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Introduction: Angiogenesis and epidermal growth factor receptor signaling are potential therapeutic targets in triple negative breast cancer (TNBC). We hypothesized that targeting these critical pathways would prolong progression-free survival with first-line therapy for metastatic TNBC.

Patients and Methods: We conducted a phase II trial of nab-paclitaxel and bevacizumab, followed by maintenance therapy with bevacizumab and erlotinib, for patients with metastatic TNBC. During induction, the patients received nab-paclitaxel 100 mg/m 2 intravenously (days 1, 8, and 15) and bevacizumab 10 mg/kg intravenously (days 1 and 15) every 28 days for 6 cycles. Patients free of progression at 24 weeks received maintenance therapy with bevacizumab 10 mg/kg intravenously every 2 weeks and oral erlotinib 150 mg/d until disease progression. The primary endpoint was progression-free survival (PFS). The secondary endpoints were best overall response, overall survival (OS), and adverse events. We explored the measurement of circulating tumor cells as a prognostic marker.

Results: A total of 55 evaluable patients were enrolled. The median PFS and OS for the cohort was 9.1 months (95% confidence interval, 7.2-11.1) and 18.1 months (95% confidence interval, 15.6-21.7), respectively. Of the 53 patients with measurable disease, 39 (74%) had experienced a partial response and 10 (19%) had stable disease using the Response Evaluation Criteria In Solid Tumors. The most common toxicities were uncomplicated neutropenia, fatigue, and neuropathy. Decreased circulating tumor cells from baseline to the first assessment correlated with longer PFS and OS.

Conclusion: Nab-paclitaxel and bevacizumab, followed by maintenance targeted therapy with bevacizumab and erlotinib, resulted in PFS similar to that of other trials. Most patients experienced a partial response (74%). Most patients received maintenance therapy (55%), providing a break from cytotoxic chemotherapy.

