3-year invasive disease-free survival (iDFS) of the strategy-based, randomized phase II PHERGain trial evaluating chemotherapy (CT) de-escalation in human epidermal growth factor receptor 2-positive (HER2[+]) early breast cancer (EBC).

被引：11

作者：

Cortes, Javier ^{[1
,2
,3
]}

Perez-Garcia, Jose Manuel ^{[1
,2
]}

Ruiz-Borrego, Manuel ^{[4
]}

Stradella, Agostina ^{[5
]}

Bermejo, Begona ^{[6
,7
]}

Escriva-de-Romani, Santiago ^{[8
]}

Calvo Martinez, Lourdes ^{[9
]}

Ribelles, Nuria ^{[10
]}

Cortes Salgado, Alfonso ^{[11
]}

Albacar, Cinta ^{[12
]}

Colleoni, Marco ^{[13
]}

Gebhart, Geraldine ^{[14
]}

Prat, Aleix ^{[15
]}

Khaldoun, Kerrou ^{[16
,17
,18
]}

Schmid, Peter ^{[19
,20
]}

Di Cosimo, Serena ^{[21
]}

Popa, Crina ^{[2
]}

Alcala-Lopez, Daniel ^{[2
]}

Sampayo-Cordero, Miguel ^{[2
]}

Llombart-Cussac, Antonio ^{[22
]}

机构：

[1] Quiron Grp, Int Breast Canc Ctr IBCC, Pangaea Oncol, Barcelona, Spain

[2] Med Scientia Innovat Res MEDSIR, Barcelona, Spain

[3] Univ Europea Madrid, Fac Biomed & Hlth Sci, Dept Med, Madrid, Spain

[4] Virgen del Ricio Univ Hosp, Barcelona, Spain

[5] Inst Catala Oncol Hosp ICO, Barcelona, Spain

[6] Hosp Clin Univ Valencia, Biomed Res Inst INCL, Med Oncol, Valencia, Spain

[7] Univ Valencia, Med Dept, Oncol Biomed Res Natl Network CIBERONC ISCIII, Madrid, Spain

[8] Vall dHebron Univ Hosp & Vall, Med Oncol, Barcelona, Spain

[9] Complejo Hosp Univ A Coruna, Med Oncol, Breast Canc Unit, La Coruna, Spain

[10] Univ Hosp Virgen de la Victoria, Malaga, Spain

[11] Ramon & Cajal Univ Hosp, Med Oncol Dept, Madrid, Spain

[12] Hosp Univ St Joan de Reus, Reus, Spain

[13] IRCCS, Ist Europeo Oncol, Senol Med, IEO, Milan, Italy

[14] Univ Libre Bruxelles, Hop Univ Bruxelles, Inst Jules Bordet, Serv Med Nucl, Brussels, Belgium

[15] Hosp Clin Barcelona, Barcelona, Spain

[16] Sorbonne Univ, Tenon Hosp IUC UPMC, APHP, Nucl Med, Paris, France

[17] Sorbonne Univ, PET Ctr Dept, Paris, France

[18] INSERM, Canc Biol & Therapeut U938, Paris, France

[19] Queen Mary Univ London, Barts Canc Inst, Barts ECMC, London, England

[20] Barts Hosp NHS Trust, London, England

[21] Fdn IRCCS Ist Nazl Tumori, Dept Adv Diagnost, Milan, Italy

[22] Univ Catolica Valencia, Hosp Arnau de Vilanova, Medica Scientia Innovat Res MEDSIR, Valencia, Spain

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2023年 / 41卷 / 17_SUPPL期

关键词：

613-135-2370-7650-2454-11358; 261-492-199-2823; 261-492-5651-2790; 281-318-6655; 6; 4; 3; 1614; 3600; 2; 38092-22447;

D O I：

10.1200/JCO.2023.41.17_suppl.LBA506

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

LBA506Background: PHERGain is assessing the feasibility of a CT-free treatment based on a dual HER2 blockade with trastuzumab and pertuzumab (HP) in patients (pts) with HER2[+] EBC using a PET-based, pathologic complete response (pCR)-adapted strategy. In an earlier analysis of this study, a total of 227 (79.7%) of 285 pts included in group B were PET-responder (RX), of whom 86 of 227 (37.9%, 95% CI, 31.6 to 44.5; p<0.0001) achieved a pCR, reaching the first primary endpoint (Perez-Garcia JM, Lancet Oncol 2021). Methods: Details of the trial design and study population have been previously reported. Here, we present the results of the second primary endpoint, 3-year iDFS, among pts included in group B who underwent surgery based on an intent-to-treat (ITT) analysis. In brief, group B included centrally-confirmed, stage I-IIIA, HER2[+] EBC pts that were initially treated with HP (<plus/minus> endocrine therapy), introducing CT in pts without PET response after two treatment cycles and/or pCR. The binomial design tested the null hypothesis that the true 3-year iDFS rate was <= 89.0% against the alternative that the 3-year iDFS was >95%. We estimated that enrolling 284 pts in group B would provide 80% power at a nominal level of one-sided alpha of 0.025, assuming a 25% dropout rate. Results: Between June 26, 2017 and April 24, 2019, 356 pts were randomly assigned (71 pts in group A and 285 pts in group B) and 63 (89.0%) and 267 (93.7%) pts proceeded to surgery in groups A and B, respectively. In group B, the 3-year iDFS rate for the ITT population was 95.4% (95% CI, 92.8 to 98), meeting the second primary endpoint (p<0.001). After a median follow-up of 43.3 months (range, 2.4-63.0), a total of 12 iDFS events were reported, including eight distant recurrences (3.0%), three locoregional ipsilateral recurrences (1.1%), and one non-related death (0.4%). Among group B/PET-RX pts with pCR that did not receive CT as part of study treatment (n = 86), only one patient had an invasive event (locoregional ipsilateral recurrence) for a 3-year iDFS rate of 98.8% (95% CI, 96.3 to 100.0). Treatment-related adverse events (AEs) and serious adverse events (SAEs) were higher in pts allocated to group A than to group B (grade <greater than or equal to>3, 61.8% vs. 32.9% [p<0.001]; SAEs, 27.9% vs. 13.8% [p=0.01]). Group B/PET-RX pts with pCR presented the lowest incidence of treatment-related grade <greater than or equal to>3 AEs (1.2%) without any SAEs. No treatment-related deaths were reported. Conclusions: Among HER2[+] EBC pts, a PET-based, pCR-adapted strategy was associated with a substantial 3-year iDFS. These results appear comparable to those reported in several studies for the combination of neoadjuvant CT and dual HER2 blockade. This strategy identifies about a third of HER2[+] EBC pts who may safely omit CT with significantly reduced toxicity. Clinical trial information: NCT5732164.

引用

页码：LBA506 / LBA506

页数：1