- Reference code :
- wf641
- Published date :
-
17 September 2003
- Expired date :
-
02 February 2031
new data confirm that ‘Zoladex’ is as effective as standard chemotherapy* in premenopausal women with hormone-sensitive tumours. When combined with tamoxifen, ‘Zoladex’ is significantly more effective than chemotherapy in these patients. new research demonstrates that healthy premenopausal women have an overwhelming preference for ‘Zoladex’ over chemotherapy For the attention of medical correspondents only Nottingham, UK, Wednesday 17 September 2003: New survival data from two key trials, presented today at the 8th Nottingham International Breast Cancer Conference, provide confirmatory evidence of the benefits of ‘Zoladex’ (goserelin) in the adjuvant treatment of premenopausal women with hormone-sensitive early breast cancer. Furthermore, newly published research demonstrates pre-menopausal women’s overwhelming preference for ‘Zoladex’ over chemotherapy.
For some time now, chemotherapy has been the standard treatment for early breast cancer in younger women, regardless of the hormone receptor-status of their tumours. The latest ‘Zoladex’ data confirm that premenopausal women with hormone-sensitive disease have another, equally effective option available to them. This means physicians and patients now have a choice of treatment options, and therapy can be tailored to the needs of individual patients. Many women cannot tolerate chemotherapy or wish to avoid it because of its distressing side effects. For these women, ‘Zoladex’ offers the choice of a well-tolerated, equally effective therapy.
The exciting new data presented at Nottingham update and confirm the previous results of two key ‘Zoladex’ trials: ABCSG Trial 5** and ZEBRA***, at extended periods of follow-up.
Six year follow-up data from the ABCSG Trial 51 show that the combination of ‘Zoladex’ 3.6 mg plus tamoxifen continues to be significantly more effective than CMF* for relapse-free survival (p=0.045) in premenopausal patients with hormone-sensitive, early breast cancer. Professor Raimund Jakesz, Chairman of the Clinical Department of General Surgery, Surgical University Clinic, Vienna General Hospital, presenting on behalf of the ABCSG Trial 5 investigators said: “We have followed patients for 6 years now, and it is encouraging to see that follow-up data confirm our initial findings. These results are very important for premenopausal women with hormone-sensitive disease because they clearly demonstrate that endocrine treatment with ‘Zoladex’ and tamoxifen has superior efficacy to chemotherapy. Chemotherapy has been the standard of care for premenopausal women for many years but it is often poorly tolerated”.
Furthermore, the updated ZEBRA data2 (median follow-up 7.3 years) show that ‘Zoladex’ 3.6mg continues to be equivalent to CMF in terms of disease-free survival (HR 1.05; 95% CI 0.88-1.24; p=0.60) in premenopausal patients with hormone-sensitive, node-positive early breast cancer. The data for overall survival are similar to and reflect those for disease-free survival (HR= 0.94, 95% CI 0.75-1.18; p=0.62). Professor Roger Blamey, Consultant General Surgeon, Nottingham City Hospital, presenting updated ZEBRA results today on behalf of the trialists’ group, commented: “We have further evidence that ‘Zoladex’ is as effective as chemotherapy in young women with hormone-sensitive early breast cancer. Although chemotherapy is effective for many women, it causes traumatic side-effects such as hair loss and nausea. ‘Zoladex’ offers premenopausal women equal efficacy to chemotherapy without the distressing cytotoxic side effects.”
The efficacy of ‘Zoladex’ in premenopausal women with hormone-sensitive breast cancer is further supported by a third trial reported today by Professor Boccardo3 , on behalf of the Italian Breast Cancer Study Group.
Further research published today, led by Lesley Fallowfield4 from Cancer Research UK, indicates that premenopausal women have an overwhelming preference for ‘Zoladex’ over chemotherapy. A questionnaire, compiled with guidance from oncology consultants and specialist breast cancer nurses, was given to 200 healthy premenopausal volunteers, aged 25-49, from a variety of socio-economic backgrounds.
