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BIG 1-98: Letrozole Reduces Recurrence More Than Tamoxifen in Early Breast Cancer: Presented at EBCC

By Paula Moyer

NICE, FRANCE -- March 27, 2006 -- Patients treated with letrozole are less likely to have a recurrence of breast cancer than are those who are treated with tamoxifen, according to research presented here at the 5^th European Breast Cancer Conference (EBCC).

The findings, from the Breast International Group 1-98 (BIG 1-98) trial, also identified several features associated with risk of recurrence, said principal investigator Louis Mauriak, MD, consultant medical oncologist, Institut Bergonié Comprehensive Cancer Center, Bordeaux, France.

The trial was primarily designed as a head-to-head comparison of letrozole (Femara) and tamoxifen, it also identified several factors that are related to the success of endocrine therapy, Dr. Mauriak said in his presentation on March 23^rd.

"Tumours with high nodal involvement, that are grade 3 or larger or have peritumoural emboli, are associated with poor response," he said, and stressed that even with node-negative disease, the presence of peritumoural emboli were significantly linked to progression (P = 10 -7).

Dr. Mauriak and colleagues initially randomised 6091 patients to a 2-arm option or a 4-arm option. The 2-arm option involved randomisation to 1 of the following: 1) 5 years of tamoxifen; 2) 5 years of letrozole. The 4-arm option involved randomisation to 1 of the 2-arm groups plus 1 of the following: 1) 2 years tamoxifen followed by 3 years of letrozole; 2) 2 years of letrozole followed by 3 years of tamoxifen.

The study was designed to determine whether any 1 treatment strategy offered advantages for disease-free survival, and particularly for distant metastasis. In the analysis presented at the EBCC, the investigators sought to identify the clinical and pathological prognostic factors associated with early disease recurrence.

At a median initial follow-up of 25.0 months, they documented progression in 3.5% of patients, consisting of distant recurrences in 201 patients and local recurrences in 16.

Final analysis involved the 5980 patients on whom complete data were available, therefore, 212 recurrences were included.

The significant factors that portended progression were tumour size, hormone receptor status, node positivity, and tumour grade (P <.001 for each), Dr. Mauriak said.

Patients with the greatest risk of recurrence had at least 4 positive nodes, tumours that were at least 5 cm in diameter, oestrogen receptor-positive and progesterone receptor-negative status, and grade 3 lesions.

Patients with high lymph node involvement were more likely to progress if they were treated with tamoxifen than with letrozole, Dr. Mauriak said.


[Presentation title: Predictors of Early Recurrence in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in the BIG 1-98 Trial. Abstract 219]

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