HER2-targeted therapies have dramatically improved outcomes of patients with HER2-positive breast cancer (BC), as demonstrated in neoadjuvant trials. This study aims to provide real-world evidence on the use and effectiveness of combined pertuzumab, trastuzumab and chemotherapy (CT) in early-stage HER2-positive BC.
Abstract Background: Pertuzumab (P) has been aproved in neoadjuvant setting for HER2 positive early breasta cancer patients in association with Trastuzumab (T) and chemotherapy. Diverse studies support this combination as NeoSphere, Tryphaena, GeparSepto or Berenice trial. Some of these studies combine P - T with taxanes and sequencing anthracyclines, and other use antraciclines-free regimen as Carboplatine-Docetaxel-P-T. The patologic complete response (pCR) showed achieve percentages from 45.8 % to 66.6% depending on chemotherapy combination. In Spain, the approval of new drugs is a national issue, but sometimes regional regulatory agencies could modify some indications. We have carry out this study in routine patients as our daily clinical practice. Aims: This is a retrospective and multicentric study that has investigated the clinical characteristics, treatment patterns, safety and clinical outcomes for patient with HER-2 positive early breast cancer patients. Methods: We have collected all HER2 positive early breast cancer patients treated with P in neoadjuvant setting in our hospitals. The effect of adding Pertuzumab on pCR was analyzed, as well as other predictive factors of response using logistic regression analyses. Results: A total of 298 patients met the selection criteria. The median age was 50 years (range 24-88 years), 54,2% were premenopausic. 4 patients were stage I, 194 patients stage II, 95 patients were stage III and one patient was stage IV. 76,3% of the patient had a ki67 >20%. The majority of the patient received anthracyclines and taxanes with P and T regimen (80,7%), 13,2% received carboplatin-docetaxel-P-T combination and only 6,1% received taxane-P-T. 292 patients were analysed for response. pCR was seen in 61,7 % of the patients, dividing by hormonal receptor (HR) status, pCR was 53,29% in HR-positive and 72,14% in HR-negative. 63,4% of the patients received breast conservative surgery. Grade 3-4 chemo-related toxicity was presented in 14,2% of patients, 3 patients presented cardiac toxicity. Different treatments patterns were seen between hospitals: only 15 patients (5,1%) complete adjuvant Pertuzumab, 4 patients (1,4%) received adjuvant Neratinib and 2 patients (0,7%) received adjuvant TDM1. Only 12 patients (4,1%) has presented a distant recurrence, 6 of them (50%) had achieved a previous pCR. Conclusion: In our knowledge, this is the biggest real-world-data presented until this year, for Pertuzumab in the neoadjuvant setting of HER2 positive breast cancer patients. Our results are consistent with those published in previous clinical trial. pCR by subtypepCR NOpCR YESTotalLuminal B HER2+7181152HER2+39101140Total110182292 Citation Format: Alejandro Falcón González, Rocío Álvarez Ambite, Elisenda Llabrés Valenti, Rocío Urbano Cubero, Maria del Carmen Álamo de la Gala, Antonia Martínez Guisado, Carlos José Rodríguez González, Marta Amérigo Góngora, Encarnación González Flores, Salvador Gámez Casado, María Valero Arbizu, Alicia Quilez Cutillas, Josefina Cruz Jurado, Pedro Sánchez Rovira, Fernando Henao Carrasco, Javier Salvador Bofill, Manuel Ruiz Borrego. Neopersur: Neoadjuvant pertuzumab in a real world data population in the south of Spain [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-18-29.
