If there is no overall survival benefit in metastatic breast cancer: Does it imply lack of efficacy? Taxanes as an example

Cancer Treatment Reviews

Volumn 39, Issue 2, 2013, Pages 189-198

  Vriens, Birgit E P J ^a,c   Lobbezoo, Dorien J A ^a,b   de Hoon, Joep P J ^a,c   Veeck, Jürgen ^a,c   Voogd, Adri C ^a,d   Tjan Heijnen, Vivianne C G ^a,c  

^a MAASTRICHT UNIVERSITY   (Netherlands)

^b MÁXIMA MEDICAL CENTER   (Netherlands)

^c MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^d MAASTRICHT UNIVERSITY   (Netherlands)

Author keywords

Breast cancer; Chemotherapy; Docetaxel; Paclitaxel; Taxanes

Indexed keywords

ANTHRACYCLINE; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; EPIRUBICIN; FLUOROURACIL; PACLITAXEL; TAXANE DERIVATIVE;

BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; DRUG EFFICACY; HUMAN; META ANALYSIS; MULTIPLE CYCLE TREATMENT; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL (TOPIC); REVIEW; SYSTEMATIC REVIEW;

BREAST NEOPLASMS; CLINICAL TRIALS AS TOPIC; FEMALE; HUMANS; NEOPLASM METASTASIS; SURVIVAL ANALYSIS; TAXOIDS; TREATMENT OUTCOME;

EID: 84869887080     PISSN: 03057372     EISSN: 15321967     Source Type: Journal    
DOI: 10.1016/j.ctrv.2012.04.005     Document Type: Review

References (54)

