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.