Lesley Fallowfield commented: “Recent data show that hormone therapy may be at least as effective as chemotherapy in treating younger women with early, hormone responsive breast cancer. The new data we’ve heard here at Nottingham adds further weight to this view. Yet, despite these data and the different impacts that the treatments have on quality of life, many clinicians do not offer women the option of ’Zoladex’. Our research showed that women view the side effect profile of ‘Zoladex’ as more acceptable, and value the chance to retain fertility. When women understand the benefits and harms of treatment options they are in a much better position to make an informed choice, so it is important that they have that opportunity to discuss and agree treatment options with their physician. The importance of patient preference in treatment decisions is becoming increasingly recognised. Indeed, the recent St Gallen Consensus described patient preference as crucial to therapeutic decision making.”5
For further information, please refer to the background information provided or visit www.cancerpressoffice.com where you can view a netcast of the press conference from Nottingham, including Professor Fallowfield and Professor Jakesz’s data presentation.
Alternatively, please contact:
Ian Evetts
Global Brand Manager, Zoladex
AstraZeneca
Tel: +44 (0) 1625 517 170
Mobile: +44 (0) 7802 470 108
‘Zoladex’ is a trademark property of the AstraZeneca Group of Companies
* Standard chemotherapy (CMF) is cyclophosphamide, methotrexate, 5-fluorouracil
** ABCSG Trial 5 – Austrian Breast and Colorectal Cancer Study
*** ZEBRA – ‘Zoladex’ in Early Breast Cancer Research Association Trial
1. Jakesz R, et al. Tamoxifen combined with goserelin vs CMF in the treatment of premenopausal patients with hormone-responsive breast cancer: an update from the ABCSG Trial 5. Presented 17th September 2003 at 8th International Breast Cancer Conference, Nottingham, UK.
2. Blamey R, et al. Goserelin vs CMF in premenopausal women with node+ve breast cancer: ZEBRA trial survival results. Presented 17th September 2003 at 8th International Breast Cancer Conference, Nottingham, UK.
3. Boccardo F, et al. CMF vs Tamoxifen (TMX) plus goserelin (GOS) as adjuvant treatment of ER positive (ER+ve) premenopausal breast cancer. Updated results of a multicentric trial. Presented 17th September 2003 at 8th International Breast Cancer Conference, Nottingham, UK.
4. Fallowfield LJ, et al. Same gain, less pain? Pre-menopausal women’s preferences for either adjuvant chemotherapy or goserelin. Cancer Research UK Psychosocial Oncology Group, Brighton & Sussex Medical School. Presented 17th September 2003 at 8th International Breast Cancer Conference, Nottingham, UK.
5. Goldhirsch A, et al. Meeting Highlights: Updated International Expert Consensus on the Primary Therapy of Early Breast Cancer. J Clin Oncol 2003; 21. September 1st issue.
The exciting new data presented at Nottingham update and confirm the previous results of two key ‘Zoladex’ trials: ABCSG Trial 5** and ZEBRA***, at extended periods of follow-up.
Six year follow-up data from the ABCSG Trial 51 show that the combination of ‘Zoladex’ 3.6 mg plus tamoxifen continues to be significantly more effective than CMF* for relapse-free survival (p=0.045) in premenopausal patients with hormone-sensitive, early breast cancer. Professor Raimund Jakesz, Chairman of the Clinical Department of General Surgery, Surgical University Clinic, Vienna General Hospital, presenting on behalf of the ABCSG Trial 5 investigators said: “We have followed patients for 6 years now, and it is encouraging to see that follow-up data confirm our initial findings. These results are very important for premenopausal women with hormone-sensitive disease because they clearly demonstrate that endocrine treatment with ‘Zoladex’ and tamoxifen has superior efficacy to chemotherapy. Chemotherapy has been the standard of care for premenopausal women for many years but it is often poorly tolerated”.
