Multicentric neoadjuvant pilot Phase II study of cetuximab combined with docetaxel in operable triple negative breast cancer

International Journal of Cancer

Volumn 138, Issue 9, 2016, Pages 2274-2280

  Nabholtz, J M ^a,b,c,d   Chalabi, N ^a,b,c   Radosevic Robin, N ^a,b   Dauplat, M M ^a,b   Mouret Reynier, M A ^a,d   Van Praagh, I ^d   Servent, V ^e   Jacquin, Jp ^f   Benmammar, K E ^d   Kullab, S ^d   Bahadoor, M R K ^b,d   Kwiatkowski, F ^a,b   Cayre, A ^a,b   Abrial, C ^a,b,c   Durando, X ^a,b,c,d   Bignon, Y J ^a,b   Chollet, P ^a,b,g   Penault Llorca, F ^a,b  

^a UNIVERSITÉ CLERMONT AUVERGNE   (France)

^b Jean Perrin Comprehensive Cancer Centre   (France)

^c CIC 501 UMR 766   (France)

^d Medical Oncology   (France)

^e Oscar Lambret Comprehensive Cancer Center   (France)

^f Cancer Institute Lucien Neuwirth   (France)

^g INSERM   (France)

Author keywords

anti EGFR therapy; neoadjuvant chemotherapy; pathological complete response; predictive biomarkers; triple negative breast cancer

Indexed keywords

CD8 ANTIGEN; CETUXIMAB; DOCETAXEL; TRANSCRIPTION FACTOR FOXP3; ANTINEOPLASTIC AGENT; TAXOID;

ACNE; ADJUVANT THERAPY; ADULT; AGED; ANEMIA; ARTICLE; ASTHENIA; BREAST SURGERY; CANCER ADJUVANT THERAPY; CLINICAL ARTICLE; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRY SKIN; EDEMA; ERYTHEMA; FEBRILE NEUTROPENIA; FEMALE; GENE MUTATION; HAND FOOT SYNDROME; HUMAN; HUMAN TISSUE; LEUKOPENIA; LYMPHOCYTOPENIA; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAIL DISEASE; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PILOT STUDY; PRIORITY JOURNAL; PRURITUS; SIDE EFFECT; STRIA; THROMBOCYTOPENIA; TRIPLE NEGATIVE BREAST CANCER; TUMOR ASSOCIATED LEUKOCYTE; VOMITING; XEROSIS; ADJUVANT CHEMOTHERAPY; CARCINOMA, DUCTAL, BREAST; CLINICAL TRIAL; MASTECTOMY; MIDDLE AGED; MULTIMODALITY CANCER THERAPY; NEOADJUVANT THERAPY; PROCEDURES; TRIPLE NEGATIVE BREAST NEOPLASMS;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, DUCTAL, BREAST; CETUXIMAB; CHEMOTHERAPY, ADJUVANT; COMBINED MODALITY THERAPY; FEMALE; HUMANS; MASTECTOMY; MIDDLE AGED; NEOADJUVANT THERAPY; PILOT PROJECTS; TAXOIDS; TRIPLE NEGATIVE BREAST NEOPLASMS;

EID: 84958934037     PISSN: 00207136     EISSN: 10970215     Source Type: Journal    
DOI: 10.1002/ijc.29952     Document Type: Article

References (43)

