Sequential administration of dose-dense epirubicin/cyclophosphamide followed by docetaxel/capecitabine for patients with HER2-negative and locally advanced or node-positive breast cancer

Cancer Chemotherapy and Pharmacology

Volumn 65, Issue 3, 2010, Pages 457-465

  Nieto, Yago ^a,b   Aramendía, José Manuel ^a   Espinós, Jaime ^a   De La Cruz, Susana ^a   Fernández Hidalgo, Oscar ^a   Santisteban, Marta ^a   Arbea, Leyre ^a   Aristu, Javier ^a   Martínez Monge, Rafael ^a   Moreno, Marta ^a   Pina, Luis ^a   Sola, Josu ^a   Zornoza, Gerardo ^a   Regueira, Fernando Martínez ^a  

^a UNIVERSITY CLINIC OF NAVARRA   (Spain)

^b UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

Adjuvant; Breast cancer; Capecitabine; Docetaxel; Neoadjuvant; Phase II trial

Indexed keywords

CAPECITABINE; CYCLOPHOSPHAMIDE; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; GRANULOCYTE COLONY STIMULATING FACTOR; LEVOFLOXACIN; PYRIDOXINE; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; DRUG DERIVATIVE; FLUOROURACIL; TAXOID;

ADULT; AGED; ANEMIA; ARTICLE; BREAST CANCER; CANCER RELAPSE; CANCER STAGING; CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE REDUCTION; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; HAND FOOT SYNDROME; HEART LEFT VENTRICLE EJECTION FRACTION; HORMONAL THERAPY; HUMAN; HUMAN TISSUE; MAJOR CLINICAL STUDY; NAIL; NEUTROPENIA; NUCLEAR MAGNETIC RESONANCE IMAGING; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PREOPERATIVE PERIOD; PRIORITY JOURNAL; SIDE EFFECT; SKIN TOXICITY; STOMATITIS; THROMBOCYTOPENIA; TREATMENT RESPONSE; TUMOR VOLUME; BREAST TUMOR; CHEMICALLY INDUCED DISORDER; DOSE RESPONSE; DRUG ADMINISTRATION; FEVER; LYMPH NODE; METABOLISM; MIDDLE AGED; MUCOSA INFLAMMATION; PATHOLOGY; PHASE 2 CLINICAL TRIAL; PROSPECTIVE STUDY; SURVIVAL;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CYCLOPHOSPHAMIDE; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; EPIRUBICIN; FEMALE; FEVER; FLUOROURACIL; HUMANS; LYMPH NODES; MIDDLE AGED; MUCOSITIS; NEUTROPENIA; PROSPECTIVE STUDIES; RECEPTOR, ERBB-2; SURVIVAL ANALYSIS; TAXOIDS;

EID: 75549085295     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-009-1049-y     Document Type: Article

References (49)

