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Obesity is an independent adverse prognostic factor for death after breast cancer, although the statistical significance was minimal when several other patient characteristics were considered, according to results of a phase 3 study.
The randomized, double blind Breast International Group (BIG) 1-98 trial included postmenopausal women with endocrine-responsive early-stage invasive breast cancer. Researchers compared 5 years of adjuvant monotherapy with tamoxifen or letrozole with sequenced regimens that included 2 years of one followed by 3 years of the other.
Researchers enrolled 8,028 women from 1998 to 2003. They recorded height and weight at randomization to calculate baseline BMI. They classified patients as normal (<25 kg/m2), overweight (25 to <30 kg/m2) and obese (>30 kg/m2).
The current report assessed 4,760 patients who were randomly assigned to 5 years of monotherapy with tamoxifen (n=2378) or letrozole (n=2,382). At randomization, 1,097 of these patients were obese and 1,734 were overweight. The overall median BMI was 26.1 kg/m2 at randomization.
In this study, obese patients had larger tumors (P<0.001) and more positive lymph nodes, and their tumors were more often progesterone receptor-positive (P<0.001).
At a median follow-up of 8.7 years, 17% of patients had died. Patients who were obese had slightly poorer OS (HR=1.19; 95% CI, 0.99-1.44) than patients with a normal BMI, although the difference was not statistically significant. The researchers observed no trend in OS in overweight vs. normal weight patients (HR=1.02; 95% CI, 0.86-1.20).
The results also demonstrated that letrozole was more effective than tamoxifen in reducing DFS events, overall deaths, breast cancer recurrence and distant metastases across all BMI categories.
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