Comparison of subcutaneous and intravenous administration of trastuzumab : A phase i/ib trial in healthy male volunteers and patients with her2-positive breast cancer

Journal of Clinical Pharmacology

Volumn 53, Issue 2, 2013, Pages 192-201

  Wynne, Chris ^a   Harvey, Vernon ^b   Schwabe, Christian ^b   Waaka, Devonie ^a   McIntyre, Christine ^c   Bittner, Beate ^c  

^a Christchurch Clinical Studies   (New Zealand)

^b Auckland Clinical Studies   (New Zealand)

^c F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

Breast cancer; HER2 positive; Pharmacokinetics; Subcutaneous; Trastuzumab

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; RECOMBINANT HYALURONIDASE; TRASTUZUMAB;

ABDOMINAL PAIN; ACNE; AREA UNDER THE CURVE; ARTICLE; BREAST CANCER; CLINICAL ARTICLE; CONTROLLED STUDY; DIARRHEA; DOSE CALCULATION; DRUG ABSORPTION; DRUG ADMINISTRATION ROUTE; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; ELECTROCARDIOGRAM; FEMALE; FLU LIKE SYNDROME; GOOD CLINICAL PRACTICE; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INFUSION RELATED REACTION; INJECTION SITE DISCOMFORT; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE SWELLING; MALE; MAXIMUM PLASMA CONCENTRATION; MUSCULOSKELETAL PAIN; NORMAL HUMAN; OPEN STUDY; PHASE 1 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TIME TO MAXIMUM PLASMA CONCENTRATION; UPPER RESPIRATORY TRACT INFECTION; VASCULAR ACCESS; VITAL SIGN;

ADMINISTRATION, INTRAVENOUS; ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; BREAST NEOPLASMS; FEMALE; HUMANS; INJECTIONS, SUBCUTANEOUS; MALE; MIDDLE AGED; RECEPTOR, ERBB-2; YOUNG ADULT;

EID: 84877913217     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270012436560     Document Type: Article

References (21)

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. Chang HR. Trastuzumab-based neoadjuvant therapy in patients with HER2-positive breast cancer. Cancer . 2010;116:2856-2867.
3. Ross JS, Slodkowska EA, Symmans WF, Pusztai L, Ravdin PM, Hortobagyi GN. The HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicine. Oncologist . 2009;14:320-368.
4. Gianni L, Eiermann W, Semiglazov V, et al. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet . 2010;375:377-384.
5. Gianni L, Dafni U, Gelber RD, et al. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol . 2011;12:236-244.
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. 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.
8. 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.
9. Bang YJ, van Cutsem E, Feyereislova A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet . 2010;376:687-697.
10. Herceptin [prescribing information]. 2010. http://www.gene.com/gene/ products/information/pdf/herceptin-prescribing.pdf
11. Byrd JC, Peterson BL, Rai KR, et al. Fludarabine followed by alemtuzumab consolidation for previously untreated chronic lymphocytic leukemia: final report of Cancer and Leukemia Group B study 19901. Leuk Lymphoma . 2009;50:1589-1596.
12. Supersaxo A, Hein WR, Steffen H. Effect of molecular weight on the lymphatic absorption of water-soluble compounds following subcutaneous administration. Pharm Res . 1990;7:167-169.
13. Laurent UB, Dahl LB, Reed RK. Catabolism of hyaluronan in rabbit skin takes place locally, in lymph nodes and liver. Exp Physiol . 1991;76:695-703.
14. Dunn AL, Heavner JE, Racz G, Day M. Hyaluronidase: a review of approved formulations, indications and off-label use in chronic pain management. Expert Opin Biol Ther . 2010;10:127-131.
15. Hylenex [prescribing information]. 2009. http://www.hylenex.com/pdf/ prescribe.pdf
16. 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.
17. Velagapudi R, Noertershauser P, Awni W, Granneman R, Kupper H. Bioavailability of Adalimumab Following Subcutaneous Injections in Rheumatoid Arthritis Patients . Alexandria, VA: American Society for Clinical Pharmacology and Therapeutics; 2005.
18. Bruno R, Washington CB, Lu JF, Lieberman G, Banken L, Klein P. Population pharmacokinetics of trastuzumab in patients with HER2+ metastatic breast cancer. Cancer Chemother Pharmacol . 2005;56:361-369.
19. Clinical Study Report. HERA (BO16348) interim analysis: a randomized, multi-center comparison of 1 year of Herceptin treatment versus observation only in women with HER2-positive primary breast cancer who have completed adjuvant therapy. Report No. 1019820. Roche, Basel, Switzerland; 2006.
20. Mager DE, Jusko WJ. General pharmacokinetic model for drugs exhibiting target-mediated drug disposition. J Pharmacokinet Pharmacodyn . 2001;28:507-532.
21. Vogel CL, Cobleigh MA, Tripathy D, et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 2002:20: 719-726.