A multicenter REtrospective observational study of first-line treatment with PERtuzumab, trastuzumab and taxanes for advanced HER2 positive breast cancer patients. RePer Study

被引：31

作者：

Gamucci, Teresa ^{[1
,2
]}

Pizzuti, Laura ^{[3
]}

Natoli, Clara ^{[4
]}

Mentuccia, Lucia ^{[1
]}

Sperduti, Isabella ^{[5
]}

Barba, Maddalena ^{[3
,6
]}

Sergi, Domenico ^{[3
]}

Iezzi, Laura ^{[4
]}

Maugeri-Sacca, Marcello ^{[3
,6
]}

Vaccaro, Angela ^{[1
]}

Magnolfi, Emanuela ^{[1
]}

Gelibter, Alain ^{[7
]}

Barchiesi, Giacomo ^{[7
]}

Magri, Valentina ^{[7
]}

D'Onofrio, Loretta ^{[8
]}

Cassano, Alessandra ^{[9
]}

Rossi, Ernesto ^{[9
]}

Botticelli, Andrea ^{[10
]}

Moscetti, Luca ^{[11
]}

Omarini, Claudia ^{[11
]}

Fabbri, Maria Agnese ^{[12
]}

Scinto, Angelo Fedele ^{[13
]}

Corsi, Domenico ^{[13
]}

Carbognin, Luisa ^{[14
]}

Mazzotta, Marco ^{[10
]}

Bria, Emilio ^{[14
]}

Foglietta, Jennifer ^{[15
]}

Samaritani, Riccardo ^{[16
]}

Garufi, Carlo ^{[17
]}

Mariani, Luciano ^{[18
]}

Barni, Sandro ^{[19
]}

Mirabelli, Rosanna ^{[20
]}

Sarmiento, Roberta ^{[21
]}

Graziano, Vincenzo ^{[22
,23
]}

Santini, Daniele ^{[8
]}

Marchetti, Paolo ^{[10
]}

Tonini, Giuseppe ^{[8
]}

Di Lauro, Luigi ^{[3
]}

Sanguineti, Giuseppe ^{[24
]}

Paoletti, Giancarlo ^{[3
]}

Tomao, Silverio ^{[7
]}

De Maria, Ruggero ^{[25
]}

Veltri, Enzo ^{[26
]}

Paris, Ida ^{[27
]}

Giotta, Francesco ^{[28
]}

Latorre, Agnese ^{[28
]}

Giordano, Antonio ^{[29
]}

Ciliberto, Gennaro ^{[6
]}

Vici, Patrizia ^{[3
]}

机构：

[1] ASL Frosinone, Med Oncol Unit, Frosinone, Italy

[2] Sandro Pertini Hosp, Med Oncol, Rome, Italy

[3] IRCCS Regina Elena Natl Canc Inst, Div Med Oncol 2, Via Elio Chianesi 53, I-00144 Rome, Italy

[4] Ctr Sci Invecchiamento & Med Traslaz CeSI MeT, Dept Med Oral & Biotechnol Sci, Chieti, Italy

[5] IRCCS Regina Elena Natl Canc Inst, Biostat Unit, Via Elio Chianesi 53, I-00144 Rome, Italy

[6] IRCCS Regina Elena Natl Canc Inst, Sci Direct, Rome, Italy

[7] Policlin Umberto 1, Med Oncol Unit, Rome, Italy

[8] Univ Campus Biomed Rome, Dept Oncol, Rome, Italy

[9] Policlin Univ A Gemelli, Dept Med Oncol, Rome, Italy

[10] Sapienza Univ Rome, Azienda Osped St Andrea, Dept Clin & Mol Med, Rome, Italy

[11] Univ Hosp Modena, Dept Hematol & Oncol, Div Med Oncol, Modena, Italy

[12] Belcolle Hosp, Med Oncol Unit, Viterbo, Italy

[13] San Pietro Fatebenefratelli Hosp, Med Oncol Unit, Rome, Italy

[14] Univ Verona, Azienda Osped Univ Integrata, UOC Oncol, Verona, Italy

[15] Univ Perugia, Santa Maria della Misericordia Hosp, Dept Med Oncol, Perugia, Italy

