Τίτλος:
Efficacy and Safety of Neoadjuvant Treatment with Bevacizumab, Liposomal Doxorubicin, Cyclophosphamide and Paclitaxel Combination in Locally/Regionally Advanced, HER2-Negative, Grade III at Premenopausal Status Breast Cancer: A Phase II Study
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Background: In the era of personalized therapy, targeted treatment in specific patient populations is mandated. Objective: We evaluated the efficacy and safety of neoadjuvant treatment on locally advanced breast cancer (LABC) with a monoclonal agent against vascular endothelial growth factor (VEGF), bevacizumab plus chemotherapy combination of liposomal doxorubicin, cyclophosphamide and paclitaxel (PLAC-B). Methods: Patients enrolled were at premenopausal status and characterized by human epidermal growth factor receptor 2 (HER2)-negative, hormone-receptor positive (estrogen receptor/progesterone receptor-positive [ER/PR+]) or triple-negative (TNBC), LABC (T > 3 cm), with high-grade ductal carcinoma. Patients had to have a measurable disease and Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, with adequate hematologic, renal, and hepatic function. Patients received intravenous liposomal doxorubicin 30 mg/m 2 , cyclophosphamide 600 mg/m 2 , paclitaxel 120 mg/m 2 , and bevacizumab 8 mg/kg on day 1 of 15-day cycles for four cycles (four administrations as neoadjuvant treatment). The primary endpoint was complete clinical (cCR) and pathologic (pCR) response rates, while secondary endpoints included safety, breast-conserving surgery (BCS) conversion rate, and disease-free survival (DFS). Results: Sixty-two women were enrolled; 20 were ER/PR+ and 42 had TNBC. All underwent surgery, six received mastectomy, and 56 (90.3%) received BCS, with an equal conversion rate from initial indication for mastectomy. cCR was 25.8%. pCR in the breast and axilla occurred in 24 patients (38.7%). pCR was 42.9% for TNBC and 30% for ER/PR+. Hematologic adverse events (AEs) included neutropenia (74.2% total; 22.6% grade 3 [G3]) and febrile neutropenia (6.5% G3); non-hematologic G3 AEs included nausea (6.5%), mucositis (9.7%), and infection (3.2%), all of which were managed without negative sequelae. Over a 3-year follow-up, all patients were alive and DFS was 87.1%. Conclusion: PLAC-B as neoadjuvant treatment of this subpopulation with TNBC and ER/PR+ patients is effective and safe. Further studies are necessitated. © 2018, Springer International Publishing AG, part of Springer Nature.
Συγγραφείς:
Tampaki, E.C.
Tampakis, A.
Alifieris, C.E.
Krikelis, D.
Pazaiti, A.
Kontos, M.
Trafalis, D.T.
Περιοδικό:
Clinical Drug Investigation
Εκδότης:
Springer International Publishing
Λέξεις-κλειδιά:
bevacizumab; cyclophosphamide; doxorubicin; paclitaxel; antineoplastic agent; bevacizumab; cyclophosphamide; doxorubicin; epidermal growth factor receptor 2; ERBB2 protein, human; macrogol; paclitaxel, adult; advanced cancer; alopecia; anemia; anorexia; Article; bleeding; cancer combination chemotherapy; cancer grading; cancer patient; cancer surgery; constipation; deep vein thrombosis; diarrhea; drug efficacy; drug safety; dyspnea; edema; estrogen receptor positive breast cancer; fatigue; febrile neutropenia; female; hand foot and mouth disease; headache; human; hypertension; infection; major clinical study; mucosa inflammation; multiple cycle treatment; nausea; neoadjuvant chemotherapy; neurotoxicity; neutropenia; oral mucositis; pain; partial mastectomy; patient compliance; phase 2 clinical trial; premenopause; priority journal; progesterone receptor positive breast cancer; proteinuria; skin discoloration; thrombocytopenia; treatment response; triple negative breast cancer; urinary tract infection; vomiting; analogs and derivatives; breast tumor; clinical trial; diagnostic imaging; drug effect; middle aged; neoadjuvant therapy; premenopause; procedures; treatment outcome, Adult; Antineoplastic Combined Chemotherapy Protocols; Bevacizumab; Breast Neoplasms; Cyclophosphamide; Doxorubicin; Female; Humans; Middle Aged; Neoadjuvant Therapy; Neoplasm Grading; Paclitaxel; Polyethylene Glycols; Premenopause; Receptor, ErbB-2; Treatment Outcome
DOI:
10.1007/s40261-018-0655-z
