Initial testing (stage 1) of eribulin, a novel tubulin binding agent, by the pediatric preclinical testing program

Pediatric Blood and Cancer

Volumn 60, Issue 8, 2013, Pages 1325-1332

  Kolb, E Anders ^a   Gorlick, Richard ^b   Reynolds, C Patrick ^c   Kang, Min H ^c   Carol, Hernan ^d   Lock, Richard ^d   Keir, Stephen T ^e   Maris, John M ^f   Billups, Catherine A ^g   Desjardins, Christopher ^h   Kurmasheva, Raushan T ⁱ   Houghton, Peter J ⁱ   Smith, Malcolm A ^j  

^a NEMOURS ALFRED I DUPONT HOSPITAL FOR CHILDREN   (United States)

^b CHILDREN S HOSPITAL AT MONTEFIORE   (United States)

^c TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER   (United States)

^d CHILDREN S CANCER INSTITUTE AUSTRALIA FOR MEDICAL RESEARCH   (Australia)

^e DUKE UNIVERSITY MEDICAL CENTER   (United States)

^f UNIVERSITY OF PENNSYLVANIA   (United States)

^g ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^h EISAI INC   (United States)

ⁱ NATIONWIDE CHILDREN S HOSPITAL   (United States)

^j NATIONAL CANCER INSTITUTE   (United States)

more..

Author keywords

Developmental therapeutics; PI3K inhibitor; Preclinical testing

Indexed keywords

ERIBULIN;

ANIMAL EXPERIMENT; ANIMAL MODEL; AREA UNDER THE CURVE; ARTICLE; CANCER CELL; CHILDHOOD CANCER; COMPARATIVE STUDY; CONTROLLED STUDY; DRUG BINDING; DRUG BLOOD LEVEL; DRUG CYTOTOXICITY; DRUG EFFICACY; EVENT FREE SURVIVAL; EWING SARCOMA; FEMALE; GLIOBLASTOMA; HUMAN; HUMAN CELL; IC 50; IN VITRO STUDY; MAXIMUM TOLERATED DOSE; MOUSE; NEPHROBLASTOMA; NEUROBLASTOMA; NEUROBLASTOMA CELL; NONHUMAN; OSTEOSARCOMA; PRIORITY JOURNAL; RHABDOMYOSARCOMA; TUMOR GROWTH; TUMOR VOLUME; TUMOR XENOGRAFT;

ANIMALS; CELL LINE, TUMOR; FURANS; HUMANS; KETONES; MICE; MICE, INBRED BALB C; MICE, NUDE; MICE, SCID; NEOPLASMS, EXPERIMENTAL; TUBULIN MODULATORS; XENOGRAFT MODEL ANTITUMOR ASSAYS;

EID: 84879198533     PISSN: 15455009     EISSN: 15455017     Source Type: Journal    
DOI: 10.1002/pbc.24517     Document Type: Article

References (42)

