Efficacy of CPX-351, (cytarabine: DAunorubicin) liposome injection, against acute lymphoblastic leukemia (ALL) xenograft models of the Pediatric Preclinical Testing Program

Pediatric Blood and Cancer

Volumn 62, Issue 1, 2015, Pages 65-71

  Carol, Hernan ^a   Fan, Mannie M Y ^b   Harasym, Troy O ^b   Boehm, Ingrid ^a   Mayer, Lawrence D ^b   Houghton, Peter ^c   Smith, Malcolm A ^d   Lock, Richard B ^a  

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

^b Celator Pharmaceuticals   (Canada)

^c NATIONWIDE CHILDREN S HOSPITAL   (United States)

^d Cancer Therapy Evaluation Program   (United States)

Author keywords

Acute leukemia; CPX 351; Efficacy; Pharmacokinetics; Synergy

Indexed keywords

CYTARABINE; DAUNORUBICIN; LIPOSOME; ANTINEOPLASTIC AGENT;

ANIMAL EXPERIMENT; ANIMAL MODEL; AREA UNDER THE CURVE; ARTICLE; CANCER SURVIVAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG EXPOSURE; DRUG FORMULATION; DRUG HALF LIFE; ELIMINATION HALF-LIFE; EVENT FREE SURVIVAL; FEMALE; FLOW CYTOMETRY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN CELL; LYMPHATIC LEUKEMIA; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MOUSE; NONHUMAN; PRIORITY JOURNAL; TREATMENT RESPONSE; ADOLESCENT; ANIMAL; CHILD; DRUG SCREENING; MALE; NONOBESE DIABETIC MOUSE; PATHOLOGY; PEDIATRICS; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; PRESCHOOL CHILD; SCID MOUSE; TISSUE DISTRIBUTION; TREATMENT OUTCOME;

ADOLESCENT; ANIMALS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHILD; CHILD, PRESCHOOL; CYTARABINE; DAUNORUBICIN; FEMALE; HUMANS; LIPOSOMES; MALE; MAXIMUM TOLERATED DOSE; MICE; MICE, INBRED NOD; MICE, SCID; PEDIATRICS; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; TISSUE DISTRIBUTION; TREATMENT OUTCOME; XENOGRAFT MODEL ANTITUMOR ASSAYS;

EID: 84922767350     PISSN: 15455009     EISSN: 15455017     Source Type: Journal    
DOI: 10.1002/pbc.25133     Document Type: Article

References (38)

