Multicenter phase II study of Apatinib in non-triple-negative metastatic breast cancer

BMC Cancer

Volumn 14, Issue 1, 2014, Pages

  Hu, Xichun ^a,b   Cao, Jun ^a,b   Hu, Wenwei ^c   Wu, Changping ^c   Pan, Yueyin ^d   Cai, Li ^e   Tong, Zhongsheng ^f   Wang, Shusen ^g   Li, Jin ^a,b   Wang, Zhonghua ^a,b   Wang, Biyun ^a,b   Chen, Xiaoyu ^a,b   Yu, Hao ^h  

^a FUDAN UNIVERSITY SHANGHAI CANCER CENTER   (China)

^b FUDAN UNIVERSITY   (China)

^c SUZHOU UNIVERSITY   (China)

^d ANHUI MEDICAL UNIVERSITY   (China)

^e HARBIN MEDICAL UNIVERSITY   (China)

^f TIANJIN MEDICAL UNIVERSITY   (China)

^g SUN YAT SEN UNIVERSITY CANCER CENTER   (China)

^h NANJING MEDICAL UNIVERSITY   (China)

Author keywords

Apatinib; Metastatic breast cancer; VEGF

Indexed keywords

ANTHRACYCLINE; APATINIB; CAPECITABINE; EPIDERMAL GROWTH FACTOR RECEPTOR 2; PROTEIN TYROSINE KINASE INHIBITOR; TAXANE DERIVATIVE; UNCLASSIFIED DRUG; ANTINEOPLASTIC AGENT; PROTEIN KINASE INHIBITOR; PYRIDINE DERIVATIVE;

ADULT; ANOREXIA; ARTICLE; CANCER CHEMOTHERAPY; CANCER CONTROL; CANCER GROWTH; CLINICAL ARTICLE; CONTROLLED STUDY; DEATH; DIARRHEA; DIZZINESS; DRUG CYTOTOXICITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DYSPNEA; FATIGUE; FEMALE; FEVER; FOLLOW UP; HAND FOOT SYNDROME; HEART VENTRICLE ARRHYTHMIA; HEMATURIA; HUMAN; HYPERTENSION; HYPERTRANSAMINASEMIA; METASTATIC BREAST CANCER; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OPEN STUDY; OVERALL SURVIVAL; PAIN; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; PROTEINURIA; SINGLE BLIND PROCEDURE; SKIN ULCER; THROMBOCYTOPENIA; VOMITING; CHEMICALLY INDUCED; CLINICAL TRIAL; DISEASE FREE SURVIVAL; HAND-FOOT SYNDROME; MIDDLE AGED; PATHOLOGY; RETREATMENT; SURVIVAL RATE; TREATMENT OUTCOME; TRIPLE NEGATIVE BREAST NEOPLASMS;

ADULT; ANTINEOPLASTIC AGENTS; DISEASE-FREE SURVIVAL; FEMALE; HAND-FOOT SYNDROME; HUMANS; HYPERTENSION; MIDDLE AGED; PROTEIN KINASE INHIBITORS; PROTEINURIA; PYRIDINES; RETREATMENT; SURVIVAL RATE; TREATMENT OUTCOME; TRIPLE NEGATIVE BREAST NEOPLASMS;

EID: 84929090183     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-14-820     Document Type: Article

References (29)