[16] Regina Margherita Hosp, Med Oncol Unit, Rome, Italy

[17] Osped Pescara, Div Med Oncol, Pescara, Italy

[18] IRCCS Regina Elena Natl Canc Inst, Dept Gynaecol Oncol, HPV Unit, Rome, Italy

[19] ASST Bergamo Ovest, Oncol Unit, Dept Oncol, Treviglio, Italy

[20] Azienda Osped Pugliese Ciaccio, Dept Hematol & Oncol, Catanzaro, Italy

[21] San Filippo Neri Hosp, Oncol Unit, Rome, Italy

[22] SS Annunziata Hosp, Med Oncol Unit, Chieti, Italy

[23] G Bernabeo Hosp, Breast Med Oncol Unit, Ortona, Italy

[24] IRCCS Regina Elena Natl Canc Inst, Dept Radiat Oncol, Rome, Italy

[25] Univ Cattolica Sacro Cuore, Inst Gen Pathol, Rome, Italy

[26] S Maria Goretti Hosp, Oncol Unit, Latina, Italy

[27] Univ Cattolica Sacro Cuore, Gynecol Oncol Unit, Rome, Italy

[28] Giovanni Paolo II Inst, Dept Med Oncol, Bari, Italy

[29] Temple Univ, Coll Sci & Technol, Sbarro Inst Canc Res & Mol Med, Ctr Biotechnol, Philadelphia, PA 19122 USA

来源：

CANCER BIOLOGY & THERAPY | 2019年 / 20卷 / 02期

关键词：

metastatic breast cancer; pertuzumab; trastuzumab; maintenance; HER2; first-line treatment; endocrine therapy; PHASE-II TRIAL; DOCETAXEL; CHEMOTHERAPY; SURVIVAL; EFFICACY; PLUS; PACLITAXEL; CLEOPATRA; THERAPY; SAFETY;

D O I：

10.1080/15384047.2018.1523095

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

We carried out a retrospective observational study of 264 HER2-positive advanced breast cancer (ABC) patients to explore the efficacy of first-line treatment with pertuzumab/trastuzumab/taxane in real-world setting. Survival data were analyzed by Kaplan Meier curves and log rank test. Median follow-up, length of pertuzumab/trastuzumab/taxane treatment and of pertuzumab, trastuzumab maintenance were 21, 4 and 15 months, respectively. The response rate was 77.3%, and the clinical benefit rate 93.6%. Median progression-free survival (mPFS) was 21 months, and median overall survival (mOS) was not reached. When comparing patients by trastuzumab-pretreatment, similar PFS were observed, although a longer OS was reached in trastuzumab-naive patients (p = 0.02). Brain metastases at baseline and their development in course of therapy were associated with significantly shorter PFS (p = 0.0006) and shorter OS, although at a not fully statistically relevant extent (p = 0.06). The addition of maintenance endocrine therapy (ET) to pertuzumab/trastuzumab maintenance was associated with longer PFS (p = 0.0001), although no significant differences were detected in OS (p = 0.31). Results were confirmed by propensity score analysis (p = 0.003 and p = 0.46, respectively). In multivariate models, longer PFS was related to lower Performance Status (PS) (p = 0.07), metastatic stage at diagnosis (p = 0.006) and single metastatic site (p < 0.0001). An OS advantage was observed with lower PS (p < 0.0001), single metastatic site (p = 0.004), no prior exposure to trastuzumab (p = 0.004) and response to pertuzumab-based treatment (p = 0.003). Our results confirm that trastuzumab/pertuzumab/taxane is the standard of care as first-line treatment of patients with HER2-positive ABC even in the real-world setting. Moreover, the double-maintenance therapy (HER2 block and ET) is strongly recommended when feasible.

引用

页码：192 / 200

页数：9

共 28 条

[1] Phase III Randomized Study Comparing Docetaxel Plus Trastuzumab With Vinorelbine Plus Trastuzumab As First-Line Therapy of Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: The HERNATA Study [J].

Andersson, Michael ;

Lidbrink, Elisabeth ;

Bjerre, Karsten ;

Wist, Erik ;

Enevoldsen, Kristin ;

Jensen, Anders B. ;

Karlsson, Per ;

Tange, Ulla B. ;

Sorensen, Peter G. ;

Moller, Susanne ;

Bergh, Jonas ;

Langkjer, Sven T. .