1. Bai RL, Paull KD, Herald CL, et al. Halichondrin B and homohalichondrin B, marine natural products binding in the vinca domain of tubulin. Discovery of tubulin-based mechanism of action by analysis of differential cytotoxicity data. J Biol Chem 1991; 266:15882-15889.
2. Towle MJ, Salvato KA, Budrow J, et al. In vitro and in vivo anticancer activities of synthetic macrocyclic ketone analogues of halichondrin B. Cancer Res 2001; 61:1013-1021.
3. Jordan MA, Wilson L. Microtubules as a target for anticancer drugs. Nat Rev Cancer 2004; 4:253-265.
4. Smith JA, Wilson L, Azarenko O, et al. Eribulin binds at microtubule ends to a single site on tubulin to suppress dynamic instability. Biochemistry 2010; 49:1331-1337.
5. Jordan MA, Kamath K, Manna T, et al. The primary antimitotic mechanism of action of the synthetic halichondrin E7389 is suppression of microtubule growth. Mol Cancer Ther 2005; 4:1086-1095.
6. Towle MJ, Salvato KA, Wels BF, et al. Eribulin induces irreversible mitotic blockade: Implications of cell-based pharmacodynamics for in vivo efficacy under intermittent dosing conditions. Cancer Res 2011; 71:496-505.
7. Jain S, Vahdat LT. Eribulin mesylate. Clin Cancer Res 2011; 17:6615-6622.
8. Rubin E, Rosen L, Rajeev V, et al. Phase I study of E7389 administed by 1 hour infusion every 21 days. J Clin Oncol 2005; 23:2054.
9. Tan AR, Rubin EH, Walton DC, et al. Phase I study of eribulin mesylate administered once every 21 days in patients with advanced solid tumors. Clin Cancer Res 2009; 15:4213-4219.
10. Synold T, Tsao-Wei DD, Quinn DI, et al. Phase I and pharmacokinetic (PK) study of eribulin (E7389) in patients with renal dysfunction and advanced urothelial cancer: A California Cancer Consortium Trial. J Clin Oncol 2010; 28:2527.
11. Goel S, Mita AC, Mita M, et al. A phase I study of eribulin mesylate (E7389), a mechanistically novel inhibitor of microtubule dynamics, in patients with advanced solid malignancies. Clin Cancer Res 2009; 15:4207-4212.
12. Synold T, Morgan RJ, Newman EW, et al. A Phase I pharmacokinetic and target validation study of the novel anti-tubulin agent E7389: A California Cancer Consortium trial. J Clin Oncol 2005; 23:3036.
13. Vahdat LT, Pruitt B, Fabian CJ, et al. Phase II study of eribulin mesylate, a halichondrin B analog, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol 2009; 27:2954-2961.
14. Cortes J, O'Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): A phase 3 open-label randomised study. Lancet 2011; 377:914-923.
15. Preston JN, Trivedi MV. Eribulin: A novel cytotoxic chemotherapy agent. Ann Pharmacother 2012; 46:802-811.
16. Schoffski P, Ray-Coquard IL, Cioffi A, et al. Activity of eribulin mesylate in patients with soft-tissue sarcoma: A phase 2 study in four independent histological subtypes. Lancet Oncol 2011; 12:1045-1052.
17. Frgala T, Kalous O, Proffitt RT, et al. A fluorescence microplate cytotoxicity assay with a 4-log dynamic range that identifies synergistic drug combinations. Mol Cancer Ther 2007; 6:886-897.
18. Kang MH, Smith MA, Morton CL, et al. National Cancer Institute Pediatric Preclinical Testing Program: Model description for in vitro cytotoxicity testing. Pediatr Blood Cancer 2011; 56:239-249.
19. Houghton PJ, Morton CL, Tucker C, et al. The pediatric preclinical testing program: Description of models and early testing results. Pediatr Blood Cancer 2007; 49:928-940.
20. Liem NL, Papa RA, Milross CG, et al. Characterization of childhood acute lymphoblastic leukemia xenograft models for the preclinical evaluation of new therapies. Blood 2004; 103:3905-3914.
21. Taur JS, Desjardins CS, Schuck EL, et al. Interactions between the chemotherapeutic agent eribulin mesylate (E7389) and P-glycoprotein in CF-1 abcb1a-deficient mice and Caco-2 cells. Xenobiotica 2011; 41:320-326.