1. ML Citron DA Berry C Cirrincione, et al. 2003 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 21 1431 1439 10.1200/JCO.2003.09.081 1:CAS:528:DC%2BD2cXptlCks7s%3D 12668651 (Pubitemid 46594092)
2. IC Henderson DA Berry GD Demetri, et al. 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 10.1200/JCO.2003.02.063 1:CAS:528: DC%2BD2cXpsVGqs7c%3D 12637460 (Pubitemid 46594124)
3. EP Mamounas J Bryant BC Lembersky, et al. 2005 Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28 J Clin Oncol 23 3686 3696 10.1200/JCO.2005.10.517 1:CAS:528:DC%2BD2MXlslWntrw%3D 15897552 (Pubitemid 46252463)
4. L Gianni J Baselga W Eiermann, et al. 2005 Feasibility and tolerability of sequential doxorubicin/paclitaxel followed by cyclophosphamide, methotrexate, and fluorouracil and its effects on tumor response as preoperative therapy Clin Cancer Res 11 8715 8721 10.1158/1078-0432.CCR-05-0539 1:CAS:528: DC%2BD2MXhtlWrsbrI 16361558 (Pubitemid 43005921)
5. M Martín T Pienkowski J Mackey, et al. 2005 Adjuvant docetaxel for node-positive breast cancer N Engl J Med 352 2302 2313 10.1056/NEJMoa043681 15930421 (Pubitemid 40740554)
6. H Roché P Fumoleau M Spielmann, et al. 2004 Five years analysis of the PACS 01 trial: 6 cycles of FEC100 vs 3 cycles of FEC100 followed by 3 cycles of docetaxel (D) for the adjuvant treatment of node-positive breast cancer Breast Cancer Res Treat 88 Suppl 1 S16
7. J O'Shaughnessy D Miles S Vukelja, et al. 2002 Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III results J Clin Oncol 20 2812 2823 10.1200/JCO.2002.09.002 12065558 (Pubitemid 34651510)
8. N Sawada T Ishikawa Y Fukase, et al. 1998 Induction of thymidine phosphorylase activity and enhancement of capecitabine efficacy by taxol/taxotere in human cancer xenografts Clin Cancer Res 4 1013 1019 1:CAS:528:DyaK1cXisFeksr4%3D 9563897
9. M Kurosumi T Tabei K Suemasu, et al. 2000 Enhancement of immunohistochemical reactivity for thymidine phosphorylase in breast carcinoma cells after administration of docetaxel as a neoadjuvant chemotherapy in advanced breast cancer patients Oncol Rep 7 945 948 1:CAS:528: DC%2BD3cXlvFeksrY%3D 10948319
10. H Takahashi Y Maeda K Watanabe, et al. 2000 Correlation between elevated intratumoral thymidine phosphorylase and prognosis of node-positive breast carcinoma undergoing adjuvant doxifluridine treatment Int J Oncol 17 1205 1211 1:CAS:528:DC%2BD3cXos1Onurw%3D 11078806
11. Q Yang M Barbareschi I Mori, et al. 2002 Prognostic value of thymidine phosphorylase expression in breast carcinoma Int J Cancer 97 512 517 10.1002/ijc.1633 1:CAS:528:DC%2BD38XkvFentA%3D%3D 11802215 (Pubitemid 34027812)
12. T Tominaga M Toi Y Ohashi, et al. 2002 Prognostic and predictive value of thymidine phosphorylase activity in early-stage breast cancer patients Clin Breast Cancer 3 55 64 10.3816/CBC.2002.n.012 1:CAS:528:DC%2BD38Xns1Wju7k%3D 12020396
13. F Puglisi GG Cardellino D Crivellari, et al. 2008 Thymidine phosphorylase expression is associated with time to progression in patients receiving low-dose, docetaxel-modulated capecitabine for metastatic breast cancer Ann Oncol 19 1541 1546 10.1093/annonc/mdn165 1:STN:280:DC%2BD1crivFajug%3D%3D 18441329
14. M Toi H Bando S Horiguchi, et al. 2004 Modulation of thymidine phosphorylase by neoadjuvant chemotherapy in primary breast cancer Br J Cancer 90 2338 2343 1:CAS:528:DC%2BD2cXks1ahtrk%3D 15150550
15. M Pegram S Hsu G Lewis, et al. 1999 Inhibitory effects of combinations of HER-2/neu antibody and chemotherapeutic agents used for treatment of human breast cancers Oncogene 18 2241 2251 10.1038/sj.onc.1202526 1:CAS:528: DyaK1MXis12murk%3D 10327070
16. MD Pegram A Lopez G Konecny DJ Slamon 2000 Trastuzumab and chemotherapeutics: drug interactions and synergies Semin Oncol 27 6 Suppl 11 21 25 1:CAS:528:DC%2BD3MXhsFGktro%3D 11236023
17. P Therasse SG Arbuck EA Eisenhauer, et al. 2000 New guidelines to evaluate the response to treatment in solid tumors J Natl Cancer Inst 92 205 216 10.1093/jnci/92.3.205 1:STN:280:DC%2BD3c7it1Gitg%3D%3D 10655437 (Pubitemid 30099779)
18. M Piccart A Di Leo M Beauduin, et al. 2001 Phase III trial comparing two dose levels of epirubicin combined with cyclophosphamide with cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer J Clin Oncol 19 3103 3110 1:CAS:528:DC%2BD3MXltFektLo%3D 11408507
