Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial

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• 作者：Prof Cornelis JH van de Velde MD^a ; ^‡ ; ; ^{c.j.h.van_de_velde@lumc.nl} ; Daniel Rea MD^b ; ^‡ ; ; Caroline Seynaeve MD^c ; Prof Hein Putter PhD^a ; Prof Annette Hasenburg MD^d ; Jean-Michel Vannetzel MD^e ; Prof Robert Paridaens MD^f ; Prof Christos Markopoulos MD^g ; Yasuo Hozumi MD^h ; Elysee TM Hille PhD^a ; Dirk G Kieback MDⁱ ; Lina Asmar PhD^j ; Jan Smeets BSc^k ; Prof Johan WR Nortier MD^a ; Prof Peyman Hadji MD^l ; John MS Bartlett PhD^m ; Stephen E Jones MD^j
• 刊名：The Lancet
• 出版年：2011
• 出版时间：22 January 2011-28 January 2011
• 年：2011
• 卷：377
• 期：9762
• 页码：321-331
• 全文大小：320 K

文摘

Summary

Background

Aromatase inhibitors improved disease-free survival compared with tamoxifen when given as an initial adjuvant treatment or after 2–3 years of tamoxifen to postmenopausal women with hormone-receptor-positive breast cancer. We therefore compared the long-term effects of exemestane monotherapy with sequential treatment (tamoxifen followed by exemestane).

Methods

The Tamoxifen Exemestane Adjuvant Multinational (TEAM) phase 3 trial was conducted in hospitals in nine countries. Postmenopausal women (median age 64 years, range 35–96) with hormone-receptor-positive breast cancer were randomly assigned in a 1:1 ratio to open-label exemestane (25 mg once a day, orally) alone or following tamoxifen (20 mg once a day, orally) for 5 years. Randomisation was by use of a computer-generated random permuted block method. The primary endpoint was disease-free survival (DFS) at 5 years. Main analyses were by intention to treat. The trial is registered with ClinicalTrials.gov, NCT00279448, NCT00032136, and NCT00036270; NTR 267; Ethics Commission Trial 27/2001; and UMIN, C000000057.

Findings

9779 patients were assigned to sequential treatment (n=4875) or exemestane alone (n=4904), and 4868 and 4898 were analysed by intention to treat, respectively. 4154 (85 % ) patients in the sequential group and 4186 (86 % ) in the exemestane alone group were disease free at 5 years (hazard ratio 0·97, 95 % CI 0·88–1·08; p=0·60). In the safety analysis, sequential treatment was associated with a higher incidence of gynaecological symptoms (942 [20 % ] of 4814 vs 523 [11 % ] of 4852), venous thrombosis (99 [2 % ] vs 47 [1 % ]), and endometrial abnormalities (191 [4 % ] vs 19 [<1 % ]) than was exemestane alone. Musculoskeletal adverse events (2448 [50 % ] vs 2133 [44 % ]), hypertension (303 [6 % ] vs 219 [5 % ]), and hyperlipidaemia (230 [5 % ] vs 136 [3 % ]) were reported more frequently with exemestane alone.

Interpretation

Treatment regimens of exemestane alone or after tamoxifen might be judged to be appropriate options for postmenopausal women with hormone-receptor-positive early breast cancer.

Funding

Pfizer.