Research shows breast cancer reoccurrence halved

News Release

Local research shows breast cancer reoccurrence rates halved
New Zealand women and local researchers contribute to landmark study

31 New Zealand women and their oncologists have contributed to a significant step forward in the global fight against breast cancer. The first analysis of a worldwide Roche clinical trial called HERA (HERceptin Adjuvant) involved five of New Zealand’s cancer centres and has provided a landmark result.

The HERA result was announced last week at the American Society of Clinical Oncology (ASCO) meeting in Florida to an audience of 15,000. Results show that women with early stage HER2 positive breast cancer reduced their risk of their cancer coming back by 46%* when using the targeted therapy Herceptin® (trastuzumab)1.

The study was carried out in women who had completed chemotherapy after undergoing surgery for HER2 positive breast cancer, a particularly aggressive type of breast cancer evident in around 20-30% of women with the disease2. The results support the need to test women early for HER2 disease and confirm their eligibility for Herceptin as an important part of breast cancer management.

Two additional studies carried out in North America showed similar results and were also reported at the same meeting. In these studies Herceptin was generally given at the same time as chemotherapy3,4.

At present Herceptin is available and reimbursed in New Zealand for HER2 positive breast cancer patients where their cancer has spread (advanced)5. Given the HERA and other trial results Roche anticipate the approval for Herceptin treatment in early breast cancer as soon as 2007.

Auckland Oncologist and lead New Zealand trial investigator for the HERA study, Associate Professor Vernon Harvey, said the results were very encouraging for women. “The results of this trial are extremely exciting and create the prospect of a significant leap forward in treatment outcomes for women with this aggressive cancer.”

“Involvement in this research trial has given several New Zealand women a chance they would otherwise not have had and we now know it will have reduced their chance of having a recurrence of their breast cancer. It has allowed several local oncologists the opportunity to treat their patients and gain experience in the use of Herceptin much earlier in the course of the disease. It has also allowed both patients and oncologists to contribute to proving the effectiveness of a therapy that will benefit future breast cancer patients worldwide.”

The HERA trial commenced in December 2001 and recruited 5090 women from 39 countries. 31 New Zealand patients were enrolled from Auckland, Palmerston North, Wellington, Christchurch and Dunedin. This trial is one of over 40 trials Roche Products has committed to supporting in New Zealand this year.

Another trial presented at ASCO confirmed the benefits of Herceptin use in advanced breast cancer. These results showed twice as many women who received Herceptin plus chemotherapy were still alive three years after starting therapy compared to women on chemotherapy alone6.

Although New Zealanders did not participate in this trial it is significant to New Zealand women who are eligible to be treated with Herceptin for advanced breast cancer5. The survival benefit was achieved when Herceptin was given as a first treatment option rather than waiting until other therapies have failed6.

Roche Products New Zealand Director of Medical/Clinical Services Jan Campbell said local research investment has grown over the years. “New Zealand physicians have an excellent reputation worldwide for producing high quality, reliable research which has ensured Roche continues to invest in clinical research here.”

“Our participation in the HERA study is particularly exciting given the excellent results. Herceptin has demonstrated improved survival in advanced and early stage breast cancer”.

* p value <0.0001
The p value indicates the ‘statistical significance’ of these clinical studies.

ENDS

Breast cancer Facts
An estimated 1.15 million new breast cancer cases were diagnosed worldwide in 2002 with a death rate of 411,000 people a year7
In 2005, approximately 2500 New Zealand women will be diagnosed with breast cancer and 700 will die8
Maori women with breast cancer have poorer survival rates than non-Maori8
BreastScreen Aotearoa is a free national screening programme for woman aged 45 to 70 who have not been previously diagnosed with breast cancer in the last five years8,9

HER2 disease
It is essential to establish a patients HER2 status to determine if they are eligible for Herceptin therapy10
In HER2-positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumour cells. This is known as ‘HER2 positive’10
HER2-positive breast cancer is a particularly aggressive form of the disease which responds poorly to chemotherapy and progresses quickly2.
Research shows that 20-30% of breast cancers are HER2 positive2

Herceptin
Herceptin is a humanised antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential2.
Herceptin has demonstrated improved survival in both advanced (metastatic) and early-stage breast cancer1,4.
Herceptin is funded in New Zealand for patients with metastatic breast cancer whose tumours overexpress HER2
As monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease; or
In combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease5
Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat over 230,000 HER2-positive breast cancer patients worldwide.

References
Piccart-Gebhart, M. First results of the HERA trial, American Society of Clinical Oncology, Scientific Session, May 16, 2005
Harries M, Smith I. The development and clinical use of Trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002
Romond, EH et al. Doxorubicin and Cyclophosphamide followed by Paclitaxel without Trastuzumab as Adjuvant Therapy for Patients with HER-2 Positive Operable Breast Cancer. American Society of Clinical Oncology, Scientific Session, May 16, 2005
Perez EA et al. NCCTG N9831, May 2005 Update. American Society of Clinical Oncology, Scientific Session, May 16, 2005
Herceptin (Trastuzumab) Data Sheet, 1st March 2004
Extra, JM et al; Long-term survival demonstrated with trastuzumab plus docetaxel: 24-month data from a randomised trial (M77001) in HER2-positive metastatic breast cancer; ASCO May 2005.
Parkin D, Bray F, Pisani P. Global Cancer Statistics, 2002. A Cancer Journal for Clinicians 55; 2: 74-108, 2002
Ministry of Health, New Zealand, Cancer Trends and Projections, Breast cancer 2002
NZ Breast Cancer Foundation breast cancer information www.nzbcf.org.nz
Herceptin (Trastuzumab) Consumer Medicine Information, 11th May 2005

What you should know about Herceptin
HERCEPTIN®? (trastuzumab) is a Prescription Medicine used to treat patients with metastatic (spreading) breast cancer who have tumours with a large amount of the HER2 protein.

Tell your doctor if you have coronary artery disease, hypertension, heart failure, lung disease or tumours, or if you are pregnant or breastfeeding.

Possible unwanted effects: Common: chills, shivering, fever, nausea, vomiting, pain, stiffness, shaking, headache, dizziness, cough, skin rashes, weakness, fatigue, abnormal heart beat, feeling faint, insomnia, anxiety, depression, runny or blocked nose, flu-like symptoms, chest infection, pain on urination, diarrhoea, hair loss, muscle or joint soreness. Serious: shortness of breath or breathing difficulty, severe coughing, severe feet or leg swelling, chest pain, abnormal heart beat, severe diarrhoea, feeling faint.

Ask your oncologist if HERCEPTIN is right for you. Use strictly as directed. If symptoms continue or you experience side effects or would like further information, please talk to your oncologist or visit www.medsafe.govt.nz for HERCEPTIN Consumer Medicine Information. HERCEPTIN (150mg and 440mg vials) is a funded medicine under Section H of the Pharmaceutical Schedule. A prescription charge and normal oncologist fees may apply.

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