19. http://ctep.cancer.gov/forms/CTCv20-4-30-992.pdf
20. TR Fleming 1982 One-sample multiple testing procedure for phase II clinical trials Biometrics 38 143 151 10.2307/2530297 1:STN:280: DyaL383gs12gsA%3D%3D 7082756
21. P Francis JP Crown A Di Leo, et al. 2008 Adjuvant chemotherapy with sequential of concurrent and anthracycline and docetaxel: Breast International Group 02-98 randomized trial J Natl Cancer Inst 100 121 133 10.1093/jnci/djm287 1:CAS:528:DC%2BD1cXivVOnsr8%3D 18182617
22. IC Smith SD Heys AW Hutcheon, et al. 2002 Neoadjuvant chemotherapy in breast cancer: significantly enhanced response with docetaxel J Clin Oncol 20 1456 1466 10.1200/JCO.20.6.1456 1:CAS:528:DC%2BD38XivFeisbg%3D 11896092 (Pubitemid 34260523)
23. HD Bear S Anderson A Brown, et al. 2003 The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27 J Clin Oncol 21 4165 4174 10.1200/JCO.2003.12.005 1:CAS:528:DC%2BD2cXpsVajtrg%3D 14559892 (Pubitemid 46606185)
24. HD Bear S Anderson RE Smith, et al. 2006 Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-27 J Clin Oncol 24 2019 2027 10.1200/JCO.2005.04.1665 1:CAS:528:DC%2BD28Xlt1amur0%3D 16606972 (Pubitemid 46622110)
25. TR Evans A Yellowlees E Foster, et al. 2005 Phase III randomized trial of doxorubicin and docetaxel versus doxorubicin and cyclophosphamide as primary medical therapy in women with breast cancer: an anglo-celtic cooperative oncology group study J Clin Oncol 23 2988 2995 10.1200/JCO.2005.06.156 1:CAS:528:DC%2BD2MXkslGhu70%3D 15860854 (Pubitemid 46224118)
26. G Von Minckwitz G Raab A Caputo, et al. 2005 Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: the GEPARDUO study of the German Breast Group J Clin Oncol 23 2676 2685 10.1200/JCO.2005.05.078 (Pubitemid 46179457)
27. AV Patterson H Zhang A Moghaddam, et al. 1995 Increased sensitivity to the prodrug 5′-deoxy-5-fluorouridine and modulation of 5-fluoro-2′-deoxyuridine sensitivity in MCF-7 cells transfected with thymidine phosphorylase Br J Cancer 72 669 675 1:CAS:528:DyaK2MXotV2ktb4%3D 7669579
28. A Evrard P Cuq J Ciccolini, et al. 1999 Increased cytotoxicity and bystander effect of 5-fluorouracil and 5-deoxy-5-fluorouridine in human colorectal cancer cells transfected with thymidine phosphorylase Br J Cancer 80 1726 1733 10.1038/sj.bjc.6690589 1:CAS:528:DyaK1MXlvFGntrY%3D 10468288 (Pubitemid 29389624)
29. T Morita A Matsuzaki A Tokue 2001 Enhancement of sensitivity to capecitabine in human renal carcinoma cells transfected with thymidine phosphorylase cDNA Int J Cancer 92 451 456 10.1002/ijc.1212 1:CAS:528: DC%2BD3MXjtVWiurk%3D 11291085 (Pubitemid 32249725)
30. T Ishikawa F Sekiguchi Y Fukase, et al. 1998 Positive correlation between the efficacy of capecitabine and doxifluridine and the ratio of thymidine phosphorylase to dihydropyrimidine dehydrogenase activities in tumors in human cancer xenografts Cancer Res 58 685 690 1:CAS:528:DyaK1cXht1antbc%3D 9485021
31. SB Fox K Engels M Comley, et al. 1997 Relationship of elevated tumour thymidine phosphorylase in node-positive breast carcinomas to the effects of adjuvant CMF Ann Oncol 8 271 275 10.1023/A:1008280110558 1:STN:280: DyaK2s3otlOiuw%3D%3D 9137797 (Pubitemid 27153494)
32. G Gasparini M Toi R Miceli, et al. 1999 Clinical relevance of vascular endothelial growth factor and thymidine phosphorylase in patients with node-positive breast cancer treated with either adjuvant chemotherapy or hormone therapy Cancer J Sci Am 5 101 111 1:STN:280:DyaK1M3hsV2ntw%3D%3D 10198732
33. CT Dang GM D'Andrea ME Moynahan, et al. 2004 Phase II study of feasibility of dose-dense FEC followed by alternating weekly taxanes in high-risk, four or more node-positive breast cancer Clin Cancer Res 10 5754 5761 10.1158/1078-0432.CCR-04-0634 1:CAS:528:DC%2BD2cXntlyjsrg%3D 15355903 (Pubitemid 39180952)
34. P Therasse L Mauriac M Welnicka-Jaskiewicz, et al. 2003 Final results of a randomized phase III trial comparing cyclophosphamide, epirubicin, and fluorouracil with a dose-intensified epirubicin and cyclophosphamide + filgrastim as neoadjuvant treatment in locally advanced breast cancer: an EORTC-NCIC-SAKK multicenter study J Clin Oncol 21 843 850 10.1200/JCO.2003.05. 135 1:CAS:528:DC%2BD2cXpsVGqsr8%3D 12610183 (Pubitemid 46606444)