JOURNAL OF CLINICAL ONCOLOGY, 2011, 29 (03) :264-271

[2]

ARPINO G, 2016, 2016 SAN ANT BREAST

[3] Pertuzumab plus Trastuzumab plus Docetaxel for Metastatic Breast Cancer [J].

Baselga, Jose ;

Cortes, Javier ;

Kim, Sung-Bae ;

Im, Seock-Ah ;

Hegg, Roberto ;

Im, Young-Hyuck ;

Roman, Laslo ;

Pedrini, Jose Luiz ;

Pienkowski, Tadeusz ;

Knott, Adam ;

Clark, Emma ;

Benyunes, Mark C. ;

Ross, Graham ;

Swain, Sandra M. .

NEW ENGLAND JOURNAL OF MEDICINE, 2012, 366 (02) :109-119

[4] Phase II Trial of Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer That Progressed During Prior Trastuzumab Therapy [J].

Baselga, Jose ;

Gelmon, Karen A. ;

Verma, Shailendra ;

Wardley, Andrew ;

Conte, PierFranco ;

Miles, David ;

Bianchi, Giulia ;

Cortes, Javier ;

McNally, Virginia A. ;

Ross, Graham A. ;

Fumoleau, Pierre ;

Gianni, Luca .

JOURNAL OF CLINICAL ONCOLOGY, 2010, 28 (07) :1138-1144

[5] Risk of Heart Failure in Breast Cancer Patients After Anthracycline and Trastuzumab Treatment: A Retrospective Cohort Study [J].

Bowles, Erin J. Aiello ;

Wellman, Robert ;

Feigelson, Heather Spencer ;

Onitilo, Adedayo A. ;

Freedman, Andrew N. ;

Delate, Thomas ;

Allen, Larry A. ;

Nekhlyudov, Larissa ;

Goddard, Katrina A. B. ;

Davis, Robert L. ;

Habel, Laurel A. ;

Yood, Marianne Ulcickas ;

McCarty, Catherine ;

Magid, David J. ;

Wagner, Edward H. .

JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2012, 104 (17) :1293-1305

[6] Trastuzumab plus vinorelbine or taxane chemotherapy for HER2-overexpressing metastatic breast cancer: The trastuzumab and vinorelbine or taxane study [J].

Burstein, Harold J. ;

Keshaviah, Aparna ;

Baron, Ari D. ;

Hart, Ronald D. ;

Lambert-Falls, Rosemary ;

Marcom, P. Kelly ;

Gelman, Rebecca ;

Winer, Eric P. .

CANCER, 2007, 110 (05) :965-972

[7]

D'Agostino RB, 1998, STAT MED, V17, P2265, DOI 10.1002/(SICI)1097-0258(19981015)17:19<2265::AID-SIM918>3.0.CO

[8]

2-B

[9] Human epidermal growth factor receptor 2 dual blockade with trastuzumab and pertuzumab in real life: Italian clinical practice versus the CLEOPATRA trial results [J].

De Placido, Sabino ;

Giuliano, Mario ;

Schettini, Francesco ;

Von Arx, Claudia ;

Buono, Giuseppe ;

Riccardi, Ferdinando ;

Cianniello, Daniela ;

Caputo, Roberta ;

Puglisi, Fabio ;

Bonotto, Marta ;

Fabi, Alessandra ;

Bilancia, Domenico ;

Ciccarese, Mariangela ;

Lorusso, Vito ;

Michelotti, Andrea ;

Bruzzese, Dario ;

Veneziani, Bianca Maria ;

Locci, Mariavittoria ;

De laurentiis, Michelino ;

Arpino, Grazia .

BREAST, 2018, 38 :86-91

[10] Paclitaxel and gemcitabine, as first-line chemotherapy, combined with trastuzumab in patients with advanced breast cancer: A phase II study conducted by the Hellenic Cooperative Oncology Group (HeCOG) [J].

Fountzilas, G ;

Christodoulou, C ;

Tsavdaridis, D ;

Kalogera-Fountzila, A ;

Aravantinos, G ;

Razis, E ;

Kalofonos, HP ;

Papakostas, P ;

Karina, M ;

Gogas, H ;

Skarlos, D .

CANCER INVESTIGATION, 2004, 22 (05) :655-662

← 1 2 3 →