22. Devriese LA, Mergui-Roelvink M, Wanders J, et al. Eribulin mesylate pharmacokinetics in patients with solid tumors receiving repeated oral ketoconazole. Invest New Drugs 2012; 31:381-389.
23. Devriese LA, Witteveen PO, Wanders J, et al. Pharmacokinetics of eribulin mesylate in patients with solid tumors receiving repeated oral rifampicin. Br J Clin Pharmacol 2012; 75:507-515.
24. Devriese LA, Witteveen PO, Marchetti S, et al. Pharmacokinetics of eribulin mesylate in patients with solid tumors and hepatic impairment. Cancer Chemother Pharmacol 2012; 70:823-832.
25. Mukohara T, Nagai S, Mukai H, et al. Eribulin mesylate in patients with refractory cancers: A Phase I study. Invest New Drugs 2012; 30:1926-1933.
26. Sullivan MP, Sutow WW, Cangir A, et al. Vincristine sulfate in management of Wilms' tumor. Replacement of preoperative irradiation by chemotherapy. JAMA 1967; 202:381-384.
27. Sutow WW. Vincristine (NSC-67574) therapy for malignant solid tumors in children (except Wilms' tumor). Cancer Chemother Rep 1968; 52:485-487.
28. Sutow WW, Berry DH, Haddy TB, et al. Vincristine sulfate therapy in children with metastatic soft tissue sarcoma. Pediatrics 1966; 38:465-472.
29. James DH, Jr., George P. Vincristine in children with malignant solid tumors. J Pediatr 1964; 64:534-541.
30. Selawry OS, Hananian J. Vincristine treatment of cancer in children. JAMA 1963; 183:741-746.
31. Sutow WW, Vietti TJ, Fernbach DJ, et al. Evaluation of chemotherapy in children with metastatic Ewing's sarcoma and osteogenic sarcoma. Cancer Chemother Rep 1971; 55:67-78.
32. Rosen G, Nirenberg A, Caparros B, et al. Osteogenic sarcoma: Eight-percent, three-year, disease-free survival with combination chemotherapy (T-7). Natl Cancer Inst Monogr 1981; 56:213-220.
33. Souhami RL, Craft AW, Van der Eijken JW, et al. Randomised trial of two regimens of chemotherapy in operable osteosarcoma: A study of the European Osteosarcoma Intergroup. Lancet 1997; 350:911-917.
34. Edmonson JH, Green SJ, Ivins JC, et al. A controlled pilot study of high-dose methotrexate as postsurgical adjuvant treatment for primary osteosarcoma. J Clin Oncol 1984; 2:152-156.
35. Krailo M, Ertel I, Makley J, et al. A randomized study comparing high-dose methotrexate with moderate-dose methotrexate as components of adjuvant chemotherapy in childhood nonmetastatic osteosarcoma: A report from the Childrens Cancer Study Group. Med Pediatr Oncol 1987; 15:69-77.
36. Eilber F, Giuliano A, Eckardt J, et al. Adjuvant chemotherapy for osteosarcoma: A randomized prospective trial. J Clin Oncol 1987; 5:21-26.
37. Pratt CB, Champion JE, Fleming ID, et al. Adjuvant chemotherapy for osteosarcoma of the extremity. Long-term results of two consecutive prospective protocol studies. Cancer 1990; 65:439-445.
38. Kuttesch JF, Jr., Krailo MD, Madden T, et al. Phase II evaluation of intravenous vinorelbine (Navelbine) in recurrent or refractory pediatric malignancies: A Children's Oncology Group study. Pediatr Blood Cancer 2009; 53:590-593.
39. Casanova M, Ferrari A, Spreafico F, et al. Vinorelbine in previously treated advanced childhood sarcomas: Evidence of activity in rhabdomyosarcoma. Cancer 2002; 94:3263-3268.
40. Morton CL, Favours EG, Mercer KS, et al. Evaluation of ABT-751 against childhood cancer models in vivo. Invest New Drugs 2007; 25:285-295.
41. Meany HJ, Sackett DL, Maris JM, et al. Clinical outcome in children with recurrent neuroblastoma treated with ABT-751 and effect of ABT-751 on proliferation of neuroblastoma cell lines and on tubulin polymerization in vitro. Pediatr Blood Cancer 2010; 54:47-54.
42. Wong H, Choo EF, Alicke B, et al. Antitumor activity of targeted and cytotoxic agents in murine subcutaneous tumor models correlates with clinical response. Clin Cancer Res 2012; 18:3846-3855.