Furthermore, the updated ZEBRA data2 (median follow-up 7.3 years) show that ‘Zoladex’ 3.6mg continues to be equivalent to CMF in terms of disease-free survival (HR 1.05; 95% CI 0.88-1.24; p=0.60) in premenopausal patients with hormone-sensitive, node-positive early breast cancer. The data for overall survival are similar to and reflect those for disease-free survival (HR= 0.94, 95% CI 0.75-1.18; p=0.62). Professor Roger Blamey, Consultant General Surgeon, Nottingham City Hospital, presenting updated ZEBRA results today on behalf of the trialists’ group, commented: “We have further evidence that ‘Zoladex’ is as effective as chemotherapy in young women with hormone-sensitive early breast cancer. Although chemotherapy is effective for many women, it causes traumatic side-effects such as hair loss and nausea. ‘Zoladex’ offers premenopausal women equal efficacy to chemotherapy without the distressing cytotoxic side effects.”
The efficacy of ‘Zoladex’ in premenopausal women with hormone-sensitive breast cancer is further supported by a third trial reported today by Professor Boccardo3 , on behalf of the Italian Breast Cancer Study Group.
Further research published today, led by Lesley Fallowfield4 from Cancer Research UK, indicates that premenopausal women have an overwhelming preference for ‘Zoladex’ over chemotherapy. A questionnaire, compiled with guidance from oncology consultants and specialist breast cancer nurses, was given to 200 healthy premenopausal volunteers, aged 25-49, from a variety of socio-economic backgrounds.
Lesley Fallowfield commented: “Recent data show that hormone therapy may be at least as effective as chemotherapy in treating younger women with early, hormone responsive breast cancer. The new data we’ve heard here at Nottingham adds further weight to this view. Yet, despite these data and the different impacts that the treatments have on quality of life, many clinicians do not offer women the option of ’Zoladex’. Our research showed that women view the side effect profile of ‘Zoladex’ as more acceptable, and value the chance to retain fertility. When women understand the benefits and harms of treatment options they are in a much better position to make an informed choice, so it is important that they have that opportunity to discuss and agree treatment options with their physician. The importance of patient preference in treatment decisions is becoming increasingly recognised. Indeed, the recent St Gallen Consensus described patient preference as crucial to therapeutic decision making.”5
Further enquires to:
For further information, please refer to the background information provided or visit www.cancerpressoffice.com where you can view a netcast of the press conference from Nottingham, including Professor Fallowfield and Professor Jakesz’s data presentation.
Alternatively, please contact:
Ian Evetts
Global Brand Manager, Zoladex
AstraZeneca
Tel: +44 (0) 1625 517 170
Mobile: +44 (0) 7802 470 108
‘Zoladex’ is a trademark property of the AstraZeneca Group of Companies
* Standard chemotherapy (CMF) is cyclophosphamide, methotrexate, 5-fluorouracil
** ABCSG Trial 5 – Austrian Breast and Colorectal Cancer Study
*** ZEBRA – ‘Zoladex’ in Early Breast Cancer Research Association Trial
1. Jakesz R, et al. Tamoxifen combined with goserelin vs CMF in the treatment of premenopausal patients with hormone-responsive breast cancer: an update from the ABCSG Trial 5. Presented 17th September 2003 at 8th International Breast Cancer Conference, Nottingham, UK.
2. Blamey R, et al. Goserelin vs CMF in premenopausal women with node+ve breast cancer: ZEBRA trial survival results. Presented 17th September 2003 at 8th International Breast Cancer Conference, Nottingham, UK.
3. Boccardo F, et al. CMF vs Tamoxifen (TMX) plus goserelin (GOS) as adjuvant treatment of ER positive (ER+ve) premenopausal breast cancer. Updated results of a multicentric trial. Presented 17th September 2003 at 8th International Breast Cancer Conference, Nottingham, UK.
4. Fallowfield LJ, et al. Same gain, less pain? Pre-menopausal women’s preferences for either adjuvant chemotherapy or goserelin. Cancer Research UK Psychosocial Oncology Group, Brighton & Sussex Medical School. Presented 17th September 2003 at 8th International Breast Cancer Conference, Nottingham, UK.
5. Goldhirsch A, et al. Meeting Highlights: Updated International Expert Consensus on the Primary Therapy of Early Breast Cancer. J Clin Oncol 2003; 21. September 1st issue.
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