The journey of patients affected by metastatic hormone receptor-positive/HER2-negative breast cancer from CDK 4/6 inhibitors to second-line treatment: A real-world analysis of 701 patients enrolled in the GIM14/BIOMETA study

被引：1

作者：

Molinelli, Chiara ^{[1
,2
]}

Bruzzone, Marco ^{[3
]}

Blondeaux, Eva ^{[3
]}

Ruelle, Tommaso ^{[1
,2
]}

Lanzavecchia, Chiara ^{[1
,2
]}

De Laurentiis, Michelino ^{[4
]}

Russo, Stefania ^{[5
]}

Riccardi, Ferdinando ^{[6
]}

Sini, Valentina ^{[7
]}

Cognetti, Francesco ^{[8
]}

Arpino, Grazia ^{[9
]}

Fabi, Alessandra ^{[10
]}

Pugliese, Palma ^{[11
]}

Collova, Elena ^{[12
]}

Fontana, Andrea ^{[13
]}

Puglisi, Fabio ^{[14
,15
,16
]}

Bighin, Claudia ^{[17
]}

Lambertini, Matteo ^{[1
,2
]}

Del Mastro, Lucia ^{[1
,2
]}

机构：

[1] Univ Genoa, Sch Med, Dept Internal Med & Med Specialties DiMI, Genoa, Italy

[2] IRCCS Osped Policlin San Martino, Dept Med Oncol, UOC Clin Oncol Med, Genoa, Italy

[3] IRCCS Osped Policlin San Martino, UO Epidemiol Clin, Genoa, Italy

[4] Ist Nazl Tumori IRCCS Fdn G Pascale, Div Breast Med Oncol, Naples, Italy

[5] ASU FC Univ Hosp, Dept Oncol, Udine, Italy

[6] AORN Cardarelli, UOC Oncol, Naples, Italy

[7] ASL Roma 1, UOSD Ctr Oncol S Spirito & Nuovo Regina Margherit, Rome, Italy

[8] Regina Elena Inst Canc Res, Div Med Oncol 1, Rome, Italy

[9] Univ Naples Federico II, Dept Clin Med & Surg, Naples, Italy

[10] Fdn Policlin Univ A Gemelli IRCCS, Precis Med Unit Senol, Bucharest, Romania

[11] ASST Lariana Osped S Anna, SC Oncol, Como, Italy

[12] ASST Ovest Milanese Legnano, Med Oncol Unit, Milan, Italy

[13] Azienda Osped Univ Pisana, Med Oncol Unit 2, Pisa, Italy

[14] IRCCS, CRO Aviano, Natl Canc Inst, Dept Med Oncol, Aviano, Pn, Italy

[15] Univ Udine, Dept Med, Udine, Italy

[16] IRCCS, Natl Canc Inst, CRO Aviano, Aviano, Pn, Italy

[17] IRCCS Osped Policlin San Martino, Med Oncol Dept 2, Genoa, Italy

来源：

EUROPEAN JOURNAL OF CANCER | 2024年 / 213卷

关键词：

CDK; 4/6; inhibitors; Metastatic breast cancer; Luminal breast cancer; HER2-low; Second-line treatment; PLUS FULVESTRANT; SURVIVAL; GUIDELINES; EFFICACY; TRIAL;

D O I：

10.1016/j.ejca.2024.115113

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose: The aim of this study was to evaluate the effectiveness of CDK 4/6 inhibitors (CDK 4-6i) according to HER2 status (low/zero), and endocrine resistance/sensitivity, as well as the efficacy of second-line treatments, in a large real-world cohort. Methods: The GIM14/BIOMETA study (NCT02284581) is a retrospective/prospective study of the Gruppo Italiano Mammella evaluating treatment patterns and survival outcomes in patients with metastatic breast cancer (MBC). We retrieved data on patients with hormone receptor-positive/HER2-negative MBC receiving first-line CDK 4/6i. Results: Among 3832 patients enrolled in the GIM14-BIOMETA study, 701 were eligible. At a median follow-up of 24.80 months, no significant differences were found between HER2-zero and HER2-low subgroups in terms of first-line time to treatment discontinuation (TTD) (26.16 months [IQR 12.84-NR] vs. 27.60 months [IQR 12.12-64.44], p = 0.972) or overall survival (OS) (mOS>60 months for both groups, p = 0.398). Median TTD was 33.24 months (IQR 16.32-NR) for the endocrine sensitive subgroup, 19.92 months (IQR 8.88-51.24) for the secondary endocrine resistant subgroup and 17.40 months (IQR 7.44-24.72) for the primary endocrine resistant subset, respectively (p < 0.001). Among 239 patients receiving second-line treatment, no significant difference (p = 0.188) was found in terms of second-line TTD between those treated with capecitabine (6.11 months, IQR 2.96-11.47), taxane-based chemotherapy (5.06 months, IQR 2.99-9.99), everolimus plus exemestane (5.39 months, IQR 2.53-9.03) or fulvestrant (6.44 months, IQR 3.38-NR). Conclusions: Endocrine therapy plus CDK 4/6i represents an effective treatment, regardless of HER2 status (low/zero). Second-line agents did not differ significantly in terms of TTD. Endocrine resistant cancers exhibit poor response to CDK 4/6i.

引用

页数：9

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