1. Ghersi D., Wilcken N., Simes J., Donoghue E. Taxane containing regimens for metastatic breast cancer. Cochrane Database Syst Rev 2005, 2:CD003366.
2. Piccart-Gebhart M.J., Burzykowski T., Buyse M., Sledge G., Carmichael J., Luck H.J., et al. Taxanes alone or in combination with anthracyclines as first-line therapy of patients with metastatic breast cancer. J Clin Oncol 2008, 26(12):1980-1986.
3. Ferguson T., Wilcken N., Vagg R., Ghersi D., Nowak A.K. Taxanes for adjuvant treatment of early breast cancer. Cochrane Database Syst Rev 2007, CD004421.
4. Bria E., Nistico C., Cuppone F., Carlini P., Ciccarese M., Milella M., et al. Benefit of taxanes as adjuvant chemotherapy for early breast cancer: pooled analysis of 15,500 patients. Cancer 2006, 106(11):2337-2344.
5. De Laurentiis M., Cancello G., D'Agostino D., Giuliano M., Giordano A., Montagna E., et al. Taxane-based combinations as adjuvant chemotherapy of early breast cancer: a meta-analysis of randomized trials. J Clin Oncol 2008, 26(1):44-53.
6. Cardoso F., Senkus-Konefka E., Fallowfield L., Costa A., Castiglione M. Locally recurrent or metastatic breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010, 21(Suppl 5):v15-v19.
7. Citron M.L., Berry D.A., Cirrincione C., Hudis C., Winer E.P., Gradishar W.J., et al. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol 2003, 21(8):1431-1439.
8. Tierney J.F., Stewart L.A., Ghersi D., Burdett S., Sydes M.R. Practical methods for incorporating summary time-to-event data into meta-analysis. Trials 2007, 8:16.
9. Martin M., Rodriguez-Lescure A., Ruiz A., Alba E., Calvo L., Ruiz-Borrego M., et al. Randomized phase 3 trial of fluorouracil, epirubicin, and cyclophosphamide alone or followed by Paclitaxel for early breast cancer. J Natl Cancer Inst 2008, 100(11):805-814.
10. Sledge G.W., Neuberg D., Bernardo P., Ingle J.N., Martino S., Rowinsky E.K., et al. Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193). J Clin Oncol 2003, 21(4):588-592.
11. Chan S., Friedrichs K., Noel D., Pinter T., Van Belle S., Vorobiof D., et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol 1999, 17(8):2341-2354.
12. Paridaens R., Biganzoli L., Bruning P., Klijn J.G., Gamucci T., Houston S., et al. 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(4):724-733.
13. Nabholtz J.M., Falkson C., Campos D., Szanto J., Martin M., Chan S., et al. Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, phase III trial. J Clin Oncol 2003, 21(6):968-975.
14. Blohmer J.U., Schmid P., Hilfrich J., Friese K., Kleine-Tebbe A., Koelbl H., et al. Epirubicin and cyclophosphamide versus epirubicin and docetaxel as first-line therapy for women with metastatic breast cancer: final results of a randomised phase III trial. Ann Oncol 2010, 21(7):1430-1435.
15. Langley R.E., Carmichael J., Jones A.L., Cameron D.A., Qian W., Uscinska B., et al. Phase III trial of epirubicin plus paclitaxel compared with epirubicin plus cyclophosphamide as first-line chemotherapy for metastatic breast cancer: United Kingdom National Cancer Research Institute trial. J Clin Oncol 2005, 23(33):8322-8330.
16. Luck H., Thomssen C., Untch M., Kuhn W., Eidtmann H., Bois du A., et al. Multicentric phase III study in first line treatment of advanced metastatic breast cancer. Epirubicin/Paclitaxel (ET) vs Epirubicin/Cyclophosphamide (EC). A study of the Ago breast cancer group. J Clin Oncol 2000, 19:280. [abstract].
17. Biganzoli L., Cufer T., Bruning P., Coleman R., Duchateau L., Calvert A.H., et al. Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: The European Organization for Research and Treatment of Cancer 10961 Multicenter Phase III Trial. J Clin Oncol 2002, 20(14):3114-3121.
18. Bontenbal M., Creemers G.J., Braun H.J., de Boer A.C., Janssen J.T., Leys R.B., et al. Phase II to III study comparing doxorubicin and docetaxel with fluorouracil, doxorubicin, and cyclophosphamide as first-line chemotherapy in patients with metastatic breast cancer: results of a Dutch Community Setting Trial for the Clinical Trial Group of the Comprehensive Cancer Centre. J Clin Oncol 2005, 23(28):7081-7088.
