title: New schedule of bevacizumab/paclitaxel as first-line therapy for metastatic HER2-negative breast cancer in a real-life setting.
abstract: Angiogenesis plays an essential role in the growth and progression of breast cancer. This observational single center study evaluated the efficacy and safety of a new weekly schedule of bevacizumab/paclitaxel combination in the first-line treatment of unselected, HER2-negative, metastatic breast cancer (MBC) patients, in a real-life setting. Thirty-five patients (median age 56 years, range 40-81) with HER2-negative MBC were treated with paclitaxel (70 mg/m(2) ) dd 1,8,15 q21 (60 mg/m(2) if ≥65 years or secondary Cumulative Illness Rating Scale) plus bevacizumab (10 mg/kg) every 2 weeks. Twenty-two patients (63%) had ≥2 metastatic sites and 15 (43%) visceral disease. Eleven patients (31%) had a triple-negative breast cancer (TNBC). A clinical complete response (cCR) was observed in 6 (17%) cases after a median of seven cycles, a partial response (PR) in 22 (63%), and a stable disease (SD) in 6 (17%) cases; the overall clinical benefit rate was 97%. In TNBC subgroup, cCR occurred in 1 (9%) case, PR in 8 (73%), and SD in 2 (18%). At a median follow-up of 13 months (range 1-79 months), the median progression-free survival was 11 months and the median overall survival was 36 months. No grade 4 adverse events occurred. The main grade 3 toxicities observed were neutropenia (11.4%), hypertension (5.7%), stomatitis (2.8%), diarrhea (2.8%), and vomiting (2.8%). The administration of weekly paclitaxel plus bevacizumab in this real-life experience shows similar efficacy than previously reported schedules, with a comparable dose intensity and a good toxicity profile.
authors.affiliation: Medical Oncology, S. Salvatore Hospital, University of L'Aquila, L'Aquila, Italy. kcannita@gmail.com.
authors.forename: Katia
authors.initials: K
authors.lastname: Cannita
authors.affiliation: Medical Oncology, S. Salvatore Hospital, University of L'Aquila, L'Aquila, Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Paradisi
authors.affiliation: Medical Oncology, S. Salvatore Hospital, University of L'Aquila, L'Aquila, Italy.|Departement of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Cocciolone
authors.affiliation: Breast Unit, S. Salvatore Hospital, L'Aquila, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Bafile
authors.affiliation: Medical Oncology, S. Salvatore Hospital, University of L'Aquila, L'Aquila, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Rinaldi
authors.affiliation: Medical Oncology, S. Salvatore Hospital, University of L'Aquila, L'Aquila, Italy.
authors.forename: Azzurra
authors.initials: A
authors.lastname: Irelli
authors.affiliation: Medical Oncology, S. Salvatore Hospital, University of L'Aquila, L'Aquila, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Lanfiuti Baldi
authors.affiliation: Division of Radiology, S. Salvatore Hospital, L'Aquila, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Zugaro
authors.affiliation: Division of Radiology, S. Salvatore Hospital, L'Aquila, Italy.
authors.forename: Rosa
authors.initials: R
authors.lastname: Manetta
authors.affiliation: Departement of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Alesse
authors.affiliation: Departement of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.|Oncology Network ASL1 Abruzzo, UOSD Oncology Territorial Care, S. Salvatore Hospital, University of L'Aquila, L'Aquila, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Ricevuto
authors.affiliation: Medical Oncology, S. Salvatore Hospital, University of L'Aquila, L'Aquila, Italy.|Departement of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Ficorella
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality / Q000473:pathology; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D016896:Treatment Outcome
chemical_list: D000068258:Bevacizumab; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases
keywords: Bevacizumab; metastatic breast cancer; new schedule; paclitaxel; real life