Santiago González-Santiago1, Cristina Saura2,3, Eva Ciruelos4,5,3, José Luis Alonso6, Pilar de la Morena7, Marta Santisteban Eslava8, Maria Isabel Gallegos Sancho9,10, Alicia de Luna11, Elsa Dalmau12, Sonia Servitja13, Manuel Ruiz Borrego14, José Ignacio Chacón15. 1. Servicio de Oncología Médica, Hospital Universitario San Pedro de Alcántara, Avda. Pablo Naranjo, s/n, 10003, Cáceres, Spain. santigsanti@gmail.com. 2. Hospital Universitario Vall d'Hebron, Vall d'Hebrón Instituto de Oncologia (VHIO), Barcelona, Spain. 3. SOLTI Breast Cancer Research Cooperative Group, Barcelona, Spain. 4. Hospital Universitario 12 de Octubre, Madrid, Spain. 5. HM CIOCC (for its acronym in Spanish: Centro Integral Oncológico Clara Campal), Madrid, Spain. 6. Hospital Clínico Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Murcia, Spain. 7. Hospital General Universitario J.M. Morales Meseguer, Murcia, Spain. 8. Clínica Universidad de Navarra, Pamplona, Spain. 9. Hospital General de Segovia, Segovia, Spain. 10. MD Anderson Cancer Center, Madrid, Spain. 11. Hospital Clínico San Carlos, Madrid, Spain. 12. ParcTaulí Hospital Universitari, Sabadell, Barcelona, Spain. 13. Hospital del Mar, Barcelona, Spain. 14. Hospital Universitario Virgen del Rocío, Sevilla, Spain. 15. Hospital Virgen de la Salud, Toledo, Spain.
Abstract
PURPOSE: Neoadjuvant clinical trials with dual HER2 blockade with pertuzumab and trastuzumab plus chemotherapy demonstrated high rates of pathological complete response (pCR) in HER2-positive early breast cancer (BC). We investigated whether the benefit on pCR seen in clinical trials is confirmed in a real-world setting. METHODS: Multicenter, retrospective study in patients with HER2-positive early BC receiving neoadjuvant treatment with pertuzumab and trastuzumab in routine clinical practice (n = 243). The primary endpoint was total pCR (tpCR) (ypT0/is ypN0). RESULTS: A total of 243 evaluable patients were included. Pertuzumab and trastuzumab were combined with anthracyclines and taxanes in 74.1% of patients, with single-agent taxane in 11.1% of patients and with platinum-based chemotherapy (CT) in 14.4% of patients. The tpCR rate was 66.4%:71% with anthracyclines and taxanes, 59.3% with single-agent taxane, and 48.6% with platinum-based combinations. The tpCR rate was higher among patients with hormone receptor (HR)-negative tumors (80.9%) vs HR-positive tumors (55.4%) (p < 0.001). A pCR in the breast (ypT0/is) was achieved in 67.6% of patients. Of 143 patients who showed radiological complete response (rCR) (62%), 112 (78.3%) patients also achieved tpCR. Assessment of rCR by magnetic resonance imaging (MRI) showed the highest negative predictive value (NPV) for predicting tpCR (83.5%). Breast-conserving surgery was performed in 58.7% of patients. Grade 3 and grade 4 toxicities were reported in 33 (18.2%) and 12 (6.6%) patients, respectively. No toxicity leading to death was reported. CONCLUSIONS: This real-world analysis shows that neoadjuvant pertuzumab, trastuzumab, and chemotherapy achieve comparable or even higher rates of tpCR than those seen in clinical trials. The pCR benefit is higher in HR-negative tumors. The assessment of rCR by MRI showed the highest ability for predicting pCR. In addition, this neoadjuvant strategy confers an acceptable safety profile.
PURPOSE: Neoadjuvant clinical trials with dual HER2 blockade with pertuzumab and trastuzumab plus chemotherapy demonstrated high rates of pathological complete response (pCR) in HER2-positive early breast cancer (BC). We investigated whether the benefit on pCR seen in clinical trials is confirmed in a real-world setting. METHODS: Multicenter, retrospective study in patients with HER2-positive early BC receiving neoadjuvant treatment with pertuzumab and trastuzumab in routine clinical practice (n = 243). The primary endpoint was total pCR (tpCR) (ypT0/is ypN0). RESULTS: A total of 243 evaluable patients were included. Pertuzumab and trastuzumab were combined with anthracyclines and taxanes in 74.1% of patients, with single-agent taxane in 11.1% of patients and with platinum-based chemotherapy (CT) in 14.4% of patients. The tpCR rate was 66.4%:71% with anthracyclines and taxanes, 59.3% with single-agent taxane, and 48.6% with platinum-based combinations. The tpCR rate was higher among patients with hormone receptor (HR)-negative tumors (80.9%) vs HR-positive tumors (55.4%) (p < 0.001). A pCR in the breast (ypT0/is) was achieved in 67.6% of patients. Of 143 patients who showed radiological complete response (rCR) (62%), 112 (78.3%) patients also achieved tpCR. Assessment of rCR by magnetic resonance imaging (MRI) showed the highest negative predictive value (NPV) for predicting tpCR (83.5%). Breast-conserving surgery was performed in 58.7% of patients. Grade 3 and grade 4 toxicities were reported in 33 (18.2%) and 12 (6.6%) patients, respectively. No toxicity leading to death was reported. CONCLUSIONS: This real-world analysis shows that neoadjuvant pertuzumab, trastuzumab, and chemotherapy achieve comparable or even higher rates of tpCR than those seen in clinical trials. The pCR benefit is higher in HR-negative tumors. The assessment of rCR by MRI showed the highest ability for predicting pCR. In addition, this neoadjuvant strategy confers an acceptable safety profile.
Entities:
Keywords:
Breast cancer; Early stage; Epidermal growth factor receptor (HER2); Pathological complete response (pCR); Pertuzumab; Trastuzumab
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