PONDx: real-life utilization and decision impact of the 21-gene assay on clinical practice in Italy

被引:22
作者
Cognetti, Francesco [1 ]
Masetti, Riccardo [2 ]
Fabi, Alessandra [3 ]
Bianchi, Giulia [4 ]
Santini, Donatella [5 ]
Rognone, Alessia [6 ]
Catania, Giovanna [3 ]
Angelucci, Domenico [7 ]
Naso, Giuseppe [8 ]
Giuliano, Mario [9 ]
Vassalli, Lucia [10 ]
Vici, Patrizia [11 ]
Scognamiglio, Giovanni [12 ]
Generali, Daniele [13 ]
Zambelli, Alberto [14 ]
Colleoni, Marco [15 ]
Tinterri, Corrado [16 ]
Scanzi, Francesco [17 ]
Vigna, Leonardo [18 ]
Scavina, Paola [19 ]
Gamucci, Teresa [20 ]
Marrazzo, Emilia [21 ]
Scinto, Angelo Fedele [22 ]
Berardi, Rossana [23 ]
Fabbri, Maria Agnese [24 ]
Pinotti, Graziella [25 ,26 ]
Franco, Daniela [27 ]
Terribile, Daniela Andreina [2 ]
Tonini, Giuseppe [28 ]
Cianniello, Daniela [29 ]
Barni, Sandro [30 ]
机构
[1] Univ Roma La Sapienza, Dipartimento Med Clin & Mol, Rome, Italy
[2] IRCCS, Policlin Univ Agostino Gemelli, Rome, Italy
[3] IRCCS Regina Elena Natl Canc Inst, Rome, Italy
[4] Fdn IRCCS Ist Nazl Tumori, Milan, Italy
[5] Policlin St Orsola Malpighi, Bologna, Italy
[6] Osped San Raffaele, Milan, Italy
[7] Osped Gaetano Bernabeo, Ortona, Italy
[8] Policlin Umberto 1, Rome, Italy
[9] Azienda Osped Univ Federico II, Naples, Italy
[10] ASST Spedali Civili, Brescia, Italy
[11] RCCS Regina Elena Natl Canc Inst, Rome, Italy
[12] Osped Valduce, Como, Italy
[13] ASST Cremona, Cremona, Italy
[14] ASST Papa Giovanni XXIII, Bergamo, Italy
[15] Ist Europeo Oncol, Milan, Italy
[16] Ist Clin Humanitas, Rozzano, Italy
[17] IRCCS Multimed, Sesto San Giovanni, Italy
[18] Azienda Osped San Camillo Forlanini, Rome, Italy
[19] Azienda Osped San Giovanni Addolorata, Rome, Italy
[20] Osped SS Trinita, Sora, Italy
[21] Ist Clin Humanitas, Rozzano, Italy
[22] Osped San Giovani Calibita Fatebenefratelli, Rome, Italy
[23] Azienda Osped Univ Osped Riuniti Ancona, Torrette, Italy
[24] Osped Belcolle, Viterbo, Italy
[25] Osped Circolo Varese, Varese, Italy
[26] Fdn Macchi, Varese, Italy
[27] Osped Nuovo Regina Margherita, Rome, Italy
[28] Policlin Univ Campus Biomed, Rome, Italy
[29] Ist Nazl Tumori Fdn G Pascale, Naples, Italy
[30] ASST BG Ovest Osped Treviglio, Treviglio, BG, Italy
关键词
RECURRENCE SCORE ASSAY; BREAST-CANCER; PROSPECTIVE MULTICENTER; INTERNATIONAL KI67; ONCOTYPE DX; EXPRESSION; WOMEN; RECOMMENDATIONS; CHEMOTHERAPY; THERAPY;
D O I
10.1038/s41523-021-00246-4
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Clinicopathological prognostic features have limited value to identify with precision newly diagnosed patients with hormone receptor (HR)-positive, HER2-negative breast cancer (BC), who would benefit from chemotherapy (CT) in addition to adjuvant hormonal therapy (HT). The 21-gene Oncotype DX Breast Recurrence Score (RS) assay has been demonstrated to predict CT benefit, hence supporting personalized decisions on adjuvant CT. The multicenter, prospective, observational study PONDx investigated the real-life use of RS (R) results in Italy and its impact on treatment decisions. Physicians' treatment recommendations (HT +/- CT) were documented before and after availability of RS results, and changes in recommendations were determined. In the HR+ HER2- early BC population studied (N= 1738), physicians recommended CT + HT in 49% of patients pre-RS. RS-guided treatment decisions resulted in 36% reduction of CT recommendations. PONDx confirms that RS results provide clinically relevant information for CT recommendation in early-stage BC, resulting in a reduction of more than a third of CT use.
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页数:8
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