1. Sorlie T, Perou CM, Tibshirani R, et al., Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci USA 2001; 98: 10869-74.
2. Penault-Llorca F, Viale G., Pathological and molecular diagnosis of triple-negative breast cancer: a clinical perspective. Ann Oncol 2012; 23 Suppl 6: vi19-22.
3. Cleere DW., Triple-negative breast cancer: a clinical update. Commun Oncol 2010; 7: 203-11.
4. Arteaga CL, Engelman JA., ERBB receptors: from oncogene discovery to basic science to mechanism-based cancer therapeutics. Cancer Cell 2014; 25: 282-303.
5. Cheang MC, Voduc D, Bajdik C, et al., Basal-like breast cancer defined by five biomarkers has superior prognostic value than triple-negative phenotype. Clin Cancer Res 2008; 14: 1368-76.
6. Nielsen TO, Hsu FD, Jensen K, et al., Immunohistochemical and clinical characterization of the basal-like subtype of invasive breast carcinoma. Clin Cancer Res 2004; 10: 5367-74.
7. Perou CM., Molecular stratification of triple-negative breast cancers. Oncologist 2011; 16(Suppl 1): 61-70.
8. von Minckwitz G, Untch M, Blohmer JU, 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: 1796-804.
9. Liedtke C, Mazouni C, Hess KR, et al., Response to neoadjuvant therapy and long-term survival in patients with triple-negative breast cancer. J Clin Oncol 2008; 26: 1275-81.
10. Baselga J, Gomez P, Greil R, et al., Randomized phase II study of the anti-epidermal growth factor receptor monoclonal antibody cetuximab with cisplatin versus cisplatin alone in patients with metastatic triple-negative breast cancer. J Clin Oncol 2013; 31: 2586-92.
11. Nechushtan H, Vainer G, Stainberg H, et al., A phase 1/2 of a combination of Cetuximab and Taxane for "triple negative" breast cancer patients. Breast 2014; 23: 435-8.
12. Coussens LM, Pollard JW., Leukocytes in mammary development and cancer. Cold Spring Harb Perspect Biol 2011; 3.
13. Gajewski TF, Schreiber H, Fu YX., Innate and adaptive immune cells in the tumor microenvironment. Nat Immunol 2013; 14: 1014-22.
14. Liu S, Lachapelle J, Leung S, et al., CD8+ lymphocyte infiltration is an independent favorable prognostic indicator in basal-like breast cancer. Breast Cancer Res 2012; 14: R48.
15. Mahmoud SM, Paish EC, Powe DG, et al., Tumor-infiltrating CD8+ lymphocytes predict clinical outcome in breast cancer. J Clin Oncol 2011; 29: 1949-55.
16. Fontenot JD, Rasmussen JP, Williams LM, et al., Regulatory T cell lineage specification by the forkhead transcription factor foxp3. Immunity 2005; 22: 329-41.
17. Sakaguchi S, Miyara M, Costantino CM, et al., FOXP3+ regulatory T cells in the human immune system. Nat Rev Immunol 2010; 10: 490-500.
18. Vinay DS, Ryan EP, Pawelec G, et al., Immune evasion in cancer: Mechanistic basis and therapeutic strategies. Semin Cancer Biol 2015; 35: S185-98.
19. Bates GJ, Fox SB, Han C, et al., Quantification of regulatory T cells enables the identification of high-risk breast cancer patients and those at risk of late relapse. J Clin Oncol 2006; 24: 5373-80.
20. Gobert M, Treilleux I, Bendriss-Vermare N, et al., Regulatory T cells recruited through CCL22/CCR4 are selectively activated in lymphoid infiltrates surrounding primary breast tumors and lead to an adverse clinical outcome. Cancer Res 2009; 69: 2000-9.
21. Mahmoud SM, Paish EC, Powe DG, et al., An evaluation of the clinical significance of FOXP3+ infiltrating cells in human breast cancer. Breast Cancer Res Treat 2011; 127: 99-108.
22. West NR, Kost SE, Martin SD, et al., Tumour-infiltrating FOXP3(+) lymphocytes are associated with cytotoxic immune responses and good clinical outcome in oestrogen receptor-negative breast cancer. Br J Cancer 2013; 108: 155-62.
23. Yan M, Jene N, Byrne D, et al., Recruitment of regulatory T cells is correlated with hypoxia-induced CXCR4 expression, and is associated with poor prognosis in basal-like breast cancers. Breast Cancer Res 2011; 13: R47.