Titel:	Combined Targeted Therapies for First-line Treatment of Metastatic Triple Negative Breast Cancer-A Phase II Trial of Weekly Nab-Paclitaxel and Bevacizumab Followed by Maintenance Targeted Therapy With Bevacizumab and Erlotinib.
Autor/in / Beteiligte Person:	Symonds, L ; Linden, H ; Gadi, V ; Korde, L ; Rodler, E ; Gralow, J ; Redman, M ; Baker, K ; Wu, QV ; Jenkins, I ; Kurland, B ; Garrison, M ; Smith, J ; Anderson, J ; Van Haelst, C ; Specht, J
Zeitschrift:	Clinical breast cancer, Jg. 19 (2019-04-01), Heft 2, S. e283-e296
Veröffentlichung:	2011- : [New York] : Elsevier ; <i>Original Publication</i>: Dallas, Tex. : Cancer Information Group, 2019
Medientyp:	academicJournal
ISSN:	1938-0666 (electronic)
DOI:	10.1016/j.clbc.2018.12.008
Schlagwort:	Adult Aged Aged, 80 and over Albumins adverse effects Angiogenesis Inhibitors adverse effects Antineoplastic Agents administration & dosage Antineoplastic Agents adverse effects Bevacizumab adverse effects Disease-Free Survival Drug Administration Schedule Endothelial Cells pathology Erlotinib Hydrochloride adverse effects Female Humans Induction Chemotherapy Maintenance Chemotherapy Middle Aged Neoplastic Cells, Circulating pathology Paclitaxel adverse effects Protein Kinase Inhibitors adverse effects Triple Negative Breast Neoplasms blood Triple Negative Breast Neoplasms pathology Tubulin Modulators administration & dosage Tubulin Modulators adverse effects Albumins administration & dosage Angiogenesis Inhibitors administration & dosage Antineoplastic Combined Chemotherapy Protocols therapeutic use Bevacizumab administration & dosage Erlotinib Hydrochloride administration & dosage Paclitaxel administration & dosage Protein Kinase Inhibitors administration & dosage Triple Negative Breast Neoplasms drug therapy
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Corporate Authors: Seattle Cancer Care Alliance Network Investigators Publication Type: Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't Language: English [Clin Breast Cancer] 2019 Apr; Vol. 19 (2), pp. e283-e296. <i>Date of Electronic Publication: </i>2018 Dec 14. MeSH Terms: Albumins / administration & dosage ; Angiogenesis Inhibitors / administration & dosage ; Antineoplastic Combined Chemotherapy Protocols / therapeutic use ; Bevacizumab / administration & dosage ; Erlotinib Hydrochloride / administration & dosage ; Paclitaxel / administration & dosage ; Protein Kinase Inhibitors / administration & dosage ; Triple Negative Breast Neoplasms / drug therapy ; Adult ; Aged ; Aged, 80 and over ; Albumins / adverse effects ; Angiogenesis Inhibitors / adverse effects ; Antineoplastic Agents / administration & dosage ; Antineoplastic Agents / adverse effects ; Bevacizumab / adverse effects ; Disease-Free Survival ; Drug Administration Schedule ; Endothelial Cells / pathology ; Erlotinib Hydrochloride / adverse effects ; Female ; Humans ; Induction Chemotherapy ; Maintenance Chemotherapy ; Middle Aged ; Neoplastic Cells, Circulating / pathology ; Paclitaxel / adverse effects ; Protein Kinase Inhibitors / adverse effects ; Triple Negative Breast Neoplasms / blood ; Triple Negative Breast Neoplasms / pathology ; Tubulin Modulators / administration & dosage ; Tubulin Modulators / adverse effects References: Sci Rep. 2015 Oct 27;5:15746. (PMID: 26503902) ; CA Cancer J Clin. 2018 Jan;68(1):7-30. (PMID: 29313949) ; Ann Oncol. 2010 Sep;21(9):1765-71. (PMID: 20233745) ; Br J Cancer. 2008 Jun 3;98(11):1731-5. (PMID: 18506173) ; Clin Cancer Res. 2008 Dec 1;14(23):7878-83. (PMID: 19047117) ; Cell. 2012 May 11;149(4):780-94. (PMID: 22579283) ; J Clin Oncol. 2005 Sep 1;23(25):5892-9. (PMID: 16043829) ; J Clin Oncol. 2002 May 1;20(9):2310-8. (PMID: 11981002) ; JAMA Oncol. 2015 Jul;1(4):528-34; quiz 549. (PMID: 26181262) ; N Engl J Med. 2004 Aug 19;351(8):781-91. (PMID: 15317891) ; Am J Clin Oncol. 2010 Dec;33(6):637-45. (PMID: 20023571) ; Cytometry A. 2007 Feb;71(2):105-13. (PMID: 17226859) ; Eur J Cancer. 2017 Jan;70:146-155. (PMID: 27817944) ; Breast Cancer Res Treat. 2012 Nov;136(2):331-45. (PMID: 23073759) ; Clin Cancer Res. 2004 Oct 15;10(20):6897-904. (PMID: 15501967) ; Cancer Treat Rev. 2014 Sep;40(8):960-73. (PMID: 24909311) ; Clin Cancer Res. 2009 Nov 1;15(21):6639-48. (PMID: 19825949) ; Am J Cancer Res. 2016 Aug 01;6(8):1609-23. (PMID: 27648353) ; Eur J Cancer. 2008 Dec;44(18):2799-805. (PMID: 19008097) ; Nat Rev Clin Oncol. 2016 Nov;13(11):674-690. (PMID: 27184417) ; Cytokine Growth Factor Rev. 1996 Aug;7(2):133-41. (PMID: 8899291) ; J Natl Cancer Inst. 1990 Jan 3;82(1):4-6. (PMID: 1688381) ; J Clin Oncol. 2005 Nov 1;23(31):7794-803. (PMID: 16172456) ; Clin Breast Cancer. 2012 Jun;12(3):207-14. (PMID: 22520733) ; Clin Cancer Res. 2009 Dec 15;15(24):7652-7657. (PMID: 19996223) ; Breast J. 2006 Jul-Aug;12(4):360-2. (PMID: 16848847) ; N Engl J Med. 2007 Dec 27;357(26):2666-76. (PMID: 18160686) ; Cancer J. 2010 Jan-Feb;16(1):23-32. (PMID: 20164687) ; Clin Cancer Res. 2006 Jul 15;12(14 Pt 1):4331-8. (PMID: 16857808) ; N Engl J Med. 2010 Nov 11;363(20):1938-48. (PMID: 21067385) ; J Breast Cancer. 2017 Jun;20(2):150-159. (PMID: 28690651) ; Crit Rev Oncol Hematol. 1995 Jul;19(3):183-232. (PMID: 7612182) ; J Clin Oncol. 2011 Nov 10;29(32):4286-93. (PMID: 21990397) ; J Clin Oncol. 2014 Nov 1;32(31):3483-9. (PMID: 24888818) ; Proc Natl Acad Sci U S A. 2001 Sep 11;98(19):10869-74. (PMID: 11553815) ; Cancer. 2007 Jan 1;109(1):25-32. (PMID: 17146782) ; Cancer Res. 2010 Mar 1;70(5):2085-94. (PMID: 20179196) ; Mol Cancer Ther. 2007 Feb;6(2):532-41. (PMID: 17308052) ; J Clin Oncol. 2011 Apr 1;29(10):1252-60. (PMID: 21383283) ; Transl Oncol. 2016 Oct;9(5):453-457. (PMID: 27751350) ; Breast Cancer (Dove Med Press). 2016 May 20;8:93-107. (PMID: 27284266) ; Clin Breast Cancer. 2010 Feb;10(1):81-6. (PMID: 20133263) ; Lancet. 1987 Jun 20;1(8547):1398-402. (PMID: 2884496) Grant Information: P30 CA015704 United States CA NCI NIH HHS; P30 CA047904 United States CA NCI NIH HHS; S10 OD020069 United States OD NIH HHS Contributed Indexing: Keywords: Circulating endothelial cells; Circulating tumor cells; Erlotinib; Metastatic; Nab-paclitaxel bevacizumab; Triple negative breast cancer Substance Nomenclature: 0 (130-nm albumin-bound paclitaxel) ; 0 (Albumins) ; 0 (Angiogenesis Inhibitors) ; 0 (Antineoplastic Agents) ; 0 (Protein Kinase Inhibitors) ; 0 (Tubulin Modulators) ; 2S9ZZM9Q9V (Bevacizumab) ; DA87705X9K (Erlotinib Hydrochloride) ; P88XT4IS4D (Paclitaxel) Entry Date(s): Date Created: 20190210 Date Completed: 20200414 Latest Revision: 20200419 Update Code: 20240513 PubMed Central ID: PMC6440867

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Combined Targeted Therapies for First-line Treatment of Metastatic Triple Negative Breast Cancer-A Phase II Trial of Weekly Nab-Paclitaxel and Bevacizumab Followed by Maintenance Targeted Therapy With Bevacizumab and Erlotinib.