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Patients with a very aggressive form of breast cancer known as HER2-positive, could now benefit from a new faster, more efficient delivery method of Herceptin. The subcutaneous (SC) injection, given just beneath the skin, can be completed in 2-5 minutes, compared to the traditional, relatively time-consuming 30-90 minute intravenous (IV) infusion.[v] This speedier form of delivery of Herceptin is now authorised for use in the UK after a licence was granted by the European Medicines Agency (EMA). In addition, NHS England has agreed to fund its use on the NHS.
Patients could now gain up to more than an hour from each visit to the hospital for their anti-cancer therapy and 19 hours over the course of their treatment.[vi] This is valuable time and has the potential to liberate patients, enabling them to get on living their lives without the feeling of being shackled to an intravenous infusion. It also means that the relatively invasive central line or cannula would no longer need to be inserted into the patient every three weeks as is the current standard practice. Furthermore, a study has shown that 9 out of 10 patients preferred a subcutaneous version of Herceptin versus IV.[vii]
In addition to the advantages to patients, the NHS could profit from savings valued at more than £20m nationally.[i,ii,iii,iv] The benefits could be realised through time saved in preparing and administering Herceptin SC and reducing drug wastage compared to IV.i,ii,iii,iv These savings could go some way to solving the increasing capacity burden the NHS is currently facing in its chemotherapy suites as highlighted in a recent report.[viii]
Professor Lesley Fallowfield, Director Sussex Health Outcomes Research & Education in Cancer, University of Sussex said: "Time is precious to women with breast cancer, far too precious to be waiting around in busy chemotherapy centres. If subcutaneous delivery of Herceptin were to replace intravenous administration in the NHS then patients would spend less time in hospital and more time getting on with their lives. If this method is adopted in the NHS then the quality of life of women with HER 2-positive breast cancer could be dramatically improved."
Dr Mark Verrill, Consultant Medical Oncologist, Freeman Hospital, Newcastle Upon Tyne said: "The licensing of subcutaneous Herceptin is a real boost for patients. Up to now, we have only had an intravenous formulation requiring intravenous access for each 30 minute infusion. Treatment is given every three weeks and typically carries on for a year or more, so overall, it is quite intrusive. We can now give Herceptin by a 5 minute subcutaneous injection - it's much quicker and simpler. In a clinical study where women received treatment by both routes, the overwhelming majority preferred subcutaneous Herceptin. As well as the advantage for patients, subcutaneous Herceptin frees capacity on busy chemotherapy day units. It lends itself to administration in the community, resonating with the Cancer Reform Strategy drive for treatment closer to home."
Herceptin is the standard of care for HER2-positive early-stage breast cancer, based on a number of large trials involving a total of more than 13,000 people.[ix],[x],[xi],[xii]
The licence is based on the neoadjuvant HannaH trial which compared Herceptin SC with Herceptin IV given to women with untreated HER2-positive early stage breast cancer, confined to the breast and regional lymph nodes. The study had a positive outcome, showing Herceptin SC to be non-inferior to Herceptin IV, with no new or unexpected safety concerns with the SC formulation.[v]
Breast cancer is the most common cancer in the UK with more than 48,000 newly diagnosed patients in 2008.[xiii] In 2008 more than 12,000 people died of the disease.xiii In HER2-positive breast cancer, increased quantities of the HER2 receptor are present on the surface of the tumour cells. This is known as 'HER2 -positivity' and affects approximately 15 percent of people with breast cancer.[xiv] HER2-positive breast cancer is associated with a poor prognosis and faster time to relapse or progression of disease.[xv]
Herceptin is an antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. The mode of action of Herceptin is unique in that it activates the body's immune system and suppresses HER2 to target and destroy the tumour. Herceptin has demonstrated unprecedented efficacy in treating both early and advanced (metastatic) HER2-positive breast cancer as well as HER2-positive advanced (metastatic) stomach cancer. Given on its own as monotherapy as well as in combination with or following standard chemotherapy, Herceptin has been shown to improve disease-free survival, overall survival and response rates while maintaining quality of life in people with HER2-positive breast and stomach cancer[xvi], [xvii] Herceptin is indicated in Europe for the treatment of metastatic breast cancer, early breast cancer and metastatic gastric cancer and is currently approved in an IV formulation only. Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche.[xviii]
Herceptin SC represents a significant advance in the way that HER2-positive breast cancer treatment is delivered. Its combination with a recombinant human enzyme called hyaluronidase, increases its ability to penetrate the layer of tissue under the skin temporarily, minimising pain on injection and enabling a simple and more rapid administration of Herceptin compared to the intravenous infusion. In addition to reducing the time that a patient is required to spend receiving their treatment in hospital, the ready-to-use formulation may also significantly reduce pharmacy time compared to IV as there is no need to prepare an intravenous infusion and no aseptic preparation time should be required. Herceptin SC removes the need for reconstitution or dose calculation according to individual patients' body weights and a loading dose is not required.
