In Reply to Belkacemi and Tsoutsou
Adjuvant Tamoxifen Plus Ovarian Function Suppression Versus Tamoxifen Alone in Premenopausal Women With Early Breast Cancer: Patient-Reported Outcomes in the Suppression of Ovarian Function Trial
Purpose The Suppression of Ovarian Function trial showed improved disease control for tamoxifen plus ovarian function suppression (OFS) compared with tamoxifen alone for the cohort of premenopausal patients who received prior chemotherapy. We present the patient-reported outcomes. Patients and Methods The quality-of-life (QoL) analysis includes 1,722 of 2,045 premenopausal patients with hormone receptor–positive breast cancer randomly assigned to receive adjuvant treatment with 5 years of tamoxifen plus OFS or tamoxifen alone. Chemotherapy use before enrollment was optional. Patients completed a QoL form consisting of global and symptom indicators at baseline, every 6 months for 24 months, …
Ten-Year Safety and Efficacy Analyses of the Big 02-98 Phase III Trial with an Exploratory Analysis on the Role of Ki67 in Predicting Benefit of Adjuvant Docetaxel in Er Positive Patients
ABSTRACT Aim: The BIG 2-98 is a randomized phase III trial that tested the effect of adding docetaxel with anthracycline-based adjuvant chemotherapy (CT) in women with node-positive breast cancer (BC). here we present the 10 year safety and efficacy analyses and report an exploratory analysis of the predictive value of Ki67 for docetaxel efficacy. Methods: In total, 2,887 patients with node positive BC were randomly assigned to one of four treatments: (I) sequential control: doxorubicin (A, 75 mg/m2) × 4 → CMF; (II) concurrent control: AC × 4 → CMF; (III) A × 3 → docetaxel (T, 100 mg/m2) × 3 → CMF and (IV) : AT (50/75 mg/m2) × 4 → CMF. The primary objective was to evaluate the efficacy of d…
Postmastectomy Radiation Therapy in Women with T1-T2 Tumors and 1 to 3 Positive Lymph Nodes: Analysis of the Breast International Group 02-98 Trial.
Purpose To analyze the impact of postmastectomy radiation therapy (PMRT) for patients with T1-T2 tumors and 1 to 3 positive lymph nodes enrolled on the Breast International Group (BIG) 02-98 trial. Methods and Materials The BIG 02-98 trial randomized patients to receive adjuvant anthracycline with or without taxane chemotherapy. Delivery of PMRT was nonrandomized and performed according to institutional preferences. The present analysis was performed on participants with T1-T2 breast cancer and 1 to 3 positive lymph nodes who had undergone mastectomy and axillary nodal dissection. The primary objective of the present study was to examine the effect of PMRT on risk of locoregional recurrence…
Estrogen levels in premenopausal (prem) patients (pts) with hormone-receptor positive (HR+) early breast cancer (BC) receiving adjuvant triptorelin (Trip) plus exemestane (E) or tamoxifen (T) in the SOFT trial: SOFT-EST substudy.
585 Background: Optimal endocrine therapy for prem pts with early HR+ BC may depend on complete estrogen suppression with GnRH-A, and is crucial for those receiving concurrent aromatase inhibitors (AI). SOFT-EST is a prospective substudy of the phase III SOFT trial. Aims of SOFT-EST are to describe estradiol (E2), estrone (E1) and estrone sulphate (E1S) during monthly Trip + E or T and to assess if there is a group in E+Trip with suboptimal estrogen suppression (SES). Methods: All pts enrolled in SOFT from selected centers who consented, selected Trip as ovarian function suppression method and were randomized to E+Trip or T+Trip were enrolled in SOFT-EST until reaching the accrual goal (E=9…
Twelve-Month Estrogen Levels in Premenopausal Women With Hormone Receptor–Positive Breast Cancer Receiving Adjuvant Triptorelin Plus Exemestane or Tamoxifen in the Suppression of Ovarian Function Trial (SOFT): The SOFT-EST Substudy
Purpose To describe estradiol (E2), estrone (E1), and estrone sulfate (E1S) levels during the first year of monthly triptorelin plus exemestane or tamoxifen and to assess possible suboptimal suppression while receiving exemestane plus triptorelin. Patients and Methods Premenopausal patients with early breast cancer on the Suppression of Ovarian Function Trial who selected triptorelin as the ovarian suppression method and were randomly assigned to exemestane plus triptorelin or tamoxifen plus triptorelin were enrolled until the target population of 120 patients was reached. Blood sampling time points were 0, 3, 6, 12, 18, 24, 36, and 48 months. Serum estrogens were measured with a highly sen…
Final 10-year results of the Breast International Group 2-98 phase III trial and the role of Ki67 in predicting benefit of adjuvant docetaxel in patients with oestrogen receptor positive breast cancer
Aim: Breast International Group (BIG) 2-98 is a randomised phase III trial that tested the effect of adding docetaxel, either in sequence to or in combination with anthracycline-based adjuvant chemotherapy, in women with node-positive breast cancer (BC). Here, we present the 10-year final trial safety and efficacy analyses. We also report an exploratory analysis on the predictive value of Ki67 for docetaxel efficacy, in the BIG 2-98 and using a pooled analysis of three other randomised trials. Patients and methods: 2887 patients were randomly assigned in a 2 x 2 trial design to one of four treatments. The primary objective was to evaluate the overall efficacy of docetaxel on disease free su…