Abstract Background: Pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) has been reported as a surrogate endpoint for prediction of disease-free survival (DFS) and overall survival (OS) particularly in HER2-positive and triple-negative (TN) breast cancer. NAC requires imaging techniques to accurately predict pathological response and subsequently surgical planning. Magnetic resonance imaging (MRI) has been the most sensitive technique to assess response to NAC, although it is expensive and time consuming. In our hospital we use Contrast-enhanced mammography (CEM) that is easy to perform, fast, reproducible and its signs are superimposable to the MRI, with the advantages of lower cost. It allows diagnosing multifocal, multicenter and bilateral involvement, and monitoring the response to treatment with NAC.Aims: Analyze the correlation between complete radiological response (rRC) with CEM and pCR in patients treated with NAC. Analyze this correlation based on the different immunophenotypes (IF)Methods: Retrospective analysis of 112 patients with stage II-III breast cancer treated with NAC, from January 2018 to April 2020, in the Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria, with CEM performed before and after NAC. pCR categorization using the Miller and Payne system, defined pCR as a non-invasive tumor in the breast and axilla (ypT0/is N0).Results: Of 112 analyzed patients, 8 did not undergo surgery (6 patients with T4d tumors received radical radiotherapy, 1 progressed during NAC and 1 did not undergo surgery for liver failure). Median age 53 years (range 31-89). Stages: IIA 26%, IIB 47%, IIIA 16%, IIIB 10%, IIIC 1%. IF: Luminal A: 11%, Luminal B Her2-: 33%, Luminal B Her2 +: 23%, pure HER2: 21%, TN: 12%. NAC received: doxorubicin-cyclophosphamide (AC)-weekly paclitaxel 53%, Taxanes + pertuzumab + trastuzumab (PT) 39%, AC-paclitaxel + PT 4%, other 4%. 99 patients obtained radiological response: 60 (54%) rRC and 39 (35%) partial response. In 14 patients (12%) there was no response. 36% pCR (N = 37). The sensitivity (S) and specificity (E) of CEM for the evaluation of pCR were 67% and 95% respectively. S was 100% in pure HER2 and 78% in TN. The positive and negative predictive values (PPV and NPV) were 96% and 61% respectively. After a median follow-up of 19 months, 6 patients have relapsed and 2 have died.Conclusion: CSEM has an S and E to detect pCR after NAC of 67 and 95% respectively; rates higher than those offered in other series by the MRI. S and E are higher in pure HER2 and TN tumors. Citation Format: Elisenda Llabrés Valentí, Jose Carlos Antela López, Mónica Cejuela Solís, Alfonso Gómez de Liaño, Victor Vega Benítez, Marta Pavcovich, Concepción Jimenez Medina, Joel Joselito Aranda Sánchez, Isabel Reyes Rodriguez, Manuel Cazorla Betancor, Maria Eugenia Galan Garcia, Ana Alicia Tejera Hernández, Pedro Pérez Correa, Paula Junquera Rionda, Avinash Ramchandani Vaswani, Elena Vicente Rubio. Correlation of pathological complete response and radiological response with Contrast-enhanced mammography in breast cancer patients after neoadjuvant chemotherapy [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS3-11.
Pertuzumab (P) has been approved in neoadjuvant setting for HER2-positive early breast cancer patients (pts) in association with Trastuzumab (T) and chemotherapy. Diverse studies support this treatment. The pathologic complete response (pCR) showed achieve percentages from 45.8 % to 66.6% depending on chemotherapy combination. This is a retrospective and multicentric study. We have collected all HER2-positive early breast cancer pts treated with P in neoadjuvant setting in our hospitals between 2015 and 2018. The effect of adding P on pCR was analyzed, as well as other predictive factors of response using logistic regression analyses. Kaplan Meier analysis has been used for survival analysis. A total of 310 pts met the selection criteria. The median age was 51 years (22-88 years), 54,5% were premenopausal. 4 pts were stage I, 204 pts stage II, 101 pts were stage III. The majority of the patient received anthracyclines and taxanes with P and T regimen (77,1%), 16,5% received carboplatin-docetaxel-P-T combination and 6,5% received taxane-P-T. 307 pts were analysed for response. pCR was seen in 62,2 % of the pts, dividing by hormonal receptor (HR) status, pCR was 53,8% in HR-positive and 71,1% in HR-negative. Treatment was well tolerated with only 14.8 % G3-4 adverse events related to chemotherapy and 1.9% related to antiHER2 therapy. Different adjuvant treatments patterns were seen between hospitals. After a follow-up of 7,5 years, 43 pts (13,9%) had a distant relapse, 16 of them (37,2%) had achieved a previous pCR. 38,5% had CNS recurrence and 61,5% non-CNS recurrence. In multivariate analysis non-pCR pts have 3.9 relative risk of experience disease relapse event (p 0.0001; 1.84-8.88), and patients with stage III at diagnosis have 4.3 relative risk (p 0.00004; 2.15-8.75). Disease free-survival (DFS) rates at 7.5 years is 86.4 %. After separating between pCR outcomes, results were statistical significative (p < 0.0001) with DFS rates of 89.4% in pCR pts and 70.6% in non-pCR pts. In our knowledge, this is the first real-world study that shows survival results for adding Pertuzumab in the neoadjuvant setting of HER2-positive breast cancer patients. Our results are consistent with those previously published.