Endocrine Treatment with 2 Years of Tamoxifen versus 2 Years of Exemestane in Postmenopausal Patients with High-Risk Early Breast Cancer and Persisting Circulating Tumor Cells - First Results of the SUCCESS C Endocrine Treatment Sub-Study

被引：8

作者：

Schochter, Fabienne ^{[1
]}

Rack, Brigitte ^{[1
]}

Tzschaschel, Marie ^{[1
]}

Polasik, Arkadius ^{[1
]}

Andergassen, Ulrich ^{[2
]}

Trapp, Elisabeth ^{[2
]}

Alunni-Fabbroni, Marianna ^{[2
]}

Schneeweiss, Andreas ^{[3
]}

Müller, Volkmar ^{[4
]}

Pantel, Klaus ^{[5
]}

Gade, Joerg ^{[6
]}

Lorenz, Ralf ^{[7
]}

Rezai, Mahdi ^{[8
]}

Tesch, Hans ^{[9
]}

Soeling, Ulrike ^{[10
]}

Fehm, Tanja ^{[11
]}

Mahner, Sven ^{[2
]}

Schindlbeck, Christian ^{[12
]}

Lichtenegger, Werner ^{[13
]}

Beckmann, Matthias W. ^{[14
]}

Fasching, Peter A. ^{[14
]}

Janni, Wolfgang ^{[1
]}

Friedl, Thomas W. P. ^{[1
]}

机构：

[1] Univ Frauenklin Ulm, Ulm, Germany

[2] Klinikum Ludwig Maximilians Univ Munchen, Klin & Poliklin Frauenheilkunde & Geburtshilfe, Munich, Germany

[3] Univ Klinikum Heidelberg, Natl Zentrum Tumorerkrankungen, Heidelberg, Germany

[4] Univ Klinikum Hamburg Eppendorf, Klin & Poliklin Gynakol, Hamburg, Germany

[5] Univ Klinikum Hamburg Eppendorf, Inst Tumorbiol, Hamburg, Germany

[6] Diakoniekrankenhaus Friederikenstift, Klin Gynakol, Hannover, Germany

[7] Gemeinschaftspraxis Dr Lorenz Hecker & Wesche, Braunschweig, Germany

[8] Luisenkrankenhaus Dusseldorf, Klin Gynakol & Geburtshilfe, Dusseldorf, Germany

[9] Onkol Gemeinschaftspraxis, Frankfurt, Germany

[10] Gemeinschaftspraxis Siehl & Soeling, Kassel, Germany

[11] Klinikum Heinrich Heine Univ Dusseldorf, Klin Frauenheilkunde & Geburtshilfe, Dusseldorf, Germany

[12] Klinikum Traunstein, Frauenklin, Traunstein, Germany

[13] Charite Univ Klinikum, Campus Virchow, Berlin, Germany

[14] Friedrich Alexander Univ Erlangen Nurnberg, Univ Klinikum Erlangen, Frauenklin, Erlangen, Germany

来源：

ONCOLOGY RESEARCH AND TREATMENT | 2018年 / 41卷 / 03期

关键词：

Early breast cancer; Endocrine therapy; Exemestane; Tamoxifen; Circulating tumor cells; CTC clearance rate; Safety; Toxicity; THERAPY; LETROZOLE; SEQUENCE; WOMEN;

D O I：

10.1159/000485566

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: Optimal choice and sequence of endocrine treatment following adjuvant chemotherapy in postmenopausal early breast cancer patients are still under discussion and treatment stratification factors are missing. Patients and Methods: Postmenopausal women with HER2-negative, hormone receptor-positive tumors and persisting circulating tumor cells (CTCs; assessed using the FDA-approved CellSearch (R) System, Janssen Diagnostics, LLC) after chemotherapy were randomized to 2 years of tamoxifen followed by 3 years of exemestane (tamoxifen-exemestane group, n = 54) or 5 years of exemestane (exemestane-only group, n = 54). CTCs were again assessed after the first 2 years of endocrine treatment. In addition, safety data were compared between the 2 groups. Results: The 2 groups were well-balanced with regard to baseline characteristics. The CTC clearance rate after 2 years was 89% in the exemestane-only group and 97% in the tamoxifen-exemestane group (exact Fisher test, p = 0.36). The safety profile showed good tolerability with few grade 3 or 4 adverse events in both groups. Conclusion: The similar CTC clearance rate after 2 years of endocrine therapy with exemestane or tamoxifen, and the safety profiles obtained may indicate comparable efficacy and tolerability of both endocrine treatment regimens. However, these results have to be confirmed by final survival and safety analysis. (c) 2018 S. Karger GmbH, Freiburg

