Implementation of CDK4/6 Inhibitors and its Influence on the Treatment Landscape of Advanced Breast Cancer Patients - Data from the Real-World Registry PRAEGNANT

被引：12

作者：

Engler, Tobias ^{[1
]}

Fasching, Peter A. ^{[2
]}

Lueftner, Diana ^{[3
,4
]}

Hartkopf, Andreas D. ^{[5
]}

Mueller, Volkmar ^{[6
]}

Kolberg, Hans-Christian ^{[7
]}

Hadji, Peyman ^{[8
,9
]}

Tesch, Hans ^{[10
]}

Haeberle, Lothar ^{[2
,11
]}

Ettl, Johannes ^{[12
]}

Wallwiener, Markus ^{[13
]}

Beckmann, Matthias W. ^{[2
]}

Hein, Alexander ^{[2
]}

Belleville, Erik ^{[14
]}

Uhrig, Sabrina ^{[2
]}

Wimberger, Pauline ^{[15
,16
,17
,18
,19
,20
,21
]}

Hielscher, Carsten ^{[22
]}

Kurbacher, Christian M. ^{[23
]}

Wuerstlein, Rachel ^{[24
,25
]}

Untch, Michael ^{[26
]}

Taran, Florin-Andrei ^{[27
]}

Enzinger, Hans-Martin ^{[28
]}

Krabisch, Petra ^{[29
]}

Welslau, Manfred ^{[30
]}

Maasberg, Michael ^{[31
]}

Hempel, Dirk ^{[32
]}

Lux, Michael P. ^{[33
,34
,35
]}

Michel, Laura L. ^{[36
]}

Janni, Wolfgang ^{[5
]}

Wallwiener, Diethelm ^{[1
]}

Brucker, Sara Y. ^{[1
]}

Fehm, Tanja N. ^{[37
]}

Schneeweiss, Andreas ^{[36
]}

机构：

[1] Univ Tubingen, Dept Obstet & Gynecol, Tubingen, Germany

[2] Friedrich Alexander Univ Erlangen Nuremberg, Erlangen Univ Hosp, Comprehens Canc Ctr Erlangen EMN, Dept Gynecol & Obstet, Univ Str 21-23, D-91054 Erlangen, Germany

[3] Immanuel Hosp Mark Schweiz, Brandenburg, Germany

[4] Med Univ Brandenburg Theodor Fontane, Brandenburg, Germany

[5] Ulm Univ Hosp, Dept Gynecol & Obstet, Ulm, Germany

[6] Hamburg Eppendorf Univ Med Ctr, Dept Gynecol, Hamburg, Germany

[7] Marienhosp Bottrop, Dept Gynecol & Obstet, Bottrop, Germany

[8] Frankfurt Ctr Bone Hlth, Marburg, Germany

[9] Philips Univ Marburg, Marburg, Germany

[10] Bethanien Hosp, Oncol Practice, Frankfurt, Germany

[11] Erlangen Univ Hosp, Dept Gynecol & Obstet, Biostat Unit, Erlangen, Germany

[12] Tech Univ Munich, Dept Obstet & Gynecol, Klinikum Rechts Isar, Munich, Germany

[13] Heidelberg Univ Hosp, Dept Obstet & Gynecol, Heidelberg, Germany

[14] ClinSol GmbH & Co KG, Wurzburg, Germany

[15] Tech Univ Dresden, Dept Gynecol & Obstet, Carl Gustav Carus Fac Med, Dresden, Germany