35. LC Pronk P Vasey A Sparreboom, et al. 2000 A phase I and pharmacokinetic study of the combination of capecitabine and docetaxel in patients with advanced solid tumours Br J Cancer 83 22 29 10.1054/bjoc.2000.1160 1:CAS:528: DC%2BD3cXkvFOgsbo%3D 10883663
36. R Leonard J O'Shaughnessy S Vukelja, et al. 2006 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 1379 1385 10.1093/annonc/mdl134 1:STN:280:DC%2BD28rktVemsA%3D%3D 16966367 (Pubitemid 44400375)
37. M Miwa M Ura M Nishida, et al. 1998 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 1274 1281 10.1016/S0959-8049(98)00058-6 1:CAS:528: DyaK1cXltlCgsrk%3D 9849491 (Pubitemid 28342121)
38. J Schuller J Cassidy E Dumont, et al. 2000 Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patients Cancer Chemother Pharmacol 45 291 297 10.1007/s002800050043 1:CAS:528:DC%2BD3cXhtlCrtLk%3D 10755317
39. H Joensuu A Hemminki M Huovinen, et al. 2007 The FinXX trial: safety results in 600 patients (pts) randomized to either docetaxel (T) followed by cyclophosphamide (C)+ epirubicin (E)+ 5-FU (F) (CEF) or T+ capecitabine (X) followed by CEX as adjuvant therapy for early breast cancer (BC) J Clin Oncol 25 18S abstract 1103
40. F André C Mazouni C Liedtke, et al. 2008 HER2 expression and efficacy of preoperative paclitaxel/FAC chemotherapy in breast cancer Breast Cancer Res Treat 108 183 190 10.1007/s10549-007-9594-8 17468948 (Pubitemid 351311360)
41. M Colleoni G Viale D Zahrieh, et al. 2004 Chemotherapy is more effective in patients with breast cancer not expressing steroid hormone receptors: a study of preoperative treatment Clin Cancer Res 10 6622 6628 10.1158/1078-0432.CCR- 04-0380 1:CAS:528:DC%2BD2cXot1Oiu7o%3D 15475452 (Pubitemid 39346559)
42. L Gianni M Zambetti K Clark, et al. 2005 Gene expression profiles in paraffin-embedded core biopsy tissue predict response to chemotherapy in women with locally advanced breast cancer J Clin Oncol 23 7265 7277 10.1200/JCO.2005.02.0818 1:CAS:528:DC%2BD2MXhtF2nsL3K 16145055 (Pubitemid 46202341)
43. JA Sparano M Wang S Martino, et al. 2008 Weekly paclitaxel in the adjuvant treatment of breast cancer N Engl J Med 358 1663 1671 10.1056/NEJMoa0707056 1:CAS:528:DC%2BD1cXkslCitLk%3D 18420499 (Pubitemid 351549913)
44. E Rivera JA Mejia BK Arun, et al. 2008 Phase 3 study comparing the use of docetaxel on an every-3-week versus weekly schedule in the treatment of metastatic breast cancer Cancer 112 1455 1461 10.1002/cncr.23321 1:CAS:528:DC%2BD1cXktlKrtbc%3D 18300256
45. KS Lee J Ro B-H Nam, et al. 2008 A randomized phase-III trial of docetaxel/capecitabine versus doxorubicin/cyclophosphamide as primary chemotherapy for patients with stage II/III breast cancer Breast Cancer Res Treat 109 481 489 10.1007/s10549-007-9672-y 1:CAS:528:DC%2BD1cXlvVCgtro%3D 17653851 (Pubitemid 351692059)
46. RM Layman DG Thomas KA Griffith, et al. 2007 Neoadjuvant docetaxel and capecitabine and the use of thymidine phosphorylase as a predictive biomarker in breast cancer Clin Cancer Res 13 4092 4197 10.1158/1078-0432.CCR-07-0288 1:CAS:528:DC%2BD2sXnvVCiurg%3D 17634534
47. C Natoli E Cianchetti N Tinari, et al. 2007 A phase II study of dose-dense epirubicin plus cyclophosphamide followed by docetaxel plus capecitabine and pegfilgrastim support as preoperative therapy for patients with stage II, IIIA breast cancer Ann Oncol 18 1015 1020 10.1093/annonc/mdm076 1:STN:280:DC%2BD2szntVWgtg%3D%3D 17369601 (Pubitemid 47050492)
48. M Untch M Rezai S Loibl, et al. 2007 Evaluating the efficacy and safety of trastuzumab given concomitantly to epirubicin/cyclophosphamide → docetaxel ± capecitabine as neoadjuvant treatment of HER2 overexpressing primary breast cancer First analysis of the GBG/AGO intergroup study "GeparQuattro" Breast Cancer Res Treat 106 Suppl 1 S224
49. G von Minckwitz M Rezai S Loibl, et al. 2008 Capecitabine given concomitantly or in sequence with EC → docetaxel as neoadjuvant treatment for early breast cancer: GeparQuattro-a GBG/ABO intergroup study Eur J Cancer Suppl 6 108 10.1016/S1359-6349(08)70519-6