Late tamoxifen in patients previously operated for breast cancer without postoperative tamoxifen: 5-year results of a single institution randomised study.

Andrea Veronesi,Ettore Bidoli,Davide Lombardi,Gianmaria Miolo,Maria D Magri,Diana Crivellari,Simona Scalone

doi:10.1186/1471-2407-10-205

Abstract

BackgroundA population of breast cancer patients exists who, for various reasons, never received adjuvant post-operative tamoxifen (TAM). This study was aimed to evaluate the role of late TAM in these patients.MethodsFrom 1997 to 2003, patients aged 35 to 75 years, operated more than 2 years previously for monolateral breast cancer without adjuvant TAM, with no signs of metastases and no contraindication to TAM were randomized to TAM 20 mg/day orally for 2 years or follow-up alone. Events were categorized as locoregional relapse, distant metastases, metachronous breast cancer, tumours other than breast cancer and death from any causes, whichever occurred first. The sample size (197 patients per arm, plus 10% allowance) was based on the assumption of a 30% decrease in the number of events occurring at a rate of 5% annually in the 10 years following randomization. Four hundred and thirty-three patients were randomized in the study (TAM 217, follow-up 216). Patients characteristics (TAM/follow-up) included: median age 55/55 years, median time from surgery 25/25 months (range, 25-288/25-294), in situ carcinoma 18/24, oestrogen receptor (ER) positive in 75/68, negative in 70/57, unknown in 72/91 patients. Previous adjuvant treatment included chemotherapy in 131/120 and an LHRH analogue in 11/13 patients.ResultsThirty-six patients prematurely discontinued TAM after a median of 1 month, mostly because of subjective intolerance. Eighty-three events (TAM 39, follow-up 44) occurred: locoregional relapse in 10/8, distant metastases in 14/16, metachronous breast cancer in 4/10, other tumours in 11/10 patients. Less ER-positive secondary breast cancers occurred in the TAM treated patients than in follow-up patients (1 vs 10, p = 0.005). Event-free survival was similar in both groups of patients.ConclusionsThis 5-year analysis revealed significantly less metachronous ER-positive breast cancers in the TAM treated patients. No other statistically significant differences have emerged thus far.

Highlights

A population of breast cancer patients exists who, for various reasons, never received adjuvant postoperative tamoxifen (TAM)
From March 1997 to May 2003, 433 patients were randomized in the study (TAM 217, follow-up 216)
Thirty-nine events occurred in the TAM group while 44 events occurred in the control group

Summary

Introduction

A population of breast cancer patients exists who, for various reasons, never received adjuvant postoperative tamoxifen (TAM). Tamoxifen (TAM) has a well defined role in the postoperative management of oestrogen receptor (ER) positive breast cancer with a significant impact upon locoregional relapse, the development of distant metastases and of contralateral metachronous breast cancer [5]. Exists, mostly going back to past decades, either because of the low risk of relapse or because only chemotherapy was planned. Whether this population of breast cancer patients still has a chance to derive the well known benefits of TAM is not known Randomised studies have shown that TAM is able to reduce the incidence of primary breast cancer in various settings: (high-risk patients [6,7,8] and hysterectomised low-risk patients [9]).

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