Adjuvant capecitabine in combination with docetaxel and cyclophosphamide plus epirubicin for breast cancer: an open-label, randomised controlled trial

The Lancet Oncology

Volumn 10, Issue 12, 2009, Pages 1145-1151

  Joensuu, Heikki ^a   Kellokumpu Lehtinen, Pirkko Liisa ^b   Huovinen, Riikka ^c   Jukkola Vuorinen, Arja ^d   Tanner, Minna ^b   Asola, Raija ^e   Kokko, Riitta ^f   Ahlgren, Johan ^g   Auvinen, Päivi ^h   Hemminki, Akseli ^a   Paija, Outi ^c   Helle, Leena ⁱ   Nuortio, Lauri ^j   Villman, Kenneth ^k   Nilsson, Greger ^l   Lahtela, Sirpa Liisa ^a   Lehtiö, Kaisa ^a   Pajunen, Marjo ^m   Poikonen, Paula ^a   Nyandoto, Paul ⁿ   Kataja, Vesa ^h   Bono, Petri ^a   Leinonen, Mika ^o   Lindman, Henrik ^l   more..

^a HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^b TAMPERE UNIVERSITY HOSPITAL   (Finland)

^c TURKU UNIVERSITY HOSPITAL   (Finland)

^d OULU UNIVERSITY HOSPITAL   (Finland)

^e SATAKUNTA CENTRAL HOSPITAL   (Finland)

^f KANTA HÄME CENTRAL HOSPITAL   (Finland)

^g GÄVLE HOSPITAL   (Sweden)

^h KUOPIO UNIVERSITY HOSPITAL   (Finland)

ⁱ Kotka Central Hospital   (Finland)

^j NORTH KARELIA CENTRAL HOSPITAL   (Finland)

^k ÖREBRO UNIVERSITY HOSPITAL   (Sweden)

^l UPPSALA UNIVERSITY HOSPITAL   (Sweden)

^m JYVÄSKYLÄ CENTRAL HOSPITAL   (Finland)

ⁿ PÄIJÄT HÄME CENTRAL HOSPITAL   (Finland)

^o 4Pharma ^*  (Finland)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANASTROZOLE; CAPECITABINE; CORTICOSTEROID; CYCLOPHOSPHAMIDE; DOCETAXEL; EPIRUBICIN; FLUOROURACIL; HEMOPOIETIC GROWTH FACTOR; TAMOXIFEN; TRASTUZUMAB;

ADJUVANT THERAPY; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; AMENORRHEA; ARTICLE; AXILLARY LYMPH NODE; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER HORMONE THERAPY; CANCER RADIOTHERAPY; CANCER RECURRENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE FREE SURVIVAL; DRUG EFFICACY; DRUG FATALITY; DRUG RESPONSE; DRUG WITHDRAWAL; DYSPNEA; EVENING DOSAGE; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; HAND FOOT SYNDROME; HIGH RISK PATIENT; HUMAN; INFECTION; LYMPH NODE METASTASIS; MAJOR CLINICAL STUDY; MORNING DOSAGE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAIL; NAUSEA; NEUTROPENIA; OPEN STUDY; PAIN; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STOMATITIS; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CYCLOPHOSPHAMIDE; DEOXYCYTIDINE; EPIRUBICIN; FEMALE; FLUOROURACIL; HUMANS; MIDDLE AGED; RECEPTOR, ERBB-2; TAXOIDS;

EID: 70849123249     PISSN: 14702045     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1470-2045(09)70307-9     Document Type: Article

References (30)

