177–1183
    21. Ellis P, Barrett-Lee P, Johnson L, Cameron D, Wardley A, O’Reilly S, Verrill M, Smith I, Yarnold J, Coleman R, Earl H, Canney P, Twelves C, Poole C, Bloomfield D, Hopwood P, Johnston S, Dowsett M, Bartlett JM, Ellis I, Peckitt C, Hall E, Bliss JM, TACT Trial Management Group, TACT Trialists (2009) Sequential docetaxel as adjuvant chemotherapy for early breast cancer (TACT): an open-label, phase III, randomised controlled trial. Lancet 373:1681–1692
    22. Brain EG, Bachelot T, Serin D, Kirscher S, Graic Y, Eymard JC, Extra JM, Combe M, Fourme E, Noguès C, Rou?ssé J, RAPP-01 Trial Investigators (2005) Life-threatening sepsis associated with adjuvant doxorubicin plus docetaxel for intermediate-risk breast cancer. JAMA 293:2367–2371
    23. Brain EG, Debled M, Eymard J-C, Bachelot T, Extra J-M, Serin D, Combe M, Fourme E, Group of RAPP-01 Investigators (2008) Final results of the RAPP-01 Phase III Trial comparing doxorubicin and docetaxel with doxorubicin and cyclophosphamide in the adjuvant treatment of high-risk node negative and limited node positive (<=3) breast cancer patients. SABCS 2008. Cancer Res 69:82s. Abstr. 4101
    24. Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, Jukkola-Vuorinen A, Tanner M, Asola R, Kokko R, Ahlgren J, Auvinen P, Hemminki A, Paija O, Helle L, Nuortio L, Villman K, Nilsson G, Lahtela SL, Lehti? K, Pajunen M, Poikonen P, Nyandoto P, Kataja V, Bono P, Leinonen M, Lindman H, FinXX Study Investigators (2009) Adjuvant capecitabine in combination with docetaxel and cyclophosphamide plus epirubicin for breast cancer: an open-label, randomised controlled trial. J Clin Oncol 10:1145–1151
    25. Joensuu H, Sailas L, Alanko T, Sunela K, Huuhtanen R, Utriainen M, Kokko R, Bono P, Wigren T, Pyrh?nen S, Turpeenniemi-Hujanen T, Asola R, Leinonen M, Hahka-Kemppinen M, Kellokumpu-Lehtinen P (2010) Docetaxel versus docetaxel alternating with gemcitabine as treatments of advanced breast cancer: final analysis of a randomised trial. Ann Oncol 21:968–973
    26. Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C, Breast Cancer International Research Group 001 Investigators (2005) Adjuvant docetaxel for node-positive breast cancer. N Engl J Med 352:2302–2313
    27. Hugh J, Hanson J, Cheang MC, Nielsen TO, Perou CM, Dumontet C, Reed J, Krajewska M, Treilleux I, Rupin M, Magherini E, Mackey J, Martin M, Vogel C (2009) Breast cancer subtypes and response to docetaxel in node-positive breast cancer: use of an immunohistochemical definition in the BCIRG 001 trial. J Clin Oncol 27:1168–1176
    28. Cognetti F, De Laurentiis M, De Matteis A, Manzione L, Boni C, Palazzo S, Di Palma M, Papaldo P, De Placido S, Bianco AR, on behalf of the Taxit 216 Investigators (2008) Sequential epirubicin–docetaxel–CMF as adjuvant therapy for node-positive early stage breast cancer: updated results of the TAXit216 randomized trial. Ann Oncol 19(Suppl. 8):viii77. Abstr. 182-0
    29. Bianco AR, De Laurentiis M, De Placido S, De Matteis A, Manzione L, Papaldo P, Bilancia D, Di Rella F, Rossi S, Cognetti F (2008) Sequential epirubicin–docetaxel–CMF as adjuvant therapy for node-positive early-stage breast cancer: subgroup analysis of the TAXit216 randomized trial. ASCO 2008. J Clin Oncol 26(S1):Abstr. 187