引用

页码：93 / 98

页数：6

共 50 条

[21] A randomized controlled study evaluating safety and efficacy of leuprorelin acetate every-3-months depot for 2 versus 3 or more years with tamoxifen for 5 years as adjuvant treatment in premenopausal patients with endocrine-responsive breast cancer
Shiba, Eiichi
Yamashita, Hiroko
Kurebayashi, Junichi
Noguchi, Shinzaburo
Iwase, Hirotaka
Ohashi, Yasuo
Sasai, Kiyofumi
Fujimoto, Tsukasa
BREAST CANCER, 2016, 23 (03) : 499 - 509
[22] Randomized trial of 2 versus 5 years of adjuvant tamoxifen for women aged 50 years or older with early breast cancer: Italian Interdisciplinary Group for Cancer Evaluation study of adjuvant treatment in breast cancer 01
Sacco, M
Valentini, M
Belfiglio, M
Pellegrini, F
De Berardis, G
Franciosi, M
Nicolucci, A
JOURNAL OF CLINICAL ONCOLOGY, 2003, 21 (12) : 2276 - 2281
[23] First results from the multicenter phase III DATA study comparing 3 versus 6 years of anastrozole after 2-3 years of tamoxifen in postmenopausal women with hormone receptor-positive early breast cancer
Tjan-Heijnen, V. C.
Van Hellemond, I. E.
Peer, P. G.
Swinkels, A. C.
Smorenburg, C. H.
Van der Sangen, M.
Kroep, J. R.
De Graaf, H.
Honkoop, A. H.
Erdkamp, F.
Van den Berkmortel, F. W.
Kitzen, J. J.
De Boer, M.
De Roos, W. K.
Linn, S. C.
Imholz, A. L.
Seynaeve, C.
CANCER RESEARCH, 2017, 77
[24] ABCSG-16/SALSA: Prospective, open, randomised, multicentre phase III study to assess extended adjuvant treatment with 2 or 5 years' anastrozole in postmenopausal women with endocrine-responsive early breast cancer after 5 years of initial adjuvant endocrine therapy
Gnant, M.
Mlineritsch, B.
Dubsky, P.
Menzel, C.
Schippinger, W.
Manfreda, D.
Poestlberger, S.
Thaler, J.
Stierer, M.
Kubista, E.
Haslbauer, F.
Melbinger, E.
Luschin-Ebengreuth, G.
Sevelda, P.
Marth, V.
Trapl, H.
Steger, G.
Tausch, C.
Fitzal, F.
Greil, R.
Jakesz, R.
BREAST, 2009, 18 : S53 - S53
[25] Changes in bone metabolism after 2 years' treatment with exemestane (E) in postmenopausal women with early breast cancer (EBC) at low risk: Follow-up (FU) results of a randomized placebo-controlled study.
Lonning, PE
Geisler, J
Krag, LE
Ottestad, L
Risberg, T
Hagen, AI
Schlichting, E
Di Salle, E
Polli, A
Paolini, J
JOURNAL OF CLINICAL ONCOLOGY, 2005, 23 (16) : 11S - 11S
[26] Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE)
Johnston, Stephen R. D.
Harbeck, Nadia
Hegg, Roberto
Toi, Masakazu
Martin, Miguel
Shao, Zhi Min
Zhang, Qing Yuan
Martinez Rodriguez, Jorge Luis
Campone, Mario
Hamilton, Erika
Sohn, Joohyuk
Guarneri, Valentina
Okada, Morihito
Boyle, Frances
Neven, Patrick
Cortes, Javier
Huober, Jens
Wardley, Andrew
Tolaney, Sara M.
Cicin, Irfan
Smith, Ian C.
Frenzel, Martin
Headley, Desiree
Wei, Ran
San Antonio, Belen
Hulstijn, Maarten
Cox, Joanne
O'Shaughnessy, Joyce
Rastogi, Priya
JOURNAL OF CLINICAL ONCOLOGY, 2020, 38 (34) : 3987 - 3998
[27] A follow-up study of a randomized controlled study evaluating safety and efficacy of leuprorelin acetate every-3-month depot for 2 versus 3 or more years with tamoxifen for 5 years as adjuvant treatment in premenopausal patients with endocrine-responsive breast cancer
Junichi Kurebayashi
Eiichi Shiba
Tatsuya Toyama
Hiroshi Matsumoto
Minoru Okazaki
Tadashi Nomizu
Tohru Ohtake
Takaaki Fujii
Yasuo Ohashi
Breast Cancer, 2021, 28 : 684 - 697
[28] A follow-up study of a randomized controlled study evaluating safety and efficacy of leuprorelin acetate every-3-month depot for 2 versus 3 or more years with tamoxifen for 5 years as adjuvant treatment in premenopausal patients with endocrine-responsive breast cancer
Kurebayashi, Junichi
Shiba, Eiichi
Toyama, Tatsuya
Matsumoto, Hiroshi
Okazaki, Minoru
Nomizu, Tadashi
Ohtake, Tohru
Fujii, Takaaki
Ohashi, Yasuo
BREAST CANCER, 2021, 28 (03) : 684 - 697
[29] Evaluation of prevalence, number, and temporal changes of circulating tumor cells as assessed after 2 and 5 years of follow-up in patients with early breast cancer in the SUCCESS A study.
Bauer, Emanuel C. A.
Neugebauer, Julia Katharina
Andergassen, Ulrich
Jaeger, Bernadette
Jueckstock, Julia Kathrin
Fasching, Peter A.
Haeberle, Lothar
Friedl, Thomas W. P.
Schrader, Iris
Lorenz, Andreas
Tesch, Hans
Rezai, Mahdi
Thurner-Herrmanns, Elisabeth
Schneeweiss, Andreas
Beckmann, Matthias W.
Pantel, Klaus
Janni, Wolfgang
Rack, Brigitte Kathrin
JOURNAL OF CLINICAL ONCOLOGY, 2013, 31 (15)
[30] Updated results of a randomized trial of 2 versus 5 years of adjuvant tamoxifen for women aged 50 years or older with early breast cancer: Italian Interdisciplinary Group for Cancer Care Evaluation study of adjuvant treatment in breast cancer 01 (SITAM 01).
Valentini, M
Belfiglio, M
Pellegrini, F
Sacco, M
Nicolucci, A
JOURNAL OF CLINICAL ONCOLOGY, 2005, 23 (16) : 10S - 10S

← 1 2 3 4 5 →