Landmark Study in The Lancet Oncology Shows Capecitabine (Xeloda) Combination Therapy Reduces Early Breast Cancer Recurrence
- This is a third party press release. It will be issued by the
Finnish Breast Cancer Group on Wednesday 11 November 2009.
- FinXX, a Large, Phase III Randomised Study in Women With Early
Breast Cancer Shows that Adding Capecitabine (Xeloda(R)) to a
Treatment Regimen Containing Standard Agents Allows More Women to
Live Cancer-Free for Longer
Finland, November 11/PRNewswire/ -- An analysis conducted by the
Finnish Breast Cancer Group and published in The Lancet Oncology
shows women at intermediate to high-risk of early breast cancer
recurrence who received capecitabine as part of their chemotherapy
regimen had a 34% reduction in the risk of the disease returning or
death, compared with those taking the chemotherapy combination
regimen without capecitabine.
The pre-planned three-year interim analysis of a randomised,
prospective trial (known as FinXX) compared adjuvant capecitabine
in combination with docetaxel and cyclophosphamide plus epirubicin
for the treatment of early breast cancer with the standard,
non-capecitabine regimen (docetaxel, epirubicin, cyclophosphamide
and fluorouracil).[1] The analysis also found that patients taking
the capecitabine-containing regimen were significantly less likely
to have their cancer spread (distant metastasis) to another part of
the body (a 36% reduction in risk was observed). This is the first
phase III randomised trial to report efficacy of capecitabine
combination therapy in the adjuvant treatment of early breast
cancer.
"Capecitabine has already been shown to be effective in patients
with advanced breast cancer. In addition, these results from the
FinXX study show that using a capecitabine-containing regimen in
the early stages of breast cancer may offer survival benefits for
women, which is a primary goal of treatment," said Professor Heikki
Joensuu, Principal Investigator, Helsinki University Hospital,
Finland. "I am encouraged by this analysis, which demonstrates that
adding capecitabine to the chemotherapy regimen in the early stages
of breast cancer may prevent the cancer coming back," he
added.
Breast cancer is the second most common cancer in the world and
the most common cancer among women.[2] There are 1.1 million new
cases of female breast cancer each year worldwide.[2] Despite
recent advances, there is still an unmet need in the treatment and
management of early breast cancer with relapse occurring in
approximately 30% of patients, depending on individual risk
factors, even after chemotherapy.[3]
Notes to editors:
About the FinXX study
The study, led by the Finnish Breast Cancer Group, was a large
open-label, two-arm, randomised multicentre phase III study in
women with early breast cancer. 1,500 patients in Finland and
Sweden with no distant metastases who had an intermediate to high
risk of recurrence within five years from the time of diagnosis,
were recruited to the study.
- The primary objective of the study was to compare the
recurrence-free survival of patients receiving single-agent docetaxel
(T), followed by cyclophosphamide, epirubicin and 5-FU (CEF) to those
receiving docetaxel with capecitabine (XT), followed by
cyclophosphamide, epirubicin and capecitabine (CEX) in the adjuvant
treatment of early breast cancer.
- Secondary objectives included the evaluation and comparison
between the two treatment arms of:
- Safety profile
- Overall survival.
Results to date show that:
- 54 women in the capecitabine-containing arm had their cancer
return, or died compared to 80 women in the non-capecitabine
containing arm of the study.
- There were fewer deaths among those taking the capecitabine-containing
combination regimen (a 34% reduction in risk of death was observed in
this group).
- 43 women in the capecitabine-containing arm experienced tumour
growth in another part of their body compared to 72 women in the
non-capecitabine arm.
- The study participants need to be followed up for longer in order
to assess the effect of capecitabine on survival.
- This analysis is further evidence that capecitabine may have a
role in early breast cancer treatment.
About The Finnish Breast Cancer Group
The Finnish Breast Cancer Group is a scientific and educational
legitimised society for scientists and specialists who are
responsible for breast cancer diagnostics and treatment in Finland.
With 260 members The Finnish Breast Cancer Group has carried out
several clinical trials on advanced breast cancer and in adjuvant
setting on academic basis from 1991.
All trademarks used or mentioned in this release are protected
by law.
References:
1. Significant improvement in recurrence-free survival (RFS)
when capecitabine (X) is integrated into docetaxel (T) 5-FU +
epirubicin + cyclophosphamide (CEF) adjuvant therapy for high-risk
early breast cancer (BC): interim analysis of the FinXX-trial.
Presented at the San Antonio Breast Cancer Symposium, December 2008
(abstract # 82)
2. Kamanger F et al Patterns of cancer incidence, mortality and
prevalence across five continents: defining priorities to reduce
cancer disparities in different geographic regions of the world. J
Clin Oncol 2006; 24: 2137 - 2150
3. Olivotto IA, Bajdik CD, Ravdin PM, Speers CH, Coldman AJ,
Norris BD, Davis GJ, Chia SK, Gelmon KA. Population-based
validation of the prognostic model ADJUVANT! for early breast
cancer. J Clin Oncol 2005;23:2716-25.
Source: The Finnish Breast Cancer Group
For further information please contact: Finnish Breast Cancer
Group, Professor Heikki Joensuu, +358-9-471-73208,
Heikki.Joensuu@hus.fi
Posted: November 2009
