Subcutaneous trastuzumab: Development of a new formulation for treatment of HER2-positive early breast cancer

OncoTargets and Therapy

Volumn 6, Issue , 2013, Pages 89-94

  Hamizi, Salima ^a   Freyer, Gilles ^a   Bakrin, Naoual ^b   Henin, Emilie ^c   Mohtaram, Amina ^a   Le Saux, Olivia ^a   Falandry, Claire ^b  

^a HOSPICES CIVILS DE LYON   (France)

^b CENTRE HOSPITALIER LYON SUD   (France)

^c UNIVERSITÉ CLAUDE BERNARD LYON 1   (France)

Author keywords

Breast cancer; Human epidermal growth factor receptor 2; Hyaluronidase; Trastuzumab

Indexed keywords

CEFTRIAXONE; CYCLOPHOSPHAMIDE; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; FLUOROURACIL; HYALURONIC ACID; MONOCLONAL ANTIBODY; MORPHINE; PLACEBO; PROTEIN; RECOMBINANT HYALURONIDASE; TRASTUZUMAB;

ADJUVANT THERAPY; ANTIANGIOGENIC ACTIVITY; ANTINEOPLASTIC ACTIVITY; APOPTOSIS; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER SURGERY; CANCER SURVIVAL; CARBOHYDRATE METABOLISM; CELL CYCLE ARREST; CLINICAL PROTOCOL; CONTINUOUS INFUSION; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG DISTRIBUTION; DRUG DOSAGE FORM COMPARISON; DRUG DOSE COMPARISON; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG FORMULATION; DRUG PENETRATION; DRUG SAFETY; DRUG TARGETING; DRUG TOLERANCE; EARLY CANCER; ENZYME DEGRADATION; FEBRILE NEUTROPENIA; HEALTH CARE PERSONNEL; HEALTH CARE SYSTEM; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; IN VIVO STUDY; INFUSION RELATED REACTION; INJECTION SITE INFECTION; LEUKOPENIA; LOADING DRUG DOSE; MAINTENANCE DRUG DOSE; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; ONCOGENE NEU; OPTIMAL DRUG DOSE; PATIENT PREFERENCE; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PRODUCT DEVELOPMENT; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SIDE EFFECT; SIGNAL TRANSDUCTION; TREATMENT DURATION; TREATMENT OUTCOME;

EID: 84875040263     PISSN: 11786930     EISSN: None     Source Type: Journal    
DOI: 10.2147/OTT.S27733     Document Type: Review

References (37)

1. Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987;235:177-182.
2. Slamon DJ, Godolphin W, Jones LA, et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science. 1989;244:707-712.
3. Marty M, Cognetti F, Maraninchi D, et al. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group. J Clin Oncol. 2005;23:4265-4274.
4. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344:783-792.
5. Gianni L, Pienkowski T, Im YH, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13:25-32.
6. Perez EA, Romond EH, Suman VJ, et al. Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31. J Clin Oncol. 2011;29:3366-3373.
7. Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353:1659-1672.
8. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353:1673-1684.
9. Slamon D, Eiermann W, Robert N, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365:1273-1283.
10. Liberato NL, Marchetti M, Barosi G. Cost effectiveness of adjuvant trastuzumab in human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol. 2007;25:625-633.
11. Misbah S, Sturzenegger MH, Borte M, et al. Subcutaneous immunoglobulin: opportunities and outlook. Clin Exp Immunol. 2009;158 Suppl 1:51-59.
12. Gardulf A, Borte M, Ochs HD, Nicholay U; Vivaglobin Clinical Study Group. Prognostic factors for health-related quality of life in adults and children with primary antibody deficiencies receiving SCIG home therapy. Clin Immunol. 2008;126:81-88.
13. Hoffmann F, Grimbacher B, Thiel J, et al. Home-based subcutaneous immunoglobulin G replacement therapy under real-life conditions in children and adults with antibody deficiency. Eur J Med Res. 2010;15:238-245.
14. Thamer M, Zhang Y, Kaufman J, Stefanik K, Cotter DJ. Factors influencing route of administration for epoetin treatment among hemodialysis patients in the United States. Am J Kidney Dis. 2006;48:77-87.
15. Laurent TC, Fraser JR. Hyaluronan. FASEB J. 1992;6:2397-2404.
16. Menzel EJ, Farr C. Hyaluronidase and its substrate hyaluronan: biochemistry, biological activities and therapeutic uses. Cancer Lett. 1998;131:3-11.
17. Dunn AL, Heavner JE, Racz G, et al. Hyaluronidase: a review of approved formulations, indications and off-label use in chronic pain management. Expert Opin Biol Ther. 2010;10:127-131.
18. Frost GI. Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Expert Opin Drug Deliv. 2007;4:427-440.
19. Adams L. Adjuvants to local anaesthesia in ophthalmic surgery. Br J Ophthalmol. 2011;95:1345-1349.
20. Forbes GB, Deisher RW, et al. Effect of hyaluronidase on the subcutaneous absorption of electrolytes in humans. Science. 1950;111:177-179.
21. Eberhart AH, Weiler CR, Erie JC. Angioedema related to the use of hyaluronidase in cataract surgery. Am J Ophthalmol. 2004;138:142-143.
22. Ebo DG, Goossens S, Opsomer F, et al. Flow-assisted diagnosis of anaphylaxis to hyaluronidase. Allergy. 2005;60:1333-1334.
23. Bookbinder LH, Hofer A, Haller MF, et al. A recombinant human enzyme for enhanced interstitial transport of therapeutics. J Control Release. 2006;114:230-241.
24. Csoka AB, Frost GI, Stern R. The six hyaluronidase-like genes in the human and mouse genomes. Matrix Biol. 2001;20:499-508.
25. Wolf RA, Chaung LY, O'Hara D, et al. The serum kinetics of bovine testicular hyaluronidase in dogs, rats and humans. J Pharmacol Exp Ther. 1982;222:331-337.
26. Yocum RC, Kennard D, Heiner LS. Assessment and implication of the allergic sensitivity to a single dose of recombinant human hyaluronidase injection: a double-blind, placebo-controlled clinical trial. J Infus Nurs. 2007;30:293-299.
27. Thomas JR, Yocum RC, Haller MF, Flament J. The INFUSE-Morphine IIB study: use of recombinant human hyaluronidase (rHuPH20) to enhance the absorption of subcutaneous morphine in healthy volunteers. J Pain Symptom Manage. 2009;38:673-682.
28. Thomas JR, Wallace MS, Yocum RC, et al. The INFUSE-Morphine study: use of recombinant human hyaluronidase (rHuPH20) to enhance the absorption of subcutaneously administered morphine in patients with advanced illness. J Pain Symptom Manage. 2009;38:663-672.
29. Allen CH, Etzwiler LS, Miller MK, et al. Recombinant human hyaluronidase-enabled subcutaneous pediatric rehydration. Pediatrics. 2009;124:e858-e867.
30. Muchmore DB, Vaughn DE. Review of the mechanism of action and clinical efficacy of recombinant human hyaluronidase coadministration with current prandial insulin formulations. J Diabetes Sci Technol. 2010;4:419-428.
31. Harb G, Lebel F, Battikha J, Thackara JW. Safety and pharmacokinetics of subcutaneous ceftriaxone administered with or without recombinant human hyaluronidase (rHuPH20) versus intravenous ceftriaxone administration in adult volunteers. Curr Med Res Opin. 2010;26:279-288.
32. Cho HS, Mason K, Ramyar KX, et al. Structure of the extracellular region of HER2 alone and in complex with the Herceptin Fab. Nature. 2003;421:756-760.
33. Sliwkowski MX, Lofgren JA, Lewis GD, Hotaling TE, Fendly BM, Fox JA. Nonclinical studies addressing the mechanism of action of trastuzumab (Herceptin). Semin Oncol. 1999;26:60-70.
34. Clynes RA, Towers TL, Presta LG, et al. Inhibitory Fc receptors modulate in vivo cytotoxicity against tumor targets. Nat Med. 2000;6:443-446.
35. Molina MA, Codony-Servat J, Albanell J, Rojo F, Arribas J, Baselga J. Trastuzumab (herceptin), a humanized anti-Her2 receptor monoclonal antibody, inhibits basal and activated Her2 ectodomain cleavage in breast cancer cells. Cancer Res. 2001;61:4744-4749.
36. Wynne C, Harvey V, Schwabe C, Waaka D, McIntyre C, Bittner B. Comparison of subcutaneous and intravenous administration of trastuzumab: a phase I/Ib trial in healthy male volunteers and patients with HER2-positive breast cancer. J Clin Pharmacol. February 22, 2012. [Epub ahead of print.]
37. Ismael G, Hegg R, Muehlbauer S, et al. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol. 2012;13:869-878.