1. Althuis MD, Dozier JD, Anderson WF, Devesa SS, Brinton LA: Global trends in breast cancer incidence and mortality 1973-1997. Int J Epidemiol 2005, 34(2):405-412. Epub 2005 Feb 28.
2. Early Breast Cancer Trialists' Collaborative Group (EBCTCG): Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomized trials. Lancet 2005, 365(9472):1687-1717.
3. Banerjee S, Dowsett M, Ashworth A, Martin LA: Mechanisms of disease: angiogenesis and the management of breast cancer. Nat Clin Pract Oncol 2007, 4:536-550.
4. Ferrara N: Vascular endothelial growth factor basic science and clinical progress. Endocr Rev 2004, 25:581-611.
5. Miles DW, Chan A, Dirix LY, Cortés J, Pivot X, Tomczak P, Delozier T, Sohn JH, Provencher L, Puglisi F, Harbeck N, Steger GG, Schneeweiss A, Wardley AM, Chlistalla A, Romieu G: Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2010, 28:3239-3247.
6. Miller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, Shenkier T, Cella D, Davidson NE: Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 2007, 357:2666-2676.
7. Robert NJ, Diéras V, Glaspy J, Brufsky AM, Bondarenko I, Lipatov ON, Perez EA, Yardley DA, Chan SY, Zhou X, Phan SC, O'Shaughnessy J: RIBBON-1: Randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor r 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol 2011, 29:1252-1260.
8. Brufsky AM, Hurvitz S, Perez E, Swamy R, Valero V, O'Neill V, Rugo HS: RIBBON-2: a randomized, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2011, 29(32):4286-4293. Epub 2011 Oct 11.
9. Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH: Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006, 355(24):2542-2550.
10. Escudier B, Pluzanska A, Koralewski P, Ravaud A, Bracarda S, Szczylik C, Chevreau C, Filipek M, Melichar B, Bajetta E, Gorbunova V, Bay JO, Bodrogi I, Jagiello-Gruszfeld A, Moore N: AVOREN Trial investigators. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet 2007, 370(9605):2103-2111.
11. Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F: Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004, 350(23):2335-2342.
12. Burger RA, Brady MF, Bookman MA, Fleming GF, Monk BJ, Huang H, Mannel RS, Homesley HD, Fowler J, Greer BE, Boente M, Birrer MJ, Liang SX, Gynecologic Oncology Group: Incorporation of bevacizumab in the primary treatment of ovarian cancer. N Engl J Med 2011, 365(26):2473-2483.
13. Mendel DB, Laird AD, Xin X, Louie SG, Christensen JG, Li G, Schreck RE, Abrams TJ, Ngai TJ, Lee LB, Murray LJ, Carver J, Chan E, Moss KG, Haznedar JO, Sukbuntherng J, Blake RA, Sun L, Tang C, Miller T, Shirazian S, McMahon G, Cherrington JM: In vivo antitumor activity of SU11248, a novel tyrosine kinase inhibitor targeting vascularendothelial growth factor and plateletderived growth factor receptors: determination of apharmacokinetic/ pharmacodynamic relationship. Clin Cancer Res 2003, 9(1):327-337.
14. Wilhelm S, Carter C, Lynch M, Lowinger T, Dumas J, Smith RA, Schwartz B, Simantov R, Kelley S: Discovery and development of sorafenib: a multikinase inhibitor for treating cancer. Nat Rev Drug Discov 2006, 5(10):835-844.
15. Bianchi G, Loibl S, Zamagni C, Salvagni S, Raab G, Siena S, Laferriere N, Peña C, Lathia C, Bergamini L, Gianni L: Phase II multicenter, uncontrolled trial of sorafenib in patients with metastatic breast cancer. Anticancer Drugs 2009, 20:616-624.
16. Moreno-Aspitia A, Morton RF, Hillman DW, Lingle WL, Rowland KM Jr, Wiesenfeld M, Flynn PJ, Fitch TR, Perez EA: Phase II trial of sorafenib in patients with metastatic breast cancer previously exposed to anthracyclines or taxanes: North Central Cancer Treatment Group and Mayo Clinic Trial N0336. J Clin Oncol 2009, 27(1):11-5. Epub 2008 Dec 1.
17. Burstein HJ, Elias AD, Rugo HS, Cobleigh MA, Wolff AC, Eisenberg PD, Lehman M, Adams BJ, Bello CL, DePrimo SE, Baum CM, Miller KD: Phase II study of sunitinib malate, an oral multitargeted tyrosine kinase inhibitor, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol 2008, 26:1810-1816.