1. Fullmer A, O'Brien S, Kantarjian H, et al. Emerging therapy for the treatment of acute lymphoblastic leukemia. Expert Opin Emerg Drugs 2010; 15:1-11.
2. Faderl S, O'Brien S, Pui C-H, et al. Adult acute lymphoblastic leukemia. Cancer 2010; 116:1165-1176.
3. Howlader N, Noone AM, Krapcho M, et al. (eds) SEER Cancer Statistics Review, 1975-2010. National Cancer Institute; Bethesda, MD: http://seer.cancer.gov/csr/1975_2010/, based on November 2012 SEER data submission, posted to the SEER web site, April 2013.
4. Smith MA, Seibel NL, Altekruse SF, et al. Outcomes for children and adolescents with cancer: challenges for the twenty-first century. J Clin Oncol 2010; 28:2625-2634.
5. Sive JI, Buck G, Fielding A, et al. Outcomes in older adults with acute lymphoblastic leukaemia (ALL): results from the international MRC UKALL XII/ECOG 2993 trial. Br J Haematol 2012 157:463-471.
6. Freyer DR, Devidas M, La M, et al. Postrelapse survival in childhood acute lymphoblastic leukemia is independent of initial treatment intensity: a report from the Children's Oncology Group. Blood 2011; 117:3010-3015.
7. Abshire TC, Pollock BH, Billett AL, et al. Weekly polyethylene glycol conjugated L-asparaginase compared with biweekly dosing produces superior induction remission rates in childhood relapsed acute lymphoblastic leukemia: a Pediatric Oncology Group Study. Blood 2000; 96:1709-1715.
8. Kelly ME, Lu X, Devidas M, et al. Treatment of relapsed precursor-B acute lymphoblastic leukemia with intensive chemotherapy: POG (Pediatric Oncology Group) study 9411 (SIMAL 9). J Pediatr Hematol Oncol 2013; 35:509-513.
9. Raetz EA, Borowitz MJ, Devidas M, et al. Reinduction platform for children with first marrow relapse of acute lymphoblastic Leukemia: A Children's Oncology Group Study[corrected]. J Clin Oncol 2008; 26:3971-3978.
10. Oriol A, Vives S, Hernandez-Rivas JM, et al. Outcome after relapse of acute lymphoblastic leukemia in adult patients included in four consecutive risk-adapted trials by the PETHEMA Study Group. Haematologica 2010; 95:589-596.
11. Tavernier E, Boiron JM, Huguet F, et al. Outcome of treatment after first relapse in adults with acute lymphoblastic leukemia initially treated by the LALA-94 trial. Leukemia 2007; 21:1907-1914 .
12. Garcia-Manero G, Thomas DA. Salvage therapy for refractory or relapsed acute lymphocytic leukemia. Hematol Oncol Clin North Am 2001; 15:163-205.
13. Feldman E, Alberts D, Arlin Z, et al. Phase I clinical and pharmacokinetic evaluation of high-dose mitoxantrone in combination with cytarabine in patients with acute leukemia. J Clin Oncol 1993; 11:2002-2009.
14. Candoni A, Michelutti A, Simeone E, et al. Efficacy of liposomal daunorubicin and cytarabine as reinduction chemotherapy in relapsed acute lymphoblastic leukaemia despite expression of multidrug resistance-related proteins. Eur J Haematol 2006; 77:293-299.
15. Testi AM, Del Giudice I, Arcese W, et al. A single high dose of idarubicin combined with high-dose ARA-C for treatment of first relapse in childhood 'high-risk' acute lymphoblastic leukaemia: a study of the AIEOP group. Br J Haematol 2002; 118:741-747.
16. Tedeschi A, Montillo M, Strocchi E, et al. High-dose idarubicin in combination with Ara-C in patients with relapsed or refractory acute lymphoblastic leukemia: a pharmacokinetic and clinical study. Cancer Chemother Pharmacol 2007; 59:771-779.
17. Weiss M. Induction therapy of adult acute lymphocytic leukemia without the use of vincristine or prednisone. Hematol Oncol Clin North Am 2001; 15:1-7.
18. Hallböök H, Simonsson B, Ahlgren T, et al. High-dose cytarabine in upfront therapy for adult patients with acute lymphoblastic leukaemia. Br J Haematol 2002; 118:748-754.
19. Rowe JM. Optimal management of adults with ALL. Br J Haematol 2009; 144:468-483.
20. Robak T, Wierzbowska A. Current and emerging therapies for acute myeloid leukemia. Clin Ther 2009; 31:2349-2370.
21. Döhner H, Estey EH, Amadori S, et al. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood 2010; 115:453-474.
22. Tardi P, Boman N, Cullis P. Liposomal Doxorubicin. J Drug Target 1996; 4:129-140.
23. Fassas A, Anagnostopoulos A. The use of liposomal daunorubicin (DaunoXome) in acute myeloid leukemia. Leuk Lymphoma 2005; 46:795-802.
24. Mayer LD, Harasym TO, Tardi PG, et al. Ratiometric dosing of anticancer drug combinations: Controlling drug ratios after systemic administration regulates therapeutic activity in tumor-bearing mice. Mol Cancer Ther 2006; 5:1854-1863.
25. Tardi P, Johnstone S, Harasym N, et al. In vivo maintenance of synergistic cytarabine:daunorubicin ratios greatly enhances therapeutic efficacy. Leuk Res 2009; 33:129-139.
26. Feldman EJ, Lancet JE, Kolitz JE, et al. First-In-Man Study of CPX-351: A Liposomal Carrier Containing Cytarabine and Daunorubicin in a Fixed 5:1 Molar Ratio for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia. J Clin Oncol 2011; 29:979-985.
27. Lancet JE, Cortes JE, Hogge DE, et al. Phase 2B Randomized Study of CPX-351 Vs. Cytarabine (CYT) + Daunorubicin (DNR) (7 + 3 Regimen) In Newly Diagnosed AML Patients Aged 60-75. Blood (ASH Annual Meeting Abstracts) 2010; 116:655-.
28. Tyner JW, Tardi P, Mayer L, et al. Evaluation of CPX-351 (cytarabine:daunorubicin) Liposome Injection Anti-Leukemic Activity Against Primary Patient Leukemia Cells. Blood (ASH Annual Meeting Abstracts) 2010; 116:2886-.
29. 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.
30. Lock RB, Liem N, Farnsworth ML, et al. The nonobese diabetic/severe combined immunodeficient (NOD/SCID) mouse model of childhood acute lymphoblastic leukemia reveals intrinsic differences in biologic characteristics at diagnosis and relapse. Blood 2002; 99:4100-4108.
31. 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.
32. Lim WS, Tardi PG, Dos Santos N, et al. Leukemia-selective uptake and cytotoxicity of CPX-351, a synergistic fixed-ratio cytarabine:daunorubicin formulation, in bone marrow xenografts. Leuk Res 2010; 34:1214-1223.
33. Lee VW, Wang Y, Qin X, et al. Adriamycin nephropathy in severe combined immunodeficient (SCID) mice. Nephrol Dial Transplant 2006; 21:3293-3298.
34. Feldman EJ, Kolitz JE, Trang JM, et al. Pharmacokinetics of CPX-351; a nano-scale liposomal fixed molar ratio formulation of cytarabine:daunorubicin, in patients with advanced leukemia. Leuk Res 2012; 36:1283-1289.
35. Pui C-H, Robison LL, Look AT. Acute lymphoblastic leukaemia. Lancet 2008; 371:1030-1043.
36. Uckun FM, Sensel MG, Sun L, et al. Biology and treatment of childhood T-lineage acute lymphoblastic leukemia. Blood 1998; 91:735-746.
37. Tajbakhsh M, Houghton PJ, Morton CL, et al. Initial testing of cisplatin by the Pediatric Preclinical Testing Program. Pediatr Blood Cancer 2008; 50:992-1000.
38. Keshelava N, Houghton PJ, Morton CL, et al. Initial testing (stage 1) of vorinostat (SAHA) by the Pediatric Preclinical Testing Program. Pediatr Blood Cancer 2009; 53:505-508.