19. Jassem J., Pienkowski T., Pluzanska A., Jelic S., Gorbunova V., Berzins J., et al. Doxorubicin and paclitaxel versus fluorouracil, doxorubicin and cyclophosphamide as first-line therapy for women with advanced breast cancer: long-term analysis of the previously published trial. Onkologie 2009, 32(8-9):468-472.
20. Alba E., Martin M., Ramos M., Adrover E., Balil A., Jara C., et al. Multicenter randomized trial comparing sequential with concomitant administration of doxorubicin and docetaxel as first-line treatment of metastatic breast cancer: a Spanish Breast Cancer Research Group phase III study. J Clin Oncol 2004, 22(13):2587-2593.
21. Jones S., Holmes F.A., O'Shaughnessy J., Blum J.L., Vukelja S.J., McIntyre K.J., et al. 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 2009, 27(8):1177-1183.
22. Martin M., Pienkowski T., Mackey J., Pawlicki M., Guastalla J.P., Weaver C., et al. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med 2005, 352(22):2302-2313.
23. Martin M., Segui M.A., Anton A., Ruiz A., Ramos M., Adrover E., et al. Adjuvant docetaxel for high-risk, node-negative breast cancer. N Engl J Med 2010, 363(23):2200-2210.
24. Goldstein L.J., O'Neill A., Sparano J.A., Perez E.A., Shulman L.N., Martino S., et al. 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 2008, 26(25):4092-4099.
25. Brain E.G., Debled M., Eymard J.-C., Bachelot T., Extra J.-M., Serin D., et al. 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 breast cancer patients. Cancer Res 2009, 69(2):4101. [abstract].
26. Francis P., Crown J., Di Leo A., Buyse M., Balil A., Andersson M., et al. Adjuvant chemotherapy with sequential or concurrent anthracycline and docetaxel: Breast International Group 02-98 randomized trial. J Natl Cancer Inst 2008, 100(2):121-133.
27. Roché H., Allouache D., Romieu G., Bourgeois H., Canon J.-L., Serin D., et al. Five-year analysis of the FNCLCC-PACS04 Trial: FEC100 vs ED75 for the adjuvant treatment of node positive breast cancer. Cancer Res 2009, 69(24):602. [abstract].
28. Del Mastro L., Constantini M., Durando A., Michelotti A., Danese S., Aitini E., et al. Venturini M and Gruppo Oncologico Nord Ovest - Mammella Intergruppo Cyclophosphamide, epirubicin, and 5-fluorouracil versus epirubicin plus paclitaxel in node-positive early breast cancer patients: a randomized, phase III study of Gruppo Oncologico Nord Ovest-Mammella Intergruppo Group. J Clin Oncol 2008, 26(15S):516. [abstract].
29. Jones S.E., Savin M.A., Holmes F.A., O'Shaughnessy J.A., Blum J.L., Vukelja S., et al. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol 2006, 24(34):5381-5387.
30. Polyzos A., Malamos N., Boukovinas I., Adamou A., Ziras N., Kalbakis K., et al. 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 2010, 119(1):95-104.
31. Nitz U., Huober J., Lisboa B., Harbeck N., Fischer H., Moebus V., et al. Superiority of sequential docetaxel over standard FE100C in patients with intermediate risk breast cancer: survival results of the randomized intergroup phase III trial EC-Doc. Cancer Res 2009, 69(2):78. [abstract].
32. Ellis P., Barrett-Lee P., Johnson L., Cameron D., Wardley A., O'Reilly S., et al. Sequential docetaxel as adjuvant chemotherapy for early breast cancer (TACT): an open-label, phase III, randomised controlled trial. Lancet 2009, 373(9676):1681-1692.
33. Roche H., Fumoleau P., Spielmann M., Canon J.L., Delozier T., Serin D., et al. Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial. J Clin Oncol 2006, 24(36):5664-5671.
34. Buzdar A.U., Singletary S.E., Valero V., Booser D.J., Ibrahim N.K., Rahman Z., et al. Evaluation of paclitaxel in adjuvant chemotherapy for patients with operable breast cancer: preliminary data of a prospective randomized trial. Clin Cancer Res 2002, 8(5):1073-1079.
35. Janni W., Harbeck N., Sommer H.L., Rack B.K., Augustin D., Simon W., et al. AGO-Study Group. Phase III study of sequential treatment with epirubicin/cyclophosphamide followed by docetaxel compared to FEC120 in the adjuvant treatment of breast cancer patients: the German ADEBAR study. J Clin Oncol 2010, 28(15s):535. [abstract].
36. Burnell M., Levine M.N., Chapman J.A., Bramwell V., Gelmon K., Walley B., et al. Cyclophosphamide, epirubicin, and Fluorouracil versus dose-dense epirubicin and cyclophosphamide followed by Paclitaxel versus Doxorubicin and cyclophosphamide followed by Paclitaxel in node-positive or high-risk node-negative breast cancer. J Clin Oncol 2010, 28(1):77-82.