18. Li J, Zhao X, Chen L, Guo H, Lv F, Jia K, Yv K, Wang F, Li C, Qian J, Zheng C, Zuo Y: Safety and pharmacokinetics of novel selective vascular endothelial growth factor receptor-2 inhibitor YN968D1 in patients with advanced malignancies. BMC Cancer 2010, 10:529.
19. Li J, Qin S, Xu J, Guo W, Xiong J, Bai Y, Sun G, Yang Y, Wang L, Xu N, Cheng Y, Wang Z, Zheng L, Tao M, Zhu X, Ji D, Liu X, Yu H: Apatinib for chemotherapy-refractory advanced metastatic gastric cancer: results from a randomized, placebo-controlled, parallel-arm, phase II trial. J Clin Oncol 2013, 31(26):3219-3225.
20. Hu X, Zhang J, Xu B, Jiang Z, Ragaz J, Tong Z, Zhang Q, Wang X, Feng J, Pang D, Fan M, Li J, Wang B, Wang Z, Zhang Q, Sun S, Liao C: Multicenter phase II study of apatinib, a novel VEGFR inhibitor in heavily pretreated patients with metastatic triple-negative breast cancer. Int J Cancer 2014, Epub ahead of print.
21. Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM, TARGET Study Group: Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 2007, 356(2):125-134.
22. Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Häussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J, SHARP Investigators Study Group: Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 2008, 359(4):378-390.
23. Cobleigh MA, Langmuir VK, Sledge GW, Miller KD, Haney L, Novotny WF, Reimann JD, Vassel A: A phase I/II dose-escalation trial of bevacizumab in previously treated metastatic breast cancer. Semin Oncol 2003, 30(5 Suppl 16):117-124.
24. Baselga J, Segalla JG, Roché H, Del Giglio A, Pinczowski H, Ciruelos EM, Filho SC, Gómez P, Van Eyll B, Bermejo B, Llombart A, Garicochea B, Durán Má, Hoff PM, Espié M, de Moraes AA, Ribeiro RA, Mathias C, Gil Gil M, Ojeda B, Morales J, Kwon Ro S, Li S, Costa F: Sorafenib in combination with capecitabine: an oral regimen for patients with HER2-negative locally advanced or metastatic breast cancer. J Clin Oncol 2012, 30:1484-1491.
25. Schwartzberg LS, Tauer KW, Hermann RC, Makari-Judson G, Isaacs C, Beck JT, Kaklamani V, Stepanski EJ, Rugo HS, Wang W, Bell-McGuinn K, Kirshner JJ, Eisenberg P, Emanuelson R, Keaton M, Levine E, Medgyesy DC, Qamar R, Starr A, Ro SK, Lokker NA, Hudis CA: Sorafenib or placebo with either gemcitabine or capecitabine in patients with HER-2-negativeadvanced breast cancer that progressed during or after bevacizumab. Clin Cancer Res 2013, 19(10):2745-2754.
26. Gradishar WJ, Kaklamani V, Sahoo TP, Lokanatha D, Raina V, Bondarde S, Jain M, Ro SK, Lokker NA, Schwartzberg L: A double-blind, randomised, placebo-controlled, phase 2b study evaluating sorafenib in combination with paclitaxel as a first-line therapy in patients with HER2-negative advanced breast cancer. Eur J Cancer 2013, 49:312-322.
27. Mariani G, Burdaeva O, Roman L, Staroslawska E, Udovitsa D, Driol P, Goisis G, Zamagni C, Semiglazov V, Gianni L: A double-blind, randomized phase IIb study evaluating the efficacy and safety of sorafenib compared to placebo when administered in combination with docetaxel and/or letrozole in patients with metastatic breast cancer (MDC): FM-B07-01 Trial [abstract]. Eur J Cancer 2011, 47(Suppl 2):10.
28. Rugo HS, Stopeck AT, Joy AA, Chan S, Verma S, Lluch A, Liau KF, Kim S, Bycott P, Rosbrook B, Bair AH, Soulieres D: Randomized, placebocontrolled, double-blind, phase II study of axitinib plus docetaxel versus docetaxel plus placebo in patients with metastatic breast cancer. J Clin Oncol 2011, 29(18):2459-2465.
29. Tang JR, Markham NE, Lin YJ, McMurtry IF, Maxey A, Kinsella JP, Abman SH: Inhaled nitric oxide attenuates pulmonary hypertension and improves lung growth in infant rats after neonatal treatment with a VEGF receptor inhibitor. Am J Physiol Lung Cell Mol Physiol 2004, 287(2):L344-51.