    30. Roché H, Fumoleau P, Spielmann M, Canon JL, Delozier T, Serin D, Symann M, Kerbrat P, Soulié P, Eichler F, Viens P, Monnier A, Vindevoghel A, Campone M, Goudier MJ, Bonneterre J, Ferrero JM, Martin AL, Genève J, Asselain B (2005) Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial. J Clin Oncol 24:5664–5671
    31. Francis P, Crown J, Di Leo A, Buyse M, Balil A, Andersson M, Nordenskj?ld B, Lang I, Jakesz R, Vorobiof D, Gutiérrez J, van Hazel G, Dolci S, Jamin S, Bendahmane B, Gelber RD, Goldhirsch A, Castiglione-Gertsch M, Piccart-Gebhart M, BIG 02-98 Collaborative Group (2008) Adjuvant chemotherapy with sequential or concurrent anthracycline and docetaxel: Breast International Group 02-98 randomized trial. J Natl Cancer Inst 100:121–133. Erratum in: J Natl Cancer Inst 2008; 100:1655
    32. Nitz U, Huober J, Lisboa B, Harbeck N, Fischer H, Moebus V, Hoffmann G, Augustin D, Weiss E, Gluz O, Kuhn W, on behalf of the West German Study Group (WSG) and the AGO Mamma (2008) Superiority of sequential EC docetaxel over standard FE100C in patients with intermediate risk breast cancer: survival results of the randomized intergroup phase III trial: EC-Doc. SABCS 2008. Cancer Res 69:82s. Abstr. 78
    33. Polyzos A, Malamos N, Boukovinas I, Adamou A, Ziras N, Kalbakis K, Kakolyris S, Syrigos K, Papakotoulas P, Kouroussis C, Karvounis N, Vamvakas L, Christophyllakis C, Athanasiadis A, Varthalitis I, Georgoulias V, Mavroudis D (2009) FEC versus sequential docetaxel followed by epirubicin/cyclophosphamide as adjuvant chemotherapy in women with axillary node-positive early breast cancer: a randomized study of the Hellenic Oncology Research Group (HORG). Breast Cancer Res Treat 119:95–104
    34. Roché H, Allouache D, Romieu G, Bourgeois H, Canon JL, Serin D, Viens P, Mauriac L, Monnier A, Vindevoghel A, Dohollou N, Luporsi E, Ferrero JM, Audhuy B, Dopchie C, Cany L, Brain E, Jimenez M, Roca L, Spielmann M, for the FNCLCC Breast Group (2010) Five year analysis of the FNCLCC-PACS04 Trial: FEC 100 vs ED75 for adjuvant treatment of node-positive breast cancer. Cancer Res 69(24 Suppl):Abstr. 603
    35. Janni W, Harbeck N, Sommer H, Rack B, Augustin D, Simon W, Jueckstock J, Wischnik A, Annecke K, Friese K, Kiechle M (2010) Sequential treatment with epirubicin/cyclophosphamide, followed by docetaxel is equieffective, but less toxic than FEC120 in the adjuvant treatment of breast cancer patients with extensive lymph node involvement: the German ADEBAR Phase III Study. Cancer Res 69(24 Suppl):Abstr. 604
    36. Bria E, Nistico C, Cuppone F, Carlini P, Ciccarese M, Milella M, Natoli G, Terzoli E, Cognetti F, Giannarelli D (2006) Benefit of taxanes as adjuvant chemotherapy for early breast cancer: pooled analysis of 15,500 patients. Cancer 106:2337–2344
    37. Eiermann W, Pienkowski T, Crown J, Chap L, Pawlicki M, Martin M, Chan A, Saleh M, Sehdev S, Provencher L, von Minckwitz G, Semiglazov V, Slamon D, Tabah-Fisch I, Buyse M, Riva A, Taupin H, Sauter G, Mackey J, on behalf of the BCIRG 005 investigators (2009) BCIRG 005, main efficacy analysis: a phase III randomized trial comparing docetaxel in combination with doxorubicin and cyclophosphamide (TAC) versus doxorubicin and cyclophosphamide followed by docetaxel (AC–T) in women with Her2 negative axillary lymph node positive early breast cancer. SABCS 2008 proceedings. Cancer Res 69(Suppl):Abstr. 77
