Trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel in the neoadjuvant setting of HER-2 positive breast cancer

详细信息    查看全文

• 作者：Moisés Uriarte-Pinto ; Ángel Escolano-Pueyo…
• 关键词：Cardiotoxicity ; Docetaxel ; HER2 ; breast cancer ; Liposomal doxorubicin ; Trastuzumab
• 刊名：Pharmacy World Science
• 出版年：2016
• 出版时间：April 2016
• 年：2016
• 卷：38
• 期：2
• 页码：446-453
• 全文大小：593 KB
• 参考文献：1.Miller E, Lee HJ, Lulla A, Hernandez L, Gokare P, Lim B. Current treatment of early breast cancer: adjuvant and neoadjuvant therapy. F1000Res. 2014;3:198.PubMed PubMedCentral
  2.Bilal E, Dutkowski J, Guinney J, Jang IS, Logsdon BA, Pandey G, et al. Improving breast cancer survival analysis through competition-based multidimensional modeling. PLoS Comput Biol. 2013;9(5):e1003047.CrossRef PubMed PubMedCentral
  3.Natoli C, Vici P, Sperduti I, Grassadonia A, Bisagni G, Tinari N, et al. Effectiveness of neoadjuvant trastuzumab and chemotherapy in HER2-overexpressing breast cancer. J Cancer Res Clin Oncol. 2013;139(7):1229–40.CrossRef PubMed PubMedCentral
  4.Hudis CA. Trastuzumab–mechanism of action and use in clinical practice. N Engl J Med. 2007;357(1):39–51.CrossRef PubMed
  5.Pritchard KI, Messersmith H, Elavathil L, Trudeau M, O’Malley F, Dhesy-Thind B. HER-2 and topoisomerase II as predictors of response to chemotherapy. J Clin Oncol. 2008;26(5):736–44.CrossRef PubMed
  6.Cooke T, Reeves J, Lanigan A, Stanton P. HER2 as a prognostic and predictive marker for breast cancer. Ann Oncol. 2001;12(Suppl 1):S23–8.CrossRef PubMed
  7.Gianni L, Dafni U, Gelber RD, Azambuja E, Muehlbauer S, Goldhirsch A, et al. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol. 2011;12(3):236–44.CrossRef PubMed
  8.Alcobia A, Leandro A, Domingos S, Costa G, Branco V. Assessment of trastuzumab use in adjuvant therapy. Eur J Hosp Pharm Sci Pract. 2012;19(2):163–4.CrossRef
  9.Antón A, Ruiz A, Plazaola A, Calvo L, Seguí MA, Santaballa A, et al. Phase II clinical trial of liposomal-encapsulated doxorubicin citrate and docetaxel, associated with trastuzumab, as neoadjuvant treatment in stages II and IIIA HER2-overexpressing breast cancer patients. GEICAM 2003-03 study. Ann Oncol. 2011;22(1):74–9.CrossRef PubMed
  10.Petrelli F, Borgonovo K, Cabiddu M, Ghilardi M, Barni S. Neoadjuvant chemotherapy and concomitant trastuzumab in breast cancer: a pooled analysis of two randomized trials. Anticancer Drugs. 2011;22(2):128–35.CrossRef PubMed
  11.Wildiers H, Neven P, Christiaens MR, Squifflet P, Amant F, Weltens C, et al. Neoadjuvant capecitabine and docetaxel (plus trastuzumab): an effective non-anthracycline-based chemotherapy regimen for patients with locally advanced breast cancer. Ann Oncol. 2011;22(3):588–94.CrossRef PubMed
  12.Valachis A, Mauri D, Polyzos NP, Chlouverakis G, Mavroudis D, Georgoulias V. Trastuzumab combined to neoadjuvant chemotherapy in patients with HER2-positive breast cancer: a systematic review and meta-analysis. Breast. 2011;20(6):485–90.CrossRef PubMed
  13.Buzdar AU, Ibrahim NK, Francis D, Booser DJ, Thomas ES, Theriault RL, et al. Significantly higher pathologic complete remission rate after neoadjuvant therapy With trastuzumab, paclitaxel, and epirubicin chemotherapy: results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer. J Clin Oncol. 2005;23(16):3676–85.CrossRef PubMed
  14.Gianni L, Eiermann W, Semiglazov V, Manikhas A, Lluch A, Tjulandin S, et al. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet. 2010;375(9712):377–84.CrossRef PubMed
  15.von Minckwitz G, Untch M, Blohmer J-UJ-U, Costa SD, Eidtmann H, Fasching PA, et al. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol. 2012;30(15):1796–804.CrossRef
  16.Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344(11):783–92.CrossRef PubMed
  17.Venturini M, Bighin C, Monfardini S, Cappuzzo F, Olmeo N, Durando A, et al. Multicenter phase II study of trastuzumab in combination with epirubicin and docetaxel as first-line treatment for HER2-overexpressing metastatic breast cancer. Breast Cancer Res Treat. 2006;95(1):45–53.CrossRef PubMed
