Tamoxifen with or without breast irradiation in women 50 years of age or older with early breast cancer.

BACKGROUND: We determined the effect of breast irradiation plus tamoxifen on disease-free survival and local relapse in women 50 years of age or older who had T1 or T2 node-negative breast cancer. METHODS: Between December 1992 and June 2000, 769 women with early breast cancer (tumor diameter, 5 cm or less) were randomly assigned to receive breast irradiation plus tamoxifen (386 women) or tamoxifen alone (383 women). The median follow-up was 5.6 years. RESULTS: The rate of local relapse at five years was 7.7 percent in the tamoxifen group and 0.6 percent in the group given tamoxifen plus irradiation (hazard ratio, 8.3; 95 percent confidence interval, 3.3 to 21.2; P<0.001), with corresponding five-year disease-free survival rates of 84 percent and 91 percent (P=0.004). A planned subgroup analysis of 611 women with T1, receptor-positive tumors indicated a benefit from radiotherapy (five-year rates of local relapse, 0.4 percent with tamoxifen plus radiotherapy and 5.9 percent with tamoxifen alone; P<0.001). Overall, there was a significant difference in the rate of axillary relapse at five years (2.5 percent in the tamoxifen group and 0.5 percent in the group given tamoxifen plus irradiation, P=0.049), but no significant difference in the rates of distant relapse or overall survival. CONCLUSIONS: As compared with tamoxifen alone, radiotherapy plus tamoxifen significantly reduces the risk of breast and axillary recurrence after lumpectomy in women with small, node-negative, hormone-receptor-positive breast cancers.

Pretreatment proliferation parameters do not add predictive power to clinical factors in cervical cancer treated with definitive radiation therapy.

PURPOSE: To examine the prognostic value of tumor proliferation measurements in women with carcinoma of the uterine cervix. We report an update of a prospective study focusing on whether pretreatment proliferation parameters are associated with clinical outcome, relative to other established clinical factors. MATERIALS AND METHODS: One hundred and one patients were recruited into the study from years 1991 to 1999. The LI for in vivo bromodeoxyuridine incorporation by the tumor and the potential doubling time (T(pot)) were determined by flow cytometry (fc). LI and its staining pattern were also assessed by immunohistochemistry (ih) using tissue sections. Apoptosis was assessed histologically using morphological criteria. Patients were treated with definitive radiation therapy. RESULTS: A successful fc measurement for LI-fc and T(pot) was possible in 95 patients (94%). The median/mean LI-fc was 6.6/7.6% (range 1.4-36.1%), and for LI-ih, 10.8/11.5%. To date, 43 patients have died of disease, and the median follow-up for alive patients is 6.2 years (range 1.3-9.3 years). Among 88 patients who completely responded to treatment, 40 patients have relapsed (14 pelvic, 23 distant, and 3 pelvic and distant). In univariate analysis, the significant factors for adverse disease-free survival were large tumor size (P = 0.0001), low hemoglobin (P = 0.001), pelvic lymph node status (P = 0.004), stage (P = 0.013), and overall treatment time (P = 0.0008). In multivariate analysis, only tumor size, pelvic lymph node status, and overall treatment time remained significant for disease-free survival. LI-fc, LI-ih, T(pot), ploidy, pattern of bromodeoxyuridine staining, and apoptosis were not significantly associated with clinical outcome in univariate or multivariate analyses. CONCLUSIONS: These mature data indicate that none of the pretreatment proliferation parameters have prognostic significance in the radical radiotherapy of carcinoma of the uterine cervix, despite the significance of overall treatment time for treatment outcome.

Factors influencing arm and axillary symptoms after treatment for node negative breast carcinoma.

BACKGROUND: The purpose of the current study was to identify the factors that contribute to postoperative arm symptoms following breast conserving surgery in a well-defined cohort of node negative breast carcinoma patients. METHODS: A convenience sample of 370 women >/= 50 years of age with node negative breast carcinoma who were participants in a randomized controlled trial designed to assess the need for breast radiation in addition to tamoxifen were surveyed. Axillary dissection was optional for patients 65 years or older and who were clinically node negative. RESULTS: A total of 65.1% (241/370) of women had ipsilateral shoulder or arm symptoms. Multivariate analysis revealed that axillary dissection, breast radiation, and younger age (odds ratio = 11.2, 1.65, and 3.8 respectively) were significantly (P < 0.05) associated with increased ipsilateral shoulder or arm symptoms. Treatment with axillary dissection and breast radiation were significant factors (P < 0.02) associated with the self-reporting of arm swelling (odds ratio = 4.4 and 2.0, respectively). Patients 70 years old or greater reported significantly fewer arm symptoms (odds ratio = 0.26, P < 0.05) after axillary dissection. CONCLUSIONS: Arm symptoms were present in about 80% of patients who underwent breast conserving surgery, axillary dissection, and breast radiation in the current study. These symptoms were significantly associated with the use of axillary dissection, breast radiation, and younger age. Older patients experienced fewer arm symptoms after standard treatment for node negative breast carcinoma, and thus older age should not be a contraindication to axillary dissection.