Landmark Study In The Lancet Oncology Shows Capecitabine (Xeloda(R)) Combination Therapy Reduces Early Breast Cancer Recurrence
December 28, 2011
Healthcare Prof:
An analysis conducted by the Finnish Breast Cancer Group and published in the Lancet Oncology shows ladies at intermediate to high-risk of early breast cancer recurrence who received capecitabine as part of their chemotherapy regimen had a 34% reduction within the risk of the illness 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 remedy of early breast cancer with the standard, non-capecitabine regimen (docetaxel, epirubicin, cyclophosphamide and fluorouracil).[1] The analysis also discovered that patients taking the capecitabine-containing regimen had been significantly less likely to have their cancer spread (distant metastasis) to another part of the body (a 36% reduction in threat 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 inside the early stages of breast cancer might offer survival benefits for girls, 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 towards the chemotherapy regimen within the early stages of breast cancer may prevent the cancer coming back,” he added.
Breast cancer is the second most common cancer within the world and the most common cancer amongst ladies.[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 within the remedy and management of early breast cancer with relapse occurring in approximately 30% of patients, depending on individual danger factors, even after chemotherapy.[3]
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 girls with early breast cancer. 1,500 patients in Finland and Sweden with no distant metastases who had an intermediate to high danger of recurrence within five years from the time of diagnosis, had been 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 thos receiving docetaxel with capecitabine (XT), followed by cyclophosphamide, epirubicin and capecitabine (CEX) within the adjuvant treatment of early breast cancer.
— Secondary objectives included the evaluation and comparison among the two treatment arms of:
— Safety profile
— Overall survival
Results to date show that:
— 54 ladies inside the capecitabine-containing arm had their cancer return, or died compared to 80 women in the non-capecitabine containing arm of the study.
— There had been fewer deaths among those taking the capecitabine-containing combination regimen (a 34% reduction in threat of death was observed in this group).
— 43 females inside the capecitabine-containing arm skilled tumour growth in another part of their body compared to 72 ladies 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 might have a role in early breast cancer remedy.
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 remedy 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.
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References:
(1) Important 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 in the San Antonio Breast Cancer Symposium, December 2008 (abstract # 82)
(two) 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
Filed under: French Village