24. Denkert C, Loibl S, Noske A, et al., Tumor-associated lymphocytes as an independent predictor of response to neoadjuvant chemotherapy in breast cancer. J Clin Oncol 2010; 28: 105-13.
25. Denkert C, von Minckwitz G, Brase JC, et al., Tumor-infiltrating lymphocytes and response to neoadjuvant chemotherapy with or without Carboplatin in human epidermal growth factor receptor 2-positive and triple-negative primary breast cancers. J Clin Oncol 2015; 33: 983-91.
26. Issa-Nummer Y, Darb-Esfahani S, Loibl S, et al., Prospective validation of immunological infiltrate for prediction of response to neoadjuvant chemotherapy in HER2-negative breast cancer-a substudy of the neoadjuvant GeparQuinto trial. PLoS One 2013; 8: e79775.
27. Loi S, Michiels S, Salgado R, et al., Tumor infiltrating lymphocytes are prognostic in triple negative breast cancer and predictive for trastuzumab benefit in early breast cancer: results from the FinHER trial. Ann Oncol 2014; 25: 1544-50.
28. Chevallier B, Roche H, Olivier JP, et al., Inflammatory breast cancer. Pilot study of intensive induction chemotherapy (FEC-HD) results in a high histologic response rate. Am J Clin Oncol 1993; 16: 223-8.
29. Sataloff DM, Mason BA, Prestipino AJ, et al., Pathologic response to induction chemotherapy in locally advanced carcinoma of the breast: a determinant of outcome. J Am Coll Surg 1995; 180: 297-306.
30. [Recommendations for the immunohistochemistry of the hormonal receptors on paraffin sections in breast cancer. Update 1999. Group for Evaluation of Prognostic Factors using Immunohistochemistry in Breast Cancer (GEFPICS-FNCLCC)]. Ann Pathol 1999; 19: 336-43.
31. Penault-Llorca F, Vincent-Salomon A, et al., [Update of the GEFPICS' recommendations for HER2 status determination in breast cancers in France]. Ann Pathol 2010; 30: 357-73.
32. Wolff AC, Hammond ME, Schwartz JN, et al., American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol 2007; 25: 118-45.
33. Elston CW, Ellis IO., Pathological prognostic factors in breast cancer. I. The value of histological grade in breast cancer: experience from a large study with long-term follow-up. Histopathology 1991; 19: 403-10.
34. Lakhani SR, Ellis IO, Schnitt SJ, et al., WHO classification of tumors of the breast, 4th edn. International Agency for Research on Cancer, Geneva: 2012.
35. Kwiatkowski F, Girard M, Hacene K, et al., [Sem: a suitable statistical software adaptated for research in oncology]. Bull Cancer 2000; 87: 715-21.
36. Amat S, Bougnoux P, Penault-Llorca F, et al., Neoadjuvant docetaxel for operable breast cancer induces a high pathological response and breast-conservation rate. Br J Cancer 2003; 88: 1339-45.
37. Wang-Lopez Q, Chalabi N, Abrial C, et al., Can pathologic complete resonse (pCR) be used as a surrogate marker of survival after neoadjuvant therapy for breast cancer? Crit Rev Oncol Hematol 2015; 95: 88-104.
38. Nabholtz JM, Abrial C, Mouret-Reynier MA, et al., Multicentric neoadjuvant phase II study of panitumumab combined with an anthracycline/taxane based chemotherapy in operable triple negative breast cancer: Identification of biologically-defined signatures predicting treatment impact. Ann Oncol 2014; 25 (8); 1570-77.
39. Lips EH, Mulder L, Oonk A, et al., Triple-negative breast cancer: BRCAness and concordance of clinical features with BRCA1-mutation carriers. Br J Cancer 2013; 108: 2172-7.
40. Generali D, Leek R, Fox SB, et al., EGFR mutations in exons 18-21 in sporadic breast cancer. Ann Oncol 2007; 18: 203-5.
41. West NR, Milne K, Truong PT, et al., Tumor-infiltrating lymphocytes predict response to anthracycline-based chemotherapy in estrogen receptor-negative breast cancer. Breast Cancer Res 2011; 13: R126.
42. Mattarollo SR, Loi S, Duret H, et al., Pivotal role of innate and adaptive immunity in anthracycline chemotherapy of established tumors. Cancer Res 2011; 71: 4809-20.
43. Dudek AM, Garg AD, Krysko DV, et al., Inducers of immunogenic cancer cell death. Cytokine Growth Factor Rev 2013; 24: 319-33.