1. Goldhirsch A., Wood W.C., Gelber R.D., et al. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Ann Oncol 18 (2007) 1133-1144
2. Pestalozzi B., Castiglione M., and on behalf of the ESMO Guidelines Working Group. Primary breast cancer: ESMO Clinical Recommendations for diagnosis, treatment and follow-up. Ann Oncol 19 suppl 2 (2008) ii7-ii10
3. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: breast cancer V.2.2008. http://www.nccn.org/professionals/physician_gls/PDF/breast.pdf (accessed Nov 3, 2009).
4. Martin M., Pienkowski T., Mackey J., et al., for the Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med 352 (2005) 2302-2313
5. Roché H., Fumoleau P., Spielmann M., et al. Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 trial. J Clin Oncol 24 (2006) 5664-5671
6. De Laurentiis M., Cancello G., D'Agostino D., et al. Taxane-based combinations as adjuvant chemotherapy of early breast cancer: a meta-analysis of randomized trials. J Clin Oncol 26 (2008) 44-53
7. Miwa M., Ura M., Nishida M., et al. Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. Eur J Cancer 34 (1998) 1274-1281
8. Endo M., Shinbori N., Fukase Y., et al. Induction of thymidine phosphorylase expression and enhancement of efficacy of capecitabine or 5′-deoxy-5-fluorouridine by cyclophosphamide in mammary tumor models. Int J Cancer 83 (1999) 127-134
9. Fujimoto-Ouchi K., Tanaka Y., and Tominaga T. Schedule dependency of antitumor activity in combination therapy with capecitabine/5′-deoxy-5-fluorouridine and docetaxel in breast cancer models. Clin Cancer Res 7 (2001) 1079-1086
10. Sawada N., Ishikawa T., Fukase Y., Nishidi M., Yoshikubo M., and Ishitsuka H. Induction of thymidine phosphorylase activity and enhancement of capecitabine efficacy by taxol/taxotere in human cancer xenografts. Clin Cancer Res 4 (1998) 1013-1019
11. Toi M., Bando H., Horiguchi S., et al. Modulation of thymidine phosphorylase by neoadjuvant chemotherapy in primary breast cancer. Br J Cancer 90 (2004) 2338-2343
12. O'Shaughnessy J., Miles D., Vukelja S., 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 20 (2002) 2812-2823
13. Lundin J., Lundin M., Holli K., et al. Omission of histologic grading from clinical decision making may result in overuse of adjuvant therapies in breast cancer: results from a nationwide study. J Clin Oncol 19 (2001) 28-36
14. Liu S., Chia S.K., Mehl E., et al. Progesterone receptor is a significant factor associated with clinical outcomes and effect of adjuvant tamoxifen therapy in breast cancer patients. Breast Cancer Res Treat (2009) 10.1007/s10549-009-0318-0 published online Feb 10.
15. Ravaioli A., Pasini G., Polselli A., et al. Staging of breast cancer: new recommended standard procedure. Breast Cancer Res Treat 72 (2002) 53-60
16. Myers R.E., Johnston M., Pritchard K., Levine M., Oliver T., and the Breast Cancer Disease Site Group of the Cancer Care Ontario Practice Guidelines Initiative. Baseline staging tests in primary breast cancer: a practice guideline. CMAJ 164 (2001) 1439-1444
17. Pocock S.J. Group sequential methods in the design and analysis of clinical trials. Biometrika 64 (1977) 191-199
18. Muss H.B., Berry D.A., Cirrincione C.T., et al., for the CALGB Investigators. Adjuvant chemotherapy in older women with early-stage breast cancer. N Engl J Med 360 (2009) 2055-2065
19. von Minckwitz G., Rezai M., Loibl S., et al. Capecitabine given concomitantly or in sequence with EC→docetaxel as neoadjuvant treatment for early breast cancer: GeparQuattro-a GBG/AGO intergroup-study. Eur J Cancer Suppl 7 (2008) 108 (abstr 203).
20. Steger G.G., Greil R., Jakesz R., et al. A randomized phase III study comparing epirubicin, docetaxel, and capecitabine (EDC) to epirubicin and docetaxel (ED) as neoadjuvant treatment for early breast cancer: first results of the Austrian Breast and Colorectal Cancer Study Group-Trial 24 (ABCSG-24). Eur J Cancer Suppl 7 (2009) 3 (abstr 4BA).
21. Berton-Rigaud D, Roché H, Penault-Llorca F, et al. Benefit of neoadjuvant capecitabine + epirubicin + cyclophosphamide (CEX) versus 5-FU + epirubicin + cyclophosphamide (FEC) for operable breast cancer (BC) followed by adjuvant docetaxel (T). 2008 ASCO Annual Meeting; May 30-June 3, 2008; Chicago, IL, USA. Abstract 598.
22. Kosmas C., Kallistratos M.S., Kopterides P., et al. Cardiotoxicity of fluoropyrimidines in different schedules of administration: a prospective study. J Cancer Res Clin Oncol 134 (2008) 75-82
23. Swain SM, Jeong J-H, Geyer CE, et al. NSABP B-30: definitive analysis of patient outcome from a randomized trial evaluating different schedules and combinations of adjuvant therapy containing doxorubicin, docetaxel and cyclophosphamide in women with operable, node-positive breast cancer. 31st Annual San Antonio Breast Cancer Symposium; Dec 10-14, 2008; San Antonio, TX, USA. Abstract 75.
24. Eiermann W, Pienkowski T, Crown J, et al. 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 (ACT) in women with Her-2/neu negative axillary lymph node positive early breast cancer. 31st Annual San Antonio Breast Cancer Symposium; Dec 10-14, 2008; San Antonio, TX, USA. Abstract 77.
25. Joensuu H., Kellokumpu-Lehtinen P.-L., Bono P., et al., for the FinHer Study Investigators. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med 354 (2006) 809-820
26. Harvey V., Mouridsen H., Semiglazov V., et al. Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer. J Clin Oncol 24 (2006) 4963-4970
27. 2 as adjuvant treatments of early breast cancer: an exploratory analysis of a randomised trial. Ann Oncol 20 (2009) 595-596
28. Leonard R., O'Shaughnessy J., Vukelja S., et al. Detailed analysis of a randomized phase III trial: can the tolerability of capecitabine plus docetaxel be improved without compromising its survival advantage?. Ann Oncol 17 (2006) 1379-1385
29. Gluck S, Russell C, O'Shaughnessy J, et al. Relationship between survival and estrogen receptor (ER) status in pts with metastatic breast cancer (MBC) treated with capecitabine (C) and docetaxel (D): an exploratory data analysis. 2009 ASCO Annual Meeting; May 29-June 2, 2009; Orlando, FL, USA. Abstract 1024.
30. Ellis P., Barrett-Lee P., Johnson L., et al., for the TACT Trial Management Group and the TACT Trialists. Sequential docetaxel as adjuvant chemotherapy for early breast cancer (TACT): an open-label, phase III, randomised controlled trial. Lancet 373 (2009) 1681-1692