37. Gianni L., Baselga J., Eiermann W., Porta V.G., Semiglazov V., Lluch A., et al. Phase III trial evaluating the addition of paclitaxel to doxorubicin followed by cyclophosphamide, methotrexate, and fluorouracil, as adjuvant or primary systemic therapy: European Cooperative Trial in Operable Breast Cancer. J Clin Oncol 2009, 27(15):2474-2481.
38. Bianco A., De Matteis, Manzione L., Boni C., Palazzo S., Di Palma M., et al. Sequential Epirubicin-Docetaxel-CMF as adjuvant therapy of early breast cancer: results of the Taxit 216 multicenter phase III trial. J Clin Oncol 2006, 24(18S):2.
39. Mamounas E.P., Bryant J., Lembersky B., Fehrenbacher L., Sedlacek S.M., Fisher B., et al. Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28. J Clin Oncol 2005, 23(16):3686-3696.
40. Henderson I.C., Berry D.A., Demetri G.D., Cirrincione C.T., Goldstein L.J., Martino S., et al. 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 2003, 21(6):976-983.
41. Fountzilas G., Skarlos D., Dafni U., Gogas H., Briasoulis E., Pectasides D., et al. Postoperative dose-dense sequential chemotherapy with epirubicin, followed by CMF with or without paclitaxel, in patients with high-risk operable breast cancer: a randomized phase III study conducted by the Hellenic Cooperative Oncology Group. Ann Oncol 2005, 16(11):1762-1771.
42. Conte P.F., Guarneri V., Bruzzi P., Prochilo T., Salvadori B., Bolognesi A., et al. Concomitant versus sequential administration of epirubicin and paclitaxel as first-line therapy in metastatic breast carcinoma: results for the Gruppo Oncologico Nord Ovest randomized trial. Cancer 2004, 101(4):704-712.
43. Swain S.M., Jeong J.H., Geyer C.E., Costantino J.P., Pajon E.R., Fehrenbacher L., et al. Longer therapy, iatrogenic amenorrhea, and survival in early breast cancer. N Engl J Med 2010, 362(22):2053-2065.
44. Eiermann W., Pienkowski T., Crown J., Sadeghi S., Martin M., Chan A., et al. Phase III study of doxorubicin/cyclophosphamide with concomitant versus sequential docetaxel as adjuvant treatment in patients with human epidermal growth factor receptor 2-normal, node-positive breast cancer: BCIRG-005 trial. J Clin Oncol 2011, 29(29):3877-3884.
45. Peto R., Davies C., Godwin J., Gray R., Pan H.C., et al. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet 2012, 379(9814):432-444.
46. Khasraw M., Bell R., Dang C. Epirubicin: is it like doxorubicin in breast cancer? A clinical review. Breast 2012, 21:142-149.
47. Seidman A.D., Berry D., Cirrincione C., Harris L., Muss H., Marcom P.K., et al. Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840. J Clin Oncol 2008, 26(10):1642-1649.
48. Verrill M.W., Lee J., Cameron D.A., Agrawal R., Coleman R.E., McAdam K., et al. First results of a UK national cancer research network randomised phase 3 pharmacogenetic trial of weekly versus 3 weekly paclitaxel in patients with locally advanced or metastatic breast cancer. J Clin Oncol 2007, 25(18S):LBA1005.
49. Sparano J.A., Wang M., Martino S., Jones V., Perez E.A., Saphner T., et al. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med 2008, 358(16):1663-1671.
50. Rivera E., Mejia J.A., Arun B.K., Adinin R.B., Walters R.S., Brewster A., et al. Phase 3 study comparing the use of docetaxel on an every-3-week versus weekly schedule in the treatment of metastatic breast cancer. Cancer 2008, 112(7):1455-1461.
51. Stemmler H.J., Gutschow K., Sommer H., Malekmohammadi M., Kentenich C.H., Forstpointner R., et al. Weekly docetaxel (Taxotere) in patients with metastatic breast cancer. Ann Oncol 2001, 12(10):1393-1398.
52. Schroder C.P., de Munck L., Westermann A.M., Smit W.M., Creemers G.J., de Graaf H., et al. Weekly docetaxel in metastatic breast cancer patients: No superior benefits compared to three-weekly docetaxel. Eur J Cancer 2011, 47(9):1355-1362.
53. Mauri D., Polyzos N.P., Salanti G., Pavlidis N., Ioannidis J.P. Multiple-treatments meta-analysis of chemotherapy and targeted therapies in advanced breast cancer. J Natl Cancer Inst 2008, 100(24):1780-1791.
54. Sorlie T. Molecular classification of breast tumors: toward improved diagnostics and treatments. Methods Mol Biol 2007, 360:91-114.