Download Exemestane Versus Anastrozole in Postmenopausal Women With

EXEMESTANE VERSUS ANASTROZOLE IN
POSTMENOPAUSAL WOMEN WITH EARLY BREAST CANCER
A RANDOMIZED CONTROLLED PHASE III TRIAL
Paul E. Goss, James N. Ingle, Kathleen I. Pritchard, Matthew J. Ellis, George W. Sledge, G. Thomas
Budd, Manuela Rabaglio, Rafat H. Ansari, David B. Johnson, Richard Tozer, David P. D’Souza,
Haji Chalchal, Silvana Spadafora, Vered Stearns, Edith A. Perez, Pedro E.R. Liedke, Istvan Lang,
Catherine Elliott, Karen A. Gelmon, Judy-Anne W. Chapman, and Lois E. Shepherd
JOURNAL OF CLINICAL ONCOLOGY, VOLUME 31 NUMBER 11 APRIL 10 2013
R2 김형오
INTRODUCTION

Anastrozole and letrozole
Nonsteroidal oral aromatase inhibitors,
 The most common adjuvant endocrine therapy for hormonedependent early breast cancer in postmenopausal women
 Superior to tamoxifen, 5 years usage


Exemestane
Steroidal aromatase inhibitor
 Superior to 5 years of tamoxifen, when used 2-3 years after
2-3 years of prior tamoxifen

INTRODUCTION

Adjuvant aromatase inhibitors

Accelerated bone resorption from estrogen suppression
Exemestane may have less net impact on bone than
the nonsteroidals
 Exemestane v.s. Anastrozole and letrozole



Exemestane may suppress estrogen more than anastrozole,
and may yield superior efficacy
Both are non-cross-resistant

Switching one to another may be considered with PD
OBJECTIVE

MA-27

Exemestane might have advantages over anastrozole for 1st
line adjuvant treatment of hormone-dependent early breast
cancer in postmenopausal women
PATIENTS AND METHODS

Study population
Histologically confirmed
 Adequately excised, locally determined, hormone receptor (+)
primary invasive cancer
 Postmenopausal status

Age ≥60 years
 Age 45~59
 spontaneous cessation of menses, ≥12 months
 cessation of menses, ≤12 months, FSH postmenopausal
 Bilateral oophorectomy

PATIENTS AND METHODS

Study population
3 wks ≤ completion of CTx ≤ 3 months
 ECOG 0~2
 Min. life expectancy 5 years


Exclusion criteria
Premenopausal
 Hormone receptor (-)
 Contralateral primary breast cancer
 History of other cancer


Except non-melanoma skin cancer or carcinoma in situ of cervix
PATIENTS AND METHODS

Study end points

The primary end point


Event free survival
 Time to loco-regional/distant disease recurrence
 New primary breast cancer
 Death from any cause
Secondary end points
Overall survival
 Distant disease free survival
 Incidence of contralateral new primary breast cancer
 Clinical, laboratory safety

RESULTS
RESULTS
RESULTS
• Event frequency
– Exemestane vs anastrozole
• Distant metastasis
– 138 vs 138
• Local in-breast recur
– 54 vs 54
• Death
– 144 vs 122
• Contralateral breast ca.
– 46 vs 33
• Overall survival
– Exemestane vs anastrozole

4 year EFS rate
91% on exemestane
 91.2% on anastrolzole

• Death
– 208 vs 204
• Due to breast ca.
– 89 vs 98
RESULTS
RESULTS
DISCUSSION
Neither exemestane nor anastrozole was superior in
terms of breast cancer outcomes
 Adverse effects more in


Anastrozole


Osteoporosis, abnormal lipid levels
Exemestane

Mild LFT abnormality, atrial fibrillation
DISCUSSION
Exemestane was not superior to anastrozole
 Different adverse effect profile



Particularly concerning bone health
Exemestane should be considered another option to
anastrozole or letrozole with hormone receptor positive
postmenopausal breast cancer