An appraisal of subcutaneous trastuzumab: A new formulation meeting clinical needs

Cancer Chemotherapy and Pharmacology

Volumn 72, Issue 6, 2013, Pages 1361-1367

  Launay Vacher, Vincent ^a  

^a PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

Author keywords

Breast cancer; HER2; Subcutaneous; Trastuzumab

Indexed keywords

ABCIXIMAB; ADALIMUMAB; ALEMTUZUMAB; ANTHRACYCLINE DERIVATIVE; BASILIXIMAB; BEVACIZUMAB; CETUXIMAB; CYCLOPHOSPHAMIDE; DACLIZUMAB; DOCETAXEL; ECULIZUMAB; EFALIZUMAB; EPIRUBICIN; FLUOROURACIL; GEMTUZUMAB OZOGAMICIN; INFLIXIMAB; NATALIZUMAB; OKT 3; OMALIZUMAB; PANITUMUMAB; RECOMBINANT HYALURONIDASE; RHUPH 20; RITUXIMAB; TRASTUZUMAB; UNCLASSIFIED DRUG;

ALOPECIA; APPLICATION SITE DISCOLORATION; APPLICATION SITE SWELLING; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CONGESTIVE HEART FAILURE; COST CONTROL; DIARRHEA; DOSE CALCULATION; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ERUPTION; DRUG EXPOSURE; DRUG FORMULATION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; EPIDERMAL GROWTH FACTOR RECEPTOR 2 POSITIVE BREAST CANCER; FEBRILE NEUTROPENIA; HUMAN; INFUSION RELATED REACTION; INJECTION SITE DISCOMFORT; INJECTION SITE PAIN; INJECTION SITE REACTION; LEUKOPENIA; LOADING DRUG DOSE; LOW DRUG DOSE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL PAIN; PATIENT PREFERENCE; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; UPPER RESPIRATORY TRACT INFECTION;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; CLINICAL TRIALS AS TOPIC; DRUG DESIGN; FEMALE; HUMANS; INJECTIONS, SUBCUTANEOUS; RECEPTOR, ERBB-2;

EID: 84890379859     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-013-2289-4     Document Type: Article

References (22)

1. Slamon DJ, Leyland-Jones B, Shak S et al (2001) Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 344:783-792
2. Marty M, Cognetti F, Maraninchi D et al (2005) 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 23:4265-4274
3. Smith I, Procter M, Gelber RD et al (2007) 2-Year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet 369:29-36
4. Goldhirsch A, Piccart M, Procter M et al (2012) HERA TRIAL: 2 years versus 1 year of trastuzumab after adjuvant chemotherapy in women with HER2-positive early breast cancer at 8 years of median follow up. European Society of Medical Oncology Congress 2012; Vienna, Austria: Abstract LBA6
5. Goldhirsch A, Piccart M, Procter M et al (2012) HERA TRIAL: 2 years versus 1 year of trastuzumab after adjuvant chemotherapy in women with HER2-positive early breast cancer at 8 years of median follow up. In: San Antonio breast cancer symposium 2012; San Antonio, TX, USA: Abstract S5-2
6. Thomas JR, Yocum RC, Haller MF, von Gunten CF (2007) Assessing the role of human recombinant hyaluronidase in gravity-driven subcutaneous hydration: the INFUSE-LR study. J Palliat Med 10(6):1312-1320
7. Frost GI (2007) Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Expert Opin Drug Deliv 4(4):427-440
8. Harb G, Lebel F, Battikha J, Thackara JW (2010) 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 26(2):279-288
9. Thomas JR, Wallace MS, Yocum RC, Vaughn DE, Haller MF, Flament J (2009) 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 38(5):663-672
10. Lobo ED, Hansen RJ, Balthasar JP (2004) Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci 93(11):2645-2668
11. Wang DD, Zhang S, Zhao H, Men AY, Parivar K (2009) Fixed dosing versus body size-based dosing of monoclonal antibodies in adult clinical trials. J Clin Pharmacol 49(9):1012-1024
12. Wynne C, Harvey V, Schwabe C, Waaka D, McIntyre C, Bittner B (2012) 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 2012 Feb 22. [Epub ahead of print]
13. Ismael G, Hegg R, Muehlbauer S et al (2012) 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 13(9):869-878
14. Jackisch C, Dank M, Frasci G, et al. (2012) Additional safety results of HannaH: a phase III randomised, open-label, international study of the subcutaneous formulation of trastuzumab (H) in HER2-positive early breast cancer patients. European Society of Medical Oncology Congress 2012; Vienna, Austria: Abstract 271P
15. Melichar B, Stroyakovskiy D, Seok Ahn J et al (2012) Pathological complete response to trastuzumab subcutaneous fixed-dose formulation in the HannaH study: Subgroup analysis of patient demographics and tumour characteristics and influence of body weight and serum trough concentration of trastuzumab. European Society of Medical Oncology Congress 2012; Vienna, Austria: Abstract 254PD
16. Leyland-Jones B (2001) Dose scheduling - Herceptin. Oncology 61(Suppl 2):31-36
17. ® (trastuzumab) subcutaneous vs intravenous administration: a time & motion study. In: St Gallen international breast cancer conference, St Gallen, Switzerland, 2013. Poster no. 282
18. De Cock E, Semiglazov V, Lopez-Vivanco G, Verma S, Pivot X, Gligorov J, Hauser N, Urspruch A, Kritikou P, Knoop A (2013) Time savings with trastuzumab subcutaneous vs. intravenous administration: a time and motion study. In: St Gallen international breast cancer conference, St Gallen, Switzerland, 2013. Poster no. 209
19. Pivot X, Gligorov J, Müller V, Verma S, Knoop A, Curigliano G, Jenkins V, Scotto N, Osborne S, Fallowfield L (2013) Patient preference for subcutaneous versus intravenous adjuvant trastuzumab: results of the Prefher study. In: St Gallen International breast cancer conference, St Gallen, Switzerland, 2013. Poster no. 207
20. Pivot X, Gligorov J, Müller V, Barrett-Lee P, Verma S, Knoop A, Curigliano G, Semiglazov V, López-Vivanco G, Jenkins V, Scotto N, Osborne S, Fallowfield L (2013) Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study; for the PrefHer Study Group. Lancet Oncol;[Epub ahead of print]
21. Allen PB, Lindsay H, Tham TC (2010) How do patients with inflammatory bowel disease want their biological therapy administered? BMC Gastroenterol 10:1
22. Scarpato S, Antivalle M, Favalli EG et al (2010) Patient preferences in the choice of anti-TNF therapies in rheumatoid arthritis. Results from a questionnaire survey (RIVIERA study). Rheumatology 49(2):289-294