Advertisement

Cancer Chemotherapy and Pharmacology

, Volume 72, Issue 6, pp 1361–1367 | Cite as

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

  • Vincent Launay-VacherEmail author
Short Communication

Abstract

Trastuzumab has deeply and radically changed the course of HER2-positive breast cancer disease. The recent development of a subcutaneous (SC) formulation of trastuzumab is an important step towards improved patients’ care. SC trastuzumab at a fixed dose of 600 mg administered every 3 weeks for about 5 min provides a valid alternative to the IV, both in terms of efficacy and safety. This results in substantial time savings for patients, pharmacists, physicians and nursing staff, with a healthcare professionals’ and patients’ preference largely going to SC. In addition, the possibility to treat patients with poor venous access or to spare patients’ venous capital when necessary may also be of interest.

Keywords

Trastuzumab Breast cancer HER2 Subcutaneous 

Notes

Conflict of interest

For the past 3 years, Dr. V. Launay-Vacher has had links, mainly for research support, with Amgen, Bayer-Schering, Boehringer-Ingelheim, Celgene, Daiichi-Sankyo, Fresenius Medical Care, Gilead, Ipsen, Janssen, Leo Pharma, Pfizer, Roche and Vifor Pharma.

References

  1. 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 344:783–792PubMedCrossRefGoogle Scholar
  2. 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 23:4265–4274PubMedCrossRefGoogle Scholar
  3. 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 369:29–36PubMedCrossRefGoogle Scholar
  4. 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 LBA6Google Scholar
  5. 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 S5-2Google Scholar
  6. 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):1312–1320PubMedCrossRefGoogle Scholar
  7. 7.
    Frost GI (2007) Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Expert Opin Drug Deliv 4(4):427–440PubMedCrossRefGoogle Scholar
  8. 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):279–288PubMedCrossRefGoogle Scholar
  9. 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):663–672PubMedCrossRefGoogle Scholar
  10. 10.
    Lobo ED, Hansen RJ, Balthasar JP (2004) Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci 93(11):2645–2668PubMedCrossRefGoogle Scholar
  11. 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):1012–1024PubMedCrossRefGoogle Scholar
  12. 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]Google Scholar
  13. 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):869–878PubMedCrossRefGoogle Scholar
  14. 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 271PGoogle Scholar
  15. 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 254PDGoogle Scholar
  16. 16.
    Leyland-Jones B (2001) Dose scheduling—Herceptin. Oncology 61(Suppl 2):31–36PubMedCrossRefGoogle Scholar
  17. 17.
    Samanta K, Nawaz S, Lord S, McNamara S, Diment V (2013) Cost savings with Hercveptin® (trastuzumab) subcutaneous vs intravenous administration: a time & motion study. In: St Gallen international breast cancer conference, St Gallen, Switzerland, 2013. Poster no. 282Google Scholar
  18. 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. 209Google Scholar
  19. 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. 207Google Scholar
  20. 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]Google Scholar
  21. 21.
    Allen PB, Lindsay H, Tham TC (2010) How do patients with inflammatory bowel disease want their biological therapy administered? BMC Gastroenterol 10:1PubMedCrossRefGoogle Scholar
  22. 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):289–294PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  1. 1.Service ICARPitié-Salpêtrière HospitalParisFrance

Personalised recommendations