Herceptin SC uses Enhanze™ Technology, developed by Halozyme Therapeutics Inc., which enables the injection of larger volumes of a medication under the skin (subcutaneous). It works by reversibly breaking down a gel-like substance (hyaluronan) that forms a barrier in the tissues between cells under the skin.[v]
A summary of product characteristics for Herceptin is available on the EMA website: http://www.ema.europa.eu
Published in The Lancet Oncology in 2012, the HannaH study was designed to compare Herceptin concentration in the blood (pharmacokinetics), efficacy, and safety of Herceptin SC to that of Herceptin IV in women with HER2-positive early breast cancer in the neoadjuvant setting.
The study met its co-primary endpoints which were Herceptin concentration in the blood, and efficacy as measured by pathological complete response (pCR). The results showed that the geometric mean ratio of concentration in the blood subcutaneous between the SC and IV formulations was 1.33. The pCR for patients receiving the SC formulation was 45.4% compared to 40.7% of patients who received IV. Secondary endpoints included event-free survival and overall survival. The overall safety profile in both arms of the HannaH study was comparable with that expected from standard treatment with Herceptin and chemotherapy in this setting. The most common severe adverse events ≥ grade 3 occurring with more than 5% frequency were haematological, and gastrointestinal events and infections.
[i] Roche data on file RXUKDATA00132(1). May 2013
[ii] Roche data on file RXUKDONF00316. June 2013
[iii] Roche data on file Herceptin Subcutaneous Formulation: Cost-Minimization & Budget Impact Model for early-stage breast cancer. October 2012
[iv] Roche data on file. Herceptin Subcutaneous Formulation: Cost-Minimization & Budget Impact Model for metastatic breast cancer. October 2012
[v] Ismael G 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(9):869-78
[vi] Burcombe, R et al. Subcutaneous Trastuzumab (Herceptin®): A UK Time and Motion Study in Comparison with Intravenous Formulation for the Treatment of Patients with HER2-Positive Early Breast Cancer. Advances in Breast Cancer Research, 2013, 2, 133-140
[vii] Pivot, X et al. Patient preference for subcutaneous versus intravenous trastuzumab: Results of the PrefHer study presented at St Gallen (March 2013)
[viii] Hawkes N. The Cancer Capacity Challenge: A report on the unsustainable burden facing NHS resources in chemotherapy suites. January 2013
[ix] Joensuu H et al. Adjuvant docetaxel or vinorelbine with or without Herceptin for breast cancer. N Engl J Med 2006; 354:809-20
[x] Piccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, et al. Herceptinafter adjuvant chemotherapy in HER2-Positive breast cancer; N Engl J Med 2005; 353:1659-72
[xi] Romond E, Perez EA, Bryant J, et al. Herceptin plus Adjuvant Chemotherapy for Operable HER2-Positive Breast Cancer. N Engl J Med 2005; 353:1673-84.
[xii] Smith I, Procter M, Gelber RD. 2-year follow-up of Herceptinafter adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet 2007; 369:29-36
[xiii] Cancer Research UK. Cancer Stats: Breast Cancer. Last accessed 05.08.13
[xiv] Ibrahim M et al. United Kingdom National External Quality Assurance Scheme HER2 Testing: The Value of National Audit, EQA and Laboratory Accreditation. International Association of Pathology, Athens 2009.
[xv] Di Leo A, et al. Current status of HER2 testing. Oncol 2002;63 (suppl.1):33–39
[xvi] Rugo H et al. Effect of Herceptinon Health-Related Quality of Life in Patients With HER2-Positive Metastatic Breast Cancer: Data From Three Clinical Trials. Clin Breast Cancer 2010; 1;10(4):288-93
[xvii] Bang, Y, Van Cutsem, E et al. Herceptinin 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;9742:687-697
[xviii] Herceptin Summary of Product Characteristics. Last Accessed 05.08.13
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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