  18.O’Brien MER, Wigler N, Inbar M, Rosso R, Grischke E, Santoro A, et al. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX™/Doxil®) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol. 2004;15(3):440–9.CrossRef PubMed
  19.Baselga J, Manikhas A, Cortés J, Llombart A, Roman L, Semiglazov VF, et al. Phase III trial of nonpegylated liposomal doxorubicin in combination with trastuzumab and paclitaxel in HER2-positive metastatic breast cancer. Ann Oncol. 2014;25(3):592–8.CrossRef PubMed PubMedCentral
  20.Gavilá J, Guerrero A, Climent MA, Fernández A, Gozalbo F, Carrascosa M, et al. Efficacy and safety of neoadjuvant chemotherapy with concurrent liposomal-encapsulated doxorubicin, paclitaxel and trastuzumab for human epidermal growth factor receptor 2-positive breast cancer in clinical practice. Int J Clin Oncol. 2014;20(3):480–9.CrossRef PubMed
  21.Bloom HJG, Richardson WW. Histological grading and prognosis in breast cancer. Br J Cancer. 1957;11(3):359–77.CrossRef PubMed PubMedCentral
  22.Ogston KN, Miller ID, Payne S, Hutcheon AW, Sarkar TK, Smith I, et al. A new histological grading system to assess response of breast cancers to primary chemotherapy: prognostic significance and survival. Breast. 2003;12(5):320–7.CrossRef PubMed
  23.Brown-Glaberman U, Dayao Z, Royce M. HER2-targeted therapy for early-stage breast cancer: a comprehensive review. Oncology. 2014;28(4):281–9.PubMed
  24.Pernas Simon S. Neoadjuvant therapy of early stage human epidermal growth factor receptor 2 positive breast cancer: latest evidence and clinical implications. Ther Adv Med Oncol. 2014;6(5):210–21.CrossRef PubMed PubMedCentral
  25.Untch M, Fasching PA, Konecny GE, HasmuΪler S, Lebeau A, Kreienberg R, et al. Pathologic complete response after neoadjuvant chemotherapy plus trastuzumab predicts favorable survival in human epidermal growth factor receptor 2-overexpressing breast cancer: results from the TECHNO Trial of the AGO and GBG study groups. J Clin Oncol. 2011;29(25):3351–7.CrossRef PubMed
  26.Amat S, Penault-Llorca F, Cure H, Le Bouedëc G, Achard J-L, Van Praagh I, et al. Scarff-Bloom-Richardson (SBR) grading: a pleiotropic marker of chemosensitivity in invasive ductal breast carcinomas treated by neoadjuvant chemotherapy. Int J Oncol. 2002;20(4):791–6.PubMed
  27.Sánchez-Muñoz A, Plata-Fernández YM, Fernández M, Jaén-Morago A, Fernández-Navarro M, de la Torre-Cabrera C, et al. The role of immunohistochemistry in breast cancer patients treated with neoadjuvant chemotherapy: an old tool with an enduring prognostic value. Clin Breast Cancer. 2013;13(2):146–52.CrossRef PubMed
  28.Costa RB, Kurra G, Greenberg L, Geyer CE. Efficacy and cardiac safety of adjuvant trastuzumab-based chemotherapy regimens for HER2-positive early breast cancer. Ann Oncol. 2010;21(11):2153–60.CrossRef PubMed
  29.Onitilo AA, Engel JM, Stankowski RV. Cardiovascular toxicity associated with adjuvant trastuzumab therapy: prevalence, patient characteristics, and risk factors. Ther Adv Drug Saf. 2014;5(4):154–66.CrossRef PubMed PubMedCentral
  30.Lazaridis G, Pentheroudakis G, Pavlidis N. Integrating trastuzumab in the neoadjuvant treatment of primary breast cancer: accumulating evidence of efficacy, synergy and safety. Crit Rev Oncol Hematol. 2008;66(1):31–41.CrossRef PubMed
  31.Gianni L, Eiermann W, Semiglazov V, Lluch A, Tjulandin S, Zambetti M, et al. Neoadjuvant and adjuvant trastuzumab in patients with HER2-positive locally advanced breast cancer (NOAH): follow-up of a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet Oncol. 2014;15(6):640–7.CrossRef PubMed
  32.Carver JR, Szalda D, Ky B. Asymptomatic cardiac toxicity in long-term cancer survivors: defining the population and recommendations for surveillance. Semin Oncol. 2013;40(2):229–38.CrossRef PubMed PubMedCentral
  33.Rosa GM, Gigli L, Tagliasacchi MI, Di Iorio C, Carbone F, Nencioni A, et al. Update on cardiotoxicity of anti-cancer treatments. Eur J Clin Invest. 2016;46(3):264–84.CrossRef PubMed
  34.Tanioka M, Shimizu C, Yonemori K, Yoshimura K, Tamura K, Kouno T, et al. Predictors of recurrence in breast cancer patients with a pathologic complete response after neoadjuvant chemotherapy. Br J Cancer. 2010;103(3):297–302.CrossRef PubMed PubMedCentral
  