[16] Tech Univ Dresden, Univ Hosp, Dresden, Germany

[17] Natl Ctr Tumor Dis NCT, Dresden, Germany

[18] German Canc Res Ctr, Heidelberg, Germany

[19] Tech Univ Dresden, Carl Gustav Carus Fac Med, Dresden, Germany

[20] Helmholtz Zentrum Dresden Rossendorf HZDR, Dresden, Germany

[21] German Canc Consortium DKTK, Dresden, Germany

[22] Onkol Zentrum Stralsund, Gynakol Kompetenzzentrum, Stralsund, Germany

[23] Gynecol Ctr Bonn, Dept Gynecol & Gynecol Oncol, Friedenspl, Bonn, Germany

[24] Munich Univ Hosp, Breast Ctr, Dept Gynecol & Obstet, Munich, Germany

[25] Munich Univ Hosp, CCC Munich, Munich, Germany

[26] Helios Clin Berlin Buch, Dept Gynecol & Obstet, Berlin, Germany

[27] Freiburg Univ Hosp, Dept Obstet & Gynecol, Freiburg, Germany

[28] Klinikum Bamberg, Sozialstiftung Bamberg, Dept Gynecol & Obstet, Bamberg, Germany

[29] Klinikum Chemnitz gGmbH, Dept Gynecol & Obstet, Chemnitz, Germany

[30] Onkol Aschaffenburg, Aschaffenburg, Germany

[31] MVZ Hamatol Onkol Mayen Koblenz GmbH, Mayen, Germany

[32] Onkol Zentrum Donauworth, Donauworth, Germany

[33] Frauenklin St Louise, Dept Gynecol & Obstet, Paderborn, Germany

[34] St Josefs Hosp, Frauenklin, Salzkotten, Germany

[35] St Vincenz Krankenhaus GmbH, Kooperat Brustzentrum Paderborn, Paderborn, Germany

[36] Heidelberg Univ Hosp, Natl Ctr Tumor Dis, German Canc Res Ctr DKFZ, Heidelberg, Germany

[37] Dusseldorf Univ Hosp, Dept Gynecol & Obstet, Dusseldorf, Germany

来源：

GEBURTSHILFE UND FRAUENHEILKUNDE | 2022年 / 82卷 / 10期

关键词：

advanced breast cancer; real world data; chemotherapy; CDK4/6; inhibitor; endocrine treatment; ENDOCRINE THERAPY; PALBOCICLIB; RIBOCICLIB; SURVIVAL; FULVESTRANT; LETROZOLE; ABEMACICLIB; COMBINATION; PROGRESSION; PATTERNS;

D O I：

10.1055/a-1880-0087

中图分类号：

R71 [妇产科学];

学科分类号：

100211 ;

摘要：

Background Comprehensive data from prospective clinical trials have led to a high level of evidence establishing CDK4/6 inhibitors in combination with endocrine treatment (CDK4/6i + ET) as a standard for the treatment of HER2-negative, hormone receptor-positive (HER2- HR+) breast cancer patients in the first-line advanced therapy setting. Data on patient populations that have been treated in the real-world setting may provide an insight into changes of patient characteristics and prognosis over time. Methods The data were extracted from the prospective real-world registry PRAEGNANT (NCT02338167). Patients had to have HER2- HR+ advanced breast cancer in the first-line metastatic setting. The chosen therapies were described as well as progression-free survival (PFS) and overall survival (OS) in relation to the given therapies and time periods during which they were indicated. Results CDK4/6 inhibitors have been rapidly implemented since their introduction in November 2016. In recent years (2018-2022), about 70-80% of the patient population have been treated with CDK4/6 inhibitors, while endocrine monotherapy was given to about 10% and chemotherapy to about 15% of all patients. The prognosis was worst in patients treated with chemotherapy. Recently, mainly patients with a good prognosis are being treated with endocrine monotherapy, and patients who are treated with chemotherapy have an unfavorable prognosis. The PFS and OS of patients treated with CDK4/6i + ET have remained similar over time despite changes in patient characteristics. Conclusion A treatment with CDK4/6i + ET has rapidly become the therapy standard for patients in the first-line advanced breast cancer setting. After the implementation of CDK4/6i + ET, endocrine monotherapy is only given to patients with a very favorable prognosis, while chemotherapy is provided to patients with a rather unfavorable prognosis. These changes in patient characteristics did not seem to influence the prognosis of patients treated with CDK4/6i + ET.