    38. Henderson IC, Berry DA, Demetri GD, Cirrincione CT, Goldstein LJ, Martino S, Ingle JN, Cooper MR, Hayes DF, Tkaczuk KH, Fleming G, Holland JF, Duggan DB, Carpenter JT, Frei E III, Schilsky RL, Wood WC, Muss HB, Norton L (2003) Improved outcomes from adding sequential paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol 21:976–983
    39. Crown J, O’Leary M, Ooi WS (2004) Docetaxel and paclitaxel in the treatment of breast cancer: a review of clinical experience. Oncologist 9(Suppl 2):24–32
    40. Andre F, Broglio K, Roche H, Martin M, Mackey JR, Penault-Llorca F, Hortobagyi GN, Pusztai L (2008) Estrogen receptor expression and efficacy of docetaxel-containing adjuvant chemotherapy in patients with node-positive breast cancer: results from a pooled analysis. J Clin Oncol 26:2636–2643
  • 作者单位:1. Institut de Cancérologie de la Loire, Oncologie Médicale, Saint-Priest en Jarez, France2. US Oncology Research, Houston, TX, USA3. Inserm, CIE3, 42055 Saint-Etienne, France4. Guy’s and St Thomas-NHS Trust, London, UK5. Frauenklinik, Klinikum der Heinrich-Heine-Universit?t Düsseldorf, Düsseldorf, Germany6. Department of Medical Oncology, University Hospital of Heraklion, Voutes, Greece7. Medical Oncology Department, Hospital Gregorio Maranon, Madrid, Spain8. EA3065, Université Jean Monnet, 42023 Saint-Etienne, France9. Unité de Recherche Clinique, Innovation, Pharmacologie, CHU Saint-Etienne, H?pital Nord, Batiment Recherche, Avenue Albert Raimond, 42055 Saint-Etienne, France
  • ISSN:1573-7217
文摘
The benefit of taxanes in the adjuvant setting for node-negative (N0) early breast cancer (EBC) has not yet been established. We conducted a meta-analysis of randomized adjuvant trials comparing docetaxel-containing versus non-taxane-containing regimens. The purpose of this study was to determine whether the incorporation of docetaxel improves disease-free survival (DFS) and overall survival (OS) in early stage breast cancer. Studies were retrieved by searching major databases and the proceedings of leading breast cancer conferences. We extracted hazard ratios (HRs) and 95% confidence intervals (CIs) for DFS and OS and obtained pooled estimates using an inverse-variance model. Fourteen randomized phase III studies were included (25,067 patients). The pooled HR estimate was 0.84 (95% CI 0.78–0.89; P < 0.001) favoring docetaxel for DFS and 0.86 (0.78–0.94; P < 0.001) for OS. In N0 patients (4,274 patients), the pooled HR estimate for DFS was 0.86 (0.73–1.00; P = 0.05). The HR for OS was equal to 1 (0.75–1.34). The improvement in DFS with docetaxel-containing regimens was observed across all subgroups (age, under or over 50; number of involved nodes; hormone receptor or HER2 status (including triple negative status), or administration schedule (sequential or concomitant). The addition of docetaxel to a non-taxane-containing regimen improves DFS and OS in high risk EBC patients. The benefit in DFS was seen across all subgroups regardless of nodal status, age, hormone receptor or HER2 status (including triple negative status), or administration schedule.

© 2004-2018 中国地质图书馆版权所有 京ICP备05064691号 京公网安备11010802017129号

地址:北京市海淀区学院路29号 邮编:100083

电话:办公室:(+86 10)66554848;文献借阅、咨询服务、科技查新:66554700