• 作者单位：Moisés Uriarte-Pinto (1)
  Ángel Escolano-Pueyo (1)
  Vicente Gimeno-Ballester (1)
  Oihana Pascual-Martínez (1)
  María Reyes Abad-Sazatornil (1)
  María José Agustín-Ferrández (1)
  
  1. Pharmacy Department, Miguel Servet University Hospital, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain
  
• 刊物类别：Medicine
• 刊物主题：Medicine & Public Health
  Internal Medicine
  Pharmacy
  
• 出版者：Springer Netherlands
• ISSN：2210-7711

文摘

Backgroud Neoadjuvant treatment based on the combination of trastuzumab plus chemotherapy is the standard of care in patients with HER2-positive early or locally advanced breast cancer. The concurrent use of trastuzumab, anthracyclines and taxanes is frequently used in this setting despite the potential cardiotoxicity of both anthracyclines and trastuzumab. However, not much information is available about this chemotherapy scheme. Objective We wanted to evaluate the efficacy and safety profile of the combination of trastuzumab, liposome-encapsulated doxorubicin and paclitaxel as neoadjuvant scheme. We also tried to establish predictive factors of pathologic complete response. Setting The study was carried out in a tertiary University Hospital of Spain. Method This is a descriptive study of the clinical practice performed in our hospital. Main outcome measure Efficacy was measured in terms of pathologic complete response, which was defined as the absence of invasive cancer cells in the breast and the axilla after neoadjuvant treatment. Results Thirty patients were included, the median age was 48. Seventeen (56.7 %) were hormonal receptor (HR) positive, 14 (46.6 %) had IIIa-b clinical stage and one of them had inflammatory breast cancer. 12 patients (40 %) achieved pCR. Patients with HR-negative BC achieved a higher pCR rate than those ones with HR-positive BC (61.5 % and 23.5 %, respectively; p value = 0.035). 21 patients (70 %) underwent breast conservative surgery. The treatment was in general well tolerated, most frequent grade 3–4 adverse events were neutropenia (20 %), asthenia and liver enzyme alteration (10 %) and febrile neutropenia (6.7 %). No patient developed heart failure, but one (3.3 %) presented a 10 % asymptomatic absolute reduction in left ventricular fraction ejection. Conclusions The studied treatment for the neoadjuvant setting of HER2 positive breast cancer seems to be an effective therapeutic option. Despite the expected high rate of cardiotoxicity of this regimen, the study results shows that this treatment regimen appears to be safe. The combination of trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel should be considered for the treatment of HER2-overexpressing breast cancer.