引用

页码：1055 / 1067

页数：13

共 49 条

[1] Estrogen and Progesterone Receptor Testing in Breast Cancer American Society of Clinical Oncology/College of American Pathologists Guideline Update
Allison, Kimberly H.
Hammond, M. Elizabeth H.
Dowsett, Mitchell
McKernin, Shannon E.
Carey, Lisa A.
Fitzgibbons, Patrick L.
Hayes, Daniel F.
Lakhani, Sunil R.
Chavez-MacGregor, Mariana
Perlmutter, Jane
Perou, Charles M.
Regan, Meredith M.
Rimm, David L.
Symmans, W. Fraser
Torlakovic, Emina E.
Varella, Leticia
Viale, Giuseppe
Weisberg, Tracey F.
McShane, Lisa M.
Wolff, Antonio C.
[J]. ARCHIVES OF PATHOLOGY & LABORATORY MEDICINE, 2020, 144 (05) : 545 - 563
[2] Disease management patterns for postmenopausal women in Europe with hormone-receptor-positive, human epidermal growth factor receptor-2 negative advanced breast cancer
Andre, Fabrice
Neven, Patrick
Marinsek, Nina
Zhang, Jie
Baladi, Jean-Francois
Degun, Ravi
Benelli, Giancarlo
Saletan, Stephen
Jerusalem, Guy
[J]. CURRENT MEDICAL RESEARCH AND OPINION, 2014, 30 (06) : 1007 - 1016
[3] Circulating tumor DNA (ctDNA) dynamics in patients with hormone receptor positive (HR+)/HER2 negative (HER2-) advanced breast cancer (aBC) treated in first line with ribociclib (R) and letrozole (L) in the BioItaLEE trial
Bianchini, Giampaolo
Malorni, Luca
Arpino, Grazia
Zambelli, Alberto
Puglisi, Fabio
Del Mastro, Lucia
Colleoni, Marco
Montemurro, Filippo
Bianchi, Giulia
Paris, Ida
Allegrini, Giacomo
Cazzaniga, Marina Elena
Orditura, Michele
Zamagni, Claudio
Tamberi, Stefano
Castelletti, Daniela
Benelli, Matteo
Callari, Maurizio
Santoro, Angela
De Laurentiis, Michelino
[J]. CANCER RESEARCH, 2022, 82 (04)
[4] Bidard F.-C., 2022, CANC RES S4
[5] A CONFIDENCE-INTERVAL FOR THE MEDIAN SURVIVAL-TIME
BROOKMEYER, R
CROWLEY, J
[J]. BIOMETRICS, 1982, 38 (01) : 29 - 41
[6] ClinicalTrials.gov, 2022, AB COMB EMD THER 1 L
[7] Clinicaltrials.gov, 2022, COMB AB END THER HOR
[8] clinicaltrials.gov, PHAS 3 STUD ASS AZD9
[9] A Real-World Evidence Study of CDK4/6 Inhibitor Treatment Patterns and Outcomes in Metastatic Breast Cancer by Germline BRCA Mutation Status
Collins, Jenna M.
Nordstrom, Beth L.
McLaurin, Kimmie K.
Dalvi, Tapashi B.
McCutcheon, Susan C.
Bennett, James C.
Murphy, Brian R.
Singhal, Puneet K.
McCrea, Charles
Shinde, Reshma
Briceno, Josefa M.
[J]. ONCOLOGY AND THERAPY, 2021, 9 (02) : 575 - 589
[10] Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial
Cristofanilli, Massimo
Turner, Nicholas C.
Bondarenko, Igor
Ro, Jungsil
Im, Seock-Ah
Masuda, Norikazu
Colleoni, Marco
DeMichele, Angela
Loi, Sherene
Verma, Sunil
Iwata, Hiroji
Harbeck, Nadia
Zhang, Ke
Theall, Kathy Puyana
Jiang, Yuqiu
Bartlett, Cynthia Huang
Koehler, Maria
Slamon, Dennis
[J]. LANCET ONCOLOGY, 2016, 17 (04) : 425 - 439

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