A phase II trial of dose-dense neoadjuvant gemcitabine, epirubicin, and albumin-bound paclitaxel with pegfilgrastim in the treatment of patients with locally advanced breast cancer

Clinical Breast Cancer

Volumn 10, Issue 5, 2010, Pages 367-372

  Yardley, Denise ^a,b   Zubkus, John ^b   Daniel, Brooke ^c   Inhorn, Roger ^d   Lane, Cassie ^a   Vazquez, Elizabeth ^a   Naot, Yuval ^e   Burris Iii, Howard ^a,b   Hainsworth, John ^a,b  

^a SARAH CANNON RESEARCH INSTITUTE   (United States)

^b PLLC   (United States)

^c Chattanooga Oncology Hematology Associates   (United States)

^d Mercy Hospital Portland Maine   (United States)

^e ICON Florida Oncology Associates   (United States)

Author keywords

Brief duration therapy; Nab paclitaxel; Neoadjuvant chemotherapy; Pathologic complete response

Indexed keywords

ALBUMIN BOUND PACLITAXEL; EPIRUBICIN; GEMCITABINE; PACLITAXEL; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; UNCLASSIFIED DRUG;

ADULT; AGED; ANEMIA; ARTHRALGIA; ARTICLE; BLOOD TOXICITY; BREAST CANCER; BREAST CONSERVATION SURGERY; BREAST SURGERY; CANCER ADJUVANT THERAPY; CANCER SURVIVAL; CLINICAL TRIAL; DIARRHEA; FATIGUE; FEBRILE NEUTROPENIA; HUMAN; HYPERGLYCEMIA; INFECTION; LIVER FUNCTION TEST; MAJOR CLINICAL STUDY; MASTECTOMY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NEUTROPENIA; OVERALL SURVIVAL; PATIENT COMPLIANCE; PHASE 2 CLINICAL TRIAL; POSTOPERATIVE CARE; POSTOPERATIVE PERIOD; PREOPERATIVE TREATMENT; PROGRESSION FREE SURVIVAL; SENSORY NEUROPATHY; SIDE EFFECT; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT RESPONSE; VEIN THROMBOSIS;

EID: 77957776200     PISSN: 15268209     EISSN: None     Source Type: Journal    
DOI: 10.3816/CBC.2010.n.048     Document Type: Article

References (39)

1. Bear HD. Indications for neoadjuvant chemotherapy for breast cancer. Semin Oncol 1998; 25:3-12.
2. Hortobagyi GN, Ames FC, Buzdar AU, et al. Management of stage III primary breast cancer with primary chemotherapy, surgery, and radiation therapy. Cancer 1988; 62:2507-16.
3. Hortobagyi GN. Comprehensive management of locally advanced breast cancer. Cancer 1990; 66:1387-91.
4. Fisher B, Bryant J, Wolmark N, et al. Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol 1998; 16:2672-85.
5. Kaufmann M, von Minckwitz G, Bear HD, et al. Recommendations from an international expert panel on the use of neoadjuvant (primary) systemic treatment of operable breast cancer: new perspectives 2006. Ann Oncol 2007; 18:1927-34.
6. Bonadonna G, Valagussa P, Brambilla C, et al. Primary chemotherapy in operable breast cancer: eight-year experience at the Milan Cancer Institute. J Clin Oncol 1998; 16:93-100.
7. Fisher B, Mamounas EP. Preoperative chemotherapy: a model for studying the biology and therapy of primary breast cancer. J Clin Oncol 1995; 13:537-40.
8. Rouzier R, Extra JM, Klijanienko J, et al. Incidence and prognostic significance of complete axillary downstaging after primary chemotherapy in breast cancer patients with T1 to T3 tumors and cytologically proven axillary metastatic lymph nodes. J Clin Oncol 2002; 20:1304-10.
9. Kuerer HM, Newman LA, Smith TL, et al. Clinical course of breast cancer pa-tients with complete pathologic primary tumor and axillary lymph node response to doxorubicin-based neoadjuvant chemotherapy. J Clin Oncol 1999; 17:460-9.
10. Bear HD, Anderson S, Smith RE, et al. 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 2006; 24:2019-27.
11. Dieras V, Fumoleau P, Romieu G, et al. Randomized parallel study of doxorubicin plus paclitaxel and doxorubicin plus cyclophosphamide as neoadjuvant treatment of patients with breast cancer. J Clin Oncol 2004; 22:4958-65.
12. von Minckwitz G, Costa SD, Raab G, et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: a random-ized, controlled, open phase IIb study J Clin Oncol 2001; 19:3506-15.
13. von Minckwitz G, Raab G, Caputo A, et al. 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 GEPAR-DUO study of the German Breast Group. J Clin Oncol 2005; 23:2676-85.
14. Muller C, Caputo A, Schumacher M, et al. Clinical response by palpation during primary systemic therapy with four dose-dense cycles doxorubicin and docetaxel in patients with operable breast cancer: further results from a randomised controlled trial. Eur J Cancer 2007; 43:1654-61.
15. Coudert BP, Largillier R, Arnould L, et al. Multicenter phase II trial of neoadju-vant therapy with trastuzumab, docetaxel, and carboplatin for human epidermal growth factor receptor-2-overexpressing stage II or III breast cancer: results of the GETN(A)-1 trial. J Clin Oncol 2007; 25:2678-84.
16. Dawood S, Gonzalez-Angulo AM, Peintinger F, et al. Efficacy and safety of neo-adjuvant trastuzumab combined with paclitaxel and epirubicin: a retrospective review of the M. D. Anderson experience. Cancer 2007; 110:1195-200.
17. Gianni L, Semiglazov V, Manikhas GM, et al. Neoadjuvant trastuzumab plus doxorubicin, paclitaxel and CMF in locally advanced breast cancer (NOAH trial): feasibility, safety and antitumor effects. Paper presented at: the 2007 ASCO Breast Cancer Symposium; September 7-8, 2007; San Francisco, CA. Abstract 144.
18. Fogli S, Danesi R, Gennari A, et al. Gemcitabine, epirubicin and paclitaxel: phar-macokinetic and pharmacodynamic interactions in advanced breast cancer. Ann Oncol 2002; 13:919-27.
19. Sanchez-Rovira P, Jaen A, Gonzalez E, et al. Phase II trial of gemcitabine/doxoru-bicin/paclitaxel administered every other week in patients with metastatic breast cancer. Clin Breast Cancer 2000; 1:226-32.
20. Bengala C, Danesi R, Pazzagli I, et al. Sequential high-dose idarubicin (IDA) and alkylating agents with blood cell support (BCS) following epirubicin-paclitaxel-gemcitabine (GET) combination in metastatic breast cancer (MBC): a phase I/II study with pharmacokinetic profile analysis. Proc Am Soc Clin Oncol 2000; 19:258.
21. Zielinski C, Beslija S, Mrsic-Krmpotic Z, et al. Gemcitabine, epirubicin, and paclitaxel versus fluorouracil, epirubicin, and cyclophosphamide as first-line che-motherapy in metastatic breast cancer: a Central European Cooperative Oncology Group International, multicenter, prospective, randomized phase III trial. J Clin Oncol 2005; 23:1401-8.
22. Conte PF, Gennari A, Donati S, et al. Gemcitabine plus epirubicin plus taxol (GET) in advanced breast cancer: a phase II study. Breast Cancer Res Treat 2001; 68:171-9.
23. Sanchez-Rovira P, Jaen A, Gonzalez E, et al. Biweekly gemcitabine, doxorubicin, and paclitaxel as first-line treatment in metastatic breast cancer. Final results from a phase II trial. Oncology (Williston Park) 2001; 15:44-7.
24. Cappuzzo F, Mazzoni F, Gennari A, et al. Multicentric phase II trial of gemcitabine plus epirubicin plus paclitaxel as first-line chemotherapy in metastatic breast can-cer. Br J Cancer 2004; 90:31-5.
25. Demiray M, Evrensel T, Arslan M, et al. Phase II study of gemcitabine plus epi-rubicin plus paclitaxel in metastatic breast cancer patients. Turk J Cancer 2005; 35:159-65.
26. Garrone O, Principe E, Occelli M, et al. Epirubicin, gemcitabine and paclitaxel kinetically administered as first-line chemotherapy in advanced breast cancer: ac-tivity and safety. Ann Oncol 2002; 13(suppl 3):18 (abstract A63).
27. Yardley DA, Whitworth P, Greco FA, et al. Neoadjuvant gemcitabine, epirubicin, and docetaxel (GET). Preliminary results from a multicenter phase II trial in inflam-matory and locally advanced breast cancer. Breast Cancer Res Treat 2003; 18:S54.
28. Conte PF, Donati S, Gennari A, et al. Primary chemotherapy with gemcitabine, epirubicin and taxol (GET) in operable breast cancer: a phase II study. Br J Cancer 2005; 93:406-11.
29. Schmid P, Krocker J, Schulz CO, et al. Primary chemotherapy with gemcitabine, liposomal doxorubicin and docetaxel in patients with locally advanced breast cancer: results of a phase I trial. Anticancer Drugs 2005; 16:21-9.
30. Schneeweiss A, Schuetz F, Rudlowski C, et al. Dose-dense primary systemic che-motherapy with gemcitabine plus epirubicin sequentially followed by docetaxel for early breast cancer: final results of a phase I/II trial. Anticancer Drugs 2005; 16:1023-8.
31. Hamm JT, Wilson JW, Rastogi P, et al. Gemcitabine/epirubicin/paclitaxel as neoadjuvant chemotherapy in locally advanced breast cancer: a phase II trial of the NSABP Foundation Research Group. Clin Breast Cancer 2008; 8:257-63.
32. Gradishar WJ, Tjulandin S, Davidson N, et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol 2005; 23:7794-803.
33. Kaplan E, Meier P Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53:457-81.
34. Wolmark N, Wang J, Mamounas E, et al. Preoperative chemotherapy in patients with operable breast cancer: nine-year results from National Surgical Adjuvant Breast and Bowel Project B-18. J Natl Cancer Inst Monogr 2001; 96-102.
35. Schneeweiss A, Bastert G, Huober J, et al. Neoadjuvant therapy with gemcitabine in breast cancer. Oncology (Williston Park) 2004; 18:27-31.
36. Colomer R, Llombart-Cussac A, Lluch A, et al. Biweekly paclitaxel plus gem-citabine in advanced breast cancer: phase II trial and predictive value of HER2 extracellular domain. Ann Oncol 2004; 15:201-6.
37. Therasse P, Mauriac L, Welnicka-Jaskiewicz M, et al. 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 multi-center study J Clin Oncol 2003; 21:843-50.
38. Abrial C, Van Praagh I, Delva R, et al. Pathological and clinical response of a primary chemotherapy regimen combining vinorelbine, epirubicin, and paclitaxel as neoadjuvant treatment in patients with operable breast cancer. Oncologist 2005; 10:242-9.
39. Smith IC, Heys SD, Hutcheon AW, et al. Neoadjuvant chemotherapy in breast cancer: significantly enhanced response with docetaxel. J Clin